Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
ASPEN ONDANSETRON 4 MG/2 ML ASPEN ONDANSETRON 8 MG/4 ML SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ASPEN ONDANSETRON 4 MG/2 ML (Liquid Injection) ASPEN ONDANSETRON 8 MG/4 ML (Liquid Injection) COMPOSITION Each mL contains Ondansetron Hydochloride USP equivalent to 2 mg Ondansetron PHARMACOLOGICAL CLASSIFICATION A5.10 Medicines affecting autonomic functions. Serotonin antagonists. PHARMACOLOGICAL ACTION Ondansetron is a selective 5-HT3 receptor-antagonist. Chemotherapeutic agents and radiotherapy may cause release of 5- HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5-HT3 receptors. The initiation of this reflex is blocked by ondansetron. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus the effect of ondansetron in the management of the nausea and vomiting induced by chemotherapy and radiotherapy may be due to the antagonism of 5-HT3 receptors on neurons located both in the peripheral and central nervous system. In psychomotor testing, ondansetron does not cause sedation nor impair performance. Pharmacokinetics: Plasma prolactin concentrations are not altered by ondansetron. Ondansetron is rapidly absorbed following oral administration, with maximum plasma concentrations of about 30 ng/mL being attained approximately 1,6 hours after an 8 mg dose. The disposition of ondansetron following both intravenous and oral dosing is similar with a terminal elimination half life of about 3 hours and a steady-state volume of distribution of about 140 L. Plasma protein binding is 70-76%. Ondansetron is cleared from the systemic circulation predominantly by metabolism with less t Read the complete document