BROMOCRIPTINE MESYLATE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Physicians Total Care, Inc.

SNN (starptautisko nepatentēto nosaukumu):

BROMOCRIPTINE MESYLATE

Kompozīcija:

BROMOCRIPTINE 2.5 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Bromocriptine mesylate tablets and 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 therapy may be used to reduce the tumor mass prior to surgery. Bromocriptine mesylate tablet and capsule therapy is indicated in the treatment of acromegaly. Bromocriptine therapy, alone or as adjunctive therapy with pituitary irradiation or surgery, reduces serum growth hormone by 50% or more in approximately half of patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for several yea

Produktu pārskats:

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, scored tablets debossed with M over 42 on one side of the tablet and scored on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED AUGUST 2006 BROMTC:R3 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma         74146

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

BROMOCRIPTINE MESYLATE - BROMOCRIPTINE MESYLATE TABLET
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Bromocriptine mesylate, USP is an ergot derivative with potent
dopamine receptor agonist activity.
Each bromocriptine mesylate tablet for oral administration contains
2.5 mg (as the mesylate) and each
bromocriptine mesylate capsule for oral administration contains 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:
The active ingredient in bromocriptine mesylate tablets, USP is
bromocriptine mesylate, USP. The
inactive ingredients are as follows: anhydrous lactose, edetate
disodium, magnesium stearate, maleic
acid, pregelatinized starch and sodium lauryl sulfate.
Bromocriptine mesylate tablets USP, 2.5 mg meets _USP Dissolution Test
1_.
The active ingredient in bromocriptine mesylate capsules, USP is
bromocriptine mesylate, USP. The
inactive ingredients are as follows: anhydrous lactose, black iron
oxide, D&C Yellow #10 aluminum
lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red
#40 aluminum lake,
gelatin, magnesium stearate, maleic acid, n-butyl alcohol,
pregelatinized starch, propylene glycol, red
iron oxide, SDA 3A alcohol, SD-45 alcohol, shellac glaze, sodium
lauryl sulfate, titanium dioxide and
yellow iron oxide.
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 significantly reduces plasma levels of
prolactin in patients with
physiologically elevated prolactin as well as in patients with
hyperprolactinemia. The