DESMOPRESSIN ACETATE tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Carilion Materials Management

INN (Международно Name):

DESMOPRESSIN ACETATE

Композиция:

DESMOPRESSIN ACETATE 0.1 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. Desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. Desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention. Desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. Desmopressin a

Каталог на резюме:

Product: 68151-1281 NDC: 68151-1281-0 1 TABLET in a PACKAGE

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
CARILION MATERIALS MANAGEMENT
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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
maximu