Hyperprolactinemia-Associated Disorders: Conditions related to elevated prolactin levels, including amenorrhea with or without galactorrhea, infertility, and hypogonadism.

Prolactin-Secreting Adenomas: In patients planned for adenectomy, bromocriptine mesylate may be administered before surgery to reduce tumor size.

Acromegaly: Used to decrease elevated growth hormone levels in patients with acromegaly.

Parkinson’s Disease: Indicated as an adjunct to levodopa therapy (with or without a peripheral decarboxylase inhibitor) in idiopathic or postencephalitic Parkinson’s disease.

Bromocriptine mesylate is a nonhormonal, non-estrogenic agent that suppresses prolactin secretion, with minimal effects on other pituitary hormones. In patients with acromegaly, it also lowers elevated growth hormone levels. It acts as a dopamine receptor agonist, stimulating postsynaptic dopamine receptors. Dopaminergic neurons in the tuberoinfundibular pathway regulate prolactin release from the anterior pituitary by secreting dopamine, which functions as a prolactin-inhibiting factor. In the corpus striatum, dopaminergic activity plays a key role in motor control. Clinically, bromocriptine significantly reduces plasma prolactin levels in patients with hyperprolactinemia as well as in those with physiologically elevated prolactin levels.

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 Indications: 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.

Bromocriptine may interact with dopamine antagonists, butyrophenones, and certain other medications. Drugs such as phenothiazines, haloperidol, metoclopramide, and pimozide can reduce the effectiveness of bromocriptine. Concurrent use with other ergot alkaloids is not recommended.

• Uncontrolled hypertension and hypersensitivity to ergot alkaloids. In patients receiving bromocriptine for hyperprolactinemia, treatment should be discontinued if pregnancy occurs.
• Contraindicated in the postpartum period in women with a history of coronary artery disease or other serious cardiovascular conditions.

Common side effects, listed in decreasing order of frequency, include nausea, headache, dizziness, fatigue, lightheadedness, vomiting, abdominal cramps, nasal congestion, constipation, diarrhea, and drowsiness. A mild reduction in blood pressure may occur during treatment. Adverse effects can often be minimized by temporarily reducing the dose (e.g., to 0.5 mg). Laboratory abnormalities may include transient elevations in blood urea nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase, and uric acid, which are generally not clinically significant.

Pregnancy Category B: Bromocriptine should not be used during breastfeeding in postpartum women.

The safety and efficacy of bromocriptine mesylate have not been fully established in patients with renal or hepatic impairment. Caution is advised when used together with medications that lower blood pressure. It should be used carefully in patients with a history of psychotic disorders or cardiovascular disease. Patients with acromegaly, prolactinoma, or Parkinson’s disease who are treated with bromocriptine during pregnancy should be closely monitored.

Pediatric Use: There is insufficient data regarding the safety and effectiveness of bromocriptine in children under 8 years of age.

Antiparkinson drugs, Motility stimulants/Dopamine antagonist

Store below 30°C, protected from light and moisture. Keep out of reach of children.