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Viibryd

Viibryd(vilazodone hcl) – Forest

BOXED WARNING

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Monitor and observe closely for clinical worsening, suicidality, or unusual changes in behavior. Not approved for use in pediatric patients.

THERAPEUTIC CLASS

Selective serotonin reuptake inhibitor/5-HT1A-receptor partial agonist

INDICATIONS

Treatment of MDD.

ADULT DOSAGE

Adults: Usual: 40mg qd. Initial: 10mg qd for 7 days. Titrate: Increase to 20mg qd for an additional 7 days, and then an increase to 40mg qd. Reassess periodically to determine the need for maint treatment and the appropriate dose for treatment. D/C of Therapy: Gradual dose reduction is recommended. If intolerable symptoms occur following a dose decrease or upon d/c, consider resuming previously prescribed dose and decreasing the dose at a more gradual rate. Switching To/From an MAOI For Psychiatric Disorders: Allow at least 14 days between d/c of an MAOI and initiation of treatment, and allow at least 14 days between d/c of treatment and initiation of an MAOI. Use with Other MAOIs (eg, linezolid or methylene blue): Refer to PI.

HOW SUPPLIED

Tab: 10mg, 20mg, 40mg

CONTRAINDICATIONS

Use of an MAOI for psychiatric disorders either concomitantly or within 14 day of stopping treatment. Treatment within 14 days of stopping an MAOI for psychiatric disorders. Starting treatment in patients being treated with other MAOIs (eg, linezolid, IV methylene blue).

WARNINGS/PRECAUTIONS

Not approved for treatment of bipolar depression. May precipitate mixed/manic episode in patients at risk for bipolar disorder; screen for risk for bipolar disorder prior to initiating treatment. Serotonin syndrome reported; d/c immediately and initiate supportive symptomatic treatment. Caution with seizure disorders. May increase the risk of bleeding events. Activation of mania/hypomania reported; caution with a history or family history of bipolar disorder, mania, or hypomania. Adverse events reported, particularly with abrupt d/c; reduce dose gradually whenever possible. Hyponatremia may occur in association with the syndrome of inappropriate antidiuretic hormone secretion; elderly, patients taking diuretics or who are volume-depleted may be at greater risk.

ADVERSE REACTIONS

Diarrhea, N/V, dizziness, dry mouth, insomnia, abnormal dreams, decreased libido, fatigue, arthralgia, dyspepsia, flatulence, gastroenteritis, somnolence, paresthesia.

DRUG INTERACTIONS

See Contraindications. Avoid with alcohol. May cause serotonin syndrome with other serotonergic drugs (eg, triptans, TCAs, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort) and with drugs that impair metabolism of serotonin; d/c immediately if this occurs and initiate supportive symptomatic treatment. Caution with other CNS-active drugs. Increased risk of bleeding with aspirin (ASA), NSAIDs, warfarin, and other drugs that affect coagulation. Increased levels with strong CYP3A4 inhibitors (eg, ketoconazole). Reduce dose to 20mg with strong CYP3A4 inhibitors and in patients with intolerable adverse events if coadministered with moderate CYP3A4 inhibitors (eg, erythromycin). Decreased levels with CYP3A4 inducers. May increase the biotransformation of mephenytoin. May inhibit the biotransformation of substrates of CYP2C8. Increased free concentrations with other highly protein bound drugs.

PREGNANCY

Category C, caution in nursing.

MECHANISM OF ACTION

SSRI and 5-HT1A receptor partial agonist; mechanism not established. Thought to enhance serotonergic activity in the CNS through selective inhibition of serotonin reuptake.

PHARMACOKINETICS

Absorption: Absolute bioavailability (72%, with food); Cmax=156ng/mL (fed), AUC=1645ng•h/mL (fed), Tmax=4-5 hrs. Distribution: Plasma protein binding (96-99%). Metabolism: CYP3A4 (primary), CYP2C19, CYP2D6 (minor), and carboxylesterase. Elimination: Urine (1% unchanged), feces (2% unchanged); T1/2=25 hrs.

ASSESSMENT

Assess for history or family history of bipolar disorder, mania/hypomania, history of seizure disorder, volume depletion, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for clinical worsening, suicidality, unusual changes in behavior, serotonin syndrome, abnormal bleeding, activation of mania/hypomania, hyponatremia, and other adverse reactions. If d/c therapy (particularly if abrupt), monitor for d/c symptoms.

PATIENT COUNSELING

Counsel about benefits and risks of therapy. Advise to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down. Instruct not to take with an MAOI or within 14 days of stopping an MAOI, and to allow 14 days after stopping therapy before starting an MAOI. Caution about risk of serotonin syndrome, particularly with concomitant serotonergic drugs and drugs that impair metabolism of serotonin. Caution about risk of bleeding with NSAIDs, ASA, warfarin, or other drugs that affect coagulation. Warn patients about using the medication if they have history of seizure disorder. Advise to observe for signs of activation of mania/hypomania. Counsel not to d/c therapy without notifying physician. Advise to avoid alcohol. Instruct to notify physician if an allergic reaction (eg, rash, hives, swelling, or difficulty breathing) occurs, if pregnant/plan to become pregnant, or if breastfeeding/plan to breastfeed. Inform that therapy may impair physical/mental abilities.

ADMINISTRATION/STORAGE

Administration: Oral route. Take with food. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F).


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    Viibryd

    Viibryd

    Pronunciation Generic Name: vilazodone (vil AZ oh done)

    Brand Name: Viibryd

    OverviewSide EffectsInteractionsMore…

    What is vilazodone?

    Vilazodone is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

    Vilazodone is used to treat major depressive disorder (MDD).

    Vilazodone may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about vilazodone?

    Do not use vilazodone if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

    Before you take vilazodone, tell your doctor if you have liver or kidney disease, a bleeding or blood clotting disorder, seizures, bipolar disorder, low levels of sodium in your blood, or a history of drug abuse or suicidal thoughts.

    Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

    You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for the first few months of treatment, or whenever your dose is changed.

    Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

    Tell your doctor right away if you become pregnant while taking this medication. Vilazodone may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant. Do not start or stop taking vilazodone during pregnancy without your doctor’s advice.

    What should I discuss with my healthcare provider before taking vilazodone?

    Do not use vilazodone if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

    You must wait at least 14 days after stopping an MAO inhibitor before you can take vilazodone. After you stop taking vilazodone, you must wait at least 14 days before you start taking an MAOI.

    Tell your doctor about all other antidepressants you take, especially Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Oleptro, Prozac, Sarafem, Symbyax, Paxil, Pexeva, or Zoloft.

    To make sure you can safely take vilazodone, tell your doctor if you have any of these other conditions:

    • liver or kidney disease;

    • a bleeding or blood clotting disorder;
    • seizures or epilepsy;
    • bipolar disorder (manic depression); or
    • a history of drug abuse or suicidal thoughts.

    Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for the first few months of treatment, or whenever your dose is changed.

    You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

    FDA pregnancy category C. Tell your doctor right away if you become pregnant while taking this medication. Vilazodone may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant. Do not start or stop taking vilazodone during pregnancy without your doctor’s advice.

    It is not known whether vilazodone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    Do not give this medication to anyone under 18 years old without medical advice.

    How should I take vilazodone?

    Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

    Vilazodone works best if you take it with food.

    It may take several weeks or months before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve, or if they get worse.

    Do not stop using vilazodone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using vilazodone.

    Store at room temperature away from moisture and heat.

    What happens if I miss a dose?

    Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vilazodone can be fatal. Overdose symptoms may include some of the serious side effects listed in this medication guide.

    What should I avoid while taking vilazodone?

    Drinking alcohol can increase some of the side effects of vilazodone.

