|Manufacturer:||sanofi-aventis U.S. LLC|
Manufactured for:sanofi-aventis U.S.
LLCBridgewater, NJ 08807Revised July 2007a©2007 sanofi-aventis U.S.LLC
DDAVP Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.
It is ineffective for the treatment of nephrogenic diabetes insipidus.The use of DDAVP Nasal Spray in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality.
This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.There are reports of an occasional change in response with time, usually greater than 6 months.
Some patients may show a decreased responsiveness, others a shortened duration of effect.
There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.Patients are selected for therapy by establishing the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or the response to antidiuretic hormone.
Continued response to intranasal DDAVP can be monitored by urine volume and osmolality.DDAVP is also available as a solution for injection when the intranasal route may be compromised.
These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis.
Intranasal delivery may also be inappropriate where there is an impaired level of consciousness.In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
For intranasal use only.DDAVP Nasal Spray 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 Nasal Spray 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.