Trama Injection

/ Rafa

The injection is for parenteral administration either intramuscularly, by slow intravenous injection or, when diluted in solution, by infusion or patient controlled analgesia. As with all analgesic drugs the dosing of Trama Injection should be adjusted depending on the severity of the pain and the individual clinical response of the patient.
Adults: A single dose of 50 or 100 mg 4-6 hourly (1 or 2 mL of Trama injection) is usually required.
Intravenous injections must be given slowly over 2-3 minutes.
For severe (post-operative) pain, administer an initial bolus of 100 mg. during the 60 minutes following the initial bolus, further doses of 50 mg may be given every 10-20 minutes, up to a total dose of 250 mg including the initial bolus.
Subsequent doses should be 50 or 100 mg administered 4-6 hourly.
If the administration of Trama injection has been forgotten, the pain may be return. The dose should not be doubled. Administration should be continued as before.
A total daily dose of 400 mg should not be exceeded except in special clinical circumstances.
Trama 100 mg, solution for injection is injected into the veins (usually into a blood vessel under the surface of the arm), muscles (usually the buttocks) or under the skin.
Administration into the veins is slow with 1 ml Trama 100 mg, solution for injection (equivalent to 50 mg tramadol hydrochloride) per minute.
Alternatively Trama injection may be diluted with a suitable infusion solution (e.g. 0.9% physiological saline or 5% glucose solution) for i.v. infusion or for patient-controlled analgesia (PCA).
Elderly patients: Dosing as for adults but it should be noted that in a study in elderly volunteers (aged over 75 years) the elimination half-life for orally administered tramadol was increased by 17%.
Patients with renal insufficiency/renal dialysis: As the elimination of tramadol may be prolonged in patients with renal impairment, the usual initial adult doses should be employed, but prolongation of the dosage interval should be carefully considered according to the patient’s requirements. For creatinine clearance <30 ml/min the dosing should be increased to 12 hourly intervals.
For creatinine clearance <10 ml/min (severe renal impairment) tramadol is not recommended.
Tramadol is removed very slowly by haemodialysis or haemofiltration and therefore post dialysis dosing to maintain analgesia is usually unnecessary.
Patients with hepatic insufficiency: It should be noted that as the elimination of tramadol may be prolonged in severe hepatic impairment, although the usual initial adult doses should be used, prolongation of the dosing should be at 12 hourly intervals.
Children: Over 14 years: Dosage as for adults.
Children aged 1 to 14 years receive 1-2 mg tramadol hydrochloride per kg body weight as a single dose. In this case Trama solution for injection is diluted in water for injection – See prescribing information for full details.

Moderate to severe pain.

Hypersensitivity, intoxication with hypnotics, centrally acting analgesics, opioids, psychotropic drugs or alcohol, within 14 days of taking MAOI, inadequately controlled epilepsy.

Withdrawal symptoms may occur. In patients with a tendency to drug or alcohol abuse, treatment should be short term. Use with caution in hepatic/renal impairment, head injury, increased intracranial pressure, shock, risk of convulsions, respiratory depression. Tramadol may increase risk of convulsions. Not for use during light planes of anesthesia.
See literature.

Common: Nausea, dizziness, headache, somnolence, constipation, dry mouth, vomiting and sweating See literature for less frequent side effects.

See literature.