Riik: Lõuna-Aafrika Vabariik
keel: inglise
Allikas: South African Health Products Regulatory Authority (SAHPRA)
Pharmacare Limited û Woodmead
See ingredients
TABLET
EACH TABLET CONTAINS LORAZEPAM 1 mg
Registered
1990-10-02
_ZA_TRANTAB_9002_05 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 10 _ 1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE SCHEDULING STATUS S5 PROPRIETARY NAME AND DOSAGE FORM TRANQIPAM - 0,5 (tablet) TRANQIPAM - 1 (tablet) TRANQIPAM - 2,5 (tablet) COMPOSITION Each tablet of TRANQIPAM - 0,5 contains 0,5 mg of lorazepam _Excipients: _ Lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium. Contains sugar: Lactose 33,875 mg Each tablet of TRANQIPAM - 1 contains 1 mg of lorazepam _Excipients: _ Lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium. Contains sugar: Lactose 67,50 mg Each tablet of TRANQIPAM - 2,5 contains 2,5 mg of lorazepam _ZA_TRANTAB_9002_05 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 10 _ _Excipients: _ Lactose, magnesium stearate, microcrystalline cellulose, polacrilin potassium Contains sugar: Lactose 134,475 mg CATEGORY AND CLASS A 2.6 Tranquillizers PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Lorazepam is a benzodiazepine and has anxiolytic properties. Benzodiazepines presumably exert their effects by binding to specific receptors at several sites within the central nervous system, by potentiating the effects of synaptic or presynaptic inhibition mediated by gamma- aminobutyric acid. PHARMACOKINETIC PROPERTIES Lorazepam is rapidly absorbed when given orally. Peak plasma concentrations occur approximately 2 hours following administration. The half- life of unconjugated lorazepam in human plasma is approximately 12 to 16 hours. Lorazepam is about 90 % bound to plasma proteins. Conjugation with glucuronic acid to form the inactive glucuronide of lorazepam is the major metabolic pathway. Seventy to seventy five percent of the dose is excreted as the glucuronide in the urine. Metabolism is only subject to glucoronidation and is not linked to the action of the cytochrome P450 enzyme system. The plasma levels of lorazepam are proportional to the dose given. _ZA_TRANTAB_9002_05 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 3 of 10 _ INDICATIONS TRANQIPAM is Lugege kogu dokumenti