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Ddavp Injection (Desmopressin Acetate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Hemophilia A: DDAVP Injection 4 µg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.

DDAVP will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.

DDAVP will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.

DDAVP is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies.

In certain clinical situations, it may be justified to try DDAVP in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.

von Willebrand's Disease (Type I): DDAVP Injection 4 µg/mL is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with factor VIII levels greater than 5%. DDAVP will often maintain hemostasis in patients with mild to moderate von Willebrand's disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.

DDAVP will usually stop bleeding in mild to moderate von Willebrand's patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.

Those von Willebrand's disease patients who are least likely to respond are those with severe homozygous von Willebrand's disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked during administration of DDAVP to ensure that adequate levels are being achieved.

DDAVP is not indicated for the treatment of severe classic von Willebrand's disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen. (See WARNINGS.)

Diabetes Insipidus: DDAVP Injection 4 µg/mL is indicated as antidiuretic replacement therapy in the management of central (cranial) 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.

DDAVP is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may 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

Hemophilia A and von Willebrand's Disease (Type I): DDAVP Injection 4 µg/mL is administered as an intravenous infusion at a dose of 0.3 µg DDAVP/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If DDAVP Injection 4 µg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.

The necessity for repeat administration of DDAVP or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.

Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection. DDAVP Injection 4 µg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

The usual dosage range in adults is 0.5 mL (2.0 µg) to 1 mL (4.0 µg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal DDAVP and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

See directions for use of One Point Cut (OPC) ampules for DDAVP Injection on back of carton.

HOW SUPPLIED

DDAVP Injection 4 g/mL is available as a sterile solution in cartons of ten 1 mL single-dose ampules (NDC 0075-2451-01) and in 10 mL multiple-dose vials (NDC 0075-2451-53), each containing 4.0 g DDAVP per mL.

Store refrigerated 2 to 8C (36 to 46F).

Rx Only.

Keep out of the reach of children.

Manufactured for

Aventis Pharmaceuticals Inc.

Bridgewater, NJ 08807

By Ferring AB, Soldattorpsvägen 5

SE-200 61 Limhamn, Sweden

US Patents 5,500,413; 5,596,078; 5,763,407

Rev. December 2002

2002 Aventis Pharmaceuticals Inc.

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