DESMOPRESSIN ACETATE tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

BluePoint Laboratories

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 Tablets. Desmopressin Acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min). Desmopressin Acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.

Prehľad produktov:

Desmopressin Acetate Tablets 0.1 mg: 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 By: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513, India For BluePoint Laboratories Questions? 1 [phone] April 2017                                                                    

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
BLUEPOINT LABORATORIES
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DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG
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:
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
1/2
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
establis