DDAVP- desmopressin acetate tablet

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Ferring Pharmaceuticals Inc.

INN (Isem Internazzjonali):

DESMOPRESSIN ACETATE

Kompożizzjoni:

DESMOPRESSIN ACETATE 0.1 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

DDAVP 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. DDAVP 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 DDAVP can be monitored by measuring urine volume and osmolality. DDAVP Tablets are indicated for the management of primary nocturnal enuresis. DDAVP may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention. DDAVP Tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Tablets. DDAVP is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance bel

Sommarju tal-prodott:

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. 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.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

DDAVP- DESMOPRESSIN ACETATE TABLET
FERRING PHARMACEUTICALS INC.
----------
DDAVP® TABLETS (DESMOPRESSIN ACETATE)
RX ONLY
DESCRIPTION
DDAVP® TABLETS (desmopressin acetate) 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:
Mol. Wt. 1183.34
Empirical Formula: C
H N O S ·C H O ·3H O
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate
(salt) trihydrate.
DDAVP TABLETS contain either 0.1 or 0.2 mg desmopressin acetate.
Inactive ingredients include:
lactose, potato starch, magnesium stearate and povidone.
CLINICAL PHARMACOLOGY
DDAVP 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 DDAVP
(desmopressin acetate).
The plasma half-life of DDAVP followed a monoexponential time course
with t
values of 1.5 to 2.5
hours which was independent of dose.
The bioavailability of DDAVP oral tablets is about 5% compared to
intranasal DDAVP, and about
0.16% compared to intravenous DDAVP. The time to reach maximum plasma
DDAVP levels ranged
from 0.9 to 1.5 hours following oral or intranasal administration,
respectively. Following administration
of DDAVP 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 DDAVP TABLETS in patients with an established diagnosis
will result in a reduction in