ONDANSETRON HYDROCHLORIDE- ondansetron hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON 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/m 2 . - 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 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 administered

Product summary:

Ondansetron tablets USP, 4 mg (ondansetron hydrochloride USP, equivalent to 4 mg of ondansetron) are white, round, biconvex, film coated tablets debossed “R” on one side and “153” on other side and are supplied in bottles of 30, 100, 500, unit-dose packages of 100 (10 x 10) and unit-dose packages of 3 (1 x 3). Bottles of 30 NDC 55111-153-30 Bottles of 100 NDC 55111-153-01 Bottles of 500 NDC 55111-153-05 Unit Dose Packages of 100 (10 x10) NDC 55111-153-78 Unit Dose Packages of 3 (1 x 3) NDC 55111-153-13 Ondansetron tablets USP, 8 mg (ondansetron hydrochloride USP, equivalent to 8 mg of ondansetron) are yellow, round, biconvex, film coated tablets debossed “R” on one side and “154” on other side and are supplied in bottles of 30, 100, 500, unit-dose packages of  100 (10 x 10) and unit-dose packages of 3 (1 x 3). Bottles of 30 NDC 55111-154-30 Bottles of 100 NDC 55111-154-01 Bottles of 500 NDC 55111-154-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-154-78 Unit Dose Packages of 3 (1 x 3) NDC 55111-154-13 Ondansetron tablets USP, 16 mg (ondansetron hydrochloride USP, equivalent to 16 mg of ondansetron) are white, round, biconvex, film coated tablets debossed “R” on one side and “155” on other side and are supplied in bottles of 30, 500 and unit-dose packages of 100 (10 x 10). Bottles of 30 NDC 55111-155-30 Bottles of 500 NDC 55111-155-05 Unit-dose packages of 100 (10x10) NDC 55111-155-78 Ondansetron tablets USP, 24 mg (ondansetron hydrochloride USP, equivalent to 24 mg of ondansetron) are pink, round, biconvex, film coated tablets debossed “R” on one side and “156” on other side and are supplied in bottles of 30, 500, unit-dose packages of 100 (10 x 10) and unit dose packages of 1 (1 x 1). Bottles of 30 NDC 55111-156-30 Bottles of 500 NDC 55111-156-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-156-78 Unit Dose Packages of 1 (1 x 1) NDC 55111-156-11 Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Protect from light. Store blisters in cartons.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
REMEDYREPACK INC.
----------
ONDANSETRON TABLETS USP
DESCRIPTION
The active ingredient in ondansetron 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 molecular formula is C
H
N
O•HCl•2H
O, representing a molecular weight of 365.86.
Ondansetron HCl dihydrate USP is a white to off-white powder that is
soluble in methanol, sparingly
soluble in purified water and in alcohol, and slightly soluble in
isopropyl alcohol, in dichloromethane,
very slightly soluble in acetone, in chloroform and in ethyl acetate.
Each 4 mg ondansetron tablet USP for oral administration contains
ondansetron HCl dihydrate USP
equivalent to 4 mg of ondansetron. Each 8 mg ondansetrone tablet USP
for oral administration contains
ondansetron HCl dihydrate USP equivalent to 8 mg of ondansetron. Each
16 mg ondansetron tablet USP
for oral administration contains ondansetron HCl dihydrate USP
equivalent to 16 mg of ondansetron.
Each 24 mg ondansetron tablet USP for oral administration contains
ondansetron HCl dihydrate USP
equivalent to 24 mg of ondansetron.
Each tablet also contains the inactive ingredients colloidal silicon
dioxide, hypromellose 2910(5cP)
(for the 4 mg and 16 mg tablets only) and hypromellose 2910 (6cP) (for
the 8 mg and 24 mg tablets
only), iron oxide red and iron oxide black (for the 24 mg tablet
only), iron oxide yellow (for the 8 mg
and 24 mg tablets only), lactose monohydrate, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, pregelatinized starch, sodium starch glycolate,
and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Ondansetron is a selective 5-HT
receptor antagonist. While its mechanism of action has not been fully
charact