Generic Name and Formulations:
Dihydrocodeine bitartrate 16mg, aspirin 356.4mg, caffeine 30mg; caps.
Sun Pharmaceutical Industries
Indications for SYNALGOS-DC:
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. Take with food or a full glass of water. Initially 2 caps every 4hrs as needed. 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: not recommended.
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. During or within 14 days of MAOIs. Hemophilia. Reye's Syndrome. NSAID allergy. Syndrome of asthma, rhinitis, and nasal polyps.
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 tramadol (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). Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Risk of GI adverse events (including bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Dehydration. Hypovolemia. Heart failure. Severe renal or hepatic impairment: not recommended. Hyperkalemia. Coagulation disorders. Drug abusers. Ultra-rapid metabolizers (due to CYP2D6 polymorphism): avoid. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy (≥30 weeks gestation; avoid); potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.
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. 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). Paralytic ileus may occur with anticholinergics. Avoid concomitant NSAIDs, corticosteroids. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. Antagonizes uricosurics (eg, probenecid); avoid. Potentiates carbonic anhydrase inhibitors (eg, acetazolamide, methazolamide); consider reducing dose of these and monitor. Caution with methotrexate, phenytoin, valproic acid; monitor. Caution with nephrotoxic agents (eg, aminoglycosides, amphotericin B, systemic bacitracin, cisplatin, cyclosporine, foscarnet, IV vancomycin); monitor renal function closely. May antagonize diuretics, ACEIs, β-blockers; monitor. Hypoglycemia with concomitant insulin, sulfonylureas.
Opioid + salicylate + methylxanthine.
Lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus, skin reactions; respiratory depression, severe hypotension, syncope, GI ulcer/bleed, renal toxicity.