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Subutex

Subutex

Pronunciation Generic Name: buprenorphine (Sublingual route)

bue-pre-NOR-feen

OverviewSide EffectsInteractionsMore…

Commonly used brand name(s)

In the U.S.

  • Subutex

Available Dosage Forms:

  • Tablet

Therapeutic Class: Opioid Dependency

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

Uses For Subutex

Buprenorphine is used to treat opioid (narcotic) dependence or addiction. When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the narcotic is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine. It acts on the central nervous system (CNS) to help prevent the withdrawal side effects.

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

Before Using Subutex

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 buprenorphine 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 buprenorphine in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine.

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

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

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 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.

  • Alfentanil
  • Alphaprodine
  • Atazanavir
  • Codeine
  • Diazepam
  • Dihydrocodeine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Levorphanol
  • Meperidine
  • Methadone
  • Morphine
  • Morphine Sulfate Liposome
  • Oxycodone
  • Oxymorphone
  • Propoxyphene
  • Sufentanil
  • Tapentadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Darunavir
  • Etravirine
  • Fosamprenavir
  • Rifampin

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

  • Addison’s disease (adrenal gland problem) or
  • Alcohol abuse, or history of or
  • Asthma, severe or
  • Brain tumor, history of or
  • Breathing problems, severe (e.g., hypercapnia, hypoxia) or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Gallbladder disease or gallstones or
  • Head injuries, history of or
  • Heart disease or
  • Hepatitis B or C, history of or
  • Hypothyroidism (an underactive thyroid) or
  • Hypovolemia (low blood volume) or
  • Kyphoscoliosis (curvature of the spine with breathing problems) or
  • Problems with passing urine—Use with caution. May increase risk for more serious side effects.
  • Hypotension (low blood pressure) or
  • Respiratory depression (very slow breathing) or
  • Stomach problems—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of Subutex

Take this medicine exactly as directed by your doctor. 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.

Do not crush or swallow the sublingual tablet. Place the tablet under the tongue until it is dissolved. If you take 2 or more tablets at a time, place all of the tablets under the tongue together. If this is uncomfortable, place 2 tablets at a time under the tongue and repeat the process until all tablets have been taken.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 sublingual dosage form (tablets):
    • For maintenance treatment of opioid dependence:
      • Adults—
        • Suboxone® (buprenorphine and naloxone combination): buprenorphine 4 milligrams (mg)/naloxone 1 mg to buprenorphine 24 mg/naloxone 6 mg taken as a single dose once a day. Your doctor may adjust your dose as needed.
        • Subutex® (buprenorphine): 12 to 16 mg as a single dose once a day.
      • 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.

Dispose any unneeded tablets by flushing them down the toilet.

Precautions While Using Subutex

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious unwanted effects can occur if certain medicines are given together with buprenorphine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the medicines listed above while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. 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.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

If you have been using this medicine regularly for several weeks or longer, do not suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Subutex 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:

Incidence not known

  • Blurred vision
  • confusion
  • difficult or troubled breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • irregular, fast, slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • pinpoint pupils
  • relaxed and calm feeling
  • shortness of breath
  • sleepiness
  • unusual tiredness or weakness

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

  • Back pain
  • cough or hoarseness
  • difficulty having a bowel movement (stool)
  • fever or chills
  • headache
  • lower back or side pain
  • nausea
  • painful or difficult urination
  • runny nose
  • sleeplessness
  • sneezing
  • stomach pain
  • stuffy nose
  • trouble sleeping
  • unable to sleep
  • vomiting

Less common

  • Diarrhea
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • lack or loss of strength
  • sweating

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: Subutex side effects (in more detail)

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Subutex

Subutex

Pronunciation Generic Name: buprenorphine (oral) (byoo pre NOR feen)

Brand Name: Subutex

OverviewSide EffectsInteractionsMore…

What is buprenorphine?

Buprenorphine is an opioid pain medication. An opioid is sometimes called a narcotic.

Buprenorphine is used to treat narcotic addiction.

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

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

Using buprenorphine improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from buprenorphine. Follow all dosing instructions carefully.

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of buprenorphine and similar prescription drugs.

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

Wear a medical alert tag or carry an ID card stating that you take buprenorphine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are being treated for narcotic addiction.

Avoid drinking alcohol, which can increase some of the side effects of buprenorphine. Using too much of this medicine in addition to drinking alcohol can cause death.

Do not stop using buprenorphine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using buprenorphine. You may need to use less and less before you stop the medication completely.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine will affect you.

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

Do not use this medication if you are allergic to buprenorphine or naloxone (Narcan), or if you have used another narcotic drug within the past 4 hours.

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

  • asthma, COPD, sleep apnea, or other breathing disorders;

  • liver disease (especially hepatitis B or C);
  • kidney disease;
  • a thyroid disorder;
  • stomach problems;
  • enlarged prostate, urination problems;
  • gallbladder disease;
  • curvature of the spine;
  • Addison’s disease (an adrenal gland disorder);
  • a history of mental illness, personality disorder, or psychotic episode;
  • a history of drug or alcohol addiction; or
  • a history of seizures, head injury, or brain tumor.

Buprenorphine may be habit forming and should be used only by the person it was prescribed for. Never share buprenorphine with another person, especially someone with a history of drug abuse or addiction. Buprenorphine can cause withdrawal effects in a person who is addicted to narcotics. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether buprenorphine will harm an unborn baby. Buprenorphine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using buprenorphine.

Buprenorphine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using buprenorphine.

Do not give this medication to a child.

How should I take buprenorphine?

Never take buprenorphine in larger amounts, or for longer than recommended by your doctor. Using buprenorphine improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from buprenorphine. Follow all dosing instructions carefully. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of buprenorphine and similar prescription drugs.

