TRADE NAME: TRAMADOL 50mg Hard Gelatin Capsule. GENERIC NAME: Tramadol hydrochloride. COMPOSITION: Each capsule contains: Active ingredient: Tramadol Hcl 50 mg Excipients: Lactose monohydrate, magnesium stearate. Composition of capsule shell: Cap: Gelatin, Titanium dioxide, Sunset yellow, Erythrocin, Quinoline. Body: Gelatin, Titanium dioxide. PHARMACEUTICAL FORM: Hard Gelatin Capsule. PHARMACOLOGICAL ACTION: PHARMACODYNAMICS: Tramadol is a centrally acting synthetic analgesic compound. It is a non-selective pure agonist at mu, delta and kappa opioid receptors with a higher affinity for the mu receptor. Other mechanisms which may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline (norepinephrine) and enhancement of serotonin release. Tramadol opioid activity derives from low affinity binding of the parent compound to mu-opioid receptors and higher affinity binding of the active metabolite, O-desmethyl tramadol. Compared to morphine, tramadol does not show respiratory depression when given within the analgesic dosage interval. The effect of tramadol is considered 1/10 to 1/6 the effect of morphine. The gastrointestinal motility is not affected. There is minimal effect on the cardiovascular system. The contribution to human analgesia of tramadol relative to the active metabolite is unknown. Tramadol has an antitussive effect. Paediatric population Effects of enteral and parenteral administration of tramadol have been investigated in clinical trials involving more than 2000 paediatric patients ranging in age from neonate to 17 years of age. The indications for pain treatment studied in those trials included pain after surgery (mainly abdominal), after surgical tooth extractions, due to fractures, burns and traumas as well as other painful conditions likely to require analgesic treatment for at least 7 days. At single doses of up to 2 mg/kg or multiple doses of up to 8 mg/kg per day (to a maximum of 400 mg per day) efficacy of tramadol was found to be superior to placebo, and superior or equal to paracetamol, nalbuphine, pethidine or low dose morphine. The conducted trials confirmed the efficacy of tramadol. The safety profile of tramadol was similar in adult and paediatric patients older than 1 year.
