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Spironolactone Tablets IP

Spironolactone Tablets IP

Potassium-sparing diuretic | Film-coated tablets | Pharmaceutical supply enquiries

Product Composition

Spironolactone Tablets IP 25 mg: Each film-coated tablet contains Spironolactone IP 25 mg.

Spironolactone Tablets IP 50 mg: Each film-coated tablet contains Spironolactone IP 50 mg.

Usage: Prescription treatment of hypertension, heart failure and certain causes of edema.

Therapeutic category: Potassium-sparing diuretic / Mineralocorticoid receptor antagonist.

SKU: Spironolactone Tablets

Categories: Pharmaceutical Exporter India · Pharmaceutical Formulations India · WHO GMP Certified Formulations

+91 7710003340

Product Information

Spironolactone Tablets IP is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

1. Product Introduction

Spironolactone is a potassium-sparing diuretic and mineralocorticoid (aldosterone) receptor antagonist. It is used in selected patients with heart failure, hypertension, and fluid retention associated with conditions such as cirrhosis. The supplied product information confirms film-coated Spironolactone Tablets IP in 25 mg and 50 mg strengths. Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter; certifications and country-specific approvals should be verified.

2. Product Specifications

ProductSpironolactone Tablets
Active ingredientSpironolactone IP
Confirmed strengths25 mg and 50 mg
Dosage formFilm-coated tablets
Pharmacopoeial standardIP (as supplied)
CAS number52-01-7
Therapeutic classPotassium-sparing diuretic / Aldosterone antagonist
SKUSpironolactone Tablets
Other strengths100 mg mentioned in background text; not confirmed by the supplied composition
Packaging and shelf lifeConfirm against approved specifications and stability studies

3. Manufacturing Technology

Spironolactone has limited aqueous solubility, so particle-size distribution, blend uniformity, dissolution performance and formulation compatibility require control. Film-coating and suitable moisture-protective packaging can support tablet handling and stability. Any claims about micronization, flavored coatings, high-shear granulation or specific packaging formats must be supported by actual manufacturing records and validated processes.

4. Quality Assurance

Testing should follow the applicable Indian Pharmacopoeia monograph and approved product specifications. Relevant controls include identity, assay, uniformity of dosage units, dissolution, related substances, microbiological quality where applicable, and stability. Exact acceptance criteria and labeled shelf life must come from approved methods and supporting data.

5. Therapeutic Uses

Spironolactone competitively blocks aldosterone receptors, increasing sodium and water excretion while reducing potassium loss. Depending on local labeling and clinical evaluation, uses include selected heart failure patients, hypertension (including resistant hypertension), edema or ascites related to cirrhosis, and primary hyperaldosteronism. Acne and androgen-related conditions are sometimes treated off-label under specialist supervision; these are not confirmed indications for this product.

6. Export and Regulatory Support

For B2B and export enquiries, request country-specific product registration status, approved labeling, Certificate of Analysis (COA), stability documentation, and applicable manufacturing certifications. CTD/ACTD dossiers, COPP, Free Sale Certificates and shipping terms are subject to actual availability and destination-market requirements. Contact Healthy Life Pharma / Healthy Inc for confirmation.

7. Frequently Asked Questions

Q: Which strengths are confirmed?
A: Spironolactone IP 25 mg and 50 mg film-coated tablets.

Q: Is it the same as furosemide?
A: No. Spironolactone conserves potassium, whereas furosemide is a loop diuretic that can increase potassium loss.

Q: Can potassium-containing salt substitutes be used?
A: They can raise potassium to dangerous levels. Consult a clinician before using potassium supplements or salt substitutes.

8. Dosage and Administration

Dose and schedule depend on indication, kidney function, serum potassium and other medicines. For certain heart failure patients, 25 mg once daily is a common initial regimen; hypertension and edema regimens differ. Only a qualified clinician should select or adjust the dose. Take consistently as directed, often with food. Do not stop or change treatment without medical advice.

9. Side Effects and Precautions

Important risks include hyperkalemia (high blood potassium), worsening kidney function, low blood pressure, dizziness, gynecomastia and menstrual changes. Potassium and renal function require monitoring, especially after starting or changing the dose. Avoid use in hyperkalemia, Addison disease or other contraindicated conditions per local labeling. Interactions may occur with ACE inhibitors, ARBs, potassium supplements, trimethoprim and some anti-inflammatory medicines. Seek urgent care for severe weakness, palpitations or fainting.

10. Storage Instructions

Store according to the approved product label in the original packaging, protected from excess moisture and light. A specific temperature limit and shelf life must be confirmed from the marketed pack and stability data. Keep out of reach of children.

For professional and B2B reference. Prescribing information, manufacturing claims, certification and market-specific approvals require verification.