DESMOPRESSIN ACETATE spray

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Prasco Laboratories

INN (International ime):

DESMOPRESSIN ACETATE

Sastav:

DESMOPRESSIN ACETATE 10 ug in 0.1 mL

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

New Drug Application Authorized Generic

Svojstava lijeka

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE SPRAY
PRASCO LABORATORIES
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DESMOPRESSIN ACETATE
NASAL SPRAY, 10 MCG PER 0.1 ML
RX ONLY
DESCRIPTION
Desmopressin Acetate Nasal Spray 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 Acetate Nasal Spray is provided as an aqueous solution
for intranasal use.
Each mL contains:
Desmopressin acetate 0.1 mg
Sodium chloride 7.5 mg
Citric acid monohydrate 1.7 mg
Disodium phosphate dihydrate 3 mg
Benzalkonium chloride solution (50%) 0.2 mg
The Desmopressin Acetate Nasal Spray compression pump delivers 0.1 mL
(10 mcg) of desmopressin
acetate per spray.
CLINICAL PHARMACOLOGY
Desmopressin acetate contains as active substance
1-(3-mercaptopropionic acid)-8-D-arginine
vasopressin, which is a synthetic analogue of the natural hormone
arginine vasopressin. One mL (0.1
mg) of intranasal desmopressin acetate has an antidiuretic activity of
about 400 International Units (IU);
10 mcg of desmopressin acetate is equivalent to 40 IU. The change in
structure of arginine vasopressin
to desmopressin acetate has resulted in a decreased vasopressor action
and decreased actions on
visceral smooth muscle relative to the enhanced antiduretic activity,
so that clinically effective
antiduretic doses are usually below threshold levels for effects on
vascular or visceral smooth muscle.
Desmopressin acetate administered intranasally has an antiduretic
effect about one-tenth that of an
equivalent dose administered by injection.
PHARMACOKINETICS
Intranasal Desmopressin Acetate is absorbed from the nasal mucosa.
Desmopressin Acetate exhibits a
biphasic elimination profile, with half-lives of 7.8 and 75.5 minutes
for the initial and terminal phases,
respectively, in contrast to lysine vasopressin, which has ini