Krajina: Južná Afrika
Jazyk: angličtina
Zdroj: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN GRANISETRON 1 mg (tablet) ASPEN GRANISETRON 2 mg (tablet) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN GRANISETRON 1 mg (tablet) ASPEN GRANISETRON 2 mg (tablet) COMPOSITION: ASPEN GRANISETRON 1 mg: Each tablet contains Granisetron Hydrochloride equivalent to 1,0 mg Granisetron free base. ASPEN GRANISETRON 2 mg: Each tablet contains Granisetron Hydrochloride equivalent to 2,0 mg Granisetron free base. PHARMACOLOGICAL CLASSIFICATION: A.5.7.2. Anti-emetics and anti-vertigo preparations PHARMACOLOGICAL ACTION: Pharmacodynamics: Granisetron is a selective antagonist of 5-hydroxytryptamine (5-HT) 3 receptors with anti-emetic properties. Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types including 5-HT and dopamine D 2 binding sites. Pharmacokinetics: Granisetron is absorbed after oral administration, with peak plasma concentrations occurring 2 hours after dosing. Due to first-pass metabolism, the oral bioavailability of granisetron is about 60%. Granisetron has an apparent volume of distribution of about 3 L/kg. Plasma protein binding is approximately 65%. The pharmacokinetics of granisetron exhibit considerable interindividual variation. The elimination half-life is reported to be approximately 3-4 hours in healthy individuals and about 9-12 hours in cancer patients. Granisetron is metabolised primarily by 7-hydroxylation, with less than 20% of a dose recovered unchanged in urine, and the remainder being excreted in faeces and urine as metabolites. Granisetron clearance is not affected by renal impairment, but is lower in the elderly and in patients with hepatic impairment. INDICATIONS: ASPEN GRANISETRON is indicated for the prevention of nausea and vomiting induced by moderately emetogenic cytostatic therapy. CONTRA-INDIC Prečítajte si celý dokument