Acetaminophen and Oxycodone

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Acetaminophen and Oxycodone
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Black Box Warning

WARNING
See full prescribing information for complete Boxed Warning.
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 4000 milligrams per day, and often involve more than one acetaminophen containing product.

Overview

Acetaminophen and Oxycodone is a combination of opioid/acetaminophen that is FDA approved for the {{{indicationType}}} of moderate to severe pain. There is a Black Box Warning for this drug as shown here. Common adverse reactions include constipation, nausea, vomiting, dizziness, headache, lightheadedness, sedation, and somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
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Condition2
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Condition3
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Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen and Oxycodone in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetaminophen and Oxycodone in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Acetaminophen and Oxycodone in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen and Oxycodone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetaminophen and Oxycodone in pediatric patients.

Contraindications

  • ENDOCET tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product.

Warnings

WARNING
See full prescribing information for complete Boxed Warning.
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 4000 milligrams per day, and often involve more than one acetaminophen containing product.
  • Misuse, Abuse and Diversion of Opioids
  • Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
  • Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing ENDOCET tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion should not prevent the proper management of pain.
  • Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.
  • Administration of ENDOCET (Oxycodone and Acetaminophen Tablets, USP) should be closely monitored for the following potentially serious adverse reactions and complications:
  • Respiratory Depression
  • Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in ENDOCET tablets, as with all opioid agonists. Elderly and debilitated patients are at particular risk for respiratory depression as are non-tolerant patients given large initial doses of oxycodone or when oxycodone is given in conjunction with other agents that depress respiration. Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
  • In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see OVERDOSAGE).
  • Head Injury and Increased Intracranial Pressure
  • The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries.
  • Hypotensive Effect
  • Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs which compromise vasomotor tone such as phenothiazines. Oxycodone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. Oxycodone may produce orthostatic hypotension in ambulatory patients.
  • 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 4000 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.
  • 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 4000 milligrams of acetaminophen per day, even if they feel well.
  • Serious skin reactions
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
  • Hypersensitivity / anaphylaxis
  • There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs including 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 ENDOCET immediately and seek medical care if they experience these symptoms. Do not prescribe ENDOCET for patients with acetaminophen allergy.

Precautions

  • Opioid analgesics should be used with caution when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.
  • Acute Abdominal Conditions
  • The administration of ENDOCET (Oxycodone and Acetaminophen Tablets, USP) or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
  • ENDOCET tablets should be given with caution to patients with CNS depression, elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium tremens, kyphoscoliosis with respiratory depression, myxedema, and toxic psychosis.
  • ENDOCET tablets may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.
  • Following administration of ENDOCET tablets, anaphylactic reactions have been reported in patients with a known hypersensitivity to codeine, a compound with a structure similar to morphine and oxycodone. The frequency of this possible cross-sensitivity is unknown.
  • Interactions with Other CNS Depressants
  • Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with ENDOCET tablets may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
  • Interactions with Mixed Agonist/Antagonist Opioid Analgesics
  • Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.
  • Ambulatory Surgery and Postoperative Use
  • Oxycodone and other morphine-like opioids have been shown to decrease bowel motility. Ileus is a common postoperative complication, especially after intra-abdominal surgery with use of opioid analgesia. Caution should be taken to monitor for decreased bowel motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented.
  • Use in Pancreatic/Biliary Tract Disease
  • Oxycodone may cause spasm of the Sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.
  • Tolerance and Physical Dependence
  • Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
  • The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
  • In general, opioids should not be abruptly discontinued.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Acetaminophen and Oxycodone in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Acetaminophen and Oxycodone in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Acetaminophen and Oxycodone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Acetaminophen and Oxycodone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Acetaminophen and Oxycodone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Acetaminophen and Oxycodone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Acetaminophen and Oxycodone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Acetaminophen and Oxycodone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Acetaminophen and Oxycodone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Acetaminophen and Oxycodone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Acetaminophen and Oxycodone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Acetaminophen and Oxycodone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Acetaminophen and Oxycodone in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Acetaminophen and Oxycodone in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Acetaminophen and Oxycodone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Acetaminophen and Oxycodone in the drug label.

Pharmacology

There is limited information regarding Acetaminophen and Oxycodone Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Acetaminophen and Oxycodone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Acetaminophen and Oxycodone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Acetaminophen and Oxycodone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Acetaminophen and Oxycodone in the drug label.

How Supplied

Storage

There is limited information regarding Acetaminophen and Oxycodone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

  • The following information should be provided to patients receiving ENDOCET tablets by their physician, nurse, pharmacist, or caregiver:
  • Do not take ENDOCET if you are allergic to any of its ingredients.
  • If you develop signs of allergy such as a rash or difficulty breathing stop taking ENDOCET and contact your healthcare provider immediately.
  • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
  • Patients should be aware that ENDOCET tablets contain oxycodone, which is a morphine-like substance.
  • Patients should be instructed to keep ENDOCET tablets in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.
  • When ENDOCET tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.
  • Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.
  • Patients should be advised that ENDOCET tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
  • Patients should not combine ENDOCET tablets with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of a physician. When co-administered with another CNS depressant, ENDOCET tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.
  • The safe use of ENDOCET tablets during pregnancy has not been established; thus, women who are planning to become pregnant or are pregnant should consult with their physician before taking ENDOCET tablets.
  • Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue ENDOCET tablets because of the potential for serious adverse reactions to nursing infants.
  • Patients who are treated with ENDOCET tablets for more than a few weeks should be advised not to abruptly discontinue the medication. Patients should consult with their physician for a gradual discontinuation dose schedule to taper off the medication.
  • Patients should be advised that ENDOCET tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

Precautions with Alcohol

  • Alcohol-Acetaminophen and Oxycodone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "ENDOCET- oxycodone hydrochloride and acetaminophen tablet".
  2. ↑ "http://www.ismp.org". External link in |title= (help)


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