Description
Cilnidipine & Telmisartan Film-Coated Tablets (10 mg / 40 mg)
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, nephrology, and targeted 24-hour antihypertensive therapeutics. We provide ultra-high-purity, kinetically balanced Cilnidipine & Telmisartan Tablets (10 mg / 40 mg), manufactured in WHO–GMP certified, high-containment oral solid dosage facilities. This “Dual-Action CCB & ARB FDC” is a massive-volume, premium export to cardiology centers, diabetic clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, superior intervention for Resistant Hypertension and Diabetic Nephropathy.
Product Overview
This formulation operates as a sophisticated, dual-front vascular shield. It targets the two primary systems that drive high blood pressure: the physical calcium-driven constriction of the arteries and the hormonal (Angiotensin) drive that causes the body to retain salt and water.
The “Circadian Control & Kidney-Shield” Specialist:
- Mechanism 1 (The 24-Hour ARB Anchor – Telmisartan): Telmisartan is a potent Angiotensin II Receptor Blocker (ARB). It has the longest half-life (24 hours) of any drug in its class, providing “Early Morning Protection”—the dangerous window when most heart attacks occur. By blocking the AT1 receptor, it prevents vasoconstriction and halts the release of aldosterone, reducing fluid volume and protecting the heart from remodeling.
- Mechanism 2 (The Sympathetic-Sparing Vasodilator – Cilnidipine): Unlike older CCBs, Cilnidipine blocks both L-type and N-type calcium channels. While the L-type blockade relaxes the arteries, the N-type blockade silences the sympathetic nerves. This prevents the “Reflex Tachycardia” (racing heart) and “Pedal Edema” (swollen ankles) that cause patients to stop taking their medication.
- Mechanism 3 (Synergistic Nephroprotection): This is the “Kidney Rescue” FDC. Telmisartan dilates the efferent (outgoing) renal arterioles, while Cilnidipine dilates both afferent and efferent vessels. Together, they dramatically reduce intraglomerular pressure, stopping protein leakage (proteinuria) and delaying the progression of Chronic Kidney Disease (CKD) in diabetic patients.
Product Composition & Strength
We supply this product as a Precision-Blended, Bilayer or Co-Processed Tablet, packed exclusively in secure, high-barrier Alu-Alu blister strips to ensure the stability of the moisture-sensitive Telmisartan and light-sensitive Cilnidipine.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Telmisartan USP/Ph.Eur. | 40 mg | The Hormonal Stabilizer: Blocks the RAAS system to provide 24-hour systemic pressure control and metabolic benefits (PPAR-gamma activation). |
| Cilnidipine USP/Ph.Eur. | 10 mg | The Vascular Relaxant: Provides immediate N-type and L-type calcium channel blockade to lower peripheral resistance without edema. |
| Excipients | Meglumine / Sorbitol / Sodium Hydroxide / Magnesium Stearate / Titanium Dioxide (Opaque Coating) | Solubilizer / Diluent / PH Modifier / Light Shield (Engineered specifically utilizing Alkaline Matrix Solubilization. Telmisartan requires a highly alkaline environment to dissolve, while Cilnidipine is light-sensitive. Our bilayer technology ensures each API is released at its peak kinetic window). |
Technical & Logistics Specifications
| HS Code | 3004.90.99 (Medicaments containing other active substances – Cardiovascular/FDC) |
| CAS Numbers | 144701-48-4 (Telmisartan) / 132203-70-4 (Cilnidipine) |
| Dosage Form | Film-Coated Bilayer Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters (MANDATORY). Telmisartan is highly hygroscopic (absorbs water from the air). Alu-Alu is the only packaging that guarantees shelf-life in tropical Zone IVb climates. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Hygroscopic & Photolytic Stability (CRITICAL COMPLIANCE): Manufacturing Telmisartan with Cilnidipine is a technical challenge. Telmisartan degrades if exposed to even trace humidity, and Cilnidipine degrades in light. Our facility utilizes Dehumidified Cleanrooms (RH < 30%) and specialized bilayer compression to keep the molecules stable. We provide global buyers with a bioequivalent FDC that maintains 100% potency in the harshest global climates.
Therapeutic Indications
- Essential Hypertension: Treatment of patients whose blood pressure is not adequately controlled on monotherapy.
- Hypertension with Diabetes: Preferred first-line therapy to prevent Diabetic Nephropathy.
- Hypertension with CKD: Indicated for long-term renal protection and reduction of proteinuria.
Dosage & Administration
- Standard Adult Dosing: 1 tablet once daily, preferably at the same time every morning.
- Renal/Hepatic Caution: Telmisartan is biliary excreted; use with caution in patients with biliary obstructive disorders or severe hepatic impairment.
Safety Warnings (CRITICAL):
- Pregnancy (FETAL TOXICITY): Strictly contraindicated in the 2nd and 3rd trimesters. ARBs cause severe fetal injury and death. Therapy must be stopped immediately if pregnancy is detected.
- Hyperkalemia: Telmisartan can increase potassium levels. Periodic monitoring of serum electrolytes is mandatory, especially in patients with kidney disease.
- Hypotension/Syncope: Risk is higher in volume-depleted or salt-depleted patients (e.g., those on high-dose diuretics).
Global Export & Contract Manufacturing Services
Healthy Inc is a premier Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-end Cardiology FDCs and Bilayer Tablets. Whether you are a Government Tender Supplier for chronic disease programs in Africa or a B2B Pharma Marketplace partner in Latin America, we ensure secure, WHO-GMP compliant delivery.
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