Tolvaptan
Tolvaptan is a diuretic drug belonging to the selective vasopressin V2 receptor antagonist group of medicines. It is mainly used for the treatment of hyponatremia (low blood sodium levels), particularly in patients with heart failure or syndrome of inappropriate antidiuretic hormone secretion (SIADH). It is also used to slow the progression of kidney function decline in adults with autosomal dominant polycystic kidney disease (ADPKD). It works by blocking vasopressin V2 receptors in the kidneys, thereby increasing the excretion of free water without significantly increasing sodium loss. This helps raise blood sodium levels and reduces fluid accumulation. Tolvaptan is available in tablet form for oral administration. Common side effects include thirst, dry mouth, increased urination and frequent urination. Serious adverse effects may include liver injury, dehydration and excessive increases in blood sodium levels. Regular monitoring of liver function, kidney function and blood sodium levels is important. It should be used under strict medical supervision.
Tolvaptan was historically used as a respiratory medicine for the symptomatic management of certain respiratory conditions. Its former uses included:
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The import of medicines into India is regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The regulatory requirements depend on whether the product is an active pharmaceutical ingredient (API), a finished formulation, or an unapproved medicine intended for an individual patient's treatment.
Primeera Healthcare Private Limited can provide import coordination and pharmaceutical documentation assistance for Tolvaptan, subject to confirmation of its current regulatory status and eligibility for import into India.
The export of Tolvaptan from India is subject to applicable requirements under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and relevant export, customs, and destination-country regulations. Documentation requirements depend on whether the product is an active pharmaceutical ingredient (API), a finished pharmaceutical formulation, or a medicine intended for a specific market. Export eligibility and destination-country requirements must be verified before shipment.
Primeera Healthcare Private Limited can provide pharmaceutical export documentation assistance, regulatory coordination, and shipping support for Tolvaptan, subject to confirmation of its export eligibility under applicable Indian regulations and the import requirements of the destination country.
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