Oxycodone Hydrochloride and Acetaminophen

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Overview

What is Oxycodone Hydrochloride and Acetaminophen?

Each tablet for oral administration contains:

Acetaminophen, USP 325mg

*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.

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 C 18H 21NO 4•HCl and the molecular weight 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

C 18H 21NO 4•HCl MW 351.82

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 C 8H 9NO 2 and the molecular weight is 151.16. It may be represented by the following structural formula:

What does Oxycodone Hydrochloride and Acetaminophen look like?

What are the available doses of Oxycodone Hydrochloride and Acetaminophen?

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What should I talk to my health care provider before I take Oxycodone Hydrochloride and Acetaminophen?

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How should I use Oxycodone Hydrochloride and Acetaminophen?

Oxycodone and Acetaminophen Tablets, USP are indicated for the relief of moderate to moderately severe pain.

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 and acetaminophen tablets are given orally.

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

What interacts with Oxycodone Hydrochloride and Acetaminophen?

Oxycodone and 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.

What are the warnings of Oxycodone Hydrochloride and Acetaminophen?

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Misuse, Abuse and Diversion of Opiods

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 and 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 and acetaminophen tablets 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 and 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 pre-existing 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 ).

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

Precaution should be taken in patients with liver disease. Hepatotoxicity and severe hepatic failure occurred in chronic alcoholics following therapeutic doses.

What are the precautions of Oxycodone Hydrochloride and Acetaminophen?

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.

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The administration of oxycodone and acetaminophen tablets or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Oxycodone and 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 and 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 and 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 and 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 (see ).

Information for Patients/Caregivers

Patients should be aware that oxycodone and acetaminophen tablets contain oxycodone, which is a morphine-like substance.
Patients should be instructed to keep oxycodone and 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.
When oxycodone and acetaminophen 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 oxycodone and acetaminophen 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 oxycodone and 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 and acetaminophen tablets can cause dangerous additive central nervous system or respiratory depression, which can result in serious injury or death.
The safe use of oxycodone and 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 and acetaminophen tablets.
Nursing mothers should consult with their physicians about whether to discontinue nursing or discontinue oxycodone and acetaminophen tablets because of the potential for serious adverse reactions to nursing infants.
Patients who are treated with oxycodone and 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.
Patients should be advised that oxycodone and 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.

The following information should be provided to patients receiving oxycodone and acetaminophen tablets by their physician, nurse, pharmacist, or caregiver:

Laboratory Tests

Although oxycodone may cross-react with some drug urine tests, no available studies were found which determined the duration of detectability of oxycodone in urine drug screens. However, based on pharmacokinetic data, the approximate duration of detectability for a single dose of oxycodone is roughly estimated to be one to two days following drug exposure.

Urine testing for opiates may be performed to determine illicit drug use and for medical reasons such as evaluation of patients with altered states of consciousness or monitoring efficacy of drug rehabilitation efforts. The preliminary identification of opiates in urine involves the use of an immunoassay screening and thin-layer chromatography (TLC). Gas chromatography/mass spectrometry (GC/MS) may be utilized as a third-stage identification step in the medical investigational sequence for opiate testing after immunoassay and TLC. The identities of 6-keto opiates (e.g., oxycodone) can further be differentiated by the analysis of their methoximetrimethylsilyl (MO-TMS) derivative.

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 and 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

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Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.

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The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics.

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Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.

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Reduces acetaminophen absorption when administered as soon as possible after overdose.

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Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.

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The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.

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Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.

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Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.

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The pharmacologic effects of zidovudine may be decreased because of enhanced nonhepatic or renal clearance of zidovudine.

Drug/Laboratory Test Interactions

Depending on the sensitivity/specificity and the test methodology, the individual components of oxycodone and acetaminophen tablets 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

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The combination of oxycodone and acetaminophen has not been evaluated for mutagenicity. Oxycodone alone was negative in a bacterial reverse mutation assay (Ames), an chromosome aberration assay with human lymphocytes without metabolic activation and an 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.

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

Pregnancy

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

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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.

Labor and Delivery

Oxycodone and 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 and 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.

Geriatric Use

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

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.

Renal Impairment

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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.

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What are the side effects of Oxycodone Hydrochloride and Acetaminophen?

Serious adverse reactions that may be associated with oxycodone and acetaminophen tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see ).

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 and acetaminophen tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:

Body as a Whole:

Cardiovascular:

Central and Peripheral Nervous System:

Fluid and Electrolyte:

Gastrointestinal:

Hepatic:

Hearing and Vestibular:

Hematologic:

Hypersensitivity:

Metabolic and Nutritional:

Musculoskeletal:

Ocular:

Psychiatric:

Respiratory System:

Skin and Appendages:

Urogenital:

What should I look out for while using Oxycodone Hydrochloride and Acetaminophen?

Oxycodone and 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.

What might happen if I take too much Oxycodone Hydrochloride and Acetaminophen?

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.

How should I store and handle Oxycodone Hydrochloride and Acetaminophen?

Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse.They are available as follows:Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.DEA Order Form RequiredManufactured by: Hauppauge, NY 11788 Distributed by: Glasgow, KY 42141 Rev. 08-2008Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse.They are available as follows:Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.DEA Order Form RequiredManufactured by: Hauppauge, NY 11788 Distributed by: Glasgow, KY 42141 Rev. 08-2008Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse.They are available as follows:Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.DEA Order Form RequiredManufactured by: Hauppauge, NY 11788 Distributed by: Glasgow, KY 42141 Rev. 08-2008Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse.They are available as follows:Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.DEA Order Form RequiredManufactured by: Hauppauge, NY 11788 Distributed by: Glasgow, KY 42141 Rev. 08-2008Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse.They are available as follows:Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.DEA Order Form RequiredManufactured by: Hauppauge, NY 11788 Distributed by: Glasgow, KY 42141 Rev. 08-2008Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse.They are available as follows:Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.DEA Order Form RequiredManufactured by: Hauppauge, NY 11788 Distributed by: Glasgow, KY 42141 Rev. 08-2008Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse.They are available as follows:Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.DEA Order Form RequiredManufactured by: Hauppauge, NY 11788 Distributed by: Glasgow, KY 42141 Rev. 08-2008Oxycodone and Acetaminophen Tablets USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse.They are available as follows:Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature.]Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.DEA Order Form RequiredManufactured by: Hauppauge, NY 11788 Distributed by: Glasgow, KY 42141 Rev. 08-2008

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (notably µ and k) in the central nervous system for endogenous opioid-like compounds such as endorphins and enkephalins. Oxycodone produces respiratory depression through direct activity at respiratory centers in the brain stem and depresses the cough reflex by direct effect on the center of the medulla.

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.

Non-Clinical Toxicology

Oxycodone and 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.

Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with ampicillin and sulbactam for injection may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with ampicillin and sulbactam for injection and allopurinol administered concurrently. Ampicillin and sulbactam for injection and aminoglycosides should not be reconstituted together due to the inactivation of aminoglycosides by the ampicillin component of ampicillin and sulbactam for injection.

Serious adverse reactions that may be associated with oxycodone and acetaminophen tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (see ).

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 and acetaminophen tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:

Body as a Whole:

Cardiovascular:

Central and Peripheral Nervous System:

Fluid and Electrolyte:

Gastrointestinal:

Hepatic:

Hearing and Vestibular:

Hematologic:

Hypersensitivity:

Metabolic and Nutritional:

Musculoskeletal:

Ocular:

Psychiatric:

Respiratory System:

Skin and Appendages:

Urogenital:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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