THERMAZENE- silver sulfadiazine cream

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

SILVER SULFADIAZINE (UNII: W46JY43EJR) (SULFADIAZINE - UNII:0N7609K889)

Sẵn có từ:

The Pharma Network LLC

INN (Tên quốc tế):

SILVER SULFADIAZINE

Thành phần:

SILVER SULFADIAZINE 10 mg in 1 g

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Thermazene® is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns. Thermazene® is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation.      Because sulfonamide therapy is known to increase the possibility of kernicterus, Thermazene® should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life. Geriatric Use. Of the total number of subjects in clinical studies of silver sulfadiazine cream, USP 1% seven percent were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Pediatric Use. Saf

Tóm tắt sản phẩm:

Thermazene® - white to off-white cream NDC No.                              Size 53097-101-20                       20g tube 53097-101-25                       25g tube 53097-101-50                       50g tube 53097-101-85                       85g tube 53097-101-05                       50g jar 53097-101-40                       400g jar 53097-101-10                       1000g jar Store at room temperature. 15°-30°C (56°-86°F). Manufactured for: ThePharmaNetwork, LLC 180 Summit Avenue Montvale, NJ 07645 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 Product information: 1-800-272-7901 ® Registered Trademark of Coviden AG or an affiliate                                               P1852.01

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

THERMAZENE - SILVER SULFADIAZINE CREAM
THE PHARMA NETWORK LLC
----------
DESCRIPTION
Thermazene
is a soft, white, water dispersible cream containing the antimicrobial
agent silver
sulfadiazine in micronized form for topical application. Each gram of
silver sulfadiazine cream
contains 10mg of micronized silver sulfadiazine.
This active agent has the following structural formula:
Silver sulfadiazine cream contains 1% w/w silver sulfadiazine. The
vehicle in which the active
ingredient is dispersed consists of water, stearyl alcohol, white
petrolatum, polyoxyl 40 stearate,
propylene glycol, isopropyl myristate, and sorbitan monooleate with
0.3% methylparaben as a
preservative.
CLINICAL PHARMACOLOGY
Silver sulfadiazine has broad antimicrobial activity. It is
bactericidal for many gram-negative and gram-
positive bacteria as well as being effective against yeast. Results
from _in vitro_ testing are listed below.
Sufficient data have been obtained to demonstrate that silver
sulfadiazine will inhibit bacteria that are
resistant to other antimicrobial agents and that the compound is
superior to sulfadiazine.
Studies utilizing radioactive micronized silver sulfadiazine, electron
microscopy, and biochemical
techniques have revealed that the mechanism of action of silver
sulfadiazine on bacteria differs from
silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only
on the cell membrane and cell wall
to produce its bactericidal effect.
RESULTS OF _IN VITRO_ TESTING WITH
SILVER SULFADIAZINE CREAM, USP 1% CONCENTRATION
OF SILVER SULFADIAZINE NUMBER OF SENSITIVE
STRAINS / TOTAL NUMBER OF STRAINS TESTED
GENUS AND SPECIES
50 ΜG/ML
100 ΜG/ML
_Pseudomonas aeruginosa_
130/130
130/130
_Xanthomonas (Pseudomonas) Maltophilia_
7/7
7/7
®
_Enterobacter species_
48/50
50/50
_Enterobacter cloacae_
24/24
24/24
_Klebsiella species_
53/54
54/54
_Escherichia coli_
63/63
63/63
_Serratia species_
27/28
28/28
_Proteus mirabilis_
53/53
53/53
_Morganella morganii_
10/10
10/10
_Providencia rettgeri_
2/2
2/2
_Proteus vulgaris_
2/2
2/2
_P