DDAVP Rhinal Tube
"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
DDAVP Rhinal Tube
Central Cranial Diabetes Insipidus: DDAVP Rhinal Tube (desmopressin acetate rhinal tube) 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 Rhinal Tube (desmopressin acetate rhinal tube) 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 transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
DOSAGE AND ADMINISTRATION
Central Cranial Diabetes Insipidus: This drug is administered into the nose through a soft, flexible plastic rhinal tube which has four graduation marks on it that measure 0.2, 0.15, 0.1 and 0.05 mL. DDAVP Rhinal Tube (desmopressin acetate rhinal tube) 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. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)
Geriatric Use: 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. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
DDAVP Rhinal Tube (desmopressin acetate rhinal tube) is available in a 2.5 mL bottle, packaged with two rhinal tube applicators per carton (NDC 0075-2450-01). Also available in a 5.0 mL pump bottle with spray pump delivering 50 doses of 10 mcg (NDC 0075-2452-01).
Store refrigerated 2 to 8°C (36 to 46°F). When traveling, closed bottles will maintain stability for 3 weeks when stored at controlled room temperature, 20 to 25°C (68 to 77°F).
Keep out of the reach of children.
MILITARY: DDAVP Rhinal Tube (desmopressin acetate rhinal tube) , 1 x 2.5 mL (NSN 6505-01-145-6338).
Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Rev. July 2007. FDA rev date: 10/26/2007
Last reviewed on RxList: 2/12/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional DDAVP Rhinal Tube Information
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