What you need to know about drugs

Tylox

Tylox(acetaminophen, oxycodone) – Ortho-McNeil/Janssen

BOXED WARNING

Associated with cases of acute liver failure, at times resulting in liver transplant and death. Most cases associated with acetaminophen (APAP) doses >4000mg/day and involved more than one APAP-containing product.

THERAPEUTIC CLASS

Opioid analgesic

INDICATIONS

Relief of moderate to moderately severe pain.

ADULT DOSAGE

Adults: Usual: 1 cap q6h PRN. Adjust dose according to the severity of pain and response.

HOW SUPPLIED

Cap: (Oxycodone-APAP) 5mg-500mg

WARNINGS/PRECAUTIONS

Hypersensitivity and anaphylaxis reported; d/c immediately if symptoms occur. Avoid with APAP allergy. Contains Na metabisulfite; may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes. Sulfite sensitivity is seen more frequently in asthmatic people. May produce drug dependence and tolerance; potential for abuse. Respiratory depressant effects and capacity to elevate CSF pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. May obscure the diagnosis or clinical course of acute abdominal conditions or head injuries. Caution in elderly, debilitated, severe hepatic/renal impairment, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. Inappropriate for intractable/severe pain. Administration shortly before delivery may result in some degree of respiratory depression in the newborn and mother.

ADVERSE REACTIONS

Lightheadedness, dizziness, sedation, N/V, allergic reactions, euphoria, dysphoria, constipation, skin rash, pruritus, acute liver failure.

DRUG INTERACTIONS

May exhibit an additive CNS depression with other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics, or other CNS depressants (eg, alcohol); reduce dose of one or both agents when given concomitantly. May produce paralytic ileus with anticholinergics.

PREGNANCY

Category C, caution in nursing.

MECHANISM OF ACTION

Oxycodone: Semi-synthetic narcotic analgesic; produces similar action to morphine, prominently in CNS and smooth muscle organs. Produces analgesia and sedative effects. APAP: Nonopiate, nonsalicylate analgesic, and antipyretic.

ASSESSMENT

Assess for sulfite sensitivity, hypersensitivity to APAP, asthma, head injury, intracranial lesions, preexisting increase intracranial pressure, acute abdominal conditions, age, debilitated patients, hepatic/renal impairment, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for signs/symptoms of hypersensitivity reactions (eg, anaphylaxis), hepatic function, asthmatic episodes, sulfite sensitivity, respiratory depression, elevations in CSF pressure, drug dependence, tolerance, and drug abuse.

PATIENT COUNSELING

Inform that may produce dependence and has potential for abuse; instruct to take ud. Advise to d/c and contact physician immediately if develop signs of allergy (eg, rash, difficulty breathing). Inform not to take >4g/day of APAP and contact physician if exceeded the recommended dose. Inform that drug may impair mental/physical abilities required to perform hazardous tasks (eg, operating machinery/driving); instruct to exercise caution until drug does not adversely affect the ability to engage in such activities. Notify physician if pregnant/breastfeeding.

ADMINISTRATION/STORAGE

Administration: Oral route. Storage: 15-30°C (59-86°F). Protect from moisture.


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    Tylox

    Tylox

    Generic Name: oxycodone and acetaminophen (Oral route)

    a-seet-a-MIN-oh-fen, ox-i-KOE-done hye-droe-KLOR-ide

    Oral route(Tablet) Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg/day, and often involve more than one acetaminophen-containing product .

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • Endocet
    • Magnacet
    • Narvox
    • Percocet
    • Perloxx
    • Primalev
    • Roxicet
    • Roxilox
    • Tylox
    • Xolox

    Available Dosage Forms:

    • Tablet
    • Solution
    • Capsule

    Therapeutic Class: Opioid/Acetaminophen Combination

    Chemical Class: Oxycodone

    Uses For Tylox

    Oxycodone and acetaminophen combination is used to relieve moderate to moderately severe pain.

    Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

    Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

    When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

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

    Before Using Tylox

    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 oxycodone and acetaminophen combination 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 oxycodone and acetaminophen combination 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 oxycodone and acetaminophen combination.

    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.

    • Naltrexone

    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.

