ONDANSETRON- ondansetron hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON HYDROCHLORIDE 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2 . - Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. - Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. - Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, Ondansetron Hydrochloride Tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low. The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was

Product summary:

Ondansetron Hydrochloride Tablets 4 mg (5 mg ondansetron HCl dihydrate equivalent to 4 mg of ondansetron), are Round, White Coated Tablet; Unscored and Debossed “W 04” on one side and are available in: Ondansetron Hydrochloride Tablets 8 mg (10 mg ondansetron HCl dihydrate equivalent to 8 mg of ondansetron), are Oblong, Unscored, Yellow Coated Tablet; Debossed “WW” on one side and “12” on the other side and are available in: Ondansetron HCl Tablets 24 mg (30 mg of ondansetron HCl dihydrate equivalent to 24 mg of ondansetron), are Capsule Shaped, Unscored, Light Pink Coated Tablets; Debossed "WW" on one side and "24" on the other side and are available in: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON- ONDANSETRON HYDROCHLORIDE TABLET
WEST-WARD PHARMACEUTICAL CORP
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ONDANSETRON HYDROCHLORIDE TABLETS
Rev. 10/10
Rx Only
DESCRIPTION
The active ingredient in Ondansetron Hydrochloride Tablets is
ondansetron hydrochloride (HCl) as the
dihydrate, the racemic form of ondansetron and a selective blocking
agent of the serotonin 5-HT
receptor 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. It has the
following structural formula:
The empirical formula is C
H N O•HCl•2H O, representing a molecular weight of 365.9.
Ondansetron HCl dihydrate is a white to off-white powder that is
soluble in water and normal saline.
Each 4 mg Ondansetron Hydrochloride Tablet for oral administration
contains 5 mg of ondansetron HCl
dihydrate equivalent to 4 mg of ondansetron. Each 8 mg Ondansetron
Hydrochloride Tablet for oral
administration contains 10 mg of ondansetron HCl dihydrate equivalent
to 8 mg of ondansetron. Each 24
mg Ondansetron Hydrochloride Tablet for oral administration contains
30 mg of ondansetron HCl
dihydrate equivalent to 24 mg of ondansetron.
Each tablet also contains the inactive ingredients: anhydrous lactose,
colloidal silicon dioxide,
magnesium stearate, microcrystalline cellulose and pregelatinized
starch. Polishing solution contains
hypromellose and polyethylene glycol. Film coating solution contains
the following:
4 MG: opadry white YS-1-7003, hypromellose, polyethylene glycol,
polysorbate 80 and titanium
dioxide.
8 MG: opadry clear YS-1-7006, hydroxypropyl methylcellulose,
polyethylene glycol, titanium dioxide,
and yellow iron oxide.
24 MG: opadry clear, YS-1-7006, hydroxypropyl methylcellulose,
polyethylene glycol, red iron oxide,
and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
3
18
19
3
2
Ondansetron is a selective 5-HT receptor antagonist. While its
mechanism of action has not been fully
characterized, ondansetron is not a dopamine-receptor antagonist.
Serotonin receptors of