DESMOPRESSIN ACETATE- 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:

Bryant Ranch Prepack

INN (International Name):

DESMOPRESSIN ACETATE

Composition:

DESMOPRESSIN ACETATE 0.2 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: Watson Laboratories, Inc. Corona, CA 92880 Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: July 2011                                                                     195817-1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
BRYANT RANCH PREPACK
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DESMOPRESSIN ACETATE TABLETS
RX ONLY
DESCRIPTION:
Desmopressin acetate are 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:
C
H N O S ·C H O ·3H 0 Molecular Weight: 1183.34
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
desmopressin