Desmopressin Acetate Spray
Loading...Desmopressin Acetate Spray Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
- For intranasal use only.
- Desmopressin nasal spray solution 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 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 nasal spray solution 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Desmopressin Nasal Spray Solution USP, 0.01% 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 Desmopressin Nasal Spray Solution USP, 0.01% 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 desmopressin acetate can be monitored by urine volume and osmolality.
Desmopressin acetate 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.
History
There is currently no drug history available for this drug.
Other Information
Desmopressin Nasal Spray Solution USP, 0.01% is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is:
Mol. wt. 1183.34
Empirical formula: C46H64N14O12S2 • C2H4O2 • 3H2O
Chemical name: 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt).
Desmopressin Nasal Spray Solution USP, 0.01% is provided as an aqueous solution for intranasal use.
| Each mL contains: | |
| Desmopressin acetate | 0.1 mg |
| Inactives: | |
| Benzalkonium chloride solution (50% w/v) | 0.2 mg |
| Citric acid monohydrate | 1.7 mg |
| Sodium chloride | 7.5 mg |
| Sodium phosphate dibasic heptahydrate | 4.52 mg |
| Purified water to 1 mL |
The Desmopressin Nasal Spray Solution USP, 0.01% compression pump delivers 0.1 mL (10 mcg) of desmopressin acetate per spray.
Sources
Desmopressin Acetate Spray Manufacturers
-
Apotex Corp.
![Desmopressin Acetate Spray [Apotex Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Desmopressin Acetate Spray | Apotex Corp.
Central Cranial Diabetes InsipidusDesmopressin nasal spray solution dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal desmopressin acetate. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. 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 desmopressin acetate administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)
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 (4) times. The bottle will now deliver 10 mcg of drug per spray. Discard desmopressin nasal spray solution after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 mcg of drug.
Geriatric UseThis 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. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
-
Prasco Laboratories
Desmopressin Acetate Spray | Prasco Laboratories
Central Cranial Diabetes InsipidusDesmopressin Acetate Nasal Spray dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal Desmopressin Acetate. The usual dosage range in adults is 0.1 mL (10 mcg) to 0.4 mL (40 mcg) daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL (20 mcg) daily in two divided doses.
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 mL (5 mcg) to 0.3 mL (30 mcg) 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 Desmopressin Acetate administered intranasally. Fluid restriction should be observed. [See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.]
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 Desmopressin Acetate Nasal Spray after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 mcg of drug.
![Desmopressin Acetate Spray [Prasco Laboratories]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c9e4aedb-27d6-4499-9245-93937d3a375f&name=desmopressin-09.jpg)
Login To Your Free Account