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:

American Health Packaging

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 acetate tablets are 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 available for oral administration as white to off-white, round shaped, scored tablets, imprinted “APO” on one side and “DES” bisect “0.1” on the other side. They are supplied as follows: Unit dose packages of 30 (3 x 10) NDC 60687-721‐21 Desmopressin Acetate Tablets 0.2 mg are available for oral administration as white to off-white, round shaped, scored tablets, imprinted “APO” on one side and “DES” bisect “0.2” on the other side. They are supplied as follows: Unit dose packages of 30 (3 x 10) NDC 60687-732‐21 Store 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Keep out of the reach of children.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
AMERICAN HEALTH PACKAGING
----------
DESMOPRESSIN ACETATE TABLETS
8472121/1222
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:
Mol. Wt. 1129.27
Empirical Formula: C
H
N
O
S
• C
H
O
where 1

Pročitajte cijeli dokument