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:

Physicians Total Care, Inc.

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 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:

SSD™ (1% Silver Sulfadiazine) Cream : white to off-white cream. Store at controlled room temperature 15° - 30°C (59° - 86°F) SSD is a trademark of Dr. Reddy's Laboratories Louisiana, LLC Manufactured for Par Pharmaceutical Companies, Inc. Spring Valley, NY 10977 Manufactured by Dr. Reddy's Laboratories Louisiana, LLC Shreveport, LA 71106 Rev. 05/10 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

New Drug Application

Summary of Product characteristics

SILVER SULFADIAZINE - SILVER SULFADIAZINE CREAM
PHYSICIANS TOTAL CARE, INC.
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SSD™ (1% SILVER SULFADIAZINE CREAM)
SSD AF™ (1% SILVER SULFADIAZINE CREAM)
DESCRIPTION
SSD (1% Silver Sulfadiazine) Cream and SSD AF (1% Silver Sulfadiazine)
Cream are topical
antibacterial preparations which have as their active antimicrobial
ingredient silver sulfadiazine. The
active moiety is contained within an opaque, white, water miscible
cream base.
Each 1000 grams of SSD/SSD AF Cream contains 10 grams of silver
sulfadiazine
INACTIVE INGREDIENTS: cetyl alcohol (SSD Cream only), 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 1% CONCENTRATION OF SILVER
SULFADIAZINENUMBER OF SENSITIVE
STRAINS / TOTAL NUMBER OF STRAINS TESTED
GENUS AND SPECIES
50 _UG_/ML
100 _UG_/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
Escherichia coli
63/63
63/63
Serratia species
27/28
28/