Tramadol HCl 50mg

Company: Actavis Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Tramadol HCl 50mg.
Description: Dark green and yellow hard capsule marked TK on one side.
Presentation: 100. Price on request.
Indication: Moderate to severe pain.
Pharmacology: Tramadol is a centrally acting opioid analgesic. It is a non-selective pure agonist at μ-, δ- and κ-opioid receptors with a higher affinity for the μ-receptor. Other mechanisms which may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.
Dosage: Adult: To be taken whole, with sufficient liquid. Acute pain: Initial dose 50-100mg every 4-6 hours, depending on pain intensity. Maximum daily dose 400mg (unless special clinical circumstances). Chronic conditions: 50mg initially, then titrate according to pain severity. Renal impairment: cc<10ml/min, not recommended; cc<30ml/min, increase dose interval to 12 hours. Elderly: Consider dose adjustment or increase dose interval. Children: Under 12 years, not suitable.
Contraindications: Hypersensitivity to the active ingredient or the excipients. Acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic medicinal product. Epilepsy not adequately controlled by treatment. Use in narcotic withdrawal treatment. Pregnancy, lactation.
Special precautions: Caution: Opioid dependency, opiate sensitivity, head injury, shock, reduced consciousness of uncertain origin, respiratory disorders, respiratory depression, increased intracranial pressure. Convulsions may occur (increased risk at doses >400mg). Risk of tolerance, psychic and physical dependence with long term use; limit treatment to short periods under strict medical supervision in patients with tendency to drug abuse/dependence. Not suitable as a substitute for opioid dependency. Driving/operating machines.
Drug interactions: Contraindicated: MAO inhibitors (or within the last 14 day). Not recommended: Mixed agonist/antagonists (e.g. buprenorphine, nalbuphine, pentazocine). Caution: CNS depressants, carbamazepine (simultaneously or previously), drugs lowering seizure threshold (e.g. serotonin re-uptake inhibitors, tricyclic antidepressants, antipsychotics), coumarin derivatives (e.g. warfarin), CYP3A4 inhibitors (e.g. ketoconazole, erythromycin), ondansetron.
Adverse drug reactions: Dizziness, headache, somnolence, nausea, vomiting, constipation, dry mouth, sweating, fatigue.
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: 1890 333231. Fax: (021) 4619049. E-mail: contact@actavis.ie