Samsca: Dosage and Administration Instructions

Usual Dosage Guidelines

The usual starting dose for SAMSCA is 15 mg administered once daily without regard to meals. Increase the dose to 30 mg once daily٫ after at least 24 hours٫ to a maximum of 60 mg once daily٫ as needed to achieve the desired level of serum sodium.

Initiation and Titration

Patients should be in a hospital for initiation and re-initiation of therapy to evaluate the therapeutic response and avoid adverse effects. The usual starting dose for SAMSCA is 15 mg administered once daily without regard to meals.​ Increase the dose to 30 mg once daily, after at least 24 hours, to a maximum of 60 mg once daily as needed to achieve the desired level of serum sodium.​

Monitoring and Fluid Intake

During initiation and titration of SAMSCA therapy, it is crucial to regularly monitor changes in serum electrolytes and volume.​ Patients should be advised to continue fluid intake as per thirst cues.​ Avoid fluid restriction in the first 24 hours.​ Following discontinuation, resume fluid restriction and monitor serum sodium and volume status changes;

Cautions and Considerations

Tolvaptan is a substrate of P-gp.​ Co-administration with inhibitors of P-gp may require a dosage adjustment.​ It is important to monitor for changes in serum sodium levels during therapy to prevent hyponatremia complications.​ Patients should not take more than the prescribed duration to minimize the risk of liver injury.​

Special Instructions for Dose Adjustments

Based on the provided information, coadministration of SAMSCA with inhibitors or inducers of P-gp may require dosage adjustments.​ Monitoring the serum sodium levels during therapy is crucial to prevent complications. If a rapid rise in serum sodium occurs, treatment adjustments should be considered. Additionally, avoid grapefruit products while on SAMSCA as they may lead to undesired effects.​

Reporting of Side Effects

If any side effects are experienced while taking SAMSCA, promptly contact your healthcare provider.​ You can also report side effects to the FDA at 1-800-FDA-1088.​ It is essential to follow up with your doctor if you notice any unusual symptoms or reactions associated with SAMSCA.