Propantheline Bromide Tablets – Manufacturer India

1. Product Introduction

Propantheline Bromide Tablets IP 15 mg are coated oral tablets containing an antimuscarinic (anticholinergic) agent. Propantheline reduces gastrointestinal smooth-muscle spasm and secretions. It has historically been used as an adjunct in peptic ulcer management; current use depends on local prescribing guidelines and available alternatives.

Manufacturer (as supplied): Healthy Life Pharma Pvt. Ltd. Exporter (as supplied): Healthy Inc. Xyproline is the brand name supplied for this formulation. Manufacturing and export credentials should be checked against current documentation.

2. Product Specifications

3. Manufacturing and Formulation

Consistent 15 mg tablet production requires validated blending, compression, coating, in-process controls and suitable packaging. Product-specific equipment, coating process, production site, and GMP certification must be confirmed by manufacturer records before publishing as verified claims.

4. Quality Assurance

Relevant release tests may include identification, assay, uniformity of dosage units, dissolution or disintegration as required by the applicable monograph, related substances, and physical tablet quality. Exact acceptance limits and analytical methods should follow the approved IP specification and validated procedures.

5. Mechanism and Therapeutic Uses

Propantheline blocks muscarinic acetylcholine receptors, reducing gastrointestinal motility and secretions. Historically used as adjunctive therapy for peptic ulcers; use for gastrointestinal spasm or excessive sweating may be off-label or vary by jurisdiction. It is not an antibiotic and does not eradicate H. pylori or replace modern ulcer treatment.

6. Export and Regulatory Support

For procurement or third-party manufacturing enquiries, request the current manufacturing license, GMP certificate, product approval, Certificate of Analysis, stability data, labeling and country-specific registration documents. CTD/ACTD dossiers, COPP, FSC and export terms should be confirmed for the intended market rather than assumed available.

7. Frequently Asked Questions

Q: What is the strength?
A: The supplied formulation is Propantheline Bromide IP 15 mg per coated tablet.

Q: Is it a modern first-line ulcer treatment?
A: No. It has a historical adjunctive role; current ulcer treatment typically addresses acid suppression and causes such as H. pylori where relevant.

Q: Is it suitable for glaucoma?
A: It may be contraindicated in certain types of glaucoma, particularly narrow-angle glaucoma. Medical assessment is necessary.

8. Dosage and Administration

Use only as directed by the prescribing clinician and the approved local product information. Timing and dose depend on the indication and patient factors. Do not apply a fixed adult regimen universally; elderly patients may be particularly sensitive to anticholinergic effects.

9. Side Effects and Precautions

Possible adverse effects include dry mouth, constipation, blurred vision, reduced sweating, urinary retention, palpitations and heat intolerance. Important contraindications or cautions include narrow-angle glaucoma, obstructive uropathy, gastrointestinal obstruction or ileus, myasthenia gravis and certain cardiac conditions. Seek medical advice for severe symptoms. Drug interactions and individual contraindications must be reviewed by a clinician.

10. Storage Instructions

Store in the original, tightly closed packaging under the conditions stated on the approved product label; protect from moisture as specified. Keep out of reach of children. A precise temperature limit and shelf life require approved stability/label evidence.