Tolvan 15mg Tablet

✔️ Side Effects

• Increased thirst
• Dry mouth
• Dizziness
• Nausea
• Fatigue or weakness
• Increased urination
• Passing large amounts of urine
• Diarrhea
• Constipation

✔️ Tolvan should not be used in patients with:

• Allergy to tolvaptan or any component of the medicine
• Inability to produce urine (anuria)
• Severe dehydration or volume depletion
• Hypovolemic hyponatremia
• High blood sodium levels (hypernatremia)
• Inability to recognize or respond to thirst
• Pregnancy or breastfeeding

✔️ Dosage & Administration

For Hyponatremia

The usual starting dose is 15 mg once daily, with or without food. Depending on the response, the dose may be increased to 30 mg once daily after at least 24 hours, and then up to a maximum of 60 mg once daily when necessary.

Treatment for hyponatremia should not continue beyond 30 days because of the potential risk of liver injury.

For ADPKD

Treatment generally starts at 60 mg per day, divided into two doses. The dose may be gradually increased according to response and tolerability, with at least 7 days between dose adjustments, up to a maximum of 120 mg per day in divided doses.

The specific dosing schedule must be determined by the treating physician.

✔️ Use in Special Populations

• Children: Safety and effectiveness have not been established.
• Older adults: No major differences in safety or effectiveness have been identified, although individual sensitivity may vary.
• Kidney impairment: Dose adjustment is generally not required based solely on renal function, but use is not recommended in patients with extremely low kidney function (CrCl below 10 mL/min). It is not beneficial in patients who cannot produce urine.
• Liver impairment: Tolvaptan should be avoided in patients with underlying liver disease unless specifically determined appropriate by a specialist.
• Heart failure: Dose adjustment is generally not required solely because of congestive heart failure.

✔️ Drug Interactions

Tolvaptan is primarily metabolized through CYP3A enzymes. Strong CYP3A inhibitors should not be used with Tolvan, while moderate inhibitors should generally be avoided because they can significantly increase tolvaptan levels.

CYP3A inducers such as rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, and barbiturates may reduce its effectiveness and should generally be avoided.

P-glycoprotein inhibitors such as cyclosporine may increase tolvaptan exposure, and dose adjustment may be necessary.

✔️ Pregnancy & Breastfeeding

Tolvaptan should not be used during pregnancy because human safety data are limited and animal studies have shown potential reproductive risks. Women who could become pregnant should use effective contraception during treatment.

It is not known whether tolvaptan passes into human breast milk, so breastfeeding is not recommended during treatment.

✔️ Precautions & Warnings

Tolvaptan can cause the blood sodium level to rise too quickly. Rapid correction of hyponatremia can cause serious neurological complications, so sodium levels must be monitored carefully.

Tolvaptan can also affect the liver. Your doctor may perform liver-function tests before and during treatment. Seek medical advice if you develop:

• Yellowing of the skin or eyes
• Dark-colored urine
• Unusual abdominal pain
• Other symptoms suggesting liver problems

Inform your doctor if you experience difficulty speaking, swallowing, or moving your arms and legs, problems with muscle control, or significant mood changes.

✔️ Storage:

Store below 25°C in a dry place and protect from light. Keep out of reach of children.