Composition
Tab 75 mg: Tapentadol 75 mg
Indications & Dosage
Moderate to severe acute pain which can be managed only with opioid analgesics: Adult: Initially 50 mg every 4-6 hours, adjusted according to response, max. 700 mg in the first 24 hours, an additional dose of 50 mg may be taken 1 hour after the initial dose, if pain control not achieved; max. 600 mg per day. Severe chronic pain: Adult: Initially 50 mg every 12 hours, adjusted according to response; max. 500 mg per day.
Contraindications
Acute respiratory depression, comatose patients, head injury and raised intracranial pressure (opioid analgesics interfere with pupillary responses vital for neurological assessment), risk of paralytic ileus, severe renal impairment; avoid use or reduce dose; opioid effects increased, prolonged and increased cerebral sensitivity occurs.
Precautions
Impaired respiratory function (avoid in chronic obstructive pulmonary disease), inflammatory bowel disorders, adrenocortical insufficiency (reduce dose), asthma (avoid during an acute attack) convulsive disorders, debilitated patients (reduce dose), biliary tract diseases, elderly (reduced dose), hypotension, hypothyroidism (reduce dose), myasthenia gravis, obstructive bowel disorders, prostatic hypertrophy, shock, urethral stenosis. Dependence Repeated use of opioid analgesics is associated with the development of psychological and physical dependence; caution is advised.
Interactions
MAOis or CNS depressants
Pregnancy
Risk of respiratory depression and withdrawal symptoms in the neonate, risk of gastric stasis and inhalation pneumonia in the mother if opioid analgesics are used during labour and delivery
Lactation
Not recommended
Side Effects
Abdominal pain, biliary spasm, bradycardia, confusion, constipation, drug dependence, difficulty with micturition, dizziness, drowsiness, dry mouth, dysphoria, euphoria, flushing, hallucinations, headache, miosis, nausea, oedema, palpitation, postural hypotension, pruritus, rash, respiratory depression, sexual dysfunction, sleep disturbances, sweating, tachycardia, ureteric spasm, urinary retention, urticaria, vertigo, visual disturbances, vomiting, agitation, anorexia, anxiety, asthenia, diarrhoea, dyspepsia, dyspnea, fatigue, paraesthesia, vasodilatation. Rare: Angina, diverticulitis, dysphagia, impaired concentration, paralytic ileus, psychosis