Samsca OD (Tolvaptan) 15 mg 20 tab.

Samsca OD 15 mg (Tolvaptan) – 20 Tablets

Description

Samsca OD contains Tolvaptan, a selective vasopressin V₂-receptor antagonist used to treat hyponatremia (low sodium levels in the blood) associated with conditions such as heart failure and the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).

It helps increase serum sodium concentration by promoting the excretion of free water without significant loss of electrolytes.

Active Ingredient

• Tolvaptan 15 mg per tablet

Dosage Form

Oral tablets (film-coated)

Mechanism of Action

Tolvaptan selectively blocks vasopressin V₂ receptors in the renal collecting ducts.
This inhibition reduces water reabsorption in the kidneys, increases urine output (aquaretic effect), and raises serum sodium levels without affecting potassium or other electrolytes.

Indications

Samsca OD is indicated for:

• Clinically significant euvolemic or hypervolemic hyponatremia, including cases caused by:
  • Congestive heart failure
  • Cirrhosis of the liver
  • SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion)

Note: Tolvaptan is not indicated for patients who require urgent correction of hyponatremia.

Dosage and Administration

• Starting dose: 15 mg once daily, with or without food
• Titration: May increase to 30 mg or up to a maximum of 60 mg daily, as clinically indicated
• Duration: Maximum treatment duration is 30 days to reduce the risk of liver injury
• Initiation: Treatment should be started and reinitiated in a hospital setting, where serum sodium can be closely monitored

Important: Do not restrict fluid intake during the first 24 hours of treatment. Patients should drink water as needed to avoid dehydration.

Contraindications

Do not use Samsca OD in patients with:

• Hypovolemic hyponatremia
• Anuria (no urine output)
• Inability to respond appropriately to thirst
• Hypersensitivity to Tolvaptan or any component of the formulation
• Concomitant use with strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin)
• Significant liver impairment (risk of hepatotoxicity)

Warnings and Precautions

• Rapid correction of sodium may cause osmotic demyelination syndrome (ODS); sodium levels must be monitored frequently
• Risk of hepatic injury – monitor liver function
• May cause excessive thirst, dry mouth, and frequent urination
• Use caution in patients with diabetes or dehydration
• Avoid grapefruit or grapefruit juice

Adverse Reactions

Common side effects:

• Thirst
• Dry mouth
• Polyuria (frequent urination)
• Constipation
• Weakness or fatigue
• Hyperglycemia

Serious side effects:

• Signs of liver damage (abdominal pain, jaundice, dark urine)
• Overcorrection of sodium levels (confusion, speech difficulty, seizures)
• Severe dehydration

Drug Interactions

• Metabolized primarily via CYP3A4
  • Avoid strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
  • Avoid CYP3A inducers (e.g., rifampin, carbamazepine)
• Grapefruit juice may increase blood levels of Tolvaptan

Storage

Store at 20–25 °C (68–77 °F).
Keep in a dry place, protected from light and moisture.
Keep out of reach of children.

Manufacturer

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

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