    This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

    Vilazodone side effects

    Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

    Stop taking vilazodone and call your doctor at once if you have a serious side effect such as:

    • seizures (convulsions);

    • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), blood in your urine or stools, purple or red pinpoint spots under your skin;
    • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
    • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, overactive reflexes, feeling like you might pass out;
    • racing thoughts, unusual risk-taking behavior, decreased inhibitions, feelings of extreme happiness or sadness; or
    • extreme thirst with headache, nausea, vomiting, weakness, trouble concentrating, memory problems, confusion, fainting, seizure, shallow breathing or breathing that stops.

    Less serious side effects may include:

    • diarrhea, mild nausea; or

    • sleep problems (insomnia).

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    See also: Viibryd side effects (in more detail)

    What other drugs will affect vilazodone?

    Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by vilazodone. Tell your doctor if you regularly use any of these medicines, or any other antidepressant.

    Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others. Taking an NSAID with vilazodone may cause you to bruise or bleed easily.

    Many drugs can interact with vilazodone. Below is just a partial list. Tell your doctor if you are using:

    • buspirone (BuSpar);

    • cimetidine (Tagamet);
    • conivaptan (Vaprisol);
    • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);
    • imatinib (Gleevec);
    • isoniazid (for treating tuberculosis);
    • St. John’s wort;
    • tramadol (Ultram, Ultracet);
    • tryptophan (also called L-tryptophan);
    • a blood thinner such as warfarin (Coumadin, Jantoven);
    • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketex);
    • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or miconazole (Oravig);
    • a barbiturate such as phenobarbital (Solfoton) and others;
    • a diuretic (water pill);
    • heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);
    • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);
    • medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril);
    • migraine headache medicine such as almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex, Treximet), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
    • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

    This list is not complete and there are many other drugs that can interact with vilazodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

    Next Page → Side Effects

    More Viibryd resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Images
    • Drug Interactions
    • Support Group
    • 234 Reviews - Add your own review/rating
    • Viibryd Prescribing Information (FDA)
    • Viibryd Consumer Overview
    • Viibryd Advanced Consumer (Micromedex) – Includes Dosage Information
    • Viibryd MedFacts Consumer Leaflet (Wolters Kluwer)
    • Vilazodone Hydrochloride Monograph (AHFS DI)

    Compare Viibryd with other medications

    • Depression

    Where can I get more information?

    • Your pharmacist can provide more information about vilazodone.

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    Viibryd

    Viibryd

    Pronunciation Generic Name: vilazodone (vil-AZ-oh-done)

    Brand Name: Viibryd

    Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient’s doctor to be sure that the benefits of using Viibryd outweigh the risks.

    Families and caregivers must closely watch patients who take Viibryd. It is important to keep in close contact with the patient’s doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient’s doctor.

    OverviewSide EffectsInteractionsMore…

    Viibryd is used for:

    Treating depression. It may also be used for other conditions as determined by your doctor.

    Viibryd is an antidepressant. It is thought to work by increasing the activity of one of the brain chemicals (serotonin), which helps elevate mood.

    Do NOT use Viibryd if:

    • you are allergic to any ingredient in Viibryd or to nefazodone
    • you are taking tryptophan
    • you are taking or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or St. John’s wort within the last 14 days

    Contact your doctor or health care provider right away if any of these apply to you.

    Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

    Before using Viibryd:

    Some medical conditions may interact with Viibryd. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have low blood volume, low blood pressure, or low blood sodium levels; you are dehydrated; or you are on a low-salt (sodium) diet
    • if you or a family member has a history of bipolar disorder (manic-depression) or other mental or mood problems (eg, depression), suicidal thoughts or attempts, alcohol or substance abuse, or if you drink alcohol
    • if you have a history of liver problems, kidney problems, bleeding problems, or seizures
    • if you are taking a medicine that contains methylene blue

    Some MEDICINES MAY INTERACT with Viibryd. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Many prescription and nonprescription medicines (eg, used for abortion, aches and pains, allergies, blood thinning, Cushing syndrome, depression or other mental or mood problems, heart problems, hepatitis C, HIV, infections, migraine headaches, nausea or vomiting, seizures, stomach or bowel problems, swelling or fluid retention, weight loss), multivitamin products, and herbal or dietary supplements [eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort] because they may interact with Viibryd. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Viibryd

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Viibryd may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Viibryd:

    Use Viibryd as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Viibryd comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Viibryd refilled.
    • Take Viibryd by mouth with food.
    • When starting Viibryd, your doctor may slowly increase your dose to avoid side effects. Discuss any questions or concerns with your doctor.
    • It may take 1 to 4 weeks for Viibryd to work. Do not stop taking Viibryd without checking with your doctor.
    • Do not suddenly stop taking Viibryd. You may have an increased risk of side effects. If you need to stop Viibryd, your doctor will gradually lower your dose.
    • If you miss a dose of Viibryd, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

    Ask your health care provider any questions you may have about how to use Viibryd.

    Important safety information:

    • Viibryd may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Viibryd with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Do not drink alcohol while you are using Viibryd.
    • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Viibryd; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
    • Be sure to keep all doctor appointments while you are taking Viibryd.
    • Children, teenagers, and young adults who take Viibryd may be at increased risk of suicidal thoughts or actions. Watch all patients who take Viibryd closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
    • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Viibryd. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
    • Serotonin syndrome is a possibly fatal syndrome that can be caused by Viibryd. Your risk may be greater if you take Viibryd with certain other medicines (eg, “triptans,” MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
    • Tell your doctor or dentist that you take Viibryd before you receive any medical or dental care, emergency care, or surgery.
    • Use Viibryd with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
    • Viibryd should not be used in CHILDREN or TEENAGERS; safety and effectiveness in children and teenagers have not been confirmed. Children and teenagers may also be more sensitive to its effects, especially the increased risk of suicidal thoughts or actions.
    • PREGNANCY and BREAST-FEEDING: Viibryd may cause harm to the fetus if taken during the third trimester of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Viibryd while you are pregnant. Viibryd is found in breast milk. If you are or will be breast-feeding while you take Viibryd, check with your doctor. Discuss any possible risks to your baby.

    Do not suddenly stop taking Viibryd. If you do, you may have WITHDRAWAL symptoms. These may include feeling unwell or unhappy, anxious or irritable, dizzy, confused, or sluggish. You may also have nausea, unusual skin sensations, mood swings, headache, trouble sleeping, or sweating. If you need to stop Viibryd, your doctor will lower your dose over time.

    Possible side effects of Viibryd:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Decreased sexual desire or ability; diarrhea; dizziness; dry mouth; nausea; trouble sleeping; vomiting.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes; black, tarry, or bloody stools; bloody or dark urine; blurred vision; decreased coordination; fainting; hallucinations; irregular heartbeat; new or worsening agitation, anxiety, depression, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, trouble sleeping, or inability to sit still; seizures; severe or persistent dizziness; suicidal thoughts or actions; symptoms of low blood sodium levels (eg, confusion, severe or persistent headache, trouble concentrating, memory problems, weakness, unsteadiness, sluggishness); tremor; unusual bruising or bleeding; vomit that looks like coffee grounds.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; confusion; disorientation; excessive sweating; fast or irregular heartbeat; fever; hallucinations; loss of consciousness or coma; nausea, vomiting, or diarrhea; restlessness; tiredness or weakness; tremor.

    Proper storage of Viibryd: Store Viibryd at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Viibryd out of the reach of children and away from pets.

    General information:

    • If you have any questions about Viibryd, please talk with your doctor, pharmacist, or other health care provider.
    • Viibryd is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Viibryd or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Viibryd. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Viibryd. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Viibryd.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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    Viibryd

    Viibryd

    Pronunciation Generic Name: vilazodone (Oral route)

    vil-AZ-oh-done hye-droe-KLOR-ide

    Oral route(Tablet) Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Vilazodone is not approved for use in pediatric patients .

