DESMOPRESSIN ACETATE solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

Доступна с:

Sun Pharmaceutical Industries, Inc.

ИНН (Международная Имя):

DESMOPRESSIN ACETATE

состав:

DESMOPRESSIN ACETATE 0.1 mg in 1 mL

Администрация маршрут:

NASAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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