tolvaptan tablets Natrise 30mg

[Drug Name]

Generic Name: Tolvaptan Tablets

Brand Name: Tolvaptan Tablets (Sumika)

English Name: Tolvaptan Tablets

Full Pinyin Code: TuoFaPuTanPian (SuMaiKa)

[Main Ingredients] The main active ingredient is tolvaptan. Chemical Name: N-[4-[(5R)-7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl]-3-methylphenyl]-2-methylbenzamide. For details regarding molecular weight, molecular formula, and chemical structural formula, please refer to the package insert.

[Composition] Molecular Formula: C26H25ClN2O3

[Description] This product is in the form of tablets.

[Indications/Therapeutic Uses] 1. Used for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium concentration < 125 mEq/L, or hyponatremia that is less severe but symptomatic and has not responded adequately to fluid restriction), including in patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH). 2. Used for fluid retention associated with heart failure that has not responded adequately to treatment with other diuretics (e.g., loop diuretics). (For details, please refer to the package insert.)

[Specification] 30 mg × 4 tablets

[Dosage and Administration] The usual starting dose of this product is 15 mg, taken once daily; it may be taken with or without food. After at least 24 hours of administration, the dosage may be increased to 30 mg, taken once daily. Based on serum sodium concentration, the dosage may be further increased to a maximum of 60 mg, taken once daily. During the initiation of therapy and during dosage titration, serum electrolytes and volume status should be monitored frequently. Fluid restriction should be avoided during the first 24 hours of treatment. Patients taking this product should drink water promptly when thirsty. (For details, please refer to the package insert.)

[Adverse Reactions] Thirst, dry mouth, fatigue, constipation, pollakiuria (frequent urination), etc. (See Package Insert for details)

[Contraindications] 1. Patients requiring a rapid increase in serum sodium concentration. 2. Patients who are unable to sense thirst or unable to respond appropriately to thirst signals. 3. Hypovolemic hyponatremia. 4. Concomitant use with potent CYP3A inhibitors. 5. Patients with anuria. 6. Patients with hypersensitivity to any component of this product. 7. Patients with hypernatremia.

[Precautions] 1. Rapid correction of serum sodium concentration may lead to serious neurological sequelae (see WARNINGS). 2. Hepatotoxicity (see WARNINGS). 3. Gastrointestinal bleeding in patients with cirrhosis (see Package Insert for details). Please read the package insert carefully and use strictly according to physician's instructions.

[Pediatric Use] Not established.

[Geriatric Use] Not established.

[Use in Pregnancy and Lactation] Not established.

[Drug Interactions] Drug interactions may occur if used concomitantly with other medications; please consult a physician or pharmacist for details.

[Overdosage] Not established.

[Pharmacology and Toxicology] A vasopressin V2 receptor antagonist (a non-peptide AVP2 receptor antagonist) that increases plasma sodium ion concentration and facilitates the excretion of excess water via urine, thereby enhancing the kidney's ability to handle water. In polycystic kidney disease (PKD), intracellular accumulation of cyclic adenosine monophosphate (cAMP) promotes cyst growth by stimulating cyst fluid secretion and the proliferation of cyst-lining cells. Tolvaptan is a vasopressin V2 receptor antagonist that inhibits the generation and accumulation of cAMP. Tolvaptan has demonstrated favorable efficacy in various animal models of PKD.

[Pharmacokinetics] Not established.

[Storage] Protect from light; keep tightly sealed. [Packaging] Double-aluminum blister packaging; 4 tablets/blister sheet x 1 sheet/box

[Shelf Life] 36 months

Product Specifications

Product Name: Tolvaptan Tablets (Sumeca) 30mg x 4 tablets — Tolvaptan Natrise (30mg) [Note: This product is available for shipment from India only]

Common Name: Sumeca

Active Ingredient: Tolvaptan

Dosage Form: Tablets

Specification: 30mg x 4

Manufacturer: Sun Pharmaceutical Industries Ltd

Indications: Used for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium concentration <125 mEq/L, or hyponatremia that is less severe but symptomatic and has not responded to fluid restriction), including in patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).

Dosage and Administration: To evaluate the therapeutic effect of this product—and because rapid correction of hyponatremia can cause osmotic demyelination syndrome, leading to dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriplegia, seizures, coma, and death—the initiation and re-initiation of treatment with this product should be conducted in a hospital setting.

The usual starting dose of this product is 15 mg, taken once daily; it may be taken with or without food. After at least 24 hours of treatment, the dosage may be increased to 30 mg, taken once daily. Based on serum sodium concentrations, the dosage may be further increased to a maximum of 60 mg, taken once daily. During the initiation of treatment and during dosage adjustments, serum electrolytes and fluid volume status should be monitored frequently; fluid restriction should be avoided during the first 24 hours of treatment. Patients taking this product should drink water promptly whenever they feel thirsty.