    • Acetophenazine
    • Adinazolam
    • Alfentanil
    • Alprazolam
    • Amobarbital
    • Anileridine
    • Aprobarbital
    • Atazanavir
    • Brofaromine
    • Bromazepam
    • Brotizolam
    • Buprenorphine
    • Buspirone
    • Butabarbital
    • Butalbital
    • Butorphanol
    • Carisoprodol
    • Chloral Hydrate
    • Chlordiazepoxide
    • Chlorpromazine
    • Chlorzoxazone
    • Clarithromycin
    • Clobazam
    • Clonazepam
    • Clorazepate
    • Clorgyline
    • Codeine
    • Dantrolene
    • Desflurane
    • Dexmedetomidine
    • Dezocine
    • Diazepam
    • Diphenhydramine
    • Doxylamine
    • Enflurane
    • Erythromycin
    • Escitalopram
    • Estazolam
    • Eszopiclone
    • Ethchlorvynol
    • Ethopropazine
    • Fentanyl
    • Flumazenil
    • Flunitrazepam
    • Fluphenazine
    • Flurazepam
    • Fluvoxamine
    • Fospropofol
    • Furazolidone
    • Halazepam
    • Halothane
    • Hydrocodone
    • Hydromorphone
    • Hydroxyzine
    • Indinavir
    • Iproniazid
    • Isocarboxazid
    • Isoflurane
    • Itraconazole
    • Ketamine
    • Ketazolam
    • Ketoconazole
    • Lazabemide
    • Levorphanol
    • Linezolid
    • Lorazepam
    • Lormetazepam
    • Medazepam
    • Meperidine
    • Mephenesin
    • Mephobarbital
    • Meprobamate
    • Mesoridazine
    • Metaxalone
    • Methdilazine
    • Methocarbamol
    • Methohexital
    • Midazolam
    • Moclobemide
    • Morphine
    • Morphine Sulfate Liposome
    • Nalbuphine
    • Nefazodone
    • Nelfinavir
    • Nialamide
    • Nitrazepam
    • Nitrous Oxide
    • Nordazepam
    • Opium
    • Oxazepam
    • Oxycodone
    • Oxymorphone
    • Pargyline
    • Pentazocine
    • Pentobarbital
    • Perphenazine
    • Phenelzine
    • Phenobarbital
    • Prazepam
    • Procarbazine
    • Prochlorperazine
    • Promazine
    • Promethazine
    • Propiomazine
    • Propofol
    • Propoxyphene
    • Quazepam
    • Ramelteon
    • Rasagiline
    • Remifentanil
    • Ritonavir
    • Saquinavir
    • Secobarbital
    • Selegiline
    • Sertraline
    • Sevoflurane
    • Sodium Oxybate
    • Sufentanil
    • Tapentadol
    • Telithromycin
    • Temazepam
    • Thiethylperazine
    • Thiopental
    • Thioridazine
    • Toloxatone
    • Tranylcypromine
    • Triazolam
    • Trifluoperazine
    • Triflupromazine
    • Trimeprazine
    • Zaleplon
    • Zolpidem

    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.

    • Acenocoumarol
    • Carbamazepine
    • Isoniazid
    • Miconazole
    • Phenytoin
    • Rifampin
    • St John’s Wort
    • Voriconazole
    • Warfarin
    • Zidovudine

    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.

    Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Cabbage

    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, history of or
    • Brain tumor, history of or
    • Chronic obstructive pulmonary disease (COPD) or
    • CNS depression or
    • Cor pulmonale (serious heart condition) or
    • Drug dependence, especially with narcotics, or history of or
    • Enlarged prostate (BPH, prostatic hypertrophy) or
    • Head injuries, history of or
    • Hypothyroidism (an underactive thyroid) or
    • Hypovolemia (low blood volume) or
    • Kyphoscoliosis (curvature of the spine with breathing problems) or
    • Mental illness or
    • Problems with passing urine—Use with caution. May increase risk for more serious side effects.
    • Asthma, severe or
    • Hypercarbia (high carbon dioxide in the blood), severe or
    • Paralytic ileus (bowels stop working and may be blocked) or
    • Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.
    • Hypotension (low blood pressure) or
    • Pancreatitis (inflammation of the pancreas) or
    • Seizures, history of 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 oxycodone and acetaminophen

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

    Take this medicine only 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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

    Measure the oral liquid using the patient cup that comes with the package.

    Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

    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 moderate to moderately severe pain:
      • For oral dosage form (capsules):
        • Adults—One capsule every 6 hours as needed.
        • Children—Use and dose must be determined by your doctor.
      • For oral dosage form (solution):
        • Adults—5 milliliters (mL) or one teaspoonful every 6 hours as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
        • Children—Use and dose must be determined by your doctor.
      • For oral dosage form (tablets):
        • Adults—One tablet every 6 hours as needed. However, the dose is usually not more than 6 to 12 tablets per 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.

    Flush any unused capsules, liquid, or tablets down the toilet.

    Precautions While Using Tylox

    It is very important that your doctor check your progress while you are taking 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.

    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.

    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. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

    This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

    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.

    Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

    This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and 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.

    Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

    If you have been using this medicine regularly for several weeks or longer, do not change your dose or 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 prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, irritability, nausea, restlessness, 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.

    Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by 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, especially those containing acetaminophen (Tylenol (R)), and herbal or vitamin supplements.

    Tylox 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:

    More common

    • Abdominal or stomach pain
    • black, tarry stools
    • chills
    • dark urine
    • dizziness
    • fever
    • headache
    • itching
    • light-colored stools
    • loss of appetite
    • nausea
    • rash
    • unpleasant breath odor
    • unusual tiredness or weakness
    • vomiting of blood
    • yellow eyes or skin

    Rare

    • Cough or hoarseness
    • fever with or without chills
    • general feeling of tiredness or weakness
    • lower back or side pain
    • painful or difficult urination
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • unusual bleeding or bruising

    Incidence not known

    • Back, leg, or stomach pains
    • bleeding gums
    • bloating
    • blood in the urine or stools
    • blue lips and fingernails
    • blurred vision
    • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    • chest pain or discomfort
    • clay-colored stools
    • cloudy urine
    • clumsiness
    • confusion
    • constipation
    • coughing that sometimes produces a pink frothy sputum
    • decrease in the frequency of urination
    • decrease in urine volume
    • decreased awareness or responsiveness
    • decreased frequency or amount of urine
    • decreased urination
    • difficult or labored breathing
    • difficult or painful urination
    • difficult, fast, noisy breathing, sometimes with wheezing
    • difficulty in passing urine (dribbling)
    • difficulty with swallowing
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • drowsiness
    • dry mouth
    • extremely shallow or slow breathing
    • fainting
    • fast or deep breathing
    • fast, slow, irregular, pounding, or racing heartbeat or pulse
    • feeling of warmth
    • general body swelling
    • greatly decreased frequency of urination or amount of urine
    • hives or welts
    • increase in heart rate
    • increased blood pressure
    • increased sweating
    • increased thirst
    • indigestion
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • lightheadedness
    • low body temperature
    • muscle aches
    • muscle tremors
    • muscle weakness
    • nervousness
    • noisy breathing
    • nosebleeds
    • numbness or tingling in the hands, feet, or lips
    • pains in the stomach, side, or abdomen, possibly radiating to the back
    • pale skin
    • pinpoint red spots on the skin
    • pounding in the ears
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • rapid, deep breathing
    • rapid, shallow breathing
    • redness of the face, neck, arms, and occasionally, upper chest
    • redness of the skin
    • restlessness
    • seizures
    • severe constipation
    • severe sleepiness
    • severe vomiting
    • shivering
    • shortness of breath
    • skin blisters
    • skin rash
    • sleepiness
    • slow or irregular breathing
    • sore throat
    • stomach cramps
    • stomach pain, continuing
    • sudden decrease in the amount of urine
    • sunken eyes
    • sweating
    • swelling in the legs and ankles
    • swelling of the face, fingers, or lower legs
    • thirst
    • tightness in the chest
    • tiredness
    • troubled breathing
    • unpleasant breath odor
    • upper right abdominal or stomach pain
    • vomiting
    • vomiting of blood
    • weak or feeble pulse
    • weakness or heaviness of the legs
    • weight gain
    • wheezing
    • wrinkled skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Bluish lips or skin
    • change in consciousness
    • cold, clammy skin
    • extreme sleepiness
    • general feeling of discomfort or illness
    • loss of consciousness
    • no blood pressure or pulse
    • not breathing
    • stopping of heart
    • unconsciousness