    OverviewSide EffectsInteractionsMore…

    Commonly used brand name(s)

    In the U.S.

    • Viibryd
    • Viibryd Titration Pack

    Available Dosage Forms:

    • Tablet

    Therapeutic Class: Antidepressant

    Uses For Viibryd

    Vilazodone is used to treat major depressive disorder (MDD) in adults. It belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin in the brain.

    This medicine is available only with your doctor’s prescription.

    Before Using Viibryd

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of vilazodone in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vilazodone in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood) which may require caution in patients receiving vilazodone.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Clorgyline
    • Isocarboxazid
    • Lazabemide
    • Linezolid
    • Methylene Blue
    • Moclobemide
    • Pargyline
    • Phenelzine
    • Procarbazine
    • Rasagiline
    • Selegiline
    • Tranylcypromine

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Almotriptan
    • Aspirin
    • Bromfenac
    • Buspirone
    • Celecoxib
    • Citalopram
    • Desvenlafaxine
    • Diclofenac
    • Diflunisal
    • Duloxetine
    • Eletriptan
    • Escitalopram
    • Etodolac
    • Fluoxetine
    • Flurbiprofen
    • Fluvoxamine
    • Frovatriptan
    • Ibuprofen
    • Ibuprofen Lysine
    • Indomethacin
    • Ketoprofen
    • Ketorolac
    • Magnesium Salicylate
    • Mefenamic Acid
    • Meloxicam
    • Milnacipran
    • Nabumetone
    • Naproxen
    • Nefazodone
    • Nepafenac
    • Oxaprozin
    • Paroxetine
    • Piroxicam
    • Rizatriptan
    • Salsalate
    • Sertraline
    • Sibutramine
    • Sulindac
    • Sumatriptan
    • Tolmetin
    • Tramadol
    • Tryptophan
    • Venlafaxine
    • Warfarin
    • Zolmitriptan

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk—Should not be used in patients with this condition.
    • Bleeding problems or
    • Hyponatremia (low sodium in the blood) or
    • Mania, history of or
    • Seizures, history of—Use with caution. May make these conditions worse.

    Proper Use of vilazodone

    This section provides information on the proper use of a number of products that contain vilazodone. It may not be specific to Viibryd. Please read with care.

    Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

    It is best to take this medicine with food.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (tablets):
      • For treatment of depression:
        • Adults—At first, 40 milligrams (mg) once a day. Some patients may start at 10 mg once a day for one week before increasing the dose to 40 mg once a day. Your doctor may increase your dose as needed.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Precautions While Using Viibryd

    It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help prevent any unwanted effects.

    Do not take this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Do not start taking a MAO inhibitor within 14 days of stopping vilazodone. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, sweating, extremely high blood pressure, or severe convulsions.

    Vilazodone may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

    Make sure your doctor knows about all the other medicines you are using. Vilazodone may cause a serious condition called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions if taken with certain medicines such as St. John’s wort, lithium (Eskalith®, Lithobid®), tryptophan, or some pain medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.

    If you develop a skin rash, hives, difficulty with breathing, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

    This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal anti-inflammatory agents also called NSAIDs (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or warfarin (Coumadin®).

    Do not suddenly stop taking this medicine without checking first with your doctor. If you have been instructed to stop taking vilazodone, ask your doctor how to slowly decrease the dose. This will decrease your chance of having withdrawal symptoms such as dizziness, nausea, headaches, vomiting, increased sweating, irritability, nightmares, or prickling or tingling feelings.

    Hyponatremia (low sodium in the blood) may occur with this medicine. Stop using the medicine and check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

    Avoid drinking alcohol while taking this medicine.

    Vilazodone may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

    Viibryd Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Less common

    • Actions that are out of control
    • anxiety
    • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    • chest pain or discomfort
    • extra heartbeat
    • fast, irregular, pounding, or racing heartbeat or pulse
    • irritability
    • nervousness
    • shakiness in the legs, arms, hands, or feet
    • sweating
    • talking, feeling, and acting with excitement
    • trembling or shaking of the hands or feet

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Diarrhea
    • dizziness
    • dry mouth
    • nausea
    • sleeplessness
    • trouble sleeping
    • unable to sleep

    Less common

    • Abdominal or stomach pain
    • abnormal dreams
    • aching or discomfort in the lower legs or sensation of crawling in the legs
    • acid or sour stomach
    • belching
    • blindness
    • bloated
    • blurred vision
    • change in taste
    • decreased interest in sexual intercourse
    • decreased vision
    • difficulty with moving
    • drowsiness
    • dry eyes
    • excess air or gas in the stomach or intestines
    • feeling jittery
    • full feeling
    • headache, severe and throbbing
    • heartburn
    • inability to have or keep an erection
    • increased or decreased appetite
    • increased sweating
    • indigestion
    • loss in sexual ability, desire, drive, or performance
    • loss of appetite
    • loss of taste
    • muscle pain or stiffness
    • night sweats
    • not able to have an orgasm
    • pain in the joints
    • passing gas
    • relaxed and calm
    • restlessness
    • sleepiness or unusual drowsiness
    • stomach discomfort, upset, or pain
    • unusual tiredness or weakness
    • vomiting
    • weakness

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    See also: Viibryd side effects (in more detail)

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    Viibryd

    Viibryd

    Generic Name: vilazodone hydrochloride

    Dosage Form: tablet

    WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Viibryd or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Viibryd is not approved for use in pediatric patients [see Warnings and Precautions (5.1), Use in Specific Populations (8.4), and Patient Counseling Information (17.1)]

    Indications and Usage for Viibryd

    Viibryd® is indicated for the treatment of major depressive disorder (MDD). The efficacy of Viibryd was established in two 8-week, randomized, double-blind, placebo-controlled trials in adult patients with a diagnosis of MDD [see Clinical Studies (14)].

    Major depressive disorder consists of one or more major depressive episodes. A major depressive episode (DSM-IV-TR) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

    Viibryd Dosage and Administration

    Initial Treatment of Major Depressive Disorder

    The recommended dose for Viibryd is 40 mg once daily. Viibryd should be titrated, starting with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then an increase to 40 mg once daily. Viibryd should be taken with food. Viibryd blood concentrations (AUC) in the fasted state can be decreased by approximately 50% compared to the fed state, and may result in diminished effectiveness in some patients [see Clinical Pharmacology (12.3)].

    Maintenance/Continuation/Extended Treatment

    The efficacy of Viibryd has not been systematically studied beyond 8 weeks. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment.

    Dosing in Special Populations

    Pregnant Women: Neonates exposed to serotonergic antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with Viibryd, consider whether the potential benefits outweigh the potential risks of treatment [see Use in Specific Populations (8.1)].

    Nursing Mothers: There are no clinical data regarding the effect of Viibryd on lactation and nursing [see Use in Specific Populations (8.3)]. Breastfeeding in women treated with Viibryd should be considered only if the potential benefit outweighs the potential risk.

    Pediatric Patients: The safety and efficacy of Viibryd have not been studied in pediatric patients [see Use in Specific Populations (8.4)].

    Geriatric Patients: No dose adjustment is recommended on the basis of age [see Use in Specific Populations (8.5)].

    Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. Viibryd has not been studied in severe hepatic impairment [see Use in Specific Populations (8.6)].

    Renal Impairment: No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment [see Use in Specific Populations (8.7)].

    Gender: No dose adjustment is recommended on the basis of gender [see Use in Specific Populations (8.8)].

    Discontinuing Treatment

    Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as Viibryd. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing Viibryd. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate [see Warnings and Precautions (5.6)].

    Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

    At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Viibryd. Conversely, at least 14 days should be allowed after stopping Viibryd before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].

    2.6 Use of Viibryd with Other MAOIs such as Linezolid or Methylene Blue

    Do not start Viibryd in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].

