SILVER SULFADIAZINE- silver sulfadiazine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

SILVER SULFADIAZINE

Composition:

SILVER SULFADIAZINE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Silver sulfadiazine cream, USP 1% 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. Silver sulfadiazine cream, USP 1% 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, silver sulfadiazine cream, USP 1% 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 s

Product summary:

Silver sulfadiazine cream, USP 1% - white to off-white cream NDC Number                         Size 67877-124-20                       20g tube 67877-124-25                       25g tube 67877-124-05                       50g tube 67877-124-85                       85g tube 67877-124-50                       50g jar 67877-124-40                       400g jar 67877-124-10                       1000g jar Store at room temperature. 15°-30°C (56°-86°F). Manufactured for: Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 Product information: 1-877-272-7901                                             P1840.01

Authorization status:

New Drug Application

Summary of Product characteristics

SILVER SULFADIAZINE- SILVER SULFADIAZINE CREAM
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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DESCRIPTION
Silver sulfadiazine cream, USP 1% 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
_Provid