Tolvaptan Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Hyponatremia

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.

Uses: 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, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH)

Usual Adult Dose for Hyponatremia, euvolemic

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.

Uses: 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, and Syndrome of Inappropriate Antidiuretic Hormone (SIADH)

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 10 to 79 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl less than 10 mL/min): Not recommended for use.

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

BOXED WARNINGS:
-INITIATING THERAPY: Tolvaptan therapy should be initiated and reinitiated in a hospital setting.
-OSMOTIC DEMYELINATION: Rapid correction of hyponatremia (e.g., greater than 12 mEq/L/24 hrs) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Tolvaptan can be taken without regard to meals.

General:
-Grapefruit juice should be avoided during treatment with tolvaptan.
-Following discontinuation of tolvaptan, patients should be advised to resume fluid restriction and should be monitored for changes in serum sodium and volume status.

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