Description
Losartan Potassium, Amlodipine Besylate Tablets
Healthy Inc is a specialized global supplier and exporter of potent dual-mechanism antihypertensives. We provide high-stability Losartan Potassium & Amlodipine Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Total Vasodilation System” is a top export to cardiology institutes, hypertension clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the frontline fixed-dose combination (FDC) for patients with severe or resistant hypertension.
Product Overview
This formulation contains a strategic combination of an Angiotensin II Receptor Blocker (ARB) and a Calcium Channel Blocker (CCB).
The “Double-Vasodilation” Specialist:
- Mechanism (Losartan): Selectively blocks the AT1 receptor, preventing the potent vasoconstrictor Angiotensin II from binding. This relaxes blood vessels and blocks the release of aldosterone (preventing sodium retention).
- Mechanism (Amlodipine): A long-acting Dihydropyridine CCB. It inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. By relaxing the arterial smooth muscle, it significantly lowers peripheral vascular resistance.
- Synergy: The combination attacks vasoconstriction from two independent angles: Hormonal (Renin-Angiotensin System) and Mechanical (Calcium Channels). Furthermore, Losartan is known to help mitigate the peripheral edema (ankle swelling) that is a common side effect of Amlodipine monotherapy.
Product Composition & Strength
We supply this product as Film Coated Tablets (typically White or Yellow, Oval/Round). The formulation uses the Besylate salt of Amlodipine for maximum stability.
| Active Ingredient | Strength (Standard) | Therapeutic Role | |
|---|---|---|---|
| Losartan Potassium USP/BP | 50 mg | Vasodilator (ARB) | |
| Amlodipine Besylate USP/BP | 5 mg (Eq. to Base) | Vasodilator (CCB) | |
| (High Strength Variant) | 50 mg Losartan + 10 mg Amlodipine 100 mg Losartan + 5 mg Amlodipine | Resistant Hypertension | |
| Excipients | Q.S. | Microcrystalline Cellulose / Sodium Starch Glycolate | Filler / Super-Disintegrant |
*Pack Sizes: Blister packs of 10s, 14s, 15s (Calendar Pack), 30s, or Bulk HDPE Jars of 1000s.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Tablet (Film Coated) |
| Packaging | Alu-Alu Blister (Hygroscopic & Light Sensitive) |
| Storage | Store below 25°C. Protect strictly from Moisture and Light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Stability Engineering: Losartan is hygroscopic (moisture sensitive), while Amlodipine is photosensitive (light sensitive). We utilize Cold Form Alu-Alu packaging, which provides a near-perfect barrier against both humidity and UV light, ensuring the product does not degrade or discolor (turn brown) over its shelf life.
- Interaction Prevention: While compatible, we use specific grades of excipients to prevent the Trans-esterification reaction that can sometimes occur between certain binders and Amlodipine.
Therapeutic Indications (Human Use)
Indicated for the treatment of:
- Essential Hypertension: For patients whose blood pressure is not adequately controlled on Losartan or Amlodipine alone.
- Stage 2 Hypertension: Initial therapy for patients likely to need multiple drugs to achieve BP goals.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist):
- Route: Oral.
- Adults: One tablet (50/5 mg) once daily.
- Titration: Dose may be increased after 2-4 weeks to 100/5 mg or 50/10 mg depending on response.
- Administration: Can be taken with or without food. Swallow whole with water.
Safety Warnings:
- Fetal Toxicity (BLACK BOX WARNING): CONTRAINDICATED IN PREGNANCY. Losartan acts on the RAAS system and can cause fetal injury or death. Discontinue immediately if pregnancy is detected.
- Peripheral Edema: Although reduced by Losartan, Amlodipine can still cause swelling of the ankles and feet. Monitor patients.
- Hypotension: Risk of excessive blood pressure drop, especially in volume-depleted patients.
- Liver Function: Amlodipine is extensively metabolized by the liver; use caution in severe hepatic impairment.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
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