AMTRON 8mg/4ml

Ondanstron hydrochloride dihhydrate

SUPERLATIVE APPROACH FOR NAUSEA & VOMITING

TRUSTED AND RELIABLE EUROPEAN PRODUCT

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• A selective blocking agent of the serotonin 5-HT3 receptor types in brain and periphery. Useful in highly emetogenic chemotherapy & radiotherapy. Well tolerated and more effective than Metaclopromide in the treatment of established PONV.1 High levels of patient satisfaction. Doesn't cause sedation or Extra Pyramidal reactions

 

For the management of nausea and vomiting

• induced by cytotoxic chemotherapy,

• for the prevention and treatment of post-operative nausea and vomiting (PONV)

• For the prevention of nausea and vomiting associated with radiotherapy, either total body irradiation or single high dose fraction to the abdomen.

Indications:

Pharmacology
Mechanism of Action
Mechanism not fully characterized; selective 5-HT3 receptor antagonist; binds to 5-HT3 receptors both in periphery and in CNS, with primary effects in GI tract, Has no effect on dopamine receptors and therefore does not cause extrapyramidal symptoms
Absorption
Bioavailability: 56-71% (PO); food increases extent of absorption (17%)
Onset: 30 min
Peak plasma time: IV, end of infusion; IM, 30 min; PO, 2 hr (tablet) or 1 hr (soluble film)
Distribution
Protein bound: 70-76%
Vd: Children, 1.7-3.7 L/kg; adults, 2.2-2.5 L/kg
Metabolism
Extensive hepatic metabolism, with hydroxylation followed by glucuronide (indole ring) or sulfate conjugation; metabolized by CYP2D6 and partly by CYP1A2 and CYP3A4
Metabolites: Glucuronide conjugate, sulfate conjugate (inactive)
Elimination
Half-life: 2-7 hr (children <15 years); 3-7 hr (adults); patients with mild to moderate hepatic impairment, 12 hr; patients with severe hepatic impairment (Child-Pugh class C), 20 hr
Renal Clearance: 0.26-0.38 L/hr/kg
Total body clearance: 600-700 mL/min
Excretion: Primarily urine (30-70%); feces (25%)

IV Administration

Infuse over 15 minutes after further dilution with 50 mL NS/D5W
Inject undiluted over at least 30 seconds, preferably over 2-5 minutes

IM Administration

No dilution necessary for premixed injection

Storage

Store at room temperature or refrigerate
Protect from light, excessive heat, and freezing

Pack size:
5’S