Tolbis Tablets 15 mg (Tolvaptan)

Adult dose

1. Hyponatremia Serum electrolytes and changes in fluid volume should be closely monitored during initiation of treatment with this drug and during dose adjustment. The recommended initial dose for 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 in order to minimize the risk of liver injury. This drug is usually taken in the morning, swallowed whole with water without chewing, with or without food. Do not restrict fluid intake during the first 24 hours after administration of this drug, and continue fluid intake if thirst occurs. If this drug 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 drug for the indications described above, it may be prescribed only by physicians enrolled in the risk management program, and only to patients who agree to and sign the requirements specified in the program. 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 of this drug. Liver function tests must be performed monthly during the first 18 months of treatment and once every 3 months thereafter. The initial dose of this drug is 60mg per day, divided into two doses: 45mg before breakfast and 15mg 8 hours later. Thereafter, taking tolerability into consideration, increase the dose to 90mg per day (60mg+30mg) at intervals of at least 1 week, and then increase it to the target dose of 120mg per day (90mg+30mg). Dose increases should be made cautiously to avoid reduced tolerability due to rapid escalation. The dose may be reduced according to the patient's tolerability; in this case, maintain the highest dose the patient can tolerate. This drug must be swallowed whole with water without chewing. The purpose of dose adjustment is to maintain fluid balance within an acceptable range while continuously and as completely as possible inhibiting the action of vasopressin at renal vasopressin-2 (V2) receptors. 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 due to the electrolyte-free water excretion effect of this drug. Dose adjustment in patients with ADPKD taking strong CYP3A inhibitors For patients taking strong CYP3A inhibitors (such as ketoconazole or clarithromycin), the dose of this drug should be reduced as follows. Current tolvaptan dose (divided into 2 doses per day) 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 For patients taking moderate CYP3A inhibitors (such as fluconazole or erythromycin), the dose of this drug should be reduced as follows. Current tolvaptan dose (divided into 2 doses per day) Reduced dose (divided into 2 doses per day) 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.

Serum sodium levels must be adjusted slowly with this medication, so initial administration or re-initiation should occur in a hospital setting, with regular blood tests to monitor sodium levels. Rapid increases in serum sodium levels can lead to severe neurological issues, particularly in patients with liver disease or alcohol addiction. This medication can cause severe liver damage, so patients with liver disease should avoid its use, and treatment should be stopped immediately if symptoms of liver damage appear. Special registration programs must manage the prescription of this medication for patients with certain kidney diseases, and liver function tests should also be performed regularly. It should not be administered to patients allergic to this medication or similar components, those requiring rapid sodium elevation, patients with impaired thirst sensation, or those with hypovolemic hyponatremia. Caution should be taken as the administration of this medication carries risks of dehydration, hypotension, and hyperglycemia; adequate fluid intake should be maintained, and symptoms should be closely monitored. Diabetes patients, patients with cardiovascular diseases, and those with diminished kidney function should also be administered with caution, and serum potassium levels should be monitored closely. This medication may cause drowsiness or weakness, so caution is necessary when driving or operating machinery. Pregnant women or those who may become pregnant, as well as nursing mothers, should avoid its use and employ appropriate contraceptive measures. Furthermore, this medication may interact with other drugs; patients should inform their healthcare provider of any medications they are taking. In case of overdose, immediate hospital care is needed as there is no specific antidote, and symptomatic treatment is required.

• Hyponatremia
• dysarthria
• mutism
• dysphagia
• somnolence
• affective changes
• partial limb paralysis
• seizures
• coma
• death

Store this medication in a tightly closed container to avoid exposure to air or moisture, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. This storage will help maintain the drug's effectiveness and prevent degradation.

Appearance

Blue round tablets

Package unit

10 tablets/box [10 tablets/PTP X1]