ONDANSETRON HYDROCHLORIDE tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Proficient Rx LP

ІПН (Міжнародна Ім'я):

ONDANSETRON HYDROCHLORIDE

Склад:

ONDANSETRON 8 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

The concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. Ondansetron tablets are contraindicated for patients known to have hypersensitivity to the drug. Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Огляд продуктів:

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]. Protect from light.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
PROFICIENT RX LP
----------
ONDANSETRON TABLETS,USP
RX ONLY
DESCRIPTION
The active ingredient in ondansetron tablets, USP 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
365.9. Ondansetron hydrochloride USP (dihydrate) is a white to
off-white powder that is
soluble in water and normal saline.
Ondansetron tablets, USP for oral administration contain ondansetron
hydrochloride
USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron.
Each film-coated
tablet also contains the inactive ingredients anhydrous lactose,
microcrystalline cellulose,
pregelatinized starch (maize), magnesium stearate, triacetin, titanium
dioxide and
hypromellose. In addition 8 mg tablet also contains iron oxide yellow
and 24 mg tablet
also contains iron oxide red.
Meets USP dissolution test 6.
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-
3
18
19
3
2
3
3
HIAA (5-hydroxyindoleacetic acid) excretion increases after cisplatin
administration in
parallel with the onset of emesis. The released serotonin may
stimulate