BROMOCRIPTINE MESYLATE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Sandoz Inc

INN (국제 이름):

BROMOCRIPTINE MESYLATE

구성:

BROMOCRIPTINE 2.5 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 patients treated, although not usually to normal levels. Since the effects of external pituitary radiation may not become maximal for several years, adjunctive therapy with bromocriptine mesylate tablets, USP offers potential benefit before the effects of irradiation are manifested. Bromocriptine mesylate tablets, USP are indicated in the treatment of the signs and symptoms of idiopathic or postencephalitic Parkinson's disease. As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor), bromocriptine mesylate tablets, USP therapy may provide additional therapeutic benefits in those patients who are currently maintained on optimal dosages of levodopa, those who are beginning to deteriorate (develop tolerance) to levodopa therapy, and those who are experiencing "end of dose failure" on levodopa therapy. Bromocriptine mesylate tablets, USP therapy may permit a reduction of the maintenance dose of levodopa and, thus may ameliorate the occurrence and/or severity of adverse reactions associated with long-term levodopa therapy such as abnormal involuntary movements (e.g., dyskinesias) and the marked swings in motor function ("on-off" phenomenon). Continued efficacy of bromocriptine mesylate tablets, USP therapy during treatment of more than two years has not been established. Data are insufficient to evaluate potential benefit from treating newly diagnosed Parkinson's disease with bromocriptine mesylate tablets, USP. Studies have shown, however, significantly more adverse reactions (notably nausea, hallucinations, confusion and hypotension) in bromocriptine mesylate tablets, USP-treated patients than in levodopa/carbidopa-treated patients. Patients unresponsive to levodopa are poor candidates for bromocriptine mesylate tablets, USP therapy. Hypersensitivity to bromocriptine or to any of the excipients of bromocriptine mesylate, uncontrolled hypertension and sensitivity to any ergot alkaloids. In patients being treated for hyperprolactinemia, bromocriptine mesylate should be withdrawn when pregnancy is diagnosed ( see PRECAUTIONS, Hyperprolactinemic States ). In the event that bromocriptine mesylate is reinstituted to control a rapidly expanding macroadenoma (see PRECAUTIONS, Hyperprolactinemic States ) and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing bromocriptine mesylate must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When bromocriptine mesylate is being used to treat acromegaly, prolactinoma, or Parkinson’s disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of bromocriptine mesylate is considered to be medically contraindicated. The drug should not be used during the postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions unless withdrawal is considered medically contraindicated. If the drug is used in the postpartum period, the patient should be observed with caution.

제품 요약:

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. NDC 0781-5325-31 bottle of 30 tablets NDC 0781-5325-01 bottle of 100 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container. Manufactured in Slovenia by Novartis Pharmaceutical Manufacturing LLC for Sandoz Inc., Princeton, NJ 08540 Rev. March 2024

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BROMOCRIPTINE MESYLATE- BROMOCRIPTINE MESYLATE TABLET
SANDOZ INC
----------
BROMOCRIPTINE MESYLATE TABLETS, USP 2.5 MG
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, corn starch, disodium edetate, lactose
monohydrate, magnesium
stearate, maleic acid, and povidone.
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
secretion of prolactin in humans, with littl