Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)
Impax Generics
DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE 0.1 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 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
Desmopressin acetate tablets are available as follows: 0.1 mg – white to off-white, capsule-shaped tablets debossed with the numbers “93” on one side and scored between the two numbers, debossed “7316” on the other side of the tablets, in bottles of 100 (0115-1646-01). 0.2 mg – white to off-white, round-shaped tablets debossed with the numbers “93” on one side and scored between the two numbers, debossed “7317” on the other side of the tablets, in bottles of 100 (0115-1647-01). Store at 20o to 25o C (68o to 77o F) [See USP Controlled Room Temperature]. Avoid exposure to excessive heat or light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Distributed by: Impax Generics Hayward, CA 94544 1825-01 Rev. E 5/2016
Abbreviated New Drug Application
DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE TABLET IMPAX GENERICS ---------- DESMOPRESSIN ACETATE TABLETS, 0.1 MG AND 0.2 MG 7316 7317 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: C H N O S · C H O M.W. 1129.3 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) Desmopressin acetate tablets, for oral administration, contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and 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 acetate tablets, the onset of antidiuretic effect occurs at around 1 hour, and it reaches a maximum at about 4 to Lees het volledige document