|Manufacturer:||sanofi-aventis U.S. LLC|
Manufactured for:sanofi-aventis U.S.
LLCBridgewater, NJ 08807Revised July 2007a©2007 sanofi-aventis U.S.LLC
For intranasal use only.DDAVP Rhinal Tube should only be used in patients where orally administered formulations are not feasible.Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate).
DDAVP is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia.
Unless properly diagnosed and treated hyponatremia can be fatal.
Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian.
Careful medical supervision is required.When DDAVP is administered, in particular, in pediatric and geriatric patients, fluid intake should be adjusted downward in order to decrease the potential occurrence of water intoxication and hyponatremia.
(See PRECAUTIONS, Pediatric Use and Geriatric Use.) All patients receiving DDAVP therapy should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion.
Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest.Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.DDAVP should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.