DESMOPRESSIN ACETATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

KVK-TECH, INC.

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Central Diabetes Insipidus 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. Primary Nocturnal Enuresis 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 acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min). Desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.

Proizvod sažetak:

Desmopressin Acetate Tablets, 0.1 mg, are white to off-white, modified oval shape, biconvex tablets debossed “A” above deep break line and “18” below deep break line on one side and plain on the other side. The tablets are supplied as follows: Bottles of 100: NDC 10702-169-01 Desmopressin Acetate Tablets, 0.2 mg, are white to off-white, round shape, biconvex tablets debossed “A” above deep break line and “19” below deep break line on one side and plain on the other side. The tablets are supplied as follows: Bottles of 100: NDC 10702-170-01 Store at 20°C to 25°C (68°F to 77°F); excursions permitted within 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat or light. Dispense in a tight, light-resistant container, as defined in USP, with a child-resistant closure. Keep out of the reach of children. Manufactured by: KVK-Tech, Inc. 110 Terry Drive Newtown, PA 18940 Manufacturer’s code: 10702 Item ID #: 6299/01   Rev.: 02/2019

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
KVK-TECH, INC.
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DESMOPRESSIN ACETATE TABLETS
RX ONLY
DESCRIPTION
Desmopressin acetate is 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:
Mol. Wt. 1183.34
Empirical Formula:
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate
(salt) trihydrate.
Desmopressin acetate tablets contain either 0.1 or 0.2 mg desmopressin
acetate.
Inactive ingredients include: corn starch, lactose monohydrate,
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.
1/2
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