Each enteric coated tablet contains Tramadol I.P. 37.5 mg and Paracetamol I.P. 325 mg.
Dosage and administration
Adults and adolescents (≥16 years). 1-2 tabs 6 hourly. Max: 8 tablets daily
As directed by physician
Hypersensitivity to tramadol, paracetamol or opioids. Situations where opioid use may be contra-indicated (e.g. acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs). Severe hepatic impairment, uncontrolled epilepsy. Concurrent use or within 2 wk of discontinuation from MAOIs.
Warnings and Precautions
Not recommended in severe renal impairment (CrCl < 10 ml/min), severe respiratory insufficiency, liver disease or opioid dependent patients. Increased intracranial pressure or head injury, patients at risk of seizures or on drugs that may lower the seizure threshold (e.g. SSRI, TCA, antipsychotics, centrally acting analgesics or local anaesthesia), biliary tract disorders, in a state of shock or unconsciousness. May impair ability to drive or operate machinery. Avoid abrupt withdrawal. May cause withdrawal symptoms, dependence and abuse. Elderly. Pregnancy, lactation.
Increased risk serotonin syndrome with SSRI and triptans. Increased risk of seizures of SSRI, TCA, antipsychotics, centrally acting analgesics or local anaesthesia. Decreased tramadol levels with carbamazepine. Decreased analgesic efficacy of tramadol with ondansetron. Increased INR with warfarin.
Potentially Fatal: Increased risk of serotonin syndrome with MAOIs, avoid concurrent use or within 2 wk of discontinuation from MAOIs. Increased risk of CNS and respiratory depression with CNS depressants (e.g. alcohol, opioids, anaesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics).
Symptoms: Tramadol: CNS depression, respiratory depression, lethargy, seizure, cardiac arrest, coma. Paracetamol: hepatic necrosis, hepatic failure, renal tubular necrosis, hypoglycemia and coagulation defects. Management: Treatment is supportive and symptomatic with maintenance of respiratory and circulatory functions. Oral methionine or IV N-acetylcysteine may be admin up to at least 48 hr after the paracetamol overdose. Naloxone may be used to reverse respiratory depression caused by tramadol but may increase seizure risk. Haemodialysis and haemofiltration unlikely to be helpful.