Tolbis Tablet 30 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.

This drug is used to control serum sodium levels, and serious neurological problems can occur if serum sodium levels change rapidly. Therefore, when initially administered or re-administered in a hospital, serum sodium levels must be checked regularly. When treating hyponatremia, if the rate of administration of this drug is too fast, it can cause brain damage, so changes in serum sodium levels should be carefully monitored. Patients with liver dysfunction or liver disease should not use this drug, and administration should be stopped immediately if symptoms of liver damage appear. For patients with autosomal dominant polycystic kidney disease, this drug should be prescribed under strict supervision by a specialist, and regular liver function tests should be conducted. Administration should not occur in situations where there is hypersensitivity to this drug, circumstances requiring rapid elevation of serum sodium levels, dehydration, hypovolemic hyponatremia, anuria, hypernatremia, or in pregnant women. Patients with dehydration, hypovolemia, diabetes, cardiovascular diseases, hyperkalemia, urinary disorders, or renal function decline should use this drug cautiously and ensure adequate fluid intake to prevent dehydration. This drug may cause drowsiness or weakness, so care should be taken when driving or operating machinery. This drug can interact with several medications, so patients taking other medications should consult their doctor or pharmacist. Pregnant or breastfeeding women should not take this drug, and women of childbearing age should ensure proper contraception while taking this medication. In case of overdose, serum sodium levels may rise excessively and dehydration symptoms may appear, so patients should inform healthcare professionals immediately, as there is no specific antidote and they will receive symptom-dependent treatment.

• Hyponatremia
• dysarthria
• mutism
• dysphagia
• somnolence
• affective changes
• incomplete paralysis of limbs
• seizures
• coma
• death

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is advisable to maintain a storage temperature between 1 degrees Celsius and 30 degrees Celsius.

Appearance

Blue circular tablet

Package unit

10 tablets/box [10 tablets/PTP X1]