CABERGOLINE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

CABERGOLINE (UNII: LL60K9J05T) (CABERGOLINE - UNII:LL60K9J05T)

Հասանելի է:

Strides Pharma Science Limited

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas. Cabergoline Tablets, USP are contraindicated in patients with - Uncontrolled hypertension or known hypersensitivity to ergot derivatives. - History of cardiac valvular disorders, as suggested by anatomical evidence of valvulopathy of any valve, determined by pre-treatment evaluation including echocardiographic demonstration of valve leaflet thickening, valve restriction, or mixed valve restriction-stenosis (See WARNINGS ). - History of pulmonary, pericardial, or retroperitoneal fibrotic disorders. (See WARNINGS ).

Ապրանքի ամփոփագիր:

Cabergoline Tablets, USP are a white to off-white, oval shape, flat face, beveled edge tablet containing 0.5 mg cabergoline USP. Each tablet is debossed "P" bisect line "P" on one side and "673" on the other side. Cabergoline Tablets, USP are available as follows:                                                   Bottles of 8 tablets                                 NDC 64380-202-01

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

CABERGOLINE - CABERGOLINE TABLET
STRIDES PHARMA SCIENCE LIMITED
----------
CABERGOLINE TABLETS, USP
RX ONLY
DESCRIPTION
Cabergoline Tablets, USP contain cabergoline USP, a dopamine receptor
agonist. The
chemical name for cabergoline USP is
1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-
(dimethylamino)propyl]-3-ethylurea. Its molecular formula is C
H
N O , and its
molecular weight is 451.62. The structural formula is as follows:
STRUCTURE
Cabergoline USP is a white powder soluble in ethyl alcohol,
chloroform, and N, N-
dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid;
very slightly soluble
in n-hexane; and insoluble in water.
Each tablet, for oral administration, contains 0.5 mg of cabergoline
USP. Inactive
ingredients consist of citric acid, croscarmellose sodium, magnesium
stearate and
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: The secretion of prolactin by the anterior
pituitary is mainly
under hypothalamic inhibitory control, likely exerted through release
of dopamine by
tuberoinfundibular neurons. Cabergoline is a long-acting dopamine
receptor agonist with
a high affinity for D receptors. Results of _in vitro _studies
demonstrate that cabergoline
exerts a direct inhibitory effect on the secretion of prolactin by rat
pituitary lactotrophs.
Cabergoline decreased serum prolactin levels in reserpinized rats.
Receptor-binding
studies indicate that cabergoline has low affinity for dopamine D , a
- and a -adrenergic,
and 5-HT - and 5-HT -serotonin receptors.
26
37
5
2
2
1
1
2
1
2
CLINICAL STUDIES: The prolactin-lowering efficacy of cabergoline was
demonstrated in
hyperprolactinemic women in two randomized, double-blind, comparative
studies, one
with placebo and the other with bromocriptine. In the
placebo-controlled study (placebo
n=20; cabergoline n=168), cabergoline produced a dose-related decrease
in serum
prolactin levels with prolactin normalized after 4 weeks of treatment
in 29%, 76%, 74%
and 95% of the patients receiving 0.125, 0.5, 0.75, and 1 mg twice
weekly, respe