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:

Impax Generics

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 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. Desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. Desmopressin acetate 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 a

Product summary:

Desmopressin acetate tablets are available as follows: 0.1 mg – white to off-white, capsule-shaped tablets debossed with the numbers “93” on one side and scored between the two numbers, debossed “7316” on the other side of the tablets, in bottles of 100 (0115-1646-01). 0.2 mg – white to off-white, round-shaped tablets debossed with the numbers “93” on one side and scored between the two numbers, debossed “7317” on the other side of the tablets, in bottles of 100 (0115-1647-01). Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Avoid exposure to excessive heat or light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Distributed by: Impax Generics Hayward, CA 94544 1825-01 Rev. E 5/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
IMPAX GENERICS
----------
DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG
7316
7317
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:
C
H N O S · C H O M.W. 1129.3
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate
(salt)
Desmopressin acetate tablets, for oral administration, contain either
0.1 or 0.2 mg desmopressin acetate.
Inactive ingredients include: colloidal silicon dioxide, lactose
monohydrate, magnesium stearate,
povidone, pregelatinized starch, and 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 acetate tablets, the
onset of antidiuretic effect occurs at around 1 hour, and it reaches a
maximum at about 4 to