Samsca 15 mg (Tolvaptan Granules)

Adult dose

1. Hyponatremia The recommended initial dose in adults is 15mg once daily. Increase the dose to 30mg once daily at intervals of at least 24 hours, up to a maximum of 60mg once daily. This medicine is generally taken in the morning. Swallow it whole with water without chewing, regardless of meals. 2. Autosomal dominant polycystic kidney disease (ADPKD) The initial dose is 60mg daily, divided into 45mg before breakfast and 15mg 8 hours later, given twice daily. Thereafter, increase the dose at intervals of at least 1 week to 90mg daily (60mg+30mg); the target dose is 120mg daily (90mg+30mg). Always swallow this medicine whole with water without chewing. Reduce the dose when taking a strong CYP3A inhibitor, and also reduce the dose when taking a moderate CYP3A inhibitor.

This drug is used for the treatment of hyponatremia and can cause a rapid increase in serum sodium levels, so when starting or restarting treatment, serum sodium levels must be regularly monitored in a hospital setting. A rapid increase in serum sodium levels can cause severe neurological damage or be life-threatening; caution is especially needed in patients with liver disease, malnutrition, and alcoholism. Patients with liver dysfunction or cirrhosis should avoid use due to the risk of liver damage, and if symptoms of liver damage occur, the medication should be stopped immediately. This medication is also used for the treatment of autosomal dominant polycystic kidney disease, in which case liver enzyme levels and liver function should be monitored regularly. Patients with hypersensitivity or those who need to rapidly increase serum sodium levels, as well as those with dehydration, hypovolemic hyponatremia, anuria, fluid depletion, or hypernatremia, and women who are pregnant or breastfeeding should not take this medication. Furthermore, there may be risks of side effects when combined with certain potent medications, so all concomitant medications must be disclosed. This drug should be given with caution to patients with dehydration or hypovolemia, and caution is also needed for patients with diabetes or cardiovascular diseases. During treatment, adequate fluid intake should be maintained when feeling thirsty, and regular blood tests to check electrolytes and liver function are essential. Symptoms such as drowsiness, weakness, or dizziness may occur; therefore, caution should be exercised when driving or operating machinery. Women who are pregnant or may become pregnant should ensure appropriate contraception, and nursing mothers should consult with a physician regarding whether to take this medication. In cases of overdose, severe dehydration and electrolyte imbalance may occur, and immediate medical attention should be sought. Various side effects such as liver damage, changes in kidney function, and abnormalities in blood glucose or electrolytes may occur during treatment, so regular check-ups are necessary.

• Hyponatremia
• dysarthria
• mutism
• dysphagia
• drowsiness
• mood changes
• incomplete paralysis of the limbs
• seizures
• coma
• death

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. Additionally, it should be kept away from areas that are too hot or too cold, ideally stored at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Blue circular tablet (Imprint: SAMSCA, 15)

Package unit

10 tablets/box [10 tablets/PTP X 1], 30 tablets/box [10 tablets/PTP X 3], 60 tablets/bottle