Страна: Южна Африка
Език: английски
Източник: South African Health Products Regulatory Authority (SAHPRA)
Lennon
PASRIN-10 Tablets SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): PASRIN-10 Tablets COMPOSITION: Each tablet contains 10 mg buspirone hydrochloride respectively. PHARMACOLOGICAL CLASSIFICATION: A 2.6.5. Tranquillizers, miscellaneous structures. PHARMACOLOGICAL ACTION: Buspirone hydrochloride is an anxiolytic agent. The exact mechanism of buspirone's anxiolytic action in humans is not fully understood. Buspirone does not act through a benzodiazepine - receptor mechanism. Buspirone has been shown to have a high affinity for serotonin 5 - HT 1A ) receptors in the dorsal rophe neurons and a moderate affinity for brain D 2 - dopamine receptors. Buspirone hydrochloride is rapidabsorbed from the gastro-intestinal tract reaching peak plasma concentrations 60 to 90 minutes after administration. Systemic bioavailis low due to extensive first-pass metabolism but may be further increased by concurrent administration of food. Buspirone is about 95% bound to plasma proteins. Buspirone clearance is reduced in the presence of renal and hepatic function impairments. The elimination half-life of Buspirone has varied between 2 and 11 hours. INDICATIONS: Pasrin is indicated for the management of anxiety disorders with or without accompanying depression. CONTRA-INDICATIONS: Patients with known hypersensitivity to buspirone hydrochloride. Pregnancy and lactation. Patients with severe renal or hepatic impairment. Patients with a history of seizure disorders. Safety and efficacy of Pasrin in children under 18 years have not been established. WARNINGS: Pasrin may lower convulsion threshold. Pasrin should not be used concomitantly with a monoamine oxidase inhibitor. Reports have described the occurrence of elevated blood pressure in patients receiving both buspirone and monoamine oxidase inhibitors. DOSAGE AND Прочетете целия документ