INDICATIONS AND USAGE
Central Diabetes Insipidus: DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. DDAVP is ineffective for the treatment of nephrogenic diabetes insipidus.
Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to DDAVP can be monitored by measuring urine volume and osmolality.
Primary Nocturnal Enuresis: DDAVP® Tablets (desmopressin acetate) are indicated for the management of primary nocturnal enuresis. DDAVP may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.
|
DOSAGE AND ADMINISTRATION
Central Diabetes Insipidus: The dosage of DDAVP Tablets 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 previously on intranasal DDAVP therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of DDAVP Tablet therapy to assure adequate antidiuretic response. Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover.
Adults and Children: It is recommended that patients be started on doses of 0.05 mg (1/2 of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis. See Pediatric Use subsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients. Primary Nocturnal Enuresis: The dosage of DDAVP Tablets must be determined for each individual patient and adjusted according to response. Patients previously on intranasal DDAVP therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients age 6 years and older is 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response.
|
HOW SUPPLIED
| Strength |
Size |
NDC 0075- |
Color |
Markings |
|
0.1 mg
|
Bottle
of 100
|
0016-00
|
White
|
|
|
0.2 mg
|
Bottle
of 100
|
0026-00
|
White
|
|
|
Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. Avoid exposure to excessive heat or light.
This product should be dispensed in a container with a child-resistant cap. Keep out of the reach of children.
U.S. Patent Nos. 5,500,413, 5,596,078, 5,674,850, 5,047,398
Manufactured for
Aventis Pharmaceuticals Inc.
Bridgewater, NJ 08807 USA
By Ferring AB, Soldattorpsvägen 5, SE-200 61 Limhamn, Sweden
Rev. November 2002
|