    In some cases, a patient already receiving Viibryd therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Viibryd should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Viibryd may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)] .

    The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Viibryd is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)] .

    Dosage Forms and Strengths

    Viibryd Tablets are available as 10 mg, 20 mg and 40 mg immediate-release, film-coated tablets.

         10 mg pink, oval tablet, debossed with 10 on one side

         20 mg orange, oval tablet, debossed with 20 on one side

         40 mg blue, oval tablet, debossed with 40 on one side

    Contraindications

    Monoamine Oxidase Inhibitors (MAOIs)

    The use of MAOIs intended to treat psychiatric disorders with Viibryd or within 14 days of stopping treatment with Viibryd is contraindicated because of an increased risk of serotonin syndrome. The use of Viibryd within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.5), and Warnings and Precautions (5.2)] .

    Starting Viibryd in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.6), and Warnings and Precautions (5.2)] .

    Warnings and Precautions

    Clinical Worsening and Suicide Risk

    Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled studies of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with MDD and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

    The pooled analyses of placebo-controlled studies in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term studies of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled studies in adults with MDD or other psychiatric disorders included a total of 295 short-term studies (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.

    Table 1
    Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
    Increases Compared to Placebo
    <18 14 additional cases
    18-24 5 additional cases
    Decreases Compared to Placebo
    25-64 1 fewer case
    ≥65 6 fewer cases

    No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about drug effect on suicide.

    It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression.

    All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

    The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

    Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

    If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms [see Warnings and Precautions (5.6) and Dosage and Administration (2.4)].

    Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Viibryd should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose [see also Patient Counseling Information (17.1)].

    Screening patients for bipolar disorder

    A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled studies) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Viibryd is not approved for use in treating bipolar depression.

    Serotonin Syndrome

    The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Viibryd, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

    Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

    The concomitant use of Viibryd with MAOIs intended to treat psychiatric disorders is contraindicated. Viibryd should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Viibryd. Viibryd should be discontinued before initiating treatment with the MAOI [see Contraindications (4.1) and Dosage and Administration (2.5 and 2.6)].

    If concomitant use of Viibryd with other serotonergic drugs including, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases

    Treatment with Viibryd and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

    Seizures

    Viibryd has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. Like other antidepressants, Viibryd should be prescribed with caution in patients with a seizure disorder.

    Abnormal Bleeding

    The use of drugs that interfere with serotonin reuptake inhibition, including Viibryd, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.

    Patients should be cautioned about the risk of bleeding associated with the concomitant use of Viibryd and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding.

    Activation of Mania/Hypomania

    Symptoms of mania/hypomania were reported in 0.1% of patients treated with Viibryd in clinical studies. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorder who were treated with other antidepressants. As with all antidepressants, use Viibryd cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.

    Discontinuation of Treatment with Viibryd

    There have been reports of adverse events occurring upon discontinuation of serotonergic antidepressants, particularly when discontinuation is abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.

    Monitor patients for these symptoms when discontinuing Viibryd. Reduce the dose gradually whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, consider resuming the previously prescribed dose. Subsequently, the dose may be decreased, but at a more gradual rate [see Dosage and Administration, (2.4)].

    Hyponatremia

    Although no cases of hyponatremia resulting from Viibryd treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. In many cases, hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs. Also, patients taking diuretics or who are otherwise volume depleted can be at greater risk. Discontinuation of Viibryd in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.

    Adverse Reactions

    Clinical Studies Experience

    The most commonly observed adverse reactions in Viibryd-treated MDD patients in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were: diarrhea, nausea, vomiting, and insomnia.

    Patient Exposure

    The safety of Viibryd was evaluated in 2,177 patients (18-70 years of age) diagnosed with MDD who participated in clinical studies, representing 552 patient-years of exposure. In an open-label 52 week study at 40 mg daily, 599 patients were exposed to Viibryd for a total of 348 patient-years.

    The information presented in these sections was derived from studies of Viibryd 40 mg daily in major depressive disorder including: 1) 2 placebo-controlled 8-week studies in 861 patients, including 436 receiving vilazodone; and 2) an open-label 52-week study of 599 patients. These studies included a titration period of 10 mg daily for 7 days followed by 20 mg daily for 7 days. In these clinical trials, Viibryd was administered with food.

    Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

    Adverse reactions reported as reasons for discontinuation of treatment

    In the placebo-controlled studies of MDD there was no single adverse reaction leading to discontinuation in > 1% of the patients. Overall, 7.1% of the patients who received Viibryd discontinued treatment due to an adverse reaction, compared with 3.2% of placebo-treated patients in these studies.

    Common adverse reactions in placebo-controlled MDD studies

    Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of Viibryd-treated MDD patients (and greater than in placebo-treated patients) in the placebo-controlled studies.

    Table 2: Common Adverse Reactions Occurring in ≥2% of Viibryd-treated Patients and > Placebo-treated Patients
    *Includes restlessness, akathisia, and restless legs syndrome
    **Includes orgasm abnormal and anorgasmia
    ***Male patients only (Placebo n=182; Viibryd n=170)
    System Organ Class

         Preferred Term

    Viibryd

    40 mg/day

    N = 436

    Placebo

    N = 433

    Gastrointestinal disorders
         Diarrhea 28 9
         Nausea 23 5
         Dry mouth 8 5
         Vomiting 5 1
         Dyspepsia 3 2
         Flatulence 3 2
         Gastroenteritis 3 <1
    Nervous system disorders
         Dizziness 9 5
         Somnolence 3 2
         Paresthesia 3 1
         Tremor 2 0
    Psychiatric disorders
         Insomnia 6 2
         Abnormal dreams 4 1
         Libido decreased 4 <1
         Restlessness * 3 <1
         Orgasm abnormal ** 3 0
    General disorders
         Fatigue 4 3
         Feeling jittery 2 <1
    Cardiac disorders
         Palpitations 2 <1
    Musculoskeletal and connective tissue disorders
         Arthralgia 3 2
    Reproductive system and breast disorders
         Delayed ejaculation*** 2 0
         Erectile dysfunction*** 2 1
    Metabolism and nutrition disorders
         Increased appetite 2 1
    Table 3: Sexual Adverse Reactions: Percentage in the Placebo-Controlled Studies
    − Not applicable
    *Includes anorgasmia
    Males Females
    Preferred Term Viibryd

    N= 170

    Placebo

    N= 182

    Viibryd

    N=266

    Placebo

    N=251

    Decreased libido 5 0 3 <1
    Abnormal orgasm* 4 0 2 0
    Delayed ejaculation 2 0 - -
    Erectile dysfunction 2 1 - -
    Sexual dysfunction 2 0 <1 <1

    Laboratory Tests

    Viibryd has not been associated with any clinically important changes in laboratory test parameters in serum chemistry (including liver function tests), hematology and urinalysis, as measured in placebo-controlled studies. These studies include analysis of (1) mean change from baseline and (2) the proportion of patients meeting criteria for potentially clinically significant changes from baseline. Results from a 52-week open-label study were consistent with the findings from the placebo-controlled studies.

    ECG

    Viibryd has not been associated with any clinically significant effect on ECG parameters, including QT, QTc, PR and QRS intervals, or with any arrhythmogenic potential. ECGs were evaluated in a thorough QTc study at doses up to 80 mg daily with food and in the placebo-controlled studies [see Clinical Pharmacology (12.2)].

    Vital Signs

    Viibryd has not been associated with any clinically significant effect on vital signs, including systolic and diastolic blood pressure and heart rate, as measured in placebo-controlled studies. These studies included analyses of (1) change from baseline, and (2) the proportion of patients meeting criteria for potentially clinically significant changes from baseline. Results from a 52-week open-label study were consistent with the findings from the placebo-controlled studies.

