ONDANSETRON- ondansetron tablet, orally disintegrating

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Rnabaxy Pharmaceuticals Inc.

INN (שם בינלאומי):

ONDANSETRON

הרכב:

ONDANSETRON 4 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

1. Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m2 . 2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. 3. 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. 4. 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 whe

leaflet_short:

Ondansetron orally disintegrating tablets, USP 4 mg (as 4 mg ondansetron, base) are white to off-white, round, flat face, beveled edge, uncoated tablets, debossed with “RE6 ” on one side and plain on the other side. Ondansetron orally disintegrating tablets, USP 4 mg are available as: NDC 63304-346-30 Bottles of 30 NDC 63304-346-05 Bottles of 500 NDC 63304-346-69 Blister Pack of 10 Ondansetron orally disintegrating tablets, USP 8 mg (as 8 mg ondansetron, base) are white to off-white, round, flat face, beveled edge, uncoated tablets, debossed with “RE7 ” on one side and plain on the other side. Ondansetron orally disintegrating tablets, USP 8 mg are available as: NDC 63304-347-30 Bottles of 30 NDC 63304-347-05 Bottles of 500 NDC 63304-347-69 Blister Pack of 10 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. You may report side effects to FDA at 1-800-FDA-1088 .

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ONDANSETRON - ONDANSETRON TABLET, ORALLY DISINTEGRATING
RNABAXY PHARMACEUTICALS INC.
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PRESCRIBING INFORMATION
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 molecular structure:
The molecular formula is C
H N O, representing a molecular weight of 293.4.
USP disintegration test pending. Does not meet USP Disintegration
Time. This product disintegrates in
approximately 60 seconds.
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, USP also contains the
inactive ingredients aspartame, colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate,
mannitol, strawberry guarana flavor, and talc. 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.
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, 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-HIAA (5-hydroxyindoleac