Ddavp Information
Ddavp (Desmopressin) Description
Mol. wt. 1183.34
Empirical formula: CHNOS•CHO•3HO
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.
The compression pump delivers 0.1 mL (10 mcg) of Ddavp (Desmopressin) (desmopressin acetate) per spray.
Ddavp (Desmopressin) Clinical Pharmacology
Ddavp (Desmopressin) contains as active substance desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (0.1 mg) of intranasal Ddavp (Desmopressin) has an antidiuretic activity of about 400 IU; 10 mcg of desmopressin acetate is equivalent to 40 IU.
Ddavp (Desmopressin) Contraindications
Ddavp (Desmopressin) is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).
Ddavp (Desmopressin) is contraindicated in patients with hyponatremia or a history of hyponatremia.
Ddavp (Desmopressin) Precautions
Intranasal Ddavp (Desmopressin) at high dosage has infrequently produced a slight elevation of blood pressure, which disappeared with a reduction in dosage. The drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease because of possible rise in blood pressure.
Ddavp (Desmopressin) should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure and renal disorders because these patients are prone to hyponatremia.
Rare severe allergic reactions have been reported with Ddavp (Desmopressin) . Anaphylaxis has been reported rarely with intravenous and intranasal administration of Ddavp (Desmopressin) .
Fluid intake should be adjusted downward based upon discussion with the physician.
Clinical studies of Ddavp (Desmopressin) Nasal Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Ddavp (Desmopressin) is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).
(See and .)
Use of Ddavp (Desmopressin) Nasal Spray in geriatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. (See ).
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.
Ddavp (Desmopressin) Adverse Reactions
Infrequently, high dosages of intranasal Ddavp (Desmopressin) 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.
See for the possibility of water intoxication and hyponatremia.
Ddavp (Desmopressin) Overdosage
Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. (See .) In case of overdosage, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for desmopressin acetate or .
An oral LD has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.
Ddavp (Desmopressin) Dosage And Administration
Ddavp (Desmopressin) Nasal Spray
The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of Ddavp (Desmopressin) administered intranasally. Fluid restriction should be observed. (See , and .)
The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used.
The spray pump must be primed prior to the first use. To prime pump, press down four times. The bottle will now deliver 10 mcg of drug per spray. Discard after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 µg of drug.
Ddavp (Desmopressin) How Supplied
Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. STORE BOTTLE IN UPRIGHT POSITION.
Ddavp (Desmopressin)
Ddavp (Desmopressin) Patient Instruction Guide
If you accidentally deliver/administer too much of a dose, immediately telephone your doctor or a certified Regional Poison Center for advice. Possible signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention.
To administer a 10-microgram dose, place the spray nozzle in nostril and press the spray pump once. If a higher dose has been prescribed, spray half the dose in each nostril. The spray pump cannot be used for doses less than 10 micrograms or doses other than multiples of 10 micrograms.
Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP].
STORE BOTTLE IN UPRIGHT POSITION.
Ddavp (Desmopressin)
Ddavp (Desmopressin) Principal Display Panel - Ml Bottle Label
NDC 0075-2452-01
FOR INTRANASAL USE ONLY
Ddavp (Desmopressin) Principal Display Panel - Ml Bottle Carton
NDC 0075-2452-01
FOR INTRANASAL USE ONLY
