Bromolac 2.5 mg

Description

Indications
Bromocriptine mesilate is used for the treatment of various conditions associated with elevated prolactin levels and certain neurological disorders, including:

• Hyperprolactinemia-Associated Disorders: Used to manage dysfunctions linked to excessive prolactin secretion, such as amenorrhea (absence of menstruation) with or without galactorrhea (abnormal milk production), infertility, or hypogonadism.
• Prolactin-Secreting Adenomas: In cases where surgical removal (adenectomy) is planned, bromocriptine mesilate may be administered before surgery to help shrink the tumor.
• Acromegaly: Used to lower elevated growth hormone levels in individuals with acromegaly.
• Parkinson’s Disease: Prescribed as an adjunct therapy alongside levodopa (with or without a peripheral decarboxylase inhibitor) for managing idiopathic or postencephalitic Parkinson’s disease.

(Take this medication as per the guidance of a registered physician.)

Pharmacology
Bromocriptine mesilate is a dopamine receptor agonist that primarily inhibits prolactin secretion while exerting minimal effects on other pituitary hormones, except in patients with acromegaly, where it helps lower growth hormone levels. This medication works by stimulating post-synaptic dopamine receptors, particularly affecting the tuberoinfundibular pathway, which regulates prolactin release from the anterior pituitary. Additionally, in the corpus striatum, dopaminergic neurons contribute to motor function control. Clinically, bromocriptine mesilate is effective in reducing prolactin levels in patients with both physiological and pathological hyperprolactinemia.

Dosage & Administration
Bromocriptine mesilate should be taken with food. Dosage adjustments should be carefully monitored to determine the lowest effective dose.

• Hyperprolactinemia-Associated Conditions: The starting dose is 0.5 mg to 2.5 mg per day. If needed, an additional 2.5 mg can be introduced every 2 to 7 days, based on tolerance, until an optimal response is achieved. In children aged 11 to 15 years, the initial dose is 0.5 to 2.5 mg daily, which can be increased as needed, with a therapeutic range of 2.5 to 10 mg per day for prolactin-secreting adenomas.
• Acromegaly: The initial dose is 0.5 to 2.5 mg at bedtime (with food) for three days. If tolerated, an additional 0.5 to 2.5 mg may be introduced every 3 to 7 days until optimal therapeutic effects are achieved. The maximum recommended dose is 100 mg per day.
• Parkinson’s Disease: Treatment starts at a low dose of 0.5 mg (from a 2.5 mg tablet) twice daily with meals. If necessary, the dosage can be increased every 14 to 28 days by 2.5 mg per day. The maximum recommended dose is 100 mg per day.

(Take this medication as per the guidance of a registered physician.)

Drug Interactions
Bromocriptine mesilate may interact with certain medications, leading to reduced efficacy or adverse effects:

• Dopamine antagonists, such as phenothiazines, haloperidol, metoclopramide, and pimozide, may counteract the effects of bromocriptine.
• Concurrent use with other ergot alkaloids is not recommended.

Contraindications
Bromocriptine mesilate should not be used in the following cases:

• Patients with uncontrolled hypertension or hypersensitivity to ergot alkaloids.
• Pregnant women being treated for hyperprolactinemia—treatment should be discontinued upon pregnancy confirmation.
• Postpartum women with a history of coronary artery disease or other serious cardiovascular conditions.

Side Effects
Common side effects, listed in decreasing order of frequency, include:

• Gastrointestinal: Nausea, vomiting, abdominal cramps, constipation, diarrhea.
• Neurological: Headache, dizziness, drowsiness, lightheadedness, fatigue.
• Respiratory: Nasal congestion.
• Cardiovascular: Slight hypotension.

Temporary dosage reduction to 0.5 mg may help mitigate adverse effects. Laboratory test abnormalities (such as increased levels of blood urea nitrogen, SGOT, SGPT, GGPT, CPK, alkaline phosphatase, and uric acid) may occur but are generally transient and clinically insignificant.

Pregnancy & Lactation

• Pregnancy: Classified as Category B—bromocriptine mesilate should only be used during pregnancy if clearly needed.
• Lactation: Should not be used in postpartum women who are breastfeeding.

Precautions & Warnings

• The safety and efficacy of bromocriptine mesilate in patients with renal or hepatic impairment have not been established.
• Caution is advised when combining this medication with other drugs known to lower blood pressure.
• Patients with a history of psychotic disorders or cardiovascular disease should use bromocriptine with caution.
• Pregnant patients with acromegaly, prolactinoma, or Parkinson’s disease receiving bromocriptine therapy should be closely monitored.

Use in Special Populations

• Pediatric Use: Not recommended for children under 8 years of age due to a lack of safety data.

Therapeutic Class

• Antiparkinson Agents
• Motility Stimulants / Dopamine Antagonists

Storage Conditions

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