ZOFRAN ondansetron hydrochloride tablet orally disintegrating

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ondansetron hydrochloride (UNII: NMH84OZK2B) (ondansetron - UNII:4AF302ESOS)

Commercializzato da:

Cardinal Health

INN (Nome Internazionale):

ondansetron hydrochloride

Composizione:

ondansetron hydrochloride 4 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

ZOFRAN- ONDANSETRON HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING
CARDINAL HEALTH
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ZOFRAN
(ONDANSETRON HYDROCHLORIDE)
TABLETS
ZOFRAN ODT
(ONDANS ETRON)
ORALLY DISINTEGRATING TABLETS
ZOFRAN
(ONDANSETRON HYDROCHLORIDE)
ORAL SOLUTION
DESCRIPTION
The active ingredient in ZOFRAN Tablets and ZOFRAN Oral Solution 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.
The active ingredient in ZOFRAN ODT 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 empirical formula is C
H N O representing a molecular weight of 293.4.
Each 4-mg ZOFRAN Tablet for oral administration contains ondansetron
HCl dihydrate equivalent to
4 mg of ondansetron. Each 8-mg ZOFRAN Tablet for oral administration
contains ondansetron HCl
dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains
the inactive ingredients lactose,
microcrystalline cellulose, pregelatinized starch, hypromellose,
magnesium stearate, titanium dioxide,
triacetin, and iron oxide yellow (8-mg tablet only).
Each 4-mg ZOFRAN ODT Orally Disintegrating Tablet for oral
administration contains 4 mg
ondansetron base. Each 8-mg ZOFRAN ODT Orally Disintegrating Tablet
for oral administration
contains 8 mg ondansetron base. Each ZOFRAN ODT Tablet also contains
the inactive ingredients
aspartame, gelatin, mannitol, methylparaben sodium, propylparaben
s