DESMOPRESSIN ACETATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Northstar Rx LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Desmopressin Acetate Tablets 0.1mg : White to off-white, oval, biconvex, uncoated tablets debossed ‘S’ on one side and scored on the other side. Desmopressin Acetate Tablets 0.2 mg : White to off-white, round, biconvex, uncoated tablets debossed ‘I’ on one side and scored on the other side. Store at 20° to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. 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. Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513, India To report SUSPECT ADVERSE REACTIONS, Contact NorthStar Rx LLC 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fdagov/medwatch September 2018

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
NORTHSTAR RX LLC
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DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG
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:
Desmopressin acetate tablets, for oral administration, contain either
0.1 or 0.2 mg desmopressin acetate,
USP. Inactive ingredients include: lactose monohydrate, potato starch,
talc, 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 measurement of increased urine osmolality.
The use of desmopressin acetate tablets in patients with an
established diagnosis will