    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

    • Relaxed and calm

    Incidence not known

    • Acid or sour stomach
    • agitation
    • anxiety
    • bad or unusual or unpleasant (after) taste
    • belching
    • change in taste
    • cold sweats
    • constricted, pinpoint, or small pupils (black part of the eye)
    • continuing ringing or buzzing or other unexplained noise in the ears
    • cool, pale skin
    • depression
    • diarrhea
    • difficulty with moving
    • disturbed color perception
    • double vision
    • excess air or gas in the stomach or intestines
    • false or unusual sense of well-being
    • flushed, dry skin
    • fruit-like breath odor
    • full feeling
    • general feeling of discomfort or illness
    • halos around lights
    • hearing loss
    • heartburn
    • increased hunger
    • increased thirst
    • increased urination
    • indigestion
    • joint pain
    • lack or loss of strength
    • muscle cramps or spasms
    • muscle pain or stiffness
    • nervousness
    • night blindness
    • nightmares
    • overbright appearance of lights
    • passing gas
    • rash
    • red eye
    • seeing, hearing, or feeling things that are not there
    • seizures
    • severe sleepiness
    • shakiness
    • sleepiness or unusual drowsiness
    • sleeplessness
    • slurred speech
    • stomach discomfort, upset, or pain
    • stomach fullness
    • sweating
    • swollen joints
    • thirst
    • trouble sleeping
    • troubled breathing
    • tunnel vision
    • unable to sleep
    • unexplained weight loss
    • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

    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: Tylox side effects (in more detail)

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    Tylox

    Tylox

    Generic Name: acetaminophen and oxycodone (a SEET a MIN oh fen and OX i KOE done)

    Brand Name: Endocet, Magnacet, Percocet 10/325, Percocet 10/650, Percocet 2.5/325, Percocet 5/325, Percocet 7.5/325, Percocet 7.5/500, Primalev, Primlev, Roxicet, Tylox, Xolox

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is acetaminophen and oxycodone?

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

    Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

    The combination of acetaminophen and oxycodone is used to relieve moderate to severe pain.

    Acetaminophen and oxycodone may also be used for purposes not listed in this medication guide.

    What is the most important information I should know about acetaminophen and oxycodone?

    Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

    Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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

    Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

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

    Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

    What should I discuss with my healthcare provider before taking acetaminophen and oxycodone?

    Do not use this medication if you are allergic to acetaminophen (Tylenol) or oxycodone.

    Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen.

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

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

    • liver or kidney disease;
    • a history of head injury or brain tumor;
    • epilepsy or other seizure disorder;
    • low blood pressure;
    • a stomach, intestinal, or pancreas disorder;
    • underactive thyroid;
    • Addison’s disease or other adrenal gland disorder;
    • enlarged prostate, urination problems;
    • curvature of the spine;
    • mental illness; or
    • a history of drug or alcohol addiction.

    Oxycodone may be habit forming and should be used only by the person it was prescribed for. Never share acetaminophen and oxycodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

    FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Before you take acetaminophen and oxycodone, tell your doctor if you are pregnant or plan to become pregnant during treatment.

    Acetaminophen and oxycodone may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

    How should I take acetaminophen and oxycodone?

    Take exactly as prescribed. Never take acetaminophen and oxycodone in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen can damage your liver or cause death. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

    One acetaminophen and oxycodone tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

    Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

    Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and oxycodone. Do not use a stool softener (laxative) without first asking your doctor.

    Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and oxycodone.

    Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

    If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and oxycodone. You may need to stop using the medicine for a short time.

    Store at room temperature away from moisture and heat.

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

    Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

    After you have stopped using this medication, flush any unused pills down the toilet.

    What happens if I miss a dose?

    Since acetaminophen and oxycodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 use 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 acetaminophen and oxycodone can be fatal.

    The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

    Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

    What should I avoid while taking acetaminophen and oxycodone?

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

    Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

    Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

    Acetaminophen and oxycodone side effects

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

    Call your doctor at once if you have any of these serious side effects:

    • shallow breathing, slow heartbeat;

    • feeling light-headed, fainting;
    • confusion, unusual thoughts or behavior;
    • seizure (convulsions);
    • problems with urination; 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 include:

    • feeling dizzy or drowsy;

    • mild nausea, vomiting, upset stomach, constipation;
    • blurred vision; or
    • dry mouth.

    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: Tylox side effects (in more detail)

    What other drugs will affect acetaminophen and oxycodone?