    Weight

    Viibryd had no effect on body weight as measured by the mean change from baseline in the 8-week, placebo-controlled studies. The mean changes in weight were +0.16 kg in the Viibryd group and +0.18 kg in the placebo group. The proportions of patients with a weight gain ≥ 7% were 0.9% in the Viibryd group and 1.2% in the placebo group. The proportions of patients with a weight decrease ≥ 7% were 1.4% in the Viibryd group and 1.4% in the placebo group.

    Other adverse reactions observed in clinical studies

    The following listing does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.

    Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients:

    Cardiac disorders: infrequent: ventricular extrasystoles

    Eye disorders: frequent: vision blurred, dry eye; infrequent: cataracts

    General disorders: infrequent: feeling abnormal

    Metabolism and nutrition disorders: frequent: decreased appetite

    Nervous System: frequent: sedation, migraine; infrequent: dysgeusia

    Psychiatric disorders: infrequent: panic attack, mania

    Renal and Urinary disorder: infrequent: pollakiuria

    Skin and subcutaneous tissue disorders: frequent: hyperhidrosis, night sweats

    Drug Interactions

    Central Nervous System (CNS)-Active Agents

    The risk of using Viibryd in combination with other CNS-active drugs has not been systematically evaluated. Consequently, use caution when Viibryd is prescribed in combination with other CNS-active drugs.

    Monoamine Oxidase Inhibitors (MAOIs)

    [see Dosage and Administration (2.5, 2.6), Contraindications (4.1), and Warnings and Precautions (5.2)] .

    Serotonergic Drugs

    [see Dosage and Administration (2.5, 2.6), Contraindications (4.1), and Warnings and Precautions (5.2)] .

    Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)

    Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of case-control and cohort design have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when Viibryd is initiated or discontinued [see Warnings and Precautions (5.4)].

    Potential for Other Drugs to Affect Vilazodone

    Figure 1. Impact of other drugs on Vilazodone PK

    Inhibitors of CYP3A4

    Metabolism by CYP3A4 is a major elimination pathway for vilazodone. Concomitant use of Viibryd and strong inhibitors of CYP3A4 (e.g., ketoconazole) can increase vilazodone plasma concentrations by approximately 50% (see Figure 1). The Viibryd dose should be reduced to 20 mg if co-administered with a strong inhibitor of CYP3A4. During co-administration with moderate inhibitors of CYP3A4 (e.g., erythromycin), the Viibryd dose should be reduced to 20 mg for patients with intolerable adverse events. No dose adjustment is recommended when Viibryd is co-administered with mild inhibitors of CYP3A4 (e.g., cimetidine).

    Inducers of CYP3A4

    Concomitant use of Viibryd with inducers of CYP3A4 has the potential to reduce vilazodone systemic exposure. However, the effect of CYP3A4 inducers on vilazodone plasma concentrations has not been evaluated.

    Inhibitors of other CYP enzymes

    Concomitant administration of Viibryd with inhibitors of CYP2C19 and CYP2D6 is not expected to alter plasma concentrations of vilazodone. These isoforms are minor elimination pathways in the metabolism of vilazodone. In vitro studies have shown that CYP1A2, CYP2A6, CYP2C9 and CYP2E1 have minimal contribution to the metabolism of vilazodone.

    Potential for Vilazodone to Affect Other Drugs

    Drugs metabolized by CYP1A2, CYP2C9, CYP2D6, CYP3A4 or CYP2C19.

    Coadministration of Viibryd with substrates for CYP1A2, CYP2C9, CYP3A4, or CYP2D6 is unlikely to result in clinically significant changes in the concentrations of the CYP substrates. A study in healthy subjects found that Viibryd (20 mg/day for 8-10 days) had no effect on the pharmacokinetics of caffeine, flurbiprofen, nifedipine or debrisoquine, probes for CYP1A2, CYP2C9, CYP3A4, and CYP2D6, respectively. Viibryd coadministration with mephenytoin to healthy subjects resulted in a small (11%) increase in mephenytoin biotransformation, suggestive of a minor induction of CYP2C19. In vitro studies have shown that Viibryd is a moderate inhibitor of CYP2C19 and CYP2D6.

    Drugs metabolized by CYP2C8

    Coadministration of Viibryd with a CYP2C8 substrate may lead to an increase in concentration of the other drug. In vitro studies suggest that Viibryd may inhibit the biotransformation of substrates of CYP2C8. The effect of Viibryd on CYP2C8 activity has not been tested in vivo.

    Induction of CYP isoforms

    Viibryd did not induce CYP1A1, 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, 3A4 or 3A5 in an in vitro study in cultured human hepatocytes. Chronic administration of vilazodone is unlikely to induce the metabolism of drugs metabolized by these major CYP isoforms.

    Drugs Highly Bound to Plasma Protein

    The interaction between vilazodone and other highly protein-bound drugs has not been evaluated. Because vilazodone is highly bound to plasma protein, administration of Viibryd to a patient taking another drug that is highly protein bound may cause increased free concentrations of the other drug.

    Triptans

    There are postmarketing reports of serotonin syndrome with concomitant use of a serotonergic antidepressant and a triptan. If concomitant treatment with Viibryd and a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases [see Warnings and Precautions (5.2)] .

    Alcohol

    As with other psychotropic medications, the use of alcohol by patients taking Viibryd is not recommended, because of the potential for pharmacodynamic interactions.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Teratogenic Effects Pregnancy Category C

    Vilazodone caused some developmental toxicity in rats, but was not teratogenic in rats or rabbits. There are no adequate and well-controlled studies of Viibryd in pregnant women. When treating pregnant women with Viibryd, carefully consider whether the potential benefits outweigh the potential risks of treatment.

    No teratogenic effects were observed when vilazodone was given to pregnant rats or rabbits during the period of organogenesis at oral doses up to 200 and 36 mg/kg/day, respectively. These doses are 48 and 17 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 40 mg on a mg/m2 basis. Fetal body weight gain was reduced, and skeletal ossification was delayed in both rats and rabbits at these doses; these effects were not observed at doses up to 10 times the MRHD in rats or 4 times the MRHD in rabbits.

    When vilazodone was administered to pregnant rats at an oral dose of 30 times the MRHD during the period of organogenesis and throughout pregnancy and lactation, the number of live born pups was decreased. There was an increase in early postnatal pup mortality, and among surviving pups there was decreased body weight, delayed maturation, and decreased fertility in adulthood. There was some maternal toxicity at this dose. These effects were not seen at 6 times the MRHD.

    Nonteratogenic Effects Neonates exposed to Viibryd and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.2)].

    Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (including Viibryd) in pregnancy and PPHN. Other studies do not show a significant statistical association.

    Physicians should also note the results of a prospective longitudinal study of 201 pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission. Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy.

    When treating a pregnant woman with Viibryd, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. This decision can only be made on a case by case basis [see Dosage and Administration (2.3)] .

    Labor and Delivery

    The effect of Viibryd on labor and delivery in humans is unknown. Viibryd should be used during labor and delivery only if the potential benefit outweighs the potential risk.

    Nursing Mothers

    Vilazodone is excreted into the milk of lactating rats. The effect of Viibryd on lactation and nursing in humans is unknown. Breast feeding in women treated with Viibryd should be considered only if the potential benefit outweighs the potential risk to the child.

    Pediatric Use

    Clinical studies on the use of Viibryd in pediatric patients have not been conducted; therefore, the safety and effectiveness of Viibryd in the pediatric population have not been established. Viibryd is not approved for use in pediatric patients [see Box Warning and Warnings and Precautions (5.1)].

    Geriatric Use

    No dose adjustment is recommended on the basis of age (see Figure 2). Results from a single-dose (20 mg) pharmacokinetic study in elderly (> 65 years-old) vs. young (24-55 years-old) subjects demonstrated that the pharmacokinetics were generally similar between the two age groups.

