SILVER SULFADIAZENE- silver sulfadiazine cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

SILVER SULFADIAZINE

Composition:

SILVER SULFADIAZINE 10 g in 1000 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Silver Sulfadiazine Cream 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 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 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.

Product summary:

Silver Sulfadiazine Cream USP 1%: white to off-white cream. 25 gram tube                      Store at controlled room temperature 15°-30°C (59°-86°F). Manufactured for Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by Dr. Reddy's Laboratories Louisiana, LLC Shreveport, LA 71106 R05/08       110960-02 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

New Drug Application

Summary of Product characteristics

SILVER SULFADIAZENE- SILVER SULFADIAZINE CREAM
REBEL DISTRIBUTORS CORP
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SILVER SULFADIAZINE CREAM USP 1%
DESCRPITION
Silver Sulfadiazine Cream is a topical antibacterial preparation which
has its active antimicrobial
ingredient silver sulfadiazine. The active moiety is contained within
an opaque, white, water miscible
cream base.
Each 1000 grams of Silver Sulfadiazine Cream contains 10 grams of
silver sulfadiazine.
INACTIVE INGREDIANTS: cetyl alcohol, isopropyl myristate, polyoxyl 40
stearate, propylene glycol,
purified water, stearyl alcohol, sodium hydroxide, sorbitan
monooleate, white petrolatum; with 0.3%
methyl paraben, as a preservative.
Silver sulfadiazine has an emprical formula of C
H AgN O S, molecular weight of 357.14 and
structural formula as shown:
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 wall to produce its
bactericidal effect.
Results of
_In Vitro_
Testing With Silver Sulfadiazine Cream, 1% Concentration of Silver
Sulfadiazine
Number of Sensitive Strains / Total Number of Strains Tested
Genus and Species
50 µg/mL 100 µ/mL
Pseudomonas aeruginosa
130/130
130/130
Pseudomonas maltophilia
7/7
7/7
Enterobacter species
48/50
50/50
Enterobacter cloacae
24/24
24/24
Klebsiella species
53/54
54/54
10
9
4
2
Escherichia coli
63/63
63/63
Serratia species
27/28
28/28
Proteus mirabilis
53/53
53/53
Morganella morganii
10/10
10/10
Providenc