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Saptan 15

Saptan 15 Dosage/Direction for Use

tolvaptan

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma
Full Prescribing Info
Dosage/Direction for Use
Hypervolemic or euvolemic hyponatremia: Patient should be hospitalized for initiation or reinitiation of Tolvaptan therapy to evaluate therapeutic response and avoid too rapid correction of hyponatremia.
Initial: 15 mg once daily; may increase to 30 mg once daily, after at least 24 hours, to maximum of 60 mg once daily.
Avoid fluid restriction during the first 24 hours of therapy. Do not use for more than 30 days due to the risk of hepatotoxicity.
Adjunct treatment of volume overload in heart failure: Tolvaptan should be used as adjunct therapy to other diuretics (loop or thiazide diuretics, aldosterone antagonists. etc.). The usual adult dose is 15 mg once daily but it is recommended to start from 7.5 mg/day for patients whose serum sodium is less than 125 mEq/L or for whom rapid volume decrease is considered inappropriate. In order to avoid nocturnal urination, it is recommended to take Tolvaptan in the morning.
Treatment with Tolvaptan should be initiated in hospital and patients should be frequently monitored for serum sodium especially during the first day of treatment.
Renal impairment: CrCl ≥10 mL/minute: No dosage adjustment necessary.
CrCl <10 mL/minute, use not recommended.
Contraindicated in anuria.
Hepatic impairment: Avoid use with underlying liver disease, including cirrhosis; monitor closely for hepatotoxicity developing during use; discontinue use if signs/symptoms of hepatotoxicity develop (do not use for more than 30 days due to this potential risk).
Congestive heart failure: No dosage adjustment required.
Administration: Avoid fluid restriction during first 24 hours of therapy. Resume fluid restriction upon discontinuation.
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