    Of the 2177 patients in clinical studies with Viibryd, 37 (1.7%) were 65 years of age or older, and 272 (12.5%) were 55 to 64 years of age.

    Greater sensitivity of some older individuals cannot be ruled out [see Dosage and Administration (2.3)].

    Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Warnings and Precautions (5.7)].

    Hepatic Impairment

    Vilazodone is eliminated primarily by hepatic metabolism. In mild and moderate hepatic impairment, no dose adjustment is necessary (see Figure 2). Viibryd has not been studied in patients with severe hepatic impairment [see Dosage and Administration (2.3)].

    Renal Impairment

    In mild, moderate, and severe renal impairment, no dose adjustment is necessary (see Figure 2 below) [see Dosage and Administration (2.3)].

    Gender Effect

    After adjustment for body weight, the systemic exposures between males and females are similar (see Figure 2) [see Dosage and Administration (2.3)].

    Figure 2. Impact of Intrinsic Factors on Vilazodone PK

    Drug Abuse and Dependence

    Controlled Substance

    Viibryd is not a controlled substance.

    Abuse and Dependence

    Viibryd has been systematically studied in animals and did not demonstrate abuse or dependence potential. While Viibryd has not been systematically studied in humans for its potential for abuse, there was no suggested evidence of drug-seeking behavior in the clinical studies. However, it is not possible to predict on the basis of clinical experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of Viibryd (e.g., development of tolerance, drug-seeking behavior, increases in dose).

    Overdosage

    Human Experience

    There is limited clinical experience regarding human overdosage with Viibryd. Four patients and 1 patient’s child experienced an overdose of Viibryd; all recovered. The adverse reactions associated with overdose of Viibryd at doses of 200-280 mg as observed in clinical trials included serotonin syndrome, lethargy, restlessness, hallucinations, and disorientation.

    Management of Overdose

    Consult a Certified Poison Control Center for up-to-date guidance and advice. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference® (PDR). No specific antidotes for vilazodone are known. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be considered. Removal of vilazodone by dialysis has not been studied; however, the high volume of distribution of vilazodone suggests that dialysis will not be effective in reducing vilazodone plasma concentrations.

    Viibryd Description

    Viibryd Tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist.

    Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is:

    In addition to the active ingredient, Viibryd Tablets contain lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C Blue #1 (40 mg only), FD&C Yellow #6 (20 mg only) and FD&C Red #40 (10 mg only).

    Viibryd – Clinical Pharmacology

    Mechanism of action

    The mechanism of the antidepressant effect of vilazodone is not fully understood but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

    Pharmacodynamics

    Vilazodone binds with high affinity to the serotonin reuptake site (Ki= 0.1 nM), but not to the norepinephrine (Ki=56 nM) or dopamine (Ki=37 nM) reuptake sites. Vilazodone potently and selectively inhibits reuptake of serotonin (IC50= 1.6 nM). Vilazodone also binds selectively with high affinity to 5-HT1A receptors (IC50=2.1 nM) and is a 5-HT1A receptor partial agonist.

    Thorough QT Study: Treatment with Viibryd did not prolong the QTc interval. The effect of vilazodone (20, 40, 60, and 80 mg) on the QTc interval was evaluated in a randomized, placebo-, and active-controlled (moxifloxacin 400 mg), parallel-group, thorough QTc study in 157 healthy subjects. The study demonstrated an ability to detect small effects. The upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc interval was below 10 msec, based on the individual correction method (QTcI). This is below the threshold for clinical concern. However, it is unknown whether 80 mg is adequate to represent a high clinical exposure condition.

    Pharmacokinetics

    Vilazodone activity is due primarily to the parent drug. The pharmacokinetics of vilazodone (5 mg – 80 mg) are dose-proportional. Accumulation of vilazodone is predictable from single dose data, does not vary with dose, and steady-state is achieved in about 3 days. Elimination of vilazodone is primarily by hepatic metabolism with a terminal half-life of approximately 25 hours. At steady-state, after daily dosing of Viibryd 40 mg under fed conditions, the mean Cmax value is 156 ng/mL, and the mean AUC (0-24 hours) value is 1645 ng•h/mL.

    Absorption

    Vilazodone concentrations peak at a median of 4-5 hours (Tmax) after administration and decline with a terminal half-life of approximately 25 hours. The absolute bioavailability of vilazodone is 72% with food. Administration of Viibryd with food (high fat or light meal) increases oral bioavailability (Cmax increased by approximately 147-160%, and AUC increased by approximately 64-85%).

    Coadministration of Viibryd with ethanol or with a proton pump inhibitor (pantoprazole) did not affect the rate or extent of vilazodone absorption [see Drug Interactions (7.5, Figure 1)]. In addition, neither the Tmax nor terminal elimination rate of vilazodone was altered by coadministration with either pantoprazole or ethanol.

    Absorption is decreased by approximately 25% if vomiting occurs within 7 hours of ingestion; no replacement dose is needed.

    Distribution

    Vilazodone is widely distributed and approximately 96-99% protein-bound

    Metabolism and Elimination

    Viibryd is extensively metabolized through CYP and non-CYP pathways (possibly by carboxylesterase), with only 1% of the dose recovered in the urine and 2% of the dose recovered in the feces as unchanged vilazodone. CYP3A4 is primarily responsible for its metabolism among CYP pathways, with minor contributions from CYP2C19 and CYP2D6. In vitro studies with human microsomes and human hepatocytes indicate that vilazodone is unlikely to inhibit or induce the metabolism of other CYP (except for CYP2C8) substrates; and an in vivo study with probe substrates for CYP2C19, 2D6 and 3A4 showed vilazodone did not alter the pharmacokinetics of the probe substrates. However, an in vivo study with probe substrate for CYP2C19 demonstrated a minor induction of CYP2C19. Strong inhibitors of CYP3A4 (e.g., ketoconazole) can reduce the metabolism of vilazodone in vivo and increase exposure. Conversely, inducers of CYP3A4 can decrease vilazodone exposure [see Drug Interactions (7.5)].

    The presence of mild or moderate renal impairment, or mild or moderate hepatic impairment did not affect the apparent clearance of vilazodone.

    Nonclinical Toxicology

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Carcinogenesis

    Carcinogenicity studies were conducted in which B6C3F1mice and Wistar rats were given oral doses of vilazodone up to 135 and 150 mg/kg/day, respectively, for 2 years. These doses are approximately 16.5 and 36 times the maximum recommended human dose (MRHD) of 40 mg, respectively, on a mg/m2 basis.

    In mice, the incidence of hepatocellular carcinomas was increased in males at 16.5 times the MRHD; this finding was not observed at 5.5 times the MRHD. The incidence of malignant mammary gland tumors was numerically increased in females at 5.5 and 16.5 times the MRHD, with statistical significance at 16.5 the MHRD; this finding was not observed at 1.8 times the MRHD. Elevated prolactin levels were observed in a 2-week study of vilazodone administered at 5.5 and 33 times the MRHD. Increases in prolactin levels are known to cause mammary tumors in rodents.

    In the rat study, vilazodone was not carcinogenic in either sex at doses up to 36 times the MRHD.

    Mutagenesis

    Vilazodone was not mutagenic in the in vitro bacterial reverse mutation assay (Ames test). Vilazodone was negative in the in vitro V79/HGRPT mammalian cell forward mutation assay. Vilazodone was clastogenic in two in vitro mammalian cell chromosome aberration assays. However, vilazodone was negative for clastogenic activity in both an in vivo rat bone marrow chromosome aberration assay and a micronucleus test. Vilazodone was also negative in an in vivo/in vitro unscheduled DNA synthesis assay in rats.

