TRAMACAP

Tramadol hydrochloride

Description:

Tramadol is a centrally acting analgesic. It is a synthetic codeine analog that is a weak m-opioid receptor agonist. Part of its analgesic effects are produced by inhibition of uptake of norepinephrine and serotonin.

Composition:

Tramacap capsule: Each capsule contains Tramadol hydrochloride INN 50 mg.

Tramacap 2 ml Injection: Each ml of injection contains Tramadol hydrochloride INN 50 mg.

Indications:

Tramacap is indicated in the management of moderate to moderately severe pain.

Dosage & Administration:

For Capsule: Usual doses by mouth are 50 to 100 mg every 4 to 6 hours. The total daily dosage by mouth should not exceed 400 mg.

For Injection: By intravascular or by intramascular injection (over 2-3 minutes) or intravenous infusion, 50-100 mg every 4-6 hours.

Postoperative pain, 100 mg initially then 50 mg every 10-20 minutes if necessary during first hour to total max. 250 mg (including initial dose) in first hour, then 50-100 mg every 4-6 hours; max. 600 mg daily.

Contraindications:

Hypersensitivity to tramadol or any other component of this product or opioids; acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

Side-effects:

Nausea and vomiting (particularly in initial stages), constipation, drowsiness; larger doses produce respiratory depression and hypotension. Other side-effects include dry mouth, sweating, headache, vertigo, tachycardia, palpitations, hypothermia, hallucinations, dysphoria, mood changes, urticaria and pruritus.  

Special Populations:

Children: Not recommended in children because safety and efficacy in patients < 16 years of age have not been established.

Elderly: Available data do not suggest that a dosage adjustment is necessary in elderly patients 65 to 75 years of age unless they have renal or hepatic impairment. For elderly patients > 75 years old, administer < 300 mg/day in divided doses as above.

Pregnant women: Pregnancy category C: Do not use in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established.

Lactating mother: Tramadol is not recommended for obstetrical preoperative medication or for post delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.

Renal function impairment: In all patients with creatinine clearance <30 ml/min, it is recommended that the dosing interval be increased to 12 hours, with a maximum daily dose of 200 mg.

Hepatic function impairment: The recommended dose for patients with cirrhosis is 50 mg every 12 hours.

Precautions:

Tramadol should be used with care in patients with a history of epilepsy or those susceptible to seizure.

Respiratory depression: When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Administer cautiously in patients at risk for respiratory depression.

Increased intracranial pressure or head trauma: Use with caution in patients with increased intracranial pressure or head injury.

Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids. Patients who have recently taken substantial amounts may experience withdrawl symptoms.

Drug Interactions:

CNS depressant, MAO inhibitors and alcohol.

Storage:

Store in a cool dry place. Protected from light. Keep out of the reach of children.

Packing:

Tramacap capsule: Box containing 3´10 capsules in blister pack.

Tramacap 2 ml injection: Box containing 2´3 ampoules in blister pack.