Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)
Sun Pharmaceutical Industries, Inc.
DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE 0.1 mg in 1 mL
NASAL
PRESCRIPTION DRUG
Central Cranial Diabetes Insipidus: Desmopressin nasal spray solution, USP 0.01% is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. It is ineffective for the treatment of nephrogenic diabetes insipidus. The use of desmopressin nasal spray solution, USP 0.01% in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia. There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the p
Desmopressin nasal spray solution, USP 0.01% is available in a 5 mL bottle with spray pump delivering 50 sprays of 10 mcg (NDC 62756-161-91). Store in refrigerator at 2°-8°C (36°-46°F). When traveling, product will maintain stability for up to 3 weeks when stored at room temperature, 22°C (72°F). STORE BOTTLE IN UPRIGHT POSITION. Keep out of reach of children Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Industries Ltd. Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. ISS 04/2012 PJPI0203A
Abbreviated New Drug Application
DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE SOLUTION SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- DESMOPRESSIN NASAL SPRAY SOLUTION, USP 0.01% DESCRIPTION: Desmopressin nasal spray solution, USP 0.01% is 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 Molecular formula: C H N O S •C H O •3H O 1 - (3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin nasal spray solution, USP 0.01% is provided as an aqueous solution for intranasal use. Each mL Contains: Desmopressin Acetate, USP 0.1 mg Sodium Chloride 9 mg Hydrochloric Acid may be added to adjust pH (4.5 to 6) Chlorobutanol (0.5%) 5.25 mg Water for Injection q.s. to 1 mL The desmopressin nasal spray solution, USP 0.01% compression pump delivers 0.1 mL (10 mcg) of desmopressin nasal spray solution, USP 0.01% per spray. CLINICAL PHARMACOLOGY: Desmopressin acetate is a synthetic analogue of the natural hormone arginine vasopressin. One mL (0.1 mg) of intranasal desmopressin acetate has an antidiuretic activity of about 400 IU; 10 mcg of desmopressin acetate is equivalent to 40 IU. 1. The biphasic half-lives for intranasal desmopressin acetate were 7.8 and 75.5 minutes for the fast and slow phases, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone used in this condition. As a result, intranasal desmopressin acetate provides a prompt onset of antidiuretic action with a long duration after each administration. 2. The change in structure of arginine vasopressin to desmopressin acetate has resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses are usually below threshold levels for effects on vascular or visceral smooth muscle. 46 64 14 12 2 2 4 2 2 3. Desmopressin acetate administered intranasally has an antidi Lire le document complet