DESMOPRESSIN ACETATE tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Ferring Pharmaceuticals Inc.

INN (mednarodno ime):

Desmopressin acetate

Sestava:

Desmopressin acetate 0.1 mg

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

New Drug Application

Lastnosti izdelka

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
FERRING PHARMACEUTICALS INC.
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DESMOPRESSIN ACETATE TABLETS
DESCRIPTION
Desmopressin acetate tablets contain desmopressin acetate, 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 tablets contain either 0.1 or 0.2 mg desmopressin
acetate. Inactive ingredients
include: lactose, potato starch, magnesium stearate and povidone.
CLINICAL PHARMACOLOGY
Desmopressin acetate tablets contain as active substance, desmopressin
acetate, a synthetic analogue of
the natural hormone arginine vasopressin.
PHARMACOKINETICS
The mean time to reach maximum plasma desmopressin levels (t
) was 1.1 hours following
desmopressin acetate tablet administration.The plasma halflife of
desmopressin after desmopressin
acetate tablet administration followed amonoexponential time course
withmean t
value of 2.0 hours.
Geometricmeans of maximum plasma concentrations and area under the
plasma concentration-time
curves were 32.7 pg/mL and 85.2 pg*hr/mL, respectively, for
desmopressin after 3 × 0.2mg
desmopressin acetate tablet administration in healthy adult
volunteers. The bioavailability of
desmopressin acetate oral tablets is about 5% compared to intranasal
formulation, and about 0.16%
compared to intravenous formulation.
Desmopressin is mainly excreted in the urine. A pharmacokinetic study
conducted in healthy volunteers
and patients with mild, moderate, and severe renal impairment (n=24, 6
subjects in each group) receiving
single dose desmopressin acetate (2 mcg) injection demonstrated a
difference in desmopressin terminal
half-life. Terminal half life significantly increased from 3 hours in
normal healthy patients to 9 hours in
patients with severe renal impairment. (See CONTRAINDICATIONS.)