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Saptan 15

Saptan 15 Warnings

tolvaptan

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma
Full Prescribing Info
Warnings
Initiate and re-initiate in a hospital and monitor serum sodium.
Tolvaptan should be initiated and re-initiated in patients only in a hospital where scrum sodium can be monitored closely.
Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable.
Potent aquaresis (free water clearance), especially in normonatremic patients treated with Tolvaptan for heart failure, may induced hypernatremia which can lead to disturbed consciousness. If serum sodium increases above normal range, Tolvaptan should be discontinued, serum sodium should be carefully monitored and appropriate measures should be taken if necessary.
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