The buprenorphine sublingual tablet should be placed under the tongue and allowed to dissolve. Do not chew the tablet or swallow it whole. If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely.

Wear a medical alert tag or carry an ID card stating that you take buprenorphine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are being treated for narcotic addiction. Make sure your family members know you are using buprenorphine in case they need to speak for you during an emergency.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using buprenorphine. You may need to stop using the medicine for a short time.

Do not stop using buprenorphine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using buprenorphine. You may need to use less and less before you stop the medication completely.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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 buprenorphine can be fatal.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, weak pulse, weak or shallow slowed breathing (breathing may stop).

What should I avoid while taking buprenorphine?

Avoid drinking alcohol, which can increase some of the side effects of buprenorphine. Using too much of this medicine in addition to drinking alcohol can cause death.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine will affect you.

Buprenorphine side effects

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

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have a serious side effect such as:

  • slow or shallow breathing;

  • feeling light-headed, fainting;
  • confusion, unusual thoughts or behavior; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may be more likely to occur, such as:

  • headache;

  • stomach pain, nausea, vomiting, constipation;
  • warmth or tingly feeling;
  • chills, increased sweating;
  • weakness;
  • back pain;
  • anxiety, depression;
  • sleep problems (insomnia); or
  • runny nose.

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: Subutex side effects (in more detail)

What other drugs will affect buprenorphine?

Do not take buprenorphine with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

  • conivaptan (Vaprisol);

  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • nefazodone;
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rifater, Rifamate, Rimactane), or telithromycin (Ketek);
  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or miconazole (Oravig);
  • heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or
  • a sedative such as diazepam (Valium), midazolam (Versed), alprazolam (Xanax) lorazepam (Ativan), clorazepate (Tranxene), triazolam (Halcion), flurazepam (Dalmane), or temazepam (Restoril).

This list is not complete and other drugs may interact with buprenorphine. 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.

Next Page → Side Effects

More Subutex resources

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

Compare Subutex with other medications

  • Chronic Pain
  • Opiate Dependence

Where can I get more information?

  • Your pharmacist has information about buprenorphine written for health professionals that you may read.

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Subutex

Subutex

Pronunciation Generic Name: buprenorphine (byoo-pre-NOR-feen)

Brand Name: Subutex

OverviewSide EffectsInteractionsMore…

Subutex is used for:

Treating opioid dependence. It should be used as part of a complete narcotic dependence treatment plan. It may also be used for other conditions as determined by your doctor.

Subutex is an opioid (narcotic) partial agonist-antagonist. It works by binding to receptors in the brain and nervous system to help prevent withdrawal symptoms in someone who has stopped taking narcotics (eg, heroin, oxycodone).

Do NOT use Subutex if:

  • you are allergic to any ingredient in Subutex
  • you are taking sodium oxybate (GHB)

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 Subutex:

Some medical conditions may interact with Subutex. 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 a history of blood or electrolyte problems, breathing or lung problems (eg, chronic obstructive pulmonary disease), underactive thyroid, adrenal gland problems (eg, Addison disease), liver or kidney problems, an enlarged prostate gland, trouble urinating, a blockage of your bladder or urethra, gallbladder problems, or stomach problems
  • if you have a history of recent head injury, growths in the brain (eg, tumor), or increased pressure in the brain, or muscle problems (eg, myasthenia gravis)
  • if you have a history of mental or mood problems or drug or alcohol abuse

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

  • Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because the side effects of Subutex may be increased
  • Benzodiazepines (eg, diazepam), cimetidine, narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of severe drowsiness, severe breathing problems, and seizures may be increased
  • Naltrexone or rifampin because the effectiveness of Subutex may be decreased
  • Methadone because effectiveness may be decreased by Subutex

This may not be a complete list of all interactions that may occur. Ask your health care provider if Subutex 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 Subutex:

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

  • Do not swallow, crush, or chew Subutex. Place Subutex under your tongue and allow it to dissolve.
  • Do not eat, drink, or smoke while the sublingual tablet is dissolving.
  • Use Subutex regularly to receive the most benefit from it. Taking Subutex at the same time each day will help you remember to take it.
  • If you miss a dose of Subutex, 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 Subutex.

Important safety information:

  • Subutex may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Subutex. Using Subutex alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Subutex. Subutex will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
  • Do not inject Subutex. Doing so may cause severe withdrawal symptoms, severe breathing problems, and death.
  • Subutex may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Subutex.
  • LAB TESTS, including liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Subutex with caution in the ELDERLY because they may be more sensitive to its effects, especially decreased breathing and drowsiness.
  • Subutex is not recommended for use in CHILDREN younger than 16 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Subutex may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Subutex during pregnancy. Subutex is excreted in breast milk. Do not breast-feed while taking Subutex.

When used for long periods of time or at high doses, some people develop a need to continue taking Subutex. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Subutex, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Subutex:

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:

Chills; constipation; diarrhea; dizziness; drowsiness; flushing; headache; nausea; sleeplessness; stomach pain; sweating; vomiting; weakness.

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); anxiety or nervousness; dark urine; mental or mood changes (eg, depression); pale stools; slow or shallow breathing; severe or persistent stomach pain; yellowing of eyes or skin.

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 excessive drowsiness; severe dizziness; very slow and shallow breathing; very small pupils.

Proper storage of Subutex: Store Subutex at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Subutex out of the reach of children and away from pets.

General information:

  • If you have any questions about Subutex, please talk with your doctor, pharmacist, or other health care provider.
  • Subutex 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 Subutex 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 Subutex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Subutex. 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 Subutex.

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

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