Description
Generics:
Bromocriptine Mesylate
Dosage Form: Tablet.
Indications:
Hyperprolactinemia-Associated Dysfunctions: Dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism.
Prolactin secreting adenomas: ln cases where adenectomy is elected, a course of bromocriptine mesilate therapy may be used to reduce the tumor mass prior to surgery.
Acromegaly: Parkinson’s Disease: Idiopathic or postencephalitic Parkinson’s disease- As adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor).
Pharmacology:
Except in individuals with acromegaly, where it decreases high blood levels of growth hormone, bromocriptine mesilate is a nonhormonal, nonestrogenic drug that suppresses prolactin secretion in humans with little or no impact on other pituitary hormones. Bromocriptine mesilate is a dopamine receptor agonist that stimulates dopamine receptors in the post-synaptic area. Dopaminergic neurons in the tuberoinfundibular process secrete a prolactin inhibitory factor (considered to be dopamine) that modulates prolactin production from the anterior pituitary; dopaminergic neurons in the corpus striatum are engaged in motor function regulation.
Dosage guideline:
General: It is recommended that Bromocriptine mesilate be taken with food. Patients should be evaluated frequently during dose escalation to determine the lowest dosage that produces a therapeutic response.
Hyperprolactinemic lndications: The initial dosage is 0.5 mg to 2.5 mg tablet daily. An additional 2.5 mg tablet may be added to the treatment regimen as tolerated as tolerated every 2-7 days until an optimal therapeutic response is achieved.Based on limited data in children of age 11 to 15 the initial dose is 0.5 to 2.5 mg tablet daily. Dosing may need to be increased as tolerated until a therapeutic response is achieved. The therapeutic dosage ranged from 2.5-10 mg daily in children with prolactin-secreting pituitary adenomas.
Acromegaly: The initial recommended dosage is 0.5 to 2.5 mg on retiring (with food) for 3 days. An additional 0.5 to 2.5 mg should be added to the treatment regimen as tolerated every 3-7 days until patient obtains optimal therapeutic benefit. The maximal dosage should not exceed 100 mg/day.
Parkinson’s disease: The basic principle of bromocriptine mesilate therapy is to initiate treatment at a low dosage. The initial dose of Bromocriptine mesilate is 0.5 of a 2.5 mg tablet twice daily with meals. If necessary,the dosage may be increased every 14-28 days by 2.5 mg/day with meals.The safety of bromocriptine mesilate has not been demonstrated in dosages exceeding 100 mg/day.
Route of administration: Orally.
Interaction:
Dopamine antagonists, butyrophenones, and other drugs may interact with bromocriptine. Bromocriptine’s effectiveness is reduced by the following compounds: phenothiazines, haloperidol, metodopramide, and pimozide. Bromocriptine should not be used with other ergot alkaloids at the same time.
Contraindications:
Hypertension that is uncontrollable, as well as susceptibility to any ergot alkaloids. Hyperprolactinemia is a condition in which the body produces too much prolactin. When a pregnancy is detected, bromocriptine mesilate should be stopped. Women having a history of coronary artery disease or other serious cardiovascular problems should avoid the postpartum period.
Side Effects:
Nausea, headache, dizziness, tiredness, lightheadedness, vomiting, stomach cramps, nasal congestion, constipation, diarrhea, and sleepiness are the most common side effects. Treatment may cause a mild hypotensive impact. By temporarily lowering the dose to 0.5 mg, the risk of unpleasant responses can be reduced. Elevations in blood urea nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase, and uric acid are examples of abnormal laboratory findings that are typically transitory and have little clinical relevance.
Pregnancy & Lactation:
Category B pregnancy. Bromocriptine should not be taken by postpartum women while they are lactating.
 Precautions & Warnings:
Bromocriptine mesilate’s safety and effectiveness in individuals with renal or hepatic illness have yet to be determined. When using Bromocriptine in conjunction with other blood pressure-lowering medicines, caution should be used. In individuals with a history of psychosis or cardiovascular illness, the medication should be taken with care. Patients with acromegalic illness, prolactinoma, or Parkinson’s disease who are taking Bromocriptine during pregnancy should be closely monitored.
Therapeutic Class:
Antiparkinson drugs, Motility stimulants/Dopamine antagonist
Storage Conditions:
Keep the temperature below 30°C and away from light and moisture. Keep out of children’s reach.
Manufactured by: Renata Limited.
