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Desmopressin Rhinal Tube (Desmopressin Acetate Rhinal Tube) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Primary Nocturnal Enuresis: Desmopressin Acetate Rhinal Tube is indicated for the management of primary nocturnal enuresis. It may be used alone or adjunctive to behavioral conditioning or other non-pharmacological intervention. It has been shown to be effective in some cases that are refractory to conventional therapies.

Central Cranial Diabetes Insipidus: 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 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 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.

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 Desmopressin acetate in primary nocturnal enuresis have not been conducted beyond 4-8 weeks.

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. 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 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.

HOW SUPPLIED

Desmopressin Acetate Rhinal Tube is available in a 2.5 mL vial, packaged with two rhinal tube applicators per carton (NDC 55566-5020-1). Also available in a shelf packs of 10 × 2.5 mL vials (NDC 55566-5020-2).

Store refrigerated 2 to 8C (36 to 46F). When traveling, closed bottles will maintain stability for 3 weeks when stored at controlled room temperature, 20 to 25C (68 to 77F).

Rx only

Keep out of the reach of children.

Manufactured for

FERRING PHARMACEUTICALS INC.

SUFFERN, NY 10901

By Ferring Pharmaceuticals, Limhamn, Sweden

Rev. 4/03 6026-02

PATIENT INSTRUCTION GUIDE

DESMOPRESSIN

acetate

RHINAL TUBE

  1. Pull plastic tag on neck of bottle.
  2. Break security seal and remove plastic cap.
  3. Twist off the small knurled seal from the dropper. Use the same seal reversed to prevent subsequent leakage, especially if the bottle is not stored upright.
  4. The drug is administered by a soft, flexible, plastic rhinal tube which has dose marks at 0.2, 0.15, 0.1 and 0.05 mL. Take the arrow-marked part of the tube in one hand and place the fingers of the other hand around the cylindrical part of the closure. Insert the top of the dropper in a downward position into the arrow-marked end of the tube and squeeze the dropper until the solution has reached the desired calibration mark. The dose is measured from the arrow-marked end of the tube to the appropriate calibration. Disconnect the tube from the bottle by withdrawing the bottle quickly downwards. In order to prevent air bubbles from forming in the tube, maintain constant pressure on the dropper. If difficulty is experienced in filling the tube, a diabetic or tuberculin syringe may be used to draw up the dose and load the tube.
  5. Hold the tube with the fingers approximately 3/4 inch from the end and insert into a nostril until the tips of the fingers reach the nostril.
  6. Put the other end of the tube into the mouth. Hold the breath, tilt the head back and then blow with a short, strong puff through the tube so that the solution reaches the right place in the nasal cavity. Through this procedure, medication is limited to the nasal cavity and the preparation does not pass down into the throat.
    In very young patients, it may be necessary for an adult to blow the solution into the child's nose. In such cases, the tube will not need to be put into the nose as far as in the older child or adult. The tube should be placed in the nose gently just far enough so that the solution does not run out. A baby must be held firmly and securely.
  7. After use, reseal dropper tip and close the bottle with the plastic cap. Wash the tube in water and shake thoroughly, until no more water is left. The tube can then be used for the next application.

Store refrigerated 2 to 8C (36 to 46F). When traveling, closed bottles will maintain stability for 3 weeks when stored at controlled room temperature, 20 to 25C (68 to 77F).

Manufactured for

FERRING PHARMACEUTICALS INC.

SUFFERN, NY 10901

By Ferring Pharmaceuticals, Limhamn, Sweden 6026-02

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