ONDANSETRON- ondansetron tablet, orally disintegrating

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

NuCare Pharmaceuticals, Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

- 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 orally disintegrating tablets, USP 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 ap

পণ্য সারাংশ:

Ondansetron Orally Disintegrating Tablets USP, 4 mg are white to off-white, round tablets debossed with 5 on one side and E on the other side with an embossed circular edge. Bottles of 2 NDC 68071-3195-2 Bottles of 4 NDC 68071-3195-4 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING
NUCARE PHARMACEUTICALS, INC.
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ONDANSETRON ORALLY DISINTEGRATING TABLETS, USP
RX ONLY
DESCRIPTION
The active ingredient in ondansetron orally disintegrating tablets,
USP is ondansetron base, 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.
It has
the following structural formula:
The molecular formula is C
H
N
O representing a molecular weight of 293.4. Ondansetron is a
white to off-white powder.
Each 4 mg ondansetron orally disintegrating tablet, USP for oral
administration contains 4 mg
ondansetron base. Each 8 mg ondansetron orally disintegrating tablet,
USP for oral administration
contains 8 mg ondansetron base. Each ondansetron orally disintegrating
tablet also contains the inactive
ingredients mannitol, crospovidone, lactose monohydrate,
microcrystalline cellulose, aspartame,
strawberry guarana flavor, colloidal silicon dioxide, and magnesium
stearate. The strawberry guarana
flavor contains maltodextrin, propylene glycol, artificial flavors,
and acetic acid. Ondansetron orally
disintegrating tablets, USP are orally administered formulation of
ondansetron which rapidly
disintegrates on the tongue and does not require water to aid
dissolution or swallowing.
This product does not meet USP Disintegration Time. The 4 mg and 8 mg
tablets disintegrate in
approximately 60 seconds.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
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 the 5-HT
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,
3
18
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3
3
3
peripherally, or in both sites. However, cytotoxic chemo