    Do not take acetaminophen and oxycodone 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:

    • glycopyrrolate (Robinul);

    • mepenzolate (Cantil);
    • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
    • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
    • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or
    • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

    This list is not complete and other drugs may interact with acetaminophen and oxycodone. 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 Tylox resources

    • Side Effects
    • Pregnancy Warnings
    • Drug Images
    • Drug Interactions
    • 10 Reviews - Add your own review/rating
    • Tylox Prescribing Information (FDA)
    • Tylox Consumer Overview
    • Tylox Advanced Consumer (Micromedex) – Includes Dosage Information
    • Endocet MedFacts Consumer Leaflet (Wolters Kluwer)
    • Endocet Consumer Overview
    • Endocet Prescribing Information (FDA)
    • Magnacet Prescribing Information (FDA)
    • Primlev Prescribing Information (FDA)
    • Roxicet Consumer Overview
    • Roxicet Prescribing Information (FDA)
    • Roxicet solution MedFacts Consumer Leaflet (Wolters Kluwer)

    Compare Tylox with other medications

    • Chronic Pain
    • Pain

    Where can I get more information?

    • Your pharmacist can provide more information about acetaminophen and oxycodone.

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    Tylox

    Tylox

    Generic Name: acetaminophen and oxycodone hydrochloride

    Dosage Form: capsule

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Tylox®

    (oxycodone and acetaminophen capsules USP)

    analgesic CII

    For Oral Use

    HEPATOTOXICITY Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product (see WARNINGS).

    Tylox Description

    Each capsule of Tylox® (oxycodone and acetaminophen capsules USP) contains:

    *
    5 mg oxycodone hydrochloride is equivalent to 4.4815 mg oxycodone
    Oxycodone Hydrochloride USP 5 mg*
    Warning — May be habit forming.
    Acetaminophen USP 500 mg

    Inactive ingredients: docusate sodium, gelatin, magnesium stearate, sodium benzoate, sodium metabisulfite1, corn starch, FD&C Blue No. 1, FD&C Red No. 3, FD&C Red No. 40, and titanium dioxide.

    Acetaminophen occurs as a white, odorless crystalline powder, possessing a slightly bitter taste.

    The oxycodone component is 14-hydroxy-dihydrocodeinone, a white, odorless crystalline powder having a saline, bitter taste. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

    1
    See WARNINGS

    Tylox – Clinical Pharmacology

    The principal ingredient, oxycodone, is a semi-synthetic narcotic analgesic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of the oxycodone in Tylox® (oxycodone and acetaminophen capsules) are analgesia and sedation.

    Oxycodone is similar to codeine and methadone in that it retains at least one-half of its analgesic activity when administered orally.

    Acetaminophen is a nonopiate, nonsalicylate analgesic and antipyretic.

    Indications and Usage for Tylox

    Tylox® (oxycodone and acetaminophen capsules) are indicated for the relief of moderate to moderately severe pain.

    Contraindications

    Tylox® (oxycodone and acetaminophen capsules) should not be administered to patients who are hypersensitive to any component.

    Warnings

    Hepatotoxicity

    Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products (see Boxed Warning).

    The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

    Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

    Hypersensitivity/Anaphylaxis

    There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Tylox® immediately and seek medical care if they experience these symptoms. Do not prescribe Tylox® for patients with acetaminophen allergy.

    Tylox® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

    Drug Dependence

    Oxycodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Tylox® (oxycodone and acetaminophen capsules), and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, Tylox® is subject to the Federal Control Substances Act (Schedule II).

    Precautions

    General

    Head Injury and Increased Intracranial Pressure The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

    Acute Abdominal Conditions The administration of Tylox®(oxycodone and acetaminophen capsules) or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

    Special Risk Patients Tylox® should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, and prostatic hypertrophy or urethral stricture.

    Information for Patients

    • Do not take Tylox® if you are allergic to any of its ingredients.
    • If you develop signs of allergy such as a rash or difficulty breathing, stop taking Tylox® and contact your healthcare provider immediately.
    • Do not take more than 4,000 milligrams of acetaminophen per day. Call your healthcare provider if you took more than the recommended dose.
    • Oxycodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Exercise caution until you are reasonably certain that Tylox® does not adversely affect your ability to engage in such activities.

    Drug Interactions

    Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with Tylox® may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

    The concurrent use of anticholinergics with narcotics may produce paralytic ileus.

    Usage in Pregnancy

    Pregnancy Category C Animal reproductive studies have not been conducted with Tylox®. It is also not known whether Tylox® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Tylox® should not be given to a pregnant woman, unless in the judgment of the physician, the potential benefits outweigh the possible hazards.

    Nonteratogenic Effects Use of narcotics during pregnancy may produce physical dependence in the neonate.

