DESMOPRESSIN ACETATE injection solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

Dostupné z:

Hospira, Inc.

INN (Medzinárodný Name):

DESMOPRESSIN ACETATE

Zloženie:

DESMOPRESSIN ACETATE 4 ug in 1 mL

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
DES MOPRES S IN
ACETATE
INJECTION, USP
4 MCG/ML
NOVAPLUS R 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: C
H N O S • C H O • 3H O
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-