DESMOPRESSIN ACETATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Teva Pharmaceuticals USA, Inc.

INN (International ime):

DESMOPRESSIN ACETATE

Sastav:

DESMOPRESSIN ACETATE 0.1 mg

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG
7316
7317
RX ONLY
DESCRIPTION
Desmopressin acetate tablets are 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:
C
H N O S · C H O M.W. 1129.3
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate
(salt)
Desmopressin acetate tablets, for oral administration, contain either
0.1 or 0.2 mg desmopressin acetate.
Inactive ingredients include: colloidal silicon dioxide, lactose
monohydrate, magnesium stearate,
povidone, pregelatinized starch, and starch.
CLINICAL PHARMACOLOGY
Desmopressin acetate tablets contain as active substance, desmopressin
acetate, a synthetic analogue of
the natural hormone arginine vasopressin.
CENTRAL DIABETES INSIPIDUS
Dose response studies in patients with diabetes insipidus have
demonstrated that oral doses of 0.025 mg
to 0.4 mg produced clinically significant antidiuretic effects. In
most patients, doses of 0.1 mg to 0.2 mg
produced optimal antidiuretic effects lasting up to eight hours. With
doses of 0.4 mg, antidiuretic
effects were observed for up to 12 hours; measurements beyond 12 hours
were not recorded.
Increasing oral doses produced dose dependent increases in the plasma
levels of desmopressin acetate.
The plasma half-life of desmopressin acetate followed a
monoexponential time course with t
values of
1.5 to 2.5 hours which was independent of dose.
The bioavailability of desmopressin acetate oral tablets is about 5%
compared to intranasal
desmopressin acetate, and about 0.16% compared to intravenous
desmopressin acetate. The time to
reach maximum plasma desmopressin acetate levels ranged from 0.9 to
1.5 hours following oral or
intranasal administration, respectively. Following administration of
desmopressin acetate tablets, the
onset of antidiuretic effect occurs at around 1 hour, and it reaches a
maxim