    Labor and Delivery

    As with all narcotics, administration of Tylox® to the mother shortly before delivery may result in some degree of respiratory depression in the newborn and the mother, especially if higher doses are used.

    Nursing Mothers

    It is not known whether the components of Tylox® are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tylox® is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness in children have not been established.

    Adverse Reactions

    The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

    Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, skin rash, and pruritus. At higher doses, oxycodone has most of the disadvantages of morphine including respiratory depression.

    Drug Abuse and Dependence

    Tylox® capsules are a Schedule II controlled substance.

    Oxycodone can produce drug dependence and has the potential for being abused (see WARNINGS).

    Overdosage

    Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.

    Signs and Symptoms

    Toxicity from oxycodone poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Serious overdosage with oxycodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

    In acetaminophen overdosage: dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

    Treatment

    A single or multiple drug overdose with oxycodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered.

    Oxycodone Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including oxycodone. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

    Acetaminophen Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

    Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs early in the course of intoxication.

    Tylox Dosage and Administration

    Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to oxycodone can develop with continued use and that the incidence of untoward effects is dose related. This product is inappropriate even in high doses for severe or intractable pain.

    Tylox® (oxycodone and acetaminophen capsules) are given orally. The usual adult dosage is one Tylox® capsule every 6 hours as needed for pain.

    How is Tylox Supplied

    Tylox® (oxycodone and acetaminophen capsules USP) contains 5 mg oxycodone and 500 mg acetaminophen. The capsules are red and imprinted with “Tylox” “McNEIL”. Tylox® is available as follows:

    Bottles of 100 capsules – NDC 50458-526-60

    Hospital Unit Dose 100 capsules – NDC 50458-526-79

    Dispense in tight, light-resistant container as defined in the official compendium. Store at controlled room temperature (15°–30°C, 59°–86°F). Protect from moisture.

    Manufactured by:

    Janssen Ortho, LLC

    Gurabo, Puerto Rico 00778

    Manufactured for:

    PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

    Raritan, NJ 08869

    Revised October 2011

    © Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2000

    10187201

    PRINCIPAL DISPLAY PANEL – 100 Capsule Carton

    NSN 6505-01-211-6803

    NDC 50458-526-79

    CII

    Tylox®

    (OXYCODONE &

    ACETAMINOPHEN CAPSULES USP)

    Each capsule contains: Oxycodone Hydrochloride 5 mg†

    Acetaminophen 500 mg

    † 5 mg oxycodone hydrochloride is equivalent to 4.4815 mg oxycodone.

    Rx only.

    100 capsules

    UNIT DOSE PACK FOR INSTITUTIONAL USE

    PriCara®

    Division of Ortho-McNeil-Janssen

    Pharmaceuticals, Inc.

    Tylox 

    acetaminophen and oxycodone hydrochloride capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50458-526
    Route of Administration ORAL DEA Schedule CII    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    acetaminophen (acetaminophen) acetaminophen 500 mg
    oxycodone hydrochloride (oxycodone) oxycodone hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    starch, corn  
    Docusate sodium  
    FD&C Blue No. 1  
    FD&C Red No. 3  
    FD&C Red No. 40  
    Gelatin  
    Magnesium stearate  
    Sodium benzoate  
    Sodium metabisulfite  
    Titanium dioxide  
    Product Characteristics
    Color RED Score no score
    Shape CAPSULE Size 22mm
    Flavor Imprint Code Tylox;McNEIL
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:50458-526-60 100 CAPSULE (CAPSULE) in 1 BOTTLE
    2 NDC:50458-526-79 100 CAPSULE (CAPSULE) in 1 BOX, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA088790 12/12/1984
    Labeler - Ortho-McNeil-Janssen Pharmaceuticals, Inc. (063137772)
    Establishment
    Name Address ID/FEI Operations
    Janssen Ortho, LLC 062191882 MANUFACTURE
    Establishment
    Name Address ID/FEI Operations
    Diosite 409664849 API MANUFACTURE
    Establishment
    Name Address ID/FEI Operations
    Ortho-McNeil-Janssen Pharmaceuticals, Inc. 063137772 ANALYSIS
    Establishment
    Name Address ID/FEI Operations
    Mallinckrodt 097722284 ANALYSIS, API MANUFACTURE

    Revised: 07/2011   Ortho-McNeil-Janssen Pharmaceuticals, Inc.

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