DESMOPRESSIN ACETATE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

AvPAK

DCI (Denominação Comum Internacional):

DESMOPRESSIN ACETATE

Composição:

DESMOPRESSIN ACETATE 0.1 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 tablets are 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 tablets 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 tablet

Resumo do produto:

Desmopressin Acetate Tablets are available as: 0.1 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/25 on the scored side. NDC 50268-220-15 (10 Tablets per card, 5 cards per carton) 0.2 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/26 on the scored side. NDC 50268-220-15 (10 Tablets per card, 5 cards per carton) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid exposure to excessive heat or light. Dispensed in Unit Dose package. For Institutional Use Only. Keep out of the reach of children. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 09/14 AV Rev. 01/19 (P) AvPAK

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
AVPAK
----------
DESMOPRESSIN ACETATE TABLETS
DESCRIPTION:
Desmopressin acetate is a synthetic analogue of the natural pituitary
hormone 8-
arginine vasopressin (ADH), is an antidiuretic hormone affecting renal
water
conservation. It is chemically defined as 1-(3-mercaptopropionic
acid)-8-D-arginine
vasopressin monoacetate (salt) trihydrate. The structural formula is
as follows:
Desmopressin Acetate Tablets contain desmopressin acetate equivalent
to either 0.1 mg
or 0.2 mg of desmopressin acetate. In addition, each tablet contains
the following
inactive ingredients: butylated hydroxyanisole, butylated
hydroxytoluene, crospovidone,
lactose monohydrate, magnesium stearate, povidone and potato 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.
1/2
Following administration of desmopressin acetate tablets, the onset of
antidiuretic effect
occurs at around 1 h