BROMOCRIPTINE MESYLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carilion Materials Management

INN (International Name):

BROMOCRIPTINE MESYLATE

Composition:

BROMOCRIPTINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism . Bromocriptine mesylate tablets 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 therapy may be used to reduce the tumor mass prior to surgery. Bromocriptine mesylate tablets therapy is indicated in the treatment of acromegaly. Bromocriptine mesylate tablets 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 external pituitary radiation may not become

Product summary:

Product: 68151-1305 NDC: 68151-1305-0 1 TABLET in a PACKAGE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BROMOCRIPTINE MESYLATE- BROMOCRIPTINE MESYLATE TABLET
CARILION MATERIALS MANAGEMENT
----------
BROMOCRIPTINE MESYLATE TABLETS, USP
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Bromocriptine mesylate is an ergot derivative with potent dopamine
receptor agonist activity. Each
bromocriptine mesylate tablet, USP for oral administration contains
2.5 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
_Active Ingredient: _bromocriptine mesylate, USP
_Inactive Ingredients: _anhydrous lactose, colloidal silicon dioxide,
magnesium stearate, maleic acid,
povidone and pregelatinized starch.
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 agent th