DESMOPRESSIN ACETATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

DESMOPRESSIN ACETATE

Composition:

DESMOPRESSIN ACETATE 0.1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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. Available in bottles of: 100 Tablets NDC 0591-2464-01 0.2 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/26 on the scored side. Available in bottles of: 100 Tablets NDC 0591-2465-01 Dispense in a tight, light-resistant container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid exposure to excessive heat or light. Keep out of the reach of children. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: September 2014      195817-3                                                                    

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
ACTAVIS PHARMA, INC.
----------
DESMOPRESSIN ACETATE TABLETS
DESMOPRESSIN
ACETATE TABLETS
RX ONLY
REVISED: SEPTEMBER 2014
195817-3
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.
Following administration of de