Tramadol HCl, paracetamol.
Each film-coated tab contains tramadol HCl 37.5 mg and paracetamol 325 mg.
Pharmacokinetics: Paracetamol is readily absorbed form the gastrointestinal tract with peak plasma concentrations occuring about 10-60 min after oral doses. It is distributed into most body tissues. It crosses the placenta and is present in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations. The elimination half-life (t½) of paracetamol varies from about 1-3 hrs. Tramadol is readily absorbed after oral doses but is subject to some first-pass metabolism. Mean absolute bioavailability is about 70-75% after oral use and 100% after IM injection. Plasma protein-binding is about 20%. Tramadol is metabolised by N- and O-demethylation via the cytochrome P450 (CYP450) isoenzymes CYP3A4 and CYP2D6, and glucuronidation or sulfation in the liver. The metabolite O-desmethylation is pharmacologically active. Tramadol is excreted mainly in the urine, predominantly as metabolites. Tramadol is widely distributed, crosses the placenta and appears in small amounts in breast milk. The elimination t½ is about 6 hrs.
Management of moderate to severe pain.
Adults and Children >16 years 1-2 tablets every 4-6 hrs as needed. It can be administered without regard to food. Or as prescribed by the physician.
Paratram contains FD&C yellow no.5 (tartrazine) which may cause allergic reaction including bronchial asthma in certain susceptible person.
Nausea, vomiting, constipation, drowsiness, hematological reaction including thrombocytopenia, leukopenia, respiratory depression and hypotension occasionally occurred.
The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes. The absorption of paracetamol may be accelerated by drugs eg, metoclopramide. Excretion ay be affected and plasma concentrations altered when given with probenecid. Colestyramine reduces the absorption of paracetamol if given within 1 hr of paracetamol.
Store at temperatures not exceeding 30°C.
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.