ONDANSETRON HYDROCHLORIDE solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Carilion Materials Management

ІПН (Міжнародна Ім'я):

ONDANSETRON HYDROCHLORIDE

Склад:

ONDANSETRON 4 mg in 5 mL

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

The concomitant use of apomorphine with Ondansetron Oral Solution, USP is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with Ondansetron Oral Solution, USP. Ondansetron Oral Solution, USP is 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:

NDC:68151-1668-8 in a CUP of 1 SOLUTIONS

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE SOLUTION
CARILION MATERIALS MANAGEMENT
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ONDANSETRON ORAL SOLUTION, USP
RX ONLY
DESCRIPTION
The active ingredient in Ondansetron Oral Solution, 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 HCl dihydrate is a white to off-white powder that is
soluble in water and normal saline.
Each 5 mL of Ondansetron Oral Solution, USP contains 5 mg of
ondansetron HCl dihydrate equivalent to
4 mg of ondansetron. Ondansetron Oral Solution, USP contains the
inactive ingredients citric acid
anhydrous, glycerin, purified water, saccharin sodium, sodium
benzoate, sodium citrate, and strawberry
flavor.
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 onset of
emesis. The released serotonin may stimulate the vagal afferents
through the 5-HT receptors and
initiate the vomiting reflex.
In animals, the emetic response to cisplatin can be prevented by
pretreatment with an inhibitor of
serotonin synthesis,