DESMOPRESSIN ACETATE solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Physicians Total Care, Inc.

INN (Tên quốc tế):

DESMOPRESSIN ACETATE

Thành phần:

DESMOPRESSIN ACETATE 0.1 mg in 1 mL

Tuyến hành chính:

NASAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Desmopressin acetate nasal solution 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 acetate nasal solution 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 peptide. Patients are selected for therapy by establishing the dia

Tóm tắt sản phẩm:

Desmopressin Acetate Nasal Solution, 0.01% is supplied in a bottle with nasal pump dispenser with dust cover and with patient instructions in the following size: 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). KEEP OUT OF REACH OF CHILDREN. Rx Only FOR INTRANASAL USE ONLY

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
DESMOPRESSIN ACETATE
NASAL SOLUTION, 0.01%
RX ONLY
FOR INTRANASAL USE ONLY.
DESCRIPTION:
Desmopressin Acetate Nasal Solution 0.01% is a synthetic analogue of
the natural pituitary hormone 8-
arginine vasopressin (ADH), an antidiuretic hormone affecting renal
water conservation. The structural
formula for the active ingredient is:
C
H N O S Mol. Wt. 1183.34
Chemical Name: 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin
monoacetate (salt) trihydrate.
EACH ML CONTAINS: ACTIVE: Desmopressin Acetate 0.1 mg (0.01%);
INACTIVES: Sodium Chloride
and Purified Water. Hydrochloric Acid may be added to adjust pH (3.5 -
6.0). PRESERVATIVE
ADDED: Chlorobutanol 0.5%.
The desmopressin acetate nasal solution compression pump delivers 0.1
mL (10 μg) of desmopressin
acetate nasal solution per spray.
CLINICAL PHARMACOLOGY:
Desmopressin acetate is a synthetic analog of the natural hormone
arginine vasopressin. One mL (0.1
mg) of intranasal desmopressin acetate has an antidiuretic activity of
about 400 IU; 10 μg of
desmopressin acetate is equivalent to 40 IU.
1. The biphasic half-lives for desmopressin acetate were 7.8 and 75.5
minutes for the fast and slow
phases, compared with 2.5 and 14.5 minutes for Iysine 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.
3. Desmopressin acetate administered intranasally has an antidiuretic
effect about one-tenth that of an
equivalent dose administered by injection.
HUMAN PHARMACOKINETICS
Desmopressin a