国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)
Bryant Ranch Prepack
DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE 0.2 mg
ORAL
PRESCRIPTION DRUG
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 tablets are 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 tablets 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 tablet
Desmopressin Acetate Tablets are available as: 0.1 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/25 on the scored side. Available in bottles of: 100 Tablets NDC 0591-2464-01 0.2 mg: White, oval, flat-faced, beveled-edge scored tablet. Debossed with WPI on one side and 22/26 on the scored side. Available in bottles of: 100 Tablets NDC 0591-2465-01 Dispense in a tight, light-resistant container with a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid exposure to excessive heat or light. Keep out of the reach of children. Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 Distributed by: Watson Pharma, Inc. Corona, CA 92880 USA Revised: July 2011 195817-1
Abbreviated New Drug Application
DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET BRYANT RANCH PREPACK ---------- DESMOPRESSIN ACETATE TABLETS RX ONLY DESCRIPTION: Desmopressin acetate are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), is an antidiuretic hormone affecting renal water conservation. It is chemically defined as 1-(3- mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. The structural formula is as follows: C H N O S ·C H O ·3H 0 Molecular Weight: 1183.34 Desmopressin Acetate Tablets contain desmopressin acetate equivalent to either 0.1 mg or 0.2 mg of desmopressin acetate. In addition, each tablet contains the following inactive ingredients: butylated hydroxyanisole, butylated hydroxytoluene, crospovidone, lactose monohydrate, magnesium stearate, povidone and potato 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 完全なドキュメントを読む