Generic Name and Formulations:
Acetaminophen 320.5mg, caffeine 30mg, dihydrocodeine bitartrate 16mg; caps.
Indications for TREZIX:
Moderate-to-moderately severe pain.
Individualize. 2 caps every 4 hours as needed. Max 10 caps/24 hours.
Post-op pain management in children who have undergone tonsillectomy and/or adenoidectomy. Significant respiratory depression (in unmonitored settings or without resuscitative equipment). Acute or severe bronchial asthma or hypercapnia. Paralytic ileus.
Risk of respiratory depression and death related to ultra-rapid metabolizers of codeine (esp. children in post-op tonsillectomy and/or adenoidectomy). Risk of hepatotoxicity may result with acetaminophen doses >4g/day or involving more than one acetaminophen-containing product. Discontinue if anaphylaxis or hypersensitivity reactions occur. Hypotension. Volume depletion. Circulatory shock. Abuse potential. Adrenocortical insufficiency (eg, Addison’s disease). Asthma. Coma. COPD or decreased respiratory reserve (eg, emphysema, severe obesity, cor pulmonale, kyphoscoliosis). Seizures. Delirium tremens. Head injury. Increased intracranial pressure. Myxedema or hypothyroidism. Prostatic hypertrophy or urethral stricture. Toxic psychosis. Acute abdomen. Biliary tract disease. Pancreatitis. Drug abusers. Acute alcoholism. Use lowest effective dose for shortest duration. Renal or hepatic impairment. Elderly. Debilitated. Malnourished. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.
Potentiation with alcohol, other opioids, sedatives, hypnotics, muscle relaxants, general anesthetics, centrally-acting antiemetics, tranquilizers; reduce dose of one or both drugs. Concomitant phenothiazines or drugs that compromise vasomotor tone; caution. Concomitant MAOIs may cause CNS excitation, hypertension. May be antagonized by agonist/antagonist analgesics (eg, pentazocine, nalbuphine, butorphanol, buprenorphine). Increased hepatotoxicity risk with anticonvulsants (eg, phenytoin, barbiturates, carbamazepine) or isoniazid. May potentiate warfarin. May be potentiated by disulfiram, quinolones (eg, ciprofloxacin). May antagonize phenobarbital, aspirin.
Analgesic + stimulant + opioid.
Lightheadedness, dizziness, drowsiness, headache, fatigue, sedation, sweating, nausea, vomiting, constipation, pruritus, skin reactions, respiratory depression, orthostatic hypotension, cough suppression, confusion, urinary retention, hepatotoxicity, anxiety, excitement, insomnia, irritability, palpitations, tachycardia, tinnitus.