Clinical Information
Gen. Code and Des.
41562 ondansetron ORAL TAB RAPDIS 4 MG
GCN and Des.
20045 ondansetron ORAL TAB RAPDIS 4 MG
Strength
4MG ODT
Dose Form
TABLET,DISINTEGRATING
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
56222000 5-HT3 RECEPTOR ANTAGONISTS
Active Ingredients
4807 ondansetron 99614025
Inactive Ingredients
2272 mannitol 69658
2537 povidone 9003398
2605 aspartame 22839470
ZOFRAN- ondansetron hydrochloride solution
ZOFRAN ODT- ondansetron tablet, orally disintegrating
ZOFRAN- ondansetron hydrochloride tablet, film coated
GlaxoSmithKline LLC
1 INDICATIONS AND USAGE
ZOFRAN� is indicated for the prevention of nausea and vomiting associated with:
�
highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2.
�
initial and repeat courses of moderately emetogenic cancer chemotherapy.
�
radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
ZOFRAN is also indicated for the prevention of postoperative nausea and/or vomiting.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
The recommended dosage regimens for adult and pediatric patients are described in Table 1 and Table 2, respectively.
Corresponding doses of ZOFRAN tablets, ZOFRAN ODT� orally disintegrating tablets and ZOFRAN oral solution may be used interchangeably.
DOSAGE FORMS AND STRENGTHS
ZOFRAN tablets are oval, film-coated tablets engraved with "Zofran" on one side and are available in the following strengths:
�
4 mg � white tablet with "4" engraved on the other side.
�
8 mg � yellow tablet with "8" engraved on the other side.
ZOFRAN ODT orally disintegrating tablets are white, round, and plano-convex tablets available in the following strengths:
�
4 mg � debossed with "Z4" on one side.
�
8 mg � debossed with "Z8" on one side.
ZOFRAN oral solution, 4 mg/5 mL, is a clear, colorless to light yellow liquid with a characteristic strawberry odor available in a 50-mL bottle.
4 CONTRAINDICATIONS
ZOFRAN is contraindicated in patients:
1.
known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions (6.2)].
2.
receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness.
DESCRIPTION
The active ingredient in ZOFRAN tablets and ZOFRAN oral solution is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5?HT3receptor type. Chemically it is (�) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate
Mechanism of Action
Ondansetron is a selective 5?HT3 receptor antagonist. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine?receptor antagonist. Serotonin receptors of the 5?HT3 type are present both peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. It is not certain whether ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. In humans, urinary 5?hydroxyindoleacetic acid (5?HIAA) excretion increases after cisplatin administration in parallel with the onset of emesis. The released serotonin may stimulate the vagal afferents through the 5?HT3 receptors and initiate the vomiting reflex.
