Myungin Tolvaptan 30 mg

Adult dose

1. Hyponatremia Closely monitor serum electrolytes and changes in fluid volume during initiation of treatment with this medicine and during dose adjustment. The recommended initial dose in adults is 15mg once daily. To reach the target serum sodium concentration, increase the dose to 30mg once daily at intervals of at least 24 hours, up to a maximum of 60mg once daily. Do not administer for more than 30 days to minimize the risk of liver injury. Take this medicine preferably in the morning, with water, regardless of meals, and swallow it whole without chewing. Do not restrict fluid intake during the first 24 hours after taking this medicine, and continue to drink fluids if thirst occurs. If this medicine is discontinued, resume fluid restriction after discontinuation and monitor changes in serum sodium concentration and fluid volume. 2. Autosomal dominant polycystic kidney disease (ADPKD) When prescribing this medicine for the indication above, it may be prescribed only by a physician enrolled in the risk management program, and only to patients who have agreed to and signed the program requirements. Patients must comply with this program. In addition, to reduce the risk of serious irreversible liver injury, blood tests for ALT, AST, and total bilirubin are required before the first dose. Liver function tests must be performed monthly during the first 18 months of treatment and once every 3 months thereafter. The initial dose is 60mg daily, administered in 2 divided doses: 45mg before breakfast and 15mg 8 hours later. Thereafter, depending on tolerability, increase the dose at intervals of at least 1 week to 90mg daily (60mg+30mg), and then increase to the target dose of 120mg daily (90mg+30mg). Increase the dose cautiously to avoid reduced tolerability due to rapid dose escalation. The dose may be reduced according to the patient's tolerability; in this case, maintain the highest dose the patient can tolerate. Always swallow this medicine whole with water, without chewing. The purpose of dose adjustment is to continuously and as completely as possible inhibit the action of vasopressin at renal vasopressin-2 (V2) receptors while maintaining fluid balance within the acceptable range. Measurement of urine osmolality is recommended to monitor the adequacy of vasopressin inhibition. If the patient's fluid intake is inadequate, periodic monitoring of plasma osmolality, serum sodium, or body weight should be considered to monitor the risk of dehydration resulting from this medicine's electrolyte-free water excretion effect. Dose adjustment in patients with ADPKD taking strong CYP3A inhibitors In patients taking strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin), the dose of this medicine should be reduced as follows. Current tolvaptan dose (administered in 2 divided doses daily) → Reduced dose (once daily) 90+30 mg → 30 mg (reduce further to 15mg depending on tolerability) 60+30 mg → 30 mg (reduce further to 15mg depending on tolerability) 45+15 mg → 15 mg Dose adjustment in patients with ADPKD taking moderate CYP3A inhibitors In patients taking moderate CYP3A inhibitors (e.g., fluconazole, erythromycin), the dose of this medicine should be reduced as follows. Current tolvaptan dose (administered in 2 divided doses daily) → Reduced dose (administered in 2 divided doses daily) 90+30 mg → 45+15 mg 60+30 mg → 30+15 mg 45+15 mg → 15+15 mg If the reduced dose is not well tolerated, further dose reduction should be considered.

This drug should be administered in the hospital initially for the treatment of hyponatremia or upon re-administration, with careful monitoring of serum sodium levels. Rapid increases in serum sodium concentrations can lead to serious neurological problems, so regular monitoring is necessary. It is discouraged to use this drug in patients with liver disease due to the risk of liver damage. For patients with autosomal dominant polycystic kidney disease, regular liver function tests must be conducted through a special management program when prescribing this drug. This drug should not be administered to patients with specific allergies, those requiring urgent elevation of serum sodium, pregnant or nursing women, and some patients with kidney diseases. Patients showing signs of dehydration or volume depletion require caution when receiving this drug, and adequate fluid intake is important. Diabetic patients should use this drug while monitoring their blood sugar control. This drug may cause drowsiness or weakness, requiring caution when driving or operating machinery. It may interact with other medications, so particularly when combined with potent CYP3A inhibitors or diuretics, one should follow the physician's instructions. Women who are pregnant or may become pregnant must use appropriate contraception while taking this drug and should not use it during pregnancy. In cases of overdose, symptoms such as increased serum sodium concentration, dehydration, and thirst may occur, necessitating immediate consultation with medical personnel. Regular monitoring of liver function, electrolytes, kidney function, etc., is very important during the treatment to detect and manage abnormal signs early.

• Dysphonia
• mutism
• dysphagia
• somnolence
• affective change
• incomplete paralysis of limbs
• seizures
• coma
• death
• fatigue

Store this drug in a tightly closed container to prevent air or moisture from entering, at room temperature between 1 to 30 degrees Celsius. This will safely maintain the drug's efficacy.

Appearance

Blue round tablets

Package unit

10 tablets/box (10 tablets/PTP X1)