DDAVP Nasal Spray
SIDE EFFECTS
Infrequently, high dosages of intranasal DDAVP have produced transient headache and nausea. Nasal congestion, rhinitis and flushing have also been reported occasionally along with mild abdominal cramps. These symptoms disappeared with reduction in dosage. Nosebleed, sore throat, cough and upper respiratory infections have also been reported.
The following table lists the percentage of patients having adverse experiences without regard to relationship to study drug from the pooled pivotal study data for nocturnal enuresis.
| ADVERSE REACTION | PLACEBO (N=59) |
DDAVP 20 mcg (N=60) |
DDAVP 40 mcg (N=61) |
| % | % | % | |
| BODY AS A WHOLE | |||
| Abdominal Pain | 0 | 2 | 2 |
| Asthenia | 0 | 0 | 2 |
| Chills | 0 | 0 | 2 |
| Headache | 0 | 2 | 5 |
| NERVOUS SYSTEM | |||
| Dizziness | 0 | 0 | 3 |
| RESPIRATORY SYSTEM | |||
| Epistaxis | 2 | 3 | 0 |
| Nostril Pain | 0 | 2 | 0 |
| Rhinitis | 2 | 8 | 3 |
| DIGESTIVE SYSTEM | |||
| Gastrointestinal Disorder | 0 | 2 | 0 |
| Nausea | 0 | 0 | 2 |
| SPECIAL SENSES | |||
| Conjunctivitis | 0 | 2 | 0 |
| Edema Eyes | 0 | 2 | 0 |
| Lachrymation Disorder | 0 | 0 | 2 |
Post Marketing: There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.
See WARNINGS for the possibility of water intoxication and hyponatremia.
DRUG INTERACTIONS
Although the pressor activity of DDAVP is very low compared to the antidiuretic activity, use of large doses of intranasal DDAVP with other pressor agents should only be done with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.
Generic Name: Desmopressin Acetate Nasal Spray
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