    Impairment of Fertility

    Treatment of rats with vilazodone at a dose of 125 mg/kg, which is 30 times the maximum recommended human dose (MRHD) of 40 mg on a mg/m2 basis, caused impairment of male fertility with no effect on female fertility. Impaired male fertility was not observed at 6 times the MRHD.

    Clinical Studies

    The efficacy of Viibryd as a treatment for major depressive disorder was established in two 8-week, multicenter, randomized, double-blind, placebo-controlled studies in adult (18-70 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. In these studies, patients were titrated over 2 weeks to a dose of 40 mg of Viibryd with food (n=436) or placebo (n = 433) once daily. Viibryd was superior to placebo in the improvement of depressive symptoms as measured by the mean change from baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Examination of population subgroups based on age (there were few patients over 65), gender, and race did not reveal any clear evidence of differential responsiveness.

    Table 4. Summary of Results for the Primary Efficacy Endpoint
    a Least Squares Mean (95% Confidence Interval)
    Study Number Primary Endpoint LS Mean (95% CI) a difference from placebo in change from baseline
    1 MADRS -3.2 (-5.2, -1.3)
    2 MADRS -2.5 (-4.4, -0.6)

    How Supplied/Storage and Handling

    How Supplied

    Viibryd (vilazodone HCl) Tablets are supplied in the following configurations:

    10 mg, pink, oval tablet, debossed with 10 on one side

         0456-1110-30: 30-count bottles

    20 mg, orange, oval tablet, debossed with 20 on one side

         0456-1120-30: 30-count bottles

    40 mg, blue, oval tablet, debossed with 40 on one side

         0456-1140-30: 30-count bottles

    Patient Starter Kit

         0456-1100-31: blister card containing 30 tablets:

              10 mg, pink, oval, debossed with 10 on one side: 7 tablets

              20 mg, orange, oval, debossed with 20 on one side: 7 tablets

              40 mg, blue, oval, debossed with 40 on one side: 16 tablets

    Storage

    Viibryd (vilazodone HCl) Tablets should be stored at 25°C (77°F) with excursions permitted to 15°C – 30°C (59°F – 86°F) [see USP Controlled Room Temperature].

    Patient Counseling Information

    See Medication Guide (17.2).

    Information for Patients

    Advise patients and their caregivers about the benefits and risks associated with treatment with Viibryd and counsel them in its appropriate use. Advise patients and their caregivers to read the Medication Guide and assist them in understanding its contents. The complete text of the Medication Guide is reprinted at the end of this document.

    Suicide Risk

    Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down [see Box Warning and Warnings and Precautions (5.1)].

    Dosing and Administration

    Instruct patients to take Viibryd with food. When initiating treatment with Viibryd the dose should be titrated, starting with a dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then increased to 40 mg once daily.

    Concomitant Medication

    Instruct patients not to take Viibryd with an MAOI or within 14 days of stopping an MAOI and to allow 14 days after stopping Viibryd before starting an MAOI [see Contraindications (4.1)].

    Serotonin Syndrome

    Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Viibryd with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). [see Warnings and Precautions (5.2) and Drug Interactions (7.2, 7.3)].

    Seizures

    Caution patients about using Viibryd if they have a history of a seizure disorder [see Warnings and Precautions (5.3)]. Patients with a history of seizures were excluded from clinical studies.

    Abnormal Bleeding

    Caution patients about the concomitant use of Viibryd and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of abnormal bleeding [see Warnings and Precautions (5.4)].

    Activation of Mania/Hypomania

    Advise patients and their caregivers to observe for signs of activation of mania/hypomania [see Warnings and Precautions (5.5)].

    Discontinuation of Treatment

    Advise patients not to stop taking Viibryd without talking first with their healthcare provider. Patients should be aware that discontinuation effects may occur when suddenly stopping Viibryd [see Warnings and Precautions (5.6)].

    Hyponatremia

    Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly, they may be at greater risk of developing hyponatremia while taking Viibryd [see Warnings and Precautions (5.7)].

    Alcohol

    Advise patients to avoid alcohol while taking Viibryd [see Drug Interactions (7.5, 7.9)].

    Allergic Reactions

    Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing.

    Pregnancy

    Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with Viibryd [see Use in Specific Populations (8.1)].

    Nursing Mothers

    Advise patients to notify their healthcare provider if they are breastfeeding an infant and would like to continue or start Viibryd [see Use in Specific Populations (8.3)].

    Interference with Cognitive and Motor Performance

    Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that Viibryd therapy does not adversely affect their ability to engage in such activities.

    Distributed by

    Forest Pharmaceuticals, Inc.

    Subsidiary of Forest Laboratories, Inc.

    St. Louis, MO 63045, USA

    Licensed from Merck KGaA,

    Darmstadt, Germany

    Viibryd® is a registered trademark of Forest Laboratories, Inc.

    © 2011, 2012 Forest Laboratories, Inc.

    Medication Guide

    MEDICATION GUIDE

    Viibryd® [vī-brid]

    (vilazodone hydrochloride)

    Tablets

    Read this Medication Guide carefully before you start taking Viibryd and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

    What is the most important information I should know about Viibryd?

    Viibryd and other antidepressant medicines may cause serious side effects.

    Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency:

    1. Suicidal thoughts or actions:
      • Viibryd and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
      • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
      • Watch for these changes and call your healthcare provider right away if you notice:
        • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
        • Pay particular attention to such changes when Viibryd is started or when the dose is changed.

        Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

        Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

        • attempts to commit suicide
        • acting on dangerous impulses
        • acting aggressive or violent
        • thoughts about suicide or dying
        • new or worse depression
        • new or worse anxiety or panic attacks
        • feeling agitated, restless, angry or irritable
        • trouble sleeping
        • an increase in activity or talking more than what is normal for you (mania)
        • other unusual changes in behavior or mood
    2. Serotonin Syndrome:
      • agitation, hallucinations, coma or other changes in mental status
      • coordination problems or muscle twitching (overactive reflexes)
      • fast heartbeat, high or low blood pressure
      • sweating or fever
      • nausea, vomiting, or diarrhea
      • muscle stiffness or tightness
    3. Abnormal bleeding: Viibryd and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin.
    4. Seizures or convulsions.
    5. Manic episodes:
      • greatly increased energy
      • severe trouble sleeping
      • racing thoughts
      • reckless behavior
      • unusually grand ideas
      • excessive happiness or irritability
      • talking more or faster than usual
    6. Low salt (sodium) levels in the blood.

      Elderly people may be at greater risk for this. Symptoms may include:

      • headache
      • weakness or feeling unsteady
      • confusion, problems concentrating or thinking or memory problems

    Do not stop Viibryd without first talking to your healthcare provider. Stopping Viibryd suddenly may cause serious symptoms including:

    • anxiety, irritability, high or low mood, feeling restless or sleepy
    • headache, sweating, nausea, dizziness
    • electric shock-like sensations, tremor, confusion

    What is Viibryd?

    Viibryd is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). It is important to talk with your healthcare provider about the risks of treating depression and also the risk of not treating it. You should discuss all treatment choices with your healthcare provider.

    Talk to your healthcare provider if you do not think that your condition is getting better with Viibryd treatment.

    It is not known if Viibryd is safe and effective in children.

    Who should not take Viibryd?

    Do not take Viibryd if you:

    • Take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
      • Do not take an MAOI within 2 weeks of stopping Viibryd unless directed to do so by your physician.
      • Do not start Viibryd if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

      People who take Viibryd close in time to taking an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

      • high fever
      • uncontrolled muscle spasms
      • stiff muscles
      • rapid changes in heart rate or blood pressure
      • confusion
      • loss of consciousness (pass out)

    What should I tell my healthcare provider before taking Viibryd?

