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warnings
WARNINGS For intranasal use only. DESMOPRESSIN ACETATE 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 DESMOPRESSIN ACETATE (desmopressin acetate). DESMOPRESSIN ACETATE 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 DESMOPRESSIN ACETATE 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 DESMOPRESSIN ACETATE 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. DESMOPRESSIN ACETATE 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.
ADVERSE REACTIONS Infrequently, high dosages of intranasal DESMOPRESSIN ACETATE 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 percent 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) % DESMOPRESSIN ACETATE 20 mcg (N=60) % DESMOPRESSIN ACETATE 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.