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Ddavp Nasal (Desmopressin Acetate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Primary Nocturnal Enuresis: DDAVP Nasal Spray is indicated for the management of primary nocturnal enuresis. It may be used alone or adjunctive to behavioral conditioning or other nonpharmacological intervention. It has been shown to be effective in some cases that are refractory to conventional therapies.

Central Cranial Diabetes Insipidus: DDAVP Nasal Spray 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 DDAVP Nasal Spray 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 DDAVP can be monitored by urine volume and osmolality.

DDAVP 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 transphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.

DOSAGE AND ADMINISTRATION

Primary Nocturnal Enuresis: Dosage should be adjusted according to the individual. The recommended initial dose for those 6 years of age and older is 20 µg or 0.2 mL solution intranasally at bedtime. Adjustment up to 40 µg is suggested if the patient does not respond.

Some patients may respond to 10 µg and adjustment to that lower dose may be done if the patient has shown a response to 20 µg. It is recommended that one-half of the dose be administered per nostril. Adequately controlled studies with intranasal DDAVP in primary nocturnal enuresis have not been conducted beyond 4-8 weeks.

Central Cranial Diabetes Insipidus: DDAVP 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 DDAVP. 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. About1/4 to1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally.

The nasal spray pump can only deliver doses of 0.1 mL (10 µg) 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 µg of drug per spray. Discard DDAVP Nasal Spray after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 µg of drug.

HOW SUPPLIED

DDAVP Nasal Spray is available in a 5-mL bottle with spray pump delivering 50 sprays of 10 g (NDC 0075-2452-01). Desmopressin acetate is also available as DDAVP Rhinal Tube, a refrigerated product with 2.5 mL per vial, packaged with two rhinal tube applicators per carton (NDC 0075-2450-01).

Store at Controlled Room Temperature 20 to 25C (68 to 77F) [see USP].

STORE BOTTLE IN UPRIGHT POSITION.

Rx Only.

Keep out of the reach of children.

Manufactured for:

Aventis Pharmaceuticals Inc.

Bridgewater, NJ 08807

By Ferring AB, Soldattorpsvägen 5

SE-200 G1 Limhamn, Sweden

Rev. December 2002

2002 Aventis Pharmaceuticals Inc.

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