ONDANSETRON- ondansetron tablet, orally disintegrating

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NuCare Pharmaceuticals,Inc.

INN (Διεθνής Όνομα):

ONDANSETRON

Σύνθεση:

ONDANSETRON 4 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

- 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 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 apomor

Περίληψη προϊόντος:

Ondansetron orally disintegrating tablets, 4 mg (as 4 mg ondansetron base) are white to off white, oval, uncoated tablets debossed with 240 on one side and plain on the other side. NDC 68071-1977-2 BLISTER PACK OF 2 NDC 68071-1977-4 BLISTER PACK OF 4 Store between 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING
NUCARE PHARMACEUTICALS,INC.
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ONDANSETRON ORALLY DISINTEGRATING TABLETS
DESCRIPTION
The active ingredient in ondansetron orally disintegrating tablets 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.
Each 4 mg ondansetron orally disintegrating tablet for oral
administration contains 4 mg ondansetron,
USP. Each 8 mg ondansetron orally disintegrating tablet for oral
administration contains 8 mg
ondansetron, USP. Each ondansetron orally disintegrating tablet also
contains the inactive ingredients
aspartame, colloidal silicon dioxide, croscarmellose sodium, glycerol
distearate, magnesium stearate,
mannitol, talc and strawberry flavor. Ondansetron orally
disintegrating tablets are orally administered
formulation of ondansetron which rapidly disintegrates on the tongue
and does not require water to aid
dissolution or swallowing.
Does not meet USP Disintegration Time. This product disintegrates 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,
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-
hydroxyindoleacetic acid) excretion increases after cisplatin
administration in parallel with the ons