Description
Bromocriptine Mesylate Tablets (2.5mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Bromocriptine Mesylate Tablets in India. This ergot-derivative dopamine agonist is a versatile medication used globally to treat Hyperprolactinemia (high prolactin levels), Acromegaly, and Parkinson’s Disease. We produce high-purity, scored tablets designed for precise dose titration. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and endocrinology tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Bromocriptine Mesylate Tablets | | Generic Name | Bromocriptine Mesylate USP / BP / IP | | Strength | 2.5mg (Base) | | Dosage Form | Uncoated Tablet (Scored) | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Dopamine Agonist (Ergot Alkaloid) | | Shelf Life | 36 Months | | Packaging | 10×10 Amber Blister / 100s Amber Glass Bottle |
3. Manufacturing Bromocriptine Tablets We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Bromocriptine is highly Photosensitive (sensitive to light). Exposure to UV light causes it to discolor and degrade. To prevent this, we manufacture under Filtered Sodium Vapor Lighting (yellow light) and use Amber Blisters to ensure the product remains stable until it reaches the patient. We also manufacture the 2.5mg tablet with a deep, Functional Score Line. This allows patients to break the tablet cleanly into two 1.25mg halves, which is standard practice to minimize nausea during the first week of treatment.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Bromocriptine Tablets. We supply fertility clinics and neurology centers globally. We understand the specific stability requirements for ergot alkaloids during international shipping.
4. Quality Assurance We test every batch rigorously.
Related Substances: Ergot alkaloids can degrade into toxic by-products. We strictly monitor impurities to ensure safety.
Content Uniformity: We ensure that every tablet (and every half-tablet) contains the precise dosage, which is vital for hormone regulation.
Photostability: We conduct stress testing to verify the effectiveness of our amber packaging.
5. Why Use Bromocriptine Tablets? This drug mimics the action of dopamine in the brain.
Mechanism: It activates dopamine receptors (D2). Dopamine inhibits the release of Prolactin from the pituitary gland.
Effect: By lowering prolactin, it restores normal menstrual cycles and fertility in women, and treats hypogonadism in men. In Parkinson’s, it supplements the low dopamine levels to improve motor function.
Key Indications:
Hyperprolactinemia: Treatment of infertility, amenorrhea (missed periods), and galactorrhea (abnormal milk flow) caused by high prolactin.
Parkinson’s Disease: Adjunctive therapy to Levodopa for managing “On-Off” fluctuations.
Acromegaly: Adjunct therapy to reduce Growth Hormone levels.
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Bromocriptine Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is the tablet breakable? A: Yes, our 2.5mg tablet is scored (snap-tab) to allow for 1.25mg dosing, which is essential for initiating therapy without severe nausea.
Q: Why is the packaging dark/amber? A: To protect the drug from light degradation.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Hyperprolactinemia: Initially 1.25mg (half tablet) at bedtime with food. Gradually increased to 2.5mg two or three times daily.
Parkinson’s Disease: Started low (1.25mg twice daily) and titrated up slowly over several weeks.
Administration: Always take with food to reduce the risk of nausea and dizziness.
9. Side Effects and Precautions
Nausea & Vomiting: Very common, especially at the start. Slow titration and taking with food helps.
Orthostatic Hypotension: Dizziness upon standing up. Caution is advised when driving.
Fibrosis: Long-term high-dose use (rare) has been associated with pleural/retroperitoneal fibrosis.
10. Storage Instructions
Store below 25°C in a dry place.
Critical: Protect from light. Keep in the original amber blister or bottle.
Keep out of reach of children.
