DESMOPRESSIN ACETATE solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

desmopressin acetate (UNII: XB13HYU18U) (desmopressin - UNII:ENR1LLB0FP)

Inapatikana kutoka:

Ferring Pharmaceuticals Inc.

INN (Jina la Kimataifa):

desmopressin acetate

Tungo:

desmopressin 4 ug in 1 mL

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

New Drug Application

Tabia za bidhaa

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE SOLUTION
FERRING PHARMACEUTICALS INC.
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DESMOPRESSIN ACETATE INJECTION
4 MCG/ML
RX ONLY
DESCRIPTION
DESMOPRESSIN ACETATE INJECTION (desmopressin acetate) 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. 1183.34 Empirical Formula: C
H N O S •C H O •3H O
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate
(salt) trihydrate.
DESMOPRESSIN ACEATE INJECTION 4 mcg/mL is provided as a sterile,
aqueous solution for
injection.
Each mL provides:
Desmopressin acetate 4.0 mcg
Sodium chloride 9.0 mg
Hydrochloric acid to adjust pH to 4
The 10 mL vial contains chlorobutanol as a preservative (5.0 mg/mL).
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 (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.
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