BROMOCRIPTINE MESYLATE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

American Health Packaging

INN (International namn):

BROMOCRIPTINE MESYLATE

Sammansättning:

BROMOCRIPTINE 2.5 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Bromocriptine mesylate tablets, USP are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate tablets, USP 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 tablets, USP therapy may be used to reduce the tumor mass prior to surgery. Bromocriptine mesylate tablets, USP are indicated in the treatment of acromegaly. Bromocriptine mesylate tablets, USP therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately one-half of patien

Produktsammanfattning:

Bromocriptine mesylate tablets, USP are available as follows: 2.5 mg white to yellowish white round tablets, scored on one side with debossed code BCT 2 1/2 on reverse side. Unit dose packages of 30 (3 x 10) NDC 60687-286-21

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

BROMOCRIPTINE MESYLATE- BROMOCRIPTINE MESYLATE TABLET
AMERICAN HEALTH PACKAGING
----------
BROMOCRIPTINE MESYLATE TABLETS, USP
RX ONLY
8428621/0522F
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)-
monomethanesulfonate (salt).
The structural formula is:
2.5 MG TABLETS
Each tablet for oral administration contains bromocriptine mesylate
equivalent to 2.5 mg
bromocriptine. In addition, each tablet contains the following
inactive ingredients:
colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
povidone, corn
starch, maleic acid and disodium edetate.
Complies with USP Dissolution Test 1.
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 mesylate
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
long-lasting
stereotyped behavior in rodents and turning behavior in rats having
unilateral lesions in
the substantia nigra. These actions, characteristic of those produced
by dopamine, are
inhibited by dopamine antagonists and suggest a direct action of
bromocriptine on
striatal dopamine receptors.
Bromocriptine mesylate is a nonhormonal, nonestrogenic a