Tolvaptan Dosage

This dosage information may not include all the information needed to use Tolvaptan safely and effectively. See additional information for Tolvaptan.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Hyponatremia

Hypervolemic and euvolemic hyponatremia [serum sodium less than 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH):

Initial dose: 15 mg orally once a day
Maintenance dose: Increase the dose to 30 mg once a day, after at least 24 hours, to a maximum of 60 mg once a day, as needed to achieve the desired level of serum sodium.
Maximum dose: 60 mg once a day
Duration of therapy: Maximum of 30 days

Comments: During initiation and titration, frequently monitor for changes in serum electrolytes and volume. Avoid fluid restriction during the first 24 hours of therapy. Patients receiving tolvaptan should be advised that they can continue ingestion of fluid in response to thirst. Tolvaptan may be dosed without regard to meals.

Usual Adult Dose for Hyponatremia, euvolemic

Hypervolemic and euvolemic hyponatremia [serum sodium less than 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirrhosis, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH):

Initial dose: 15 mg orally once a day
Maintenance dose: Increase the dose to 30 mg once a day, after at least 24 hours, to a maximum of 60 mg once a day, as needed to achieve the desired level of serum sodium.
Maximum dose: 60 mg once a day
Duration of therapy: Maximum of 30 days

Comments: During initiation and titration, frequently monitor for changes in serum electrolytes and volume. Avoid fluid restriction during the first 24 hours of therapy. Patients receiving tolvaptan should be advised that they can continue ingestion of fluid in response to thirst. Tolvaptan may be dosed without regard to meals.

Renal Dose Adjustments

Exposure and response to tolvaptan are similar in patients with a creatinine clearance 10 to 79 mL/min and in patients without renal impairment. No dose adjustment is necessary. Exposure and response to tolvaptan in patients with a creatinine clearance less than 10 mL/min or in patients on chronic dialysis have not been studied and, because drug effects on serum sodium levels are likely lost at very low levels of renal function, use in patients with a creatinine clearance less than 10 mL/min is not recommended. No benefit can be expected in patients who are anuric.

Liver Dose Adjustments

Moderate and severe hepatic impairment do not affect exposure to tolvaptan to a clinically relevant extent. No dose adjustment of tolvaptan is necessary.

Precautions

Patients should be in a hospital for initiation and reinitiation of therapy to evaluate the therapeutic response and because too rapid correction of hyponatremia can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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