BROMOCRIPTINE MESYLATE capsule

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Zydus Pharmaceuticals USA Inc.

INN (Међународно име):

BROMOCRIPTINE MESYLATE

Састав:

BROMOCRIPTINE 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate capsules are 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 mesylate capsule therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate capsule therapy is indicated in the treatment of acromegaly. Bromocriptine mesylate capsule therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately ½ of patients treated, although not usually to normal levels. Since the effects of exter

Резиме производа:

Bromocriptine Mesylate Capsules USP, 5 mg are white to off-white powder filled in size "3" empty Cellulose capsules with tan colored cap printed with "ZA 17" in black ink and white colored body printed with "5 mg" in black ink and are supplied as follows: NDC 68382-110-06 in bottle of 30 capsules with child-resistant closure NDC 68382-110-01 in bottle of 100 capsules Storage: Store at 20°C to 25°C (68°F to 77° F) [See USP Controlled Room Temperature]; in tight, light-resistant container. Dispense in a tight, light-resistant container.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

BROMOCRIPTINE MESYLATE- BROMOCRIPTINE MESYLATE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
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BROMOCRIPTINE MESYLATE CAPSULES, USP
DESCRIPTION
Bromocriptine mesylate is an ergot derivative with potent dopamine
receptor agonist
activity. Bromocriptine mesylate is chemically designated as
Ergotaman-3΄, 6΄, 18-trione,
2-bromo-12΄-hydroxy-2΄-(1-methylethyl)-5΄-(2-methylpropyl)-,
(5΄α)-mono-
methanesulfonate (salt).
The structural formula is:
C
H
BrN O .CH SO Mol. wt. 750.70
Bromocriptine mesylate, USP is white or slightly colored, fine
crystalline powder and
odorless or having a weak, characteristic odor.
Each bromocriptine mesylate capsule USP, 5 mg intended for oral
administration
contains bromocriptine mesylate equivalent to 5 mg of bromocriptine.
In addition, each
capsule contains the following inactive ingredients: carrageenan,
colloidal silicon dioxide,
hypromellose, iron oxide red, lactose monohydrate, magnesium stearate,
maleic acid,
potassium hydroxide and titanium dioxide. Each capsule is printed with
black
pharmaceutical ink and has following inactive ingredients: black iron
oxide, potassium
hydroxide, propylene glycol, purified water, shellac and strong
ammonia solution.
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
32
40
5
5
4
3
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 de