ONDANSETRON- 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:

PD-Rx Pharmaceuticals, Inc.

ІПН (Міжнародна Ім'я):

ONDANSETRON HYDROCHLORIDE

Склад:

ONDANSETRON 4 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

- 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 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 apomorphine w

Огляд продуктів:

Ondansetron tablets USP, 4 mg (ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets debossed with "4" on one side and “NO” on the other side. They are supplied as follows: NDC 43063-746-12                    Bottles of 12 Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

ONDANSETRON- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
RX ONLY
DESCRIPTION
The active ingredient in ondansetron tablets 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 HCl dihydrate is a white to off-white powder that is
soluble in water and
normal saline.
Each 4 mg ondansetron tablet, USP for oral administration contains
ondansetron
hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg
ondansetron
tablet, USP for oral administration contains ondansetron hydrochloride
dihydrate
equivalent to 8 mg of ondansetron. Each tablet also contains the
inactive ingredients
croscarmellose sodium, hypromellose, lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, pregelatinized starch, titanium dioxide,
triacetin, and iron oxide
yellow (8 mg tablet only).
This product meets USP Dissolution Test 3.
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 re