BROMOCRIPTINE MESYLATE tablet BROMOCRIPTINE MESYLATE capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

BROMOCRIPTINE MESYLATE (UNII: FFP983J3OD) (BROMOCRIPTINE - UNII:3A64E3G5ZO)

から入手可能:

Sun Pharmaceutical Industries, Inc.

INN（国際名）:

BROMOCRIPTINE MESYLATE

構図:

BROMOCRIPTINE 2.5 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Bromocriptine mesylate is indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine therapy may be used to reduce the tumor mass prior to surgery. Bromocriptine therapy is indicated in the treatment of acromegaly. Bromocriptine therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately half of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine offers p

製品概要:

Bromocriptine mesylate Tablets 2.5 mg Bromocriptine mesylate tablets are available in bottles containing 30 and 100 tablets of 2.5 mg - each bottle contains a desiccant. Round, off-white, bevelled-edge scored tablets, each containing 2.5 mg bromocriptine (as the mesylate). Engraved “PARLODEL 2½’’ on one side and 017 twice on the scored side. Complies with USP dissolution test 1. Packages of 30.....................................................................................NDC 63304-962-30 Packages of 100...................................................................................NDC 63304-962-01 Bromocriptine mesylate Capsules 5 mg Caramel and white capsules, each containing 5 mg bromocriptine (as the mesylate). Imprinted in red ink “PARLODEL 5 mg’’ on one half and 102 on other half. Packages of 30..............................................................NDC 63304-158-30 Packages of 100............................................................NDC 63304-158-01 Store and Dispense Store at 68° to 77°F (20° to 25°C); excursions permitted to 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured for: Validus Pharmaceuticals LLC Parsippany, NJ 07054 Product of Italy © 2019 Validus Pharmaceuticals LLC December 2019 60116-02

認証ステータス:

New Drug Application

製品の特徴

BROMOCRIPTINE MESYLATE- BROMOCRIPTINE MESYLATE TABLET
BROMOCRIPTINE MESYLATE- BROMOCRIPTINE MESYLATE CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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BROMOCRIPTINE MESYLATE TABLETS, USP
BROMOCRIPTINE MESYLATE CAPSULES, USP
RX ONLY
DESCRIPTION
Bromocriptine mesylate is an ergot derivative with potent dopamine
receptor agonist activity. Each
bromocriptine mesylate tablet for oral administration contains 2.5 mg
and each capsule contains 5 mg
bromocriptine (as the mesylate). Bromocriptine mesylate is chemically
designated as
Ergotaman 3′,6′,18 trione, 2 bromo 12′
hydroxy 2′
(1 methylethyl) 5′
(2 methylpropyl) ,
(5′α) monomethanesulfonate (salt).
The structural formula is:
2.5 MG TABLETS
_Active Ingredient:_ bromocriptine mesylate, USP
_Inactive Ingredients:_ colloidal silicon dioxide, lactose, magnesium
stearate, maleic acid, povidone,
starch, and another ingredient
5 MG CAPSULES
_Active Ingredient:_ bromocriptine mesylate, USP
_Inactive Ingredients: _colloidal silicon dioxide, gelatin, lactose,
magnesium stearate, red iron oxide,
silicon dioxide, sodium lauryl sulfate, starch, maleic acid, titanium
dioxide, yellow iron oxide, and
another ingredient.
CLINICAL PHARMACOLOGY
Bromocriptine mesylate is a dopamine receptor agonist, which activates
post-synaptic dopamine
receptors. The dopaminergic neurons in the tuberoinfundibular process
modulate the secretion of
prolactin from the anterior pituitary by secreting a prolactin
inhibitory factor (thought to be dopamine);
in the corpus striatum the dopaminergic neurons are involved in the
control of motor function.
Clinically, bromocriptine significantly reduces plasma levels of
prolactin in patients with
physiologically elevated prolactin as well as in patients with
hyperprolactinemia. The inhibition of
physiological lactation as well as galactorrhea in pathological
hyperprolactinemic states is obtained at
dose levels that do not affect secretion of other tropic hormones from
the anterior pituitary.
Experiments have demonstrated that bromocriptine induces