Oxycodone Hydrochloride and Ibuprofen

OXYCODONE HYDROCHLORIDE AND IBUPROFEN- oxycodone hydrochloride and ibuprofen tablet, film coated
Actavis Pharma, Inc.

CII

Rx Only

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; and SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Addiction, Abuse, and Misuse
Oxycodone Hydrochloride and Ibuprofen Tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Oxycodone Hydrochloride and Ibuprofen Tablets, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see WARNINGS]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

  • complete a REMS-compliant education program,
  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
  • consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone Hydrochloride and Ibuprofen Tablets. Monitor for respiratory depression, especially during initiation of Oxycodone Hydrochloride and Ibuprofen Tablets or following a dose increase [see WARNINGS].

Accidental Ingestion
Accidental ingestion of Oxycodone Hydrochloride and Ibuprofen Tablets, especially by children, can result in a fatal overdose of Oxycodone Hydrochloride and Ibuprofen Tablets [see WARNINGS].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of Oxycodone Hydrochloride and Ibuprofen Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS].

Cytochrome P450 3A4 Interaction
The concomitant use of Oxycodone Hydrochloride and Ibuprofen Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone Hydrochloride and Ibuprofen Tablets and any CYP3A4 inhibitor or inducer [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions].

Risk from Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS, PRECAUTIONS; Drug Interactions].

  • Reserve concomitant prescribing of Oxycodone Hydrochloride and Ibuprofen Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS].

  • Oxycodone Hydrochloride and Ibuprofen Tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS, WARNINGS].

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see WARNINGS].

DESCRIPTION

Each Oxycodone Hydrochloride and Ibuprofen Tablets contain: Oxycodone hydrochloride, USP 5 mg and Ibuprofen, USP 400 mg.

Oxycodone Hydrochloride and Ibuprofen Tablets are supplied in a fixed combination tablet form for oral administration and combines the opioid analgesic agent, oxycodone hydrochloride, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.

Oxycodone hydrochloride, USP is a centrally acting semisynthetic opioid analgesic. Its chemical name is 4,5α- Epoxy-14-hydroxy-3-methoxy-methylmorphinan-6-one hydrochloride. Its molecular formula is C18 H21 NO4 •HCl and molecular weight is 351.82. Its structural formula is:

2491fc3e-figure-01

Ibuprofen, USP is a nonsteroidal anti-inflammatory agent [non-selective COX inhibitor] with analgesic and antipyretic properties. Its chemical name is (±)-2-(p-isobutylphenyl) propionic acid. Its molecular formula is C13 H18 O2 and molecular weight is 206.29. Its structural formula is:

2491fc3e-figure-02

Inactive ingredients in Oxycodone Hydrochloride and Ibuprofen Tablets include: calcium stearate, croscarmellose sodium, colloidal silicon dioxide, hydroxypropyl cellulose, microcrystalline cellulose, pregelatinized starch (corn), and stearic acid. The coloring agents consist of hypromellose, lactose monohydrate, polyethylene glycol, synthetic yellow iron oxide, titanium dioxide, and triacetin.

CLINICAL PHARMACOLOGY

Mechanism of Action
Oxycodone hydrochloride component
Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Ibuprofen component
Ibuprofen has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action, like that of other NSAIDs, is not completely understood, but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Ibuprofen is a potent inhibitor of prostaglandin synthesis in vitro. Ibuprofen concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because ibuprofen is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

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