Generic Name and Formulations:
Hydrocodone bitartrate, acetaminophen; 5mg/325mg, 7.5mg/325mg, 10mg/325mg; scored tabs.
Acute pain severe enough to require opioid analgesic and for which alternative treatments are inadequate.
Reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate.
Use lowest effective dose for shortest duration. Individualize. 5mg/325mg: 1–2 tabs every 4–6hrs as needed; max 8 tabs/day. 7.5mg/325mg, 10mg/325mg: 1 tab every 4–6hrs as needed; max 6 tabs/day. Conversion to/from other opioids: see full labeling.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.
Addiction, abuse, and misuse. Life-threatening respiratory depression. Accidental ingestion. Neonatal opioid withdrawal syndrome. Cytochrome P450 3A4 interaction. Hepatotoxicity. Risks from concomitant use with benzodiazepines or other CNS depressants.
Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Increased risk of hepatotoxicity with underlying liver disease, concomitant alcohol, acetaminophen doses >4g/day or involving >1 acetaminophen-containing product. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Acute abdominal conditions. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment; monitor. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy (Cat.C); potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
Opioid + analgesic.
Avoid concomitant other acetaminophen-containing drugs. Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May increase serum amylase. Acetaminophen may cause false (+) test results for urinary 5-hydroxyindoleacetic acid.
Light-headedness, dizziness, sedation, nausea, vomiting, constipation, somnolence; respiratory depression, severe hypotension, syncope, hepatotoxicity; rare: serious skin reactions or anaphylaxis; discontinue if occurs.
Tabs 5/325—100; 7.5/325, 10/325—100, 500
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