Drug Information

Drug Interaction:

Silver sulfadiazine+

Topical proteolytic enzymes- silver may inactivate such enzymes if these agents are used in congunction with silver sulfadiazine

Indication:

U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

8. Nanocrystalline Silver Gel 0.002% 08-01-08

For the treatment of burns and wound infections

113. Silver wound dressing 16-04-08

As an antimicrobial barrier for management

of partial thickness burns, incisions, skin grafts,

donor sites, lacerations. abarations and

Stage I-IV dermal ulcers, (vascular, venous, pressure and diabetic )

U.S.FDA APPROVED DRUGS DURING 2004

248. FDC of Epi-Growth Factor (1gm)+ 19-10-2004

Silversulphadiazine Cream For Burns

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.FDC of EPI-Growth Factor 1gm + 19-10-2004

Silver sulphadiazine cream

For Burns

2.Nonocrystalline Silver gel 04-01-2008

0.002%

For the treament of Burns and wound infections

3.Silver wound Dressing 16-04-2008

As an Antimicrobial Barrier for Management of Partial Thickness Burns,

Incisions, Skin Grafts, Donor Sites, Lacerations, Abarations and

Stage-1-IV Dermal ulcers( Vascular Venous, Pressure and Diabetic)

Adverse Reaction:

Transcient leucopenia, burning sensation, rash, pruritis, fungal overgrowth If absorbed, interstial nephritis and sulphonamide sytemic reactions (as sulponamides).

Contra-Indications:

Hypersens to contents of preparation. pregnant women at or near term , premature infants < 2 months old, (sulