BROMOCRIPTINE MESYLATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Padagis US LLC

DCI (Dénomination commune internationale):

BROMOCRIPTINE MESYLATE

Composition:

BROMOCRIPTINE 2.5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Bromocriptine Mesylate Tablets, USP are available in bottles containing 30 and 100 tablets of 2.5 mg, each bottle contains a desiccant. Bromocriptine Mesylate Tablets, USP are available containing 2.5 mg of bromocriptine (as the mesylate). The 2.5 mg tablets are white to off-white, round, bevel edged snap tablets, debossed with "PAD" over "0106" on one side and scored on the other side. Bottles of 30.........NDC 0574-0106 -03 Bottles of 100.......NDC 0574-0106 -01 Store at 20° to 25°C (68° to 77°F) [see USP for Controlled Room Temperature] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

BROMOCRIPTINE MESYLATE- BROMOCRIPTINE MESYLATE TABLET
PADAGIS US LLC
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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 that
inhibits the