Description

Tolvaptan Tablets

Healthy Inc is a specialized global supplier and exporter of advanced nephrological, cardiovascular, and critical-care therapeutics. We provide ultra-high-purity, kinetically precise Tolvaptan Tablets (15 mg / 30 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Selective Vasopressin V2-Receptor Antagonist” is a premium, high-value export to nephrology centers, intensive care units (ICUs), cardiology wards, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the definitive, life-saving intervention for severe, clinically significant hyponatremia and Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Product Overview

This formulation contains Tolvaptan, a groundbreaking neurohypophyseal hormone antagonist that fundamentally changes how the kidneys process water, completely distinct from standard loop or thiazide diuretics.

The “Selective Aquaretic & Sodium Restorer” Specialist:

• Mechanism (V2 Receptor Antagonism): In conditions like heart failure or SIADH, the body produces too much Vasopressin (Anti-Diuretic Hormone), forcing the kidneys to retain massive amounts of water, which dangerously dilutes the blood’s sodium levels (hyponatremia). Tolvaptan aggressively blocks the V2 receptors in the collecting ducts of the kidneys. This stops vasopressin from working, forcing the kidneys to excrete massive volumes of pure, free water (aquaresis).
• The “Aquaretic” Advantage: Standard diuretics (like Furosemide or Torsemide) force the body to excrete both water and sodium, which can actually worsen hyponatremia. Tolvaptan uniquely excretes water without excreting sodium, effectively concentrating the blood and safely raising serum sodium levels back to normal.
• ADPKD Disease Modification: Beyond hyponatremia, high-dose Tolvaptan is a globally recognized, disease-modifying therapy for Autosomal Dominant Polycystic Kidney Disease (ADPKD). By blocking vasopressin, it actively slows the growth of fluid-filled cysts in the kidneys and delays the decline of renal function in these patients.

Product Composition & Strength

We supply this product as a Precision-Blended Uncoated Tablet, packed in highly secure, moisture-resistant Alu-Alu blister strips to ensure absolute stability of the complex active pharmaceutical ingredient across diverse hospital environments.

*Pack Sizes: 1×10 or 10×10 Alu-Alu Blisters (Optimized for strict inpatient ICU dispensing and specialized outpatient nephrology regimens). Higher strengths (45mg, 60mg, 90mg) for ADPKD protocols available upon specialized institutional request.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Intensive Care Distributors, and Nephrology Networks.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Critical-Care Kinetic Validation: Because Tolvaptan directly manipulates systemic sodium levels, any flaw in dose uniformity or dissolution can trigger fatal neurological consequences. Our facilities utilize advanced high-shear homogenizers and strictly validated multipoint dissolution profiling via HPLC to guarantee that every tablet releases the API with absolute predictability, meeting the exact pharmacokinetic demands of ICU protocols.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of complex renal, cardiovascular, and metabolic crises:

• Clinically Significant Hyponatremia: Treatment of euvolemic and hypervolemic hyponatremia (serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH).
• Autosomal Dominant Polycystic Kidney Disease (ADPKD): Slowing kidney function decline in adults at risk of rapidly progressing ADPKD (often utilizing specialized high-dose, split-dosing regimens).

Dosage & Administration

Recommended Dosage (Strictly as per Nephrologist/Intensivist Guidelines):

• MANDATORY HOSPITAL INITIATION: Tolvaptan MUST be initiated and re-initiated in a hospital setting so that serum sodium levels and neurological status can be closely monitored.
• Standard Hyponatremia Dosing: The usual starting dose is 15 mg administered once daily. The dose may be increased to a maximum of 60 mg once daily, strictly based on serum sodium response.
• Fluid Restriction Warning (CRITICAL): During the first 24 hours of therapy, fluid restriction is generally not recommended, as patients will experience massive thirst and aquaresis; restricting fluids can lead to excessively rapid sodium correction.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Osmotic Demyelination Syndrome – ODS): If Tolvaptan corrects serum sodium levels too rapidly (greater than 12 mEq/L/24 hours), it can cause Osmotic Demyelination Syndrome (previously known as Central Pontine Myelinolysis). This causes permanent, catastrophic brain damage, paralysis, coma, or death. Frequent sodium monitoring is absolutely mandatory.
• BLACK BOX WARNING (Hepatotoxicity): Tolvaptan can cause severe and potentially fatal liver injury, particularly in patients taking the drug long-term for ADPKD. Liver enzymes (ALT, AST) and bilirubin must be tested before initiation and monitored rigorously throughout treatment. It should not be used for more than 30 days when treating hyponatremia.
• CYP3A4 Interactions: Tolvaptan is heavily metabolized by CYP3A4. Co-administration with strong CYP3A4 inhibitors (like Ketoconazole or Clarithromycin) is strictly contraindicated, as it will massively spike Tolvaptan blood levels and risk fatal sodium correction.

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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Nephrology and Critical Care Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable ICU Tender Supplier for cardiovascular programs 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 Specialty Medicine Wholesaler receives WHO-GMP certified products at competitive rates.