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Losartan Potassium Tablets product image

Losartan Potassium Tablets

Composition: Losartan Potassium IP 25 mg / 50 mg

Usage: Management of high blood pressure (hypertension)

Category: Cardiovascular / Antihypertensive Drugs

Therapeutic category: Angiotensin II Receptor Blocker (ARB)

SKU: Losartan Tablets

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

Product Information

Losartan Potassium Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Manufactured by: Healthy Life Pharma Pvt. Ltd. (certification subject to verification)
Exported by: Healthy Inc (export credentials subject to verification)

1. Product Introduction

Losartan Potassium Tablets are oral angiotensin II receptor blockers (ARBs) used to manage hypertension. Depending on approved labeling and patient characteristics, losartan may also be used in certain patients with type 2 diabetes and nephropathy, and for stroke-risk reduction in selected patients with hypertension and left ventricular hypertrophy.

Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter. Contract manufacturing, certifications, and market availability should be confirmed against current company documents.

2. Product Specifications

Product nameLosartan Potassium Tablets
CompositionLosartan Potassium IP 25 mg or 50 mg per film-coated tablet
Confirmed single-agent strengths25 mg / 50 mg
Additional strength100 mg mentioned in the description; product availability not confirmed by supplied composition
Dosage formFilm-coated tablet
Therapeutic classAngiotensin II Receptor Blocker (ARB)
CAS number124750-99-8 (losartan potassium)
StandardsIP for supplied compositions; USP/BP claims require product-specific confirmation
Packaging and shelf lifeTo be confirmed against approved pack and stability data

Separate combination products: Losartan Potassium 50 mg + Hydrochlorothiazide 12.5 mg, and Losartan Potassium 50 mg + Amlodipine 5 mg (as besylate), are distinct formulations, not strengths of losartan-only tablets. See Losartan + Hydrochlorothiazide and Losartan + Amlodipine.

3. Manufacturing Technology

Manufacture of losartan tablets requires controlled blending, compression, coating, and packaging to achieve consistent quality. Moisture protection and validated processes may be relevant to product stability. Claims about specific humidity limits, direct-compression methods, Alu-Alu packs, or serialization should be substantiated by actual manufacturing and packaging records.

4. Quality Assurance

Quality testing may include identification, assay, content uniformity, dissolution, related substances, and stability testing against the applicable approved specification. Risk-based assessment and testing for relevant nitrosamine and other potentially mutagenic impurities should follow current regulatory requirements. Specific test results, release limits and compliance cannot be inferred without batch documentation.

5. Pharmacology and Clinical Use

Losartan selectively blocks angiotensin II at AT1 receptors, reducing vasoconstriction and aldosterone effects, which lowers blood pressure. Uses vary by jurisdiction and may include hypertension, diabetic nephropathy in eligible patients with type 2 diabetes, and reduction of stroke risk in selected hypertensive patients with left ventricular hypertrophy.

Unlike ACE inhibitors, ARBs generally cause less bradykinin-associated cough, but cough and angioedema can still occur. Losartan is not a cure for hypertension.

6. Export and Regulatory Support

For B2B enquiries, request current product specifications, available strengths, approved labels, certificates of analysis, GMP evidence, registration dossiers, export permissions, and country-specific availability. CTD/ACTD dossiers, COPP, FSC and shipping terms must be confirmed with the manufacturer/exporter before making a regulatory or commercial commitment.

7. Frequently Asked Questions

Q: Is losartan the same as Cozaar?
A: Cozaar is a brand of losartan. Pharmaceutical equivalence and bioequivalence of a particular generic product require appropriate evidence and authorization.

Q: Is Losartan 50 mg + HCTZ 12.5 mg the same product?
A: No. It contains an additional diuretic and is a separate combination tablet.

Q: Can it increase potassium?
A: Yes. Blood potassium and kidney function may require monitoring, especially with kidney disease or interacting medicines.

Q: Can it be used during pregnancy?
A: No. Medicines acting on the renin–angiotensin system can injure or kill a developing fetus. Contact a clinician immediately if pregnancy is suspected or confirmed.

8. Dosage and Administration

Losartan is generally taken orally, with or without food, as directed by a prescriber. Dose selection and adjustments depend on the indication, blood pressure response, other medicines, age, volume status, and liver or kidney function. Do not substitute a combination tablet for losartan alone or change doses without medical advice.

9. Side Effects and Precautions

  • Pregnancy: Fetal toxicity warning; discontinue promptly under medical supervision if pregnancy occurs.
  • Potassium: Hyperkalemia can occur, especially with potassium supplements, potassium-containing salt substitutes or certain medicines.
  • Kidneys: Monitor renal function as clinically appropriate; deterioration can occur in susceptible patients, including those with renal artery stenosis.
  • Blood pressure: Dizziness, hypotension or faintness may occur, especially with dehydration or diuretics.
  • Allergy: Rare angioedema requires urgent medical attention.
  • Interactions: Discuss NSAIDs, lithium, other renin–angiotensin system medicines and potassium-raising drugs with a healthcare professional.

10. Storage Instructions

Store according to the approved product label, in the original packaging, protected from excess moisture and heat. The precise temperature limit and expiry date must be verified on the marketed pack. Keep out of reach of children.