Adult & childn >14 yr 1 single dose by IM or IV inj given slowly over 2-3 min. Max total daily dose: 400 mg (4 amp). Post-op pain Initial bolus inj followed by 50 mg doses every 30 min up to 250 mg (including initial bolus) total dose. Subsequent doses of 50 or 100 mg 4-6 hrly up to 600 mg total daily dose. Less severe pain 50 or 100 mg 4-6 hrly.
Hypersensitivity to tramadol HCl or opioids. Acute intoxication w/ alcohol, hypnotics, analgesics or psychotropic medicines. Patients receiving MAOIs or w/in 2 wk of w/drawal; w/ resp depression especially in the presence of cyanosis & excessive bronchial secretions. Increased intracranial pressure or CNS depression due to head injury or cerebral disease. Treatment of minor pain.
Rapid IV administration. Patients w/ severe hepatic & renal function impairment; prone to convulsive disorders or in shock. Enhanced risk of seizures in patients exceeding the recommended dose, patients taking TCAs or other tricyclic compounds (eg, promethazine, SSRIs & neuroleptics); patients w/ epilepsy, history of seizures, w/ a recognized risk of seizure eg, drug & alcohol w/drawal & intracranial infections, head trauma, metabolic disorders & naloxone treatment w/ tramadol overdose; cerebral convulsions. Do not use in opioid-dependent patients; patients w/ a drug abuse tendency, history of drug dependence or chronically using opioids. May affect reactions to the extent that driving ability & the ability to operate machinery may be impaired.
Nausea, vomiting, dry mouth, heartburn, constipation, fatigue, sedation, drowsiness, confusion, hallucinations, seizures. Sweating (rapid IV administration); skin rashes; bradycardia; tachycardia; flushing; bronchospasm; angioedema; syncope, anaphylaxis & anaphylactic reactions have been reported. These reactions may occur after the 1st dose. Postural hypotension or CV collapse has been observed, potential for TEN & SJS.
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