DESMOPRESSIN ACETATE tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Amring Pharmaceuticals Inc.

DCI (Dénomination commune internationale):

Desmopressin Acetate

Composition:

Desmopressin Acetate 0.1 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Central Diabetes Insipidus: 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. Primary Nocturnal Enuresis: 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 an

Descriptif du produit:

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. Avoid exposure to excessive heat or light. This product should be dispensed in a container with a child-resistant cap. Keep out of the reach of children.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
AMRING PHARMACEUTICALS INC.
----------
DESMOPRESSIN ACETATE TABLETS
RX ONLY
DESCRIPTION
DESMOPRESSIN ACETATE TABLETS (desmopressin acetate) 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:
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.
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 maximum at about 4 to
7 hours based
on the measurem