资料单张
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
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