SILVER SULFADIAZINE- silver sulfadazine cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

SILVER SULFADIAZINE (UNII: W46JY43EJR) (SILVER CATION - UNII:57N7B0K90A)

Tillgänglig från:

DIRECT RX

INN (International namn):

SILVER SULFADIAZINE

Sammansättning:

SILVER SULFADIAZINE 10 mg in 1 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

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 PRINCIPAL DISPLAY PANEL - 25g NDC 67877-124-25 Ascend                                                            Rx Laboratories, LLC                                           ONLY Silver Sulfadiazine Cream, USP 1%                  Net Wt. 25g

Bemyndigande status:

New Drug Application

Produktens egenskaper

SILVER SULFADIAZINE- SILVER SULFADAZINE CREAM
DIRECT RX
----------
SILVER SULFADIAZINE
DESCRIPTION SECTION
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 SECTION
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
Pro