Generic Name and Formulations:
Acetaminophen 320.5mg, caffeine 30mg, dihydrocodeine bitartrate 16mg; caps.
Indications for TREZIX:
Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Use lowest effective dose for shortest duration. Individualize. Initially 2 caps every 4hrs as needed. Max 10 caps/24hrs. Conversion from other opioids: see full labeling. Concomitant use or discontinuation of CYP2D6 inhibitors, CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually by 25–50% every 2–4 days.
<12yrs: see Contraindications.
Children <12yrs. Post-op management in children <18yrs following tonsillectomy and/or adenoidectomy. 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. Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children. Neonatal opioid withdrawal syndrome. Hepatotoxicity. Cytochrome P450 interactions. 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). Risk of life-threatening respiratory depression and death related to ultra-rapid metabolizers of codeine (esp. in children for post-tonsillectomy and/or adenoidectomy pain). Avoid in adolescents 12–18yrs with conditions associated with hypoventilation (eg, post-op status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, concomitant drugs that cause respiratory depression). 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 acetaminophen doses >4g/day, alcohol abusers. Adrenal insufficiency. Head injury. Increased intracranial pressure. Dehydration. Hypovolemia. Circulatory shock. Asthma. CNS depression. Coma. Delirium tremens. Myxedema or hypothyroidism. Prostatic hypertrophy or urethral stricture. Toxic psychosis. Acute abdomen. Biliary tract disease. Acute pancreatitis. Seizure disorders. Discontinue at the 1st sign of rash or any other hypersensitivity. Severe renal or hepatic impairment (monitor). Malnourished. Drug abusers. Ultra-rapid metabolizers (due to CYP2D6 polymorphism): avoid. 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.
Analgesic + stimulant + opioid.
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. Avoid concomitant other acetaminophen-containing products. Increased risk of hepatotoxicity with phenytoin, barbiturates, carbamazepine, other anticonvulsants, isoniazid. 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. May be affected by CYP2D6 inhibitors (eg, amiodarone, quinidine, fluoxetine, paroxetine, bupropion). Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May potentiate warfarin. May be potentiated by disulfiram, ciprofloxacin. May antagonize phenobarbital, aspirin.
Lightheadedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, skin reactions (may be severe), anxiety, excitement, insomnia, irritability, tremor, diarrhea, palpitations, tachycardia, tinnitus; respiratory depression, severe hypotension, syncope, hepatotoxicity; rare: hypersensitivity reactions.
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