DESMOPRESSIN SUMMARY
Desmopressin
Acetate
Injection
DESMOPRESSIN ACETATE Injection 4 µg/mL is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation.
Hemophilia A: DESMOPRESSIN ACETATE Injection 4 µg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.
DESMOPRESSIN ACETATE will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.
DESMOPRESSIN ACETATE will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
DESMOPRESSIN ACETATE 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 DESMOPRESSIN ACETATE in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.
von Willebrand's Disease (Type I): DESMOPRESSIN ACETATE 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%. DESMOPRESSIN ACETATE 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.
DESMOPRESSIN ACETATE 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 DESMOPRESSIN ACETATE to ensure that adequate levels are being achieved.
DESMOPRESSIN ACETATE 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: DESMOPRESSIN ACETATE 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. DESMOPRESSIN ACETATE is ineffective for the treatment of nephrogenic diabetes insipidus.
DESMOPRESSIN ACETATE 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.
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