bromocriptine mesylate- Bromocriptine Mesylate tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Bromocriptine Mesylate (UNII: FFP983J3OD) (Bromocriptine - UNII:3A64E3G5ZO)

Tilgjengelig fra:

Lek Pharmaceuticals

INN (International Name):

Bromocriptine Mesylate

Legemiddelform:

TABLET

Sammensetning:

2.5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate 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 therapy may be used to reduce the tumor mass prior to surgery. Acromegaly Bromocriptine mesylate tablets are indicated in the treatment of acromegaly. Bromocriptine mesylate therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately one-half of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for

Produkt oppsummering:

Bromocriptine mesylate tablets, USP 2.5 mg are white to yellowish white round tablets, scored on one side with debossed code BCT 2 1/2 on reverse side, and are available in bottles of 30 and 100. Store below 25°C (77°F). Dispense in a tight, light-resistant container as defined in the USP. Keep this and all drugs out of the reach of children.   Rx Only Rev. October 2002     Manufactured by Lek Pharmaceuticals d.d. Verovøkova 57, Ljubljana, Slovenia

Preparatomtale

BROMOCRIPTINE MESYLATE - BROMOCRIPTINE MESYLATE TABLET
LEK PHARMACEUTICALS
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BROMOCRIPTINE MESYLATE TABLETS, USP 2.5 MG
Rev. 10-02
DESCRIPTION
Bromocriptine mesylate is an ergot derivative with potent dopamine
receptor agonist activity.
Bromocriptine mesylate is chemically designated as 2-bromoergocryptine
monomethanesulfonate
(salt).* Bromocriptine mesylate is a white or slightly colored, fine
crystalline powder odorless or
having a weak characteristic odor.
STRUCTURAL FORMULA
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.
CLINICAL PHARMACOLOGY
Bromocriptine mesylate is a dopamine receptor agonist, which activates
postsynaptic 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
hyperprolactine-mic 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 striataldopamine receptors. Bromocriptine mesylate is
a nonhormonal, nonestrogenic
agent that inh