DESMOPRESSIN ACETATE- desmopressin acetate injection, solution
Hospira, Inc.
NOVAPLUS� Rx only
DESCRIPTION
Desmopressin Acetate Injection, USP 4 mcg/mL is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:
Mol. Wt. 1183.31
Molecular Formula: C46 H64 N14 O12 S2 � C2 H4 O2 � 3H2 O
structural formula desmopressin acetate injection
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1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.
Desmopressin Acetate Injection, USP 4 mcg/mL is provided as a sterile, aqueous solution for intravenous or subcutaneous use. Each mL contains desmopressin acetate, 4 mcg (equivalent to 0.004 mg of desmopressin) and sodium chloride, 9 mg. May contain hydrochloric acid for pH adjustment. The pH range is 3.5 to 6.0.
CLINICAL PHARMACOLOGY
Desmopressin Acetate Injection 4 mcg/mL contains as active substance, desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (4 mcg) of desmopressin acetate solution has an antidiuretic activity of about 16 IU; 1 mcg of desmopressin acetate is equivalent to 4 IU.
Desmopressin acetate has been shown to be more potent than arginine vasopressin in increasing plasma levels of factor VIII activity in patients with hemophilia and von Willebrand's disease Type I.
Dose-response studies were performed in healthy persons, using doses of 0.1 to 0.4 mcg/kg body weight, infused over a 10-minute period. Maximal dose response occurred at 0.3 to 0.4 mcg/kg. The response to desmopressin acetate of factor VIII activity and plasminogen activator is dose-related, with maximal plasma levels of 300 to 400 percent of initial concentrations obtained after infusion of 0.4 mcg/kg body weight. The increase is rapid and evident within 30 minutes, reaching a maximum at a point ranging from 90 minutes to two hours. The factor VIII related antigen and ristocetin cofactor activity were also increased to a smaller degree, but still are dose-dependent.
