Each capsule contains: Tramadol Hydrochloride 50 mg.
Opioid Analgesic.
Pharmacology: Pharmacokinetics: Tramadol HCl is a centrally acting analgesic, chemically not related to opiates. Though its mechanism of action is not fully understood, binding to neuronal opioid receptor and inhibition of neuronal reuptake of norepinephrine and serotonin appears to be involved in its analgesic actions. Its metabolite desmethyltramadol (M1) is up to 200 times more potent than tramadol in binding to opioid receptors and is pharmacologically active, but its contribution to analgesia of tramadol in humans is unknown. Tramadol HCl is rapidly and completely absorbed following oral administration. Detectable blood levels are reached within 15 to 45 minutes and mean peak plasma concentrations are achieved in 1.6 to 2 hours post dose. A single oral dose of 100 mg produces mean peak plasma drug concentration of 280 to 308 mcg/L. Mean oral bioavailability after single dose is 68%. Following multiple oral administration, oral bioavailability increases to 90-100% with 16% higher peak plasma concentration. Tramadol HCl is extensively metabolised (up to 85% of the dose) in the liver and excreted via kidneys. About 15-30% is excreted as unchanged drug and 60-85% as metabolites. Among various metabolites, 0-dimethyltramadol (MI) is pharmacologically active. The elimination half life of Tramadol and the active metabolite (MI) in young healthy volunteers is 5.1 to 5.9 hours and 6.7 hours respectively. In subjects above age of 75 years the half life of Tramadol is slightly prolonged (7 hours). In patients with impaired renal function (creatinine clearance between 5-80 mL/min) the half life of Tramadol was 1.5 to 2 times higher. Similarly in patients with liver cirrhosis the plasma concentration and half life is increased by a factor of 2 to 3.
Tramadol HCl is indicated for the management of severe acute or chronic pain and pain during or following diagnostic or surgical procedures.
Tramadol HCl can be administered orally in a dosage of 50/100 mg every 4-6 hours as needed. The daily dose should not exceed more than 400 mg per day. In patients above 75 years, daily dose should not exceed 300 mg. In patients with renal impairment, the recommended dosage is 50 mg to 100 mg every 12 hours. In patients with liver cirrhosis, the recommended dosage is 50 mg every 12 hours. For long treatment, the dosage of Tramadol HCl requires to be individualized as risk of dependence can not be entirely excluded. It should not be given for longer than therapeutically necessary.
Patients with history of hypersensitivity to it, or in cases of acute intoxication with alcohol, sedatives, hypnotics, tranquilisers, other centrally acting analgesics, opioids or psychotropic drugs.
Tramadol HCl should be used with caution and in reduced dosages in patients receiving CNS depressants like anaesthetic agents, phenothiazines, tranquilisers, sedative hypnotics, opioids etc. In patients with epilepsy, patients at the risk of seizures and along with the drugs like MAO inhibitors, neuroleptics etc, that lower seizure threshold. Tramadol HCl should be used during pregnancy and during labour only if the potential benefit justifies the potential risk to the fetus, because there are no adequate and well controlled studies for establishing safe use in pregnancy.
Respiratory depression is not reported with Tramadol HCl. However, it should be used with caution when administered with anaesthetic agents or alcohol to avoid risk of respiratory depression. It should be used with caution in patients with increased intracranial pressure, head injury, acute abdominal conditions and in patients who are dependent on opioids. In rare cases, convulsions have been observed in patients receiving Tramadol. Hence, Tramadol should be used with caution in patients with epilepsy with risk of seizures and in patients taking MAO inhibitors, neuroleptics.
Tramadol HCl should be used during pregnancy and during labour only if the potential benefit justifies the potential risk to the fetus, because there are no adequate and well controlled studies for establishing safe use in pregnancy.
Tramadol HCl is well tolerated. Adverse effects possibly related to tramadol are mild, transient and rare. These are anorexia, flatulence, vasodilation, orthostatic hypotension, syncope, tachycardia, palpitations, urinary retention, visual disturbances, anxiety, confusion, euphoria, nervousness, co-ordination disturbances, allergic reactions, skin rashes, urticaria and weight loss.
Drugs that include hepatic enzymes like carbamazepine lower the plasma concentration and half life of Tramadol and its metabolite. Tramadol HCl may enhance the sedative effects of CNS depressants. It may increase the risk of seizures in patients taking MAO inhibitors and neuroleptics.
Store at temperatures not exceeding 30°C. Protect from light.
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
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