samsca tolvaptan tablet 15mg per tablet 5tablets per box

Description

Indication & Scope

Samsca® is a prescription selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic or euvolemic hyponatremia associated with heart failure, liver cirrhosis, or syndrome of inappropriate antidiuretic hormone secretion (SIADH), particularly in patients with serum sodium <125 mEq/L or symptomatic hyponatremia resistant to fluid restriction. It is also used as adjunctive therapy for fluid retention in heart failure.

Mechanism: Tolvaptan selectively blocks vasopressin V2 receptors in the renal collecting ducts, promoting excretion of electrolyte-free water (aquaresis) without significant sodium or potassium loss.
Drug class: Selective vasopressin V2-receptor antagonist (aquaretic).
Clinical use: Treatment of hypervolemic or euvolemic hyponatremia and adjunctive management of fluid overload in heart failure.

Specification

Generic Name	Tolvaptan Tablets
Brand Name	Samsca®
Ingredient	Tolvaptan
Dosage Form	Tablet
Package	15 mg/tablet, 5 tablets/box
Conditions Treated	Hypervolemic or euvolemic hyponatremia associated with heart failure, liver cirrhosis, or SIADH; fluid retention in heart failure
Taboos	Hypovolemic hyponatremia, anuria, inability to sense or respond to thirst, hypernatremia, concomitant use with strong CYP3A inhibitors, hypersensitivity to tolvaptan
Place of origin	China
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store below 30°C. Protect from freezing and excessive heat.
Manufacturer	Zhejiang Otsuka Pharmaceutical Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval Number	H20110115
Approval Date	July 18, 2025
Shelf Life	36 months

How to use ?

Recommended Dose: Start with 15 mg orally once daily. If needed, increase to 30 mg and then 60 mg once daily based on serum sodium response.

Time: Take once daily, with or without food.

Instructions for use: Initiation and dose titration should be performed in hospital. Monitor serum sodium closely to avoid overly rapid correction. Treatment duration should generally not exceed 30 days, and liver function should be monitored regularly.

Interaction: Avoid strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin) and use caution with ACE inhibitors, ARBs, potassium-sparing diuretics, and CYP3A inducers.

Side effects: Common adverse reactions include thirst, dry mouth, polyuria, nocturia, frequent urination, constipation, dizziness, hypernatremia, elevated liver enzymes, and hyperkalemia.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is Samsca® used for?

It is used to treat clinically significant hypervolemic or euvolemic hyponatremia caused by heart failure, liver cirrhosis, or SIADH.

How is Tolvaptan different from traditional diuretics?

Unlike loop or thiazide diuretics, Tolvaptan removes free water without significant sodium or potassium loss, helping correct hyponatremia.

Why must treatment begin in the hospital?

Serum sodium must be monitored closely because correcting sodium too rapidly may cause osmotic demyelination syndrome, a serious neurological complication.

Can Samsca® be used for ordinary edema?

It is mainly indicated for patients with hyponatremia or selected heart failure patients with fluid overload. It is not routinely used for uncomplicated edema.