    Before starting Viibryd, tell your healthcare provider if you:

    • have liver problems
    • have kidney problems
    • have or had seizures or convulsions
    • have bipolar disorder (manic depression) or mania
    • have low sodium levels in your blood
    • have or had bleeding problems
    • drink alcohol
    • have any other medical conditions
    • Are pregnant or plan to become pregnant. It is not known if Viibryd will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
    • Are breastfeeding or plan to breastfeed. It is not known if Viibryd passes into breast milk. You and your healthcare provider should decide if you should take Viibryd while breastfeeding.

    Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Viibryd and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.

    Especially tell your healthcare provider if you take:

    • triptans used to treat migraine headache
    • medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics
    • tramadol
    • over-the-counter supplements such as tryptophan or St. John’s Wort
    • nonsteroidal anti-inflammatory drugs (NSAIDS)
    • aspirin
    • warfarin (Coumadin, Jantoven)
    • mephenytoin (Mesantoin)
    • diuretics

    Your healthcare provider or pharmacist can tell you if it is safe to take Viibryd with your other medicines. Do not start or stop any medicine while taking Viibryd without talking to your healthcare provider first.

    How should I take Viibryd?

    • Take Viibryd exactly as prescribed. Your healthcare provider may need to change the dose of Viibryd until it is the right dose for you.
    • Take Viibryd with food. Viibryd may not work as well if you take it on an empty stomach.
    • If you miss a dose of Viibryd, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Viibryd at the same time.
    • If you take too much Viibryd, call your healthcare provider or poison control center right away, or get emergency treatment.

    What should I avoid while taking Viibryd?

    • Viibryd can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Viibryd affects you.
    • You should avoid drinking alcohol while taking Viibryd. See “What should I tell my healthcare provider before taking Viibryd?”

    What are the possible side effects of Viibryd?

    Viibryd may cause serious side effects, including:

    • See “What is the most important information I should know about Viibryd?”

    Common side effects in people who take Viibryd include:

    • diarrhea
    • nausea or vomiting
    • trouble sleeping

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Viibryd. For more information, ask your healthcare provider or pharmacist.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    How should I store Viibryd?

    Store Viibryd at room temperature (59°F to 86°F or 15°C to 30°C).

    Keep Viibryd and all medicines out of the reach of children.

    General information about Viibryd.

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Viibryd for a condition for which it was not prescribed. Do not give Viibryd to other people, even if they have the same condition. It may harm them.

    This Medication Guide summarizes the most important information about Viibryd. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Viibryd that is written for healthcare professionals.

    For more information about Viibryd call 1-800-678-1605.

    What are the ingredients in Viibryd?

    Active ingredient: vilazodone hydrochloride

    Inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and FD&C Blue #1 (40 mg only), FD&C Yellow #6 (20 mg only) and FD&C Red #40 (10 mg only).

    This Medication Guide has been approved by the U.S. Food and Drug Administration.

    Forest Pharmaceuticals, Inc.

    Subsidiary of Forest Laboratories, Inc.

    St. Louis, MO 63045, USA

    Licensed from Merck KGaA, Darmstadt, Germany

    Viibryd® is a registered trademark of Forest Laboratories, Inc.

    © 2012 Forest Laboratories, Inc.

    Revised: December 2012

    Package Label – Principal Display Panel – 10 mg Tablets 30 ct Bottle

    Rx only NDC 0456-1110-30

    30 Tablets

    ViibrydTM

    vilazodone HCl

    tablets

    10 mg

    Dispense the accompanying

    Medication Guide to each patient

    Package Label – Principal Display Panel – 20 mg Tablets 30 ct Bottle

    Rx only NDC 0456-1120-30

    30 Tablets

    ViibrydTM

    vilazodone HCl

    tablets

    20 mg

    Dispense the accompanying

    Medication Guide to each patient

    Package Label – Principal Display Panel – 40 mg Tablets 30 ct Bottle

    Rx only NDC 0456-1140-30

    30 Tablets

    ViibrydTM

    vilazodone HCl

    tablets

    40 mg

    Dispense the accompanying

    Medication Guide to each patient

    Package Label – Principal Display Panel – Starter Kit

    Rx only NDC 0456-1100-31

    ViibrydTM

    vilazodone HCl tablets

    10 mg Days 1-7

    20 mg Days 8-14

    40 mg Days 15-30

    This package contains 30 days of treatment,

    which includes 7 tablets of 10 mg, 7 tablets of 20 mg,

    and 16 tablets of 40 vilazodone HCl

    Viibryd 

    vilazodone hydrochloride tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0456-1110
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    CELLULOSE, MICROCRYSTALLINE  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    POLYVINYL ALCOHOL  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOLS  
    TALC  
    FD&C RED NO. 40  
    Product Characteristics
    Color pink (pink) Score no score
    Shape OVAL (OVAL) Size 9mm
    Flavor Imprint Code 10
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0456-1110-30 30 TABLET in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022567 04/29/2011
    Viibryd 

    vilazodone hydrochloride tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0456-1120
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    CELLULOSE, MICROCRYSTALLINE  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    POLYVINYL ALCOHOL  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOLS  
    TALC  
    FD&C YELLOW NO. 6  
    Product Characteristics
    Color yellow (yellow) Score no score
    Shape OVAL (OVAL) Size 11mm
    Flavor Imprint Code 20
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0456-1120-30 30 TABLET in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022567 04/29/2011
    Viibryd 

    vilazodone hydrochloride tablet

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0456-1140
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 40 mg
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE MONOHYDRATE  
    CELLULOSE, MICROCRYSTALLINE  
    MAGNESIUM STEARATE  
    SILICON DIOXIDE  
    POLYVINYL ALCOHOL  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOLS  
    TALC  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color blue (blue) Score no score
    Shape OVAL (OVAL) Size 14mm
    Flavor Imprint Code 40
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0456-1140-30 30 TABLET in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022567 04/29/2011
    Viibryd 

    vilazodone hydrochloride kit

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0456-1100
    Packaging
    # Item Code Package Description
    1 NDC:0456-1100-31 1 KIT in 1 BLISTER PACK
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1
    Part 2
    Part 3 16 
    Part 1 of 3
    Viibryd 

    vilazodone hydrochloride tablet, film coated

    Product Information
         
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 10 mg
    Product Characteristics
    Color pink Score no score
    Shape OVAL Size 9mm
    Flavor Imprint Code 10
    Contains         
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022567 04/29/2011
    Part 2 of 3
    Viibryd 

    vilazodone hydrochloride tablet, film coated

    Product Information
         
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 20 mg
    Product Characteristics
    Color yellow Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code 20
    Contains         
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022567 04/29/2011
    Part 3 of 3
    Viibryd 

    vilazodone hydrochloride tablet, film coated

    Product Information
         
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VILAZODONE HYDROCHLORIDE (VILAZODONE) VILAZODONE HYDROCHLORIDE 40 mg
    Product Characteristics
    Color blue Score no score
    Shape OVAL Size 14mm
    Flavor Imprint Code 40
    Contains         
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022567 04/29/2011
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022567 04/29/2011
    Labeler - Forest Laboratories, Inc. (001288281)
    Establishment
    Name Address ID/FEI Operations
    Anderson Packaging, Inc. 053217022 PACK(0456-1110, 0456-1120, 0456-1140, 0456-1100)
    Establishment
    Name Address ID/FEI Operations
    Eurofins Lancaster Laboratories, Inc 069777290 ANALYSIS(0456-1110, 0456-1120, 0456-1140, 0456-1100)
    Establishment
    Name Address ID/FEI Operations
    Forest Research Institute, Inc 932711815 ANALYSIS(0456-1110, 0456-1120, 0456-1140, 0456-1100)
    Establishment
    Name Address ID/FEI Operations
    Sharp Corporation 143696495 PACK(0456-1110, 0456-1120, 0456-1140, 0456-1100), LABEL(0456-1110, 0456-1120, 0456-1140, 0456-1100)

    Revised: 12/2012   Forest Laboratories, Inc.

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