Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRAMADOL HYDROCHLORIDE
Hovid Pharmacy Sdn. Bhd.
TRAMADOL HYDROCHLORIDE
30Tablet Tablets; 10Tablet Tablets
HOVID BERHAD
__________ _________ PENGESIC SR TABLET 100 MG DESCRIPTION 10 mm. White, round, transparent film-coated tablet, shallow convex faces and ‘hovid’ embossed on one face. COMPOSITION Each tablet contains: Tramadol Hydrochloride 100 mg ACTIONS AND PHARMACOLOGY Tramadol is a centrally-acting analgesic that is not chemically related to opiates. The mechanism of action of tramadol has not been fully determined, but it may bind to mu-opioid receptors and inhibit the reuptake of norepinephrine (NE) and serotonin. The ability of tramadol to inhibit the neuronal uptake of monoamines in the same concentration range at which it binds to mu-opioid receptors differentiates it from typical opioids. PHARMACOKINETICS Absorption Tramadol is readily absorbed after oral doses but is subject to first-pass metabolism. Mean absolute bioavailability of 100-mg dose is approximately 75%. The rate or extent of absorption is not significantly affected by administration with food. Distribution Tramadol is widely distributed, crosses the placenta, and appears in small amounts in breast milk. Protein Binding Low (20%) Biotransformation Tramadol is metabolized by N- and O-demethylation via the cytochrome P450 isoenzymes CYP3A4 and CYP2D6 and glucuronidation or sulfation in the liver. The metabolite O-des-methyltramadol is pharmacologically active. The inactive metabolites are formed by N-demethylation. Elimination Tramadol is excreted mainly in the urine, predominantly as metabolites. The elimination half life after oral doses is about 6 hours. INDICATIONS Pengesic SR tablet 100 mg is indicated for the management of moderate to severe pain. CONTRAINDICATIONS It is generally contraindicated in the following conditions: - Respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion. - In the presence of acute alcoholism, head injuries and conditions in which intracranial pressure is raised. - It should not be used in patients receiving MAO inhibitors. - Previous hypersensitivity to Tramadol. - It should not b Olvassa el a teljes dokumentumot