HYDROCODONE BITARTRATE AND IBUPROFEN- hydrocodone bitartrate and ibuprofen tablet
Amneal Pharmaceuticals of New York LLC
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
Hydrocodone bitartrate and ibuprofen exposes 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 hydrocodone bitartrate and ibuprofen, and monitor all patients regularly for the development of these behaviors and conditions (see WARNINGS: Addiction, Abuse, and Misuse).
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.
- 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 hydrocodone bitartrate and ibuprofen. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and ibuprofen or following a dose increase (see WARNINGS: Life-Threatening Respiratory Depression).
Accidental ingestion of even one dose of hydrocodone bitartrate and ibuprofen, especially by children, can result in a fatal overdose of hydrocodone (see WARNINGS: Life-Threatening Respiratory Depression).
Neonatal Opioid Withdrawal Syndrome
Prolonged use of hydrocodone bitartrate and ibuprofen 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: Neonatal Opioid Withdrawal Syndrome).
Cytochrome P450 3A4 Interaction
The concomitant use of hydrocodone bitartrate and ibuprofen with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients taking hydrocodone bitartrate and ibuprofen and any CYP3A4 inhibitor or upon discontinuation of a CYP3A4 inducer for signs and symptoms of respiratory depression and sedation (see WARNINGS: Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers, PRECAUTIONS: Drug Interactions).
Risks 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: Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants, PRECAUTIONS: Drug Interactions).
- Reserve concomitant prescribing of hydrocodone bitartrate and ibuprofen 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: Cardiovascular Thrombotic Events).
- Hydrocodone bitartrate and ibuprofen is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS, WARNINGS: Cardiovascular Thrombotic Events).
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: Gastrointestinal Bleeding, Ulceration, and Perforation).
Each hydrocodone bitartrate and ibuprofen tablet contains either:
Hydrocodone Bitartrate, USP 2.5 mg, 5 mg, 7.5 mg, or 10 mg and Ibuprofen, USP 200 mg
Hydrocodone bitartrate and ibuprofen tablets are supplied in a fixed combination tablet form for oral administration. Hydrocodone bitartrate and ibuprofen tablets combine the opioid agonist, hydrocodone bitartrate, USP, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen, USP.
Hydrocodone bitartrate, USP is a semisynthetic opioid agonist. Its chemical name is: 4,5 α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its chemical formula is: C18 H21 NO3 •C4 H6 O6 •2½H2 O, and the molecular weight is 494.50. Its structural formula is:
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 chemical formula is: C13 H18 O2 , and the molecular weight is: 206.29. Its structural formula is:
Inactive ingredients in hydrocodone bitartrate and ibuprofen 2.5 mg/200 mg, 5 mg/200 mg and 7.5 mg/200 mg tablets include: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, pregelatinized starch and titanium dioxide.
Inactive ingredients in hydrocodone bitartrate and ibuprofen 10 mg/200 mg tablets include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polydextrose, pregelatinized starch, titanium dioxide, triacetin and D&C Yellow #10 Aluminum Lake.
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