Oxycodone/Acetaminophen

Oxycodone/Acetaminophen
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: Sheng Shi, M.D. [2], Rabin Bista, M.B.B.S. [3]

Disclaimer

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Black Box Warning

Hepatotoxicity See full prescribing information for complete Boxed Warning. 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

Oxycodone/Acetaminophen is a Opioid Agonist that is FDA approved for the treatment of moderate to moderately 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, somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Relief of moderate to moderately severe pain

• Dosing information

• Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone/Acetaminophen tablets are given orally.

• Oxycodone/Acetaminophen 2.5 mg/325 mg;

• Usual adult dosage: one or 2 tablets every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

• Oxycodone/Acetaminophen 5 mg/325 mg;

• Oxycodone/Acetaminophen 7.5 mg/325 mg;

• Oxycodone/Acetaminophen 10 mg/325 mg

• Usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

This image is provided by the National Library of Medicine.

Cessation of Therapy

• In patients treated with Oxycodone/Acetaminophen tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Oxycodone/Acetaminophen tablets should not be administered to patients with known hypersensitivity to Oxycodone, acetaminophen, or any other component of this product.
• Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus.

Warnings

Hepatotoxicity See full prescribing information for complete Boxed Warning. 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 Oxycodone/Acetaminophen 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 Oxycodone/Acetaminophen (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 Oxycodone/Acetaminophen 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 .

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 Oxycodone/Acetaminophen immediately and seek medical care if they experience these symptoms. Do not prescribe Oxycodone/Acetaminophen for patients with acetaminophen allergy.

PRECAUTIONS

General

• 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 Oxycodone/Acetaminophen (Oxycodone and acetaminophen Tablets, USP) or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
• Oxycodone/Acetaminophen 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.
• Oxycodone/Acetaminophen 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 Oxycodone/Acetaminophen 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 Oxycodone/Acetaminophen 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

• Serious adverse reactions that may be associated with Oxycodone/Acetaminophen tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock .
  
• The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.
  
• Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur.
  
• Other adverse reactions obtained from postmarketing experiences with Oxycodone/Acetaminophen tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:

Body as a Whole

Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose

Cardiovascular

Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias

Central and Peripheral Nervous System

Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, [confusion]], dizziness

Fluid and Electrolyte

Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis

Gastrointestinal

Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastro-intestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus

Hepatic

Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder

Hearing and Vestibular

Hearing loss, tinnitus

Hematologic

Thrombocytopenia

Hypersensitivity

Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction

Metabolic and Nutritional

Hypoglycemia, hyperglycemia, acidosis, alkalosis

Musculoskeletal

Myalgia, rhabdomyolysis

Ocular

Miosis, visual disturbances, red eye

Psychiatric

Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide

Respiratory System

Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema

Skin and Appendages

Erythema, urticaria, rash, flushing

Urogenital

Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention

Postmarketing Experience

FDA Package Insert for Oxycodone/Acetaminophen contains no information regarding Postmarketing Experience.

Drug Interactions

Drug/Drug Interactions with Oxycodone

• opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.
• Patients receiving CNS depressants such as other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Oxycodone/Acetaminophen tablets 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 opioids may produce paralytic ileus.
• Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, naltrexone, and butorphanol) should be administered with caution to a patient who has received or is receiving a pure opioid agonist such as Oxycodone. These agonist/antagonist analgesics may reduce the analgesic effect of Oxycodone or may precipitate withdrawal symptoms.

Drug/Drug Interactions with acetaminophen

• Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.
• Anticholinergics: The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics.
• Oral Contraceptives: Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.

Charcoal (activated): Reduces acetaminophen absorption when administered as soon as possible after overdose.

• Beta Blockers (Propranolol): Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.
• Loop diuretics: The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.
• Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.
• Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
• Zidovudine: The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine.

Drug/Laboratory Test Interactions

• Depending on the sensitivity/specificity and the test methodology, the individual components of Oxycodone/Acetaminophen (Oxycodone and acetaminophen Tablets, USP) may cross-react with assays used in the preliminary detection of cocaine (primary urinary metabolite, benzoylecgonine) or marijuana (cannabinoids) in human urine. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The preferred confirmatory method is gas chromatography/mass spectrometry (GC/MS). Moreover, clinical considerations and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

acetaminophen may interfere with home blood glucose measurement systems; decreases of >20% in mean glucose values may be noted. This effect appears to be drug, concentration and system dependent.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

Teratogenic Effects

Pregnancy Category C

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

Nonteratogenic Effects

• opioids can cross the placental barrier and have the potential to cause neonatal respiratory depression. opioid use during pregnancy may result in a physically drug-dependent fetus. After birth, the neonate may suffer severe withdrawal symptoms.

Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oxycodone/Acetaminophen in women who are pregnant.

Labor and Delivery

• Oxycodone/Acetaminophen tablets are not recommended for use in women during and immediately prior to labor and delivery due to its potential effects on respiratory function in the newborn.

Nursing Mothers

• Ordinarily, nursing should not be undertaken while a patient is receiving Oxycodone/Acetaminophen tablets because of the possibility of sedation and/or respiratory depression in the infant. Oxycodone is excreted in breast milk in low concentrations, and there have been rare reports of somnolence and lethargy in babies of nursing mothers taking an Oxycodone/Acetaminophen product. acetaminophen is also excreted in breast milk in low concentrations.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

• Special precaution should be given when determining the dosing amount and frequency of Oxycodone/Acetaminophen tablets for geriatric patients, since clearance of Oxycodone may be slightly reduced in this patient population when compared to younger patients.

Gender

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

Race

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

Renal Impairment

• In a study of patients with end stage renal impairment, mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Oxycodone should be used with caution in patients with renal impairment.

Hepatic Impairment

• In a pharmacokinetic study of Oxycodone in patients with end-stage liver disease, Oxycodone plasma clearance decreased and the elimination half-life increased. Care should be exercised when Oxycodone is used in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Monitoring

FDA Package Insert for Oxycodone/Acetaminophen contains no information regarding Drug Monitoring.

IV Compatibility

There is limited information about the IV Compatibility.

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 opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, 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. An opioid 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.

Pharmacology

Oxycodone/Acetaminophen
Combination of
[[Oxycodone]]	[[opioid|opioid analgesic]]
Paracetamol	Anilide analgesic
Identifiers
CAS number	330988-72-2
ATC code	?
PubChem	?
Therapeutic considerations
Licence data	US
Pregnancy cat.	C
Legal status	Schedule II(US)
Routes	Oral

Mechanism of Action

• acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers.

Structure

• All strengths of Oxycodone/Acetaminophen also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake.

Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for Oxycodone hydrochloride is C18H21NO4•HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

This image is provided by the National Library of Medicine.

• acetaminophen, 4′-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula:

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

Absorption and Distribution

• The mean absolute oral bioavailability of Oxycodone in cancer patients was reported to be about 87%. Oxycodone has been shown to be 45% bound to human plasma proteins in vitro. The volume of distribution after intravenous administration is 211.9 ±186.6 L.
• Absorption of acetaminophen is rapid and almost complete from the GI tract after oral administration. With overdosage, absorption is complete in 4 hours. acetaminophen is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; only 20% to 50% may be bound at the concentrations encountered during acute intoxication.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

• Animal studies to evaluate the carcinogenic potential of Oxycodone and acetaminophen have not been performed.

Mutagenesis

• The combination of Oxycodone and acetaminophen has not been evaluated for mutagenicity. Oxycodone alone was negative in a bacterial reverse mutation assay (Ames), an in vitro chromosome aberration assay with human lymphocytes without metabolic activation and an in vivo mouse micronucleus assay. Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic activation and in the mouse lymphoma assay with or without metabolic activation.

Fertility

• Animal studies to evaluate the effects of Oxycodone on fertility have not been performed.

Clinical Studies

FDA Package Insert for Oxycodone/Acetaminophen contains no information regarding Clinical Studies.

How Supplied

• Oxycodone/Acetaminophen (Oxycodone and acetaminophen Tablets, USP) is supplied as follows:

2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-70 5 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70

Storage

Store at 20° to 25°C (68° to 77°F).. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Information for Patients/Caregivers

The following information should be provided to patients receiving Oxycodone/Acetaminophen tablets by their physician, nurse, pharmacist, or caregiver:

1. Do not take Oxycodone/Acetaminophen if you are allergic to any of its ingredients.
2. If you develop signs of allergy such as a rash or difficulty breathing stop taking Oxycodone/Acetaminophen and contact your healthcare provider immediately.
3. Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
4. Patients should be aware that Oxycodone/Acetaminophen tablets contain Oxycodone, which is a morphine-like substance.
5. Patients should be instructed to keep Oxycodone/Acetaminophen tablets in a secure place out of the reach of children. In the case of accidental ingestions, emergency medical care should be sought immediately.
6. When Oxycodone/Acetaminophen tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.
7. Patients should be advised not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.
8. Patients should be advised that Oxycodone/Acetaminophen tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
9. Patients should not combine Oxycodone/Acetaminophen 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, Oxycodone/Acetaminophen tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.
10. The safe use of Oxycodone/Acetaminophen 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 Oxycodone/Acetaminophen tablets.
11. Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue Oxycodone/Acetaminophen tablets because of the potential for serious adverse reactions to nursing infants.
12. Patients who are treated with Oxycodone/Acetaminophen 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.
13. Patients should be advised that Oxycodone/Acetaminophen 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-Oxycodone/Acetaminophen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

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

Look-Alike Drug Names

Percocet - Darvocet Oxycodone/Acetaminophen - Indocid Percocet - Procet Roxicet - Roxanol

Drug Shortage Status

Price

References

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

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