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:

Apotex Corp.

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 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: Bottles of 30 (NDC 60505-0257-3) Bottles of 100 (NDC 60505-0257-1) Bottles of 1000 (NDC 60505-0257-8) 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: Bottles of 30 (NDC 60505-0258-3) Bottles of 100 (NDC 60505-0258-1) Bottles of 1000 (NDC 60505-0258-8) Store 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].  Keep out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET
APOTEX CORP.
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DESMPORESSIN ACETATE TABLETS 0.1 MG, 0.2 MG
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: C46H64N14O12S2 • C2H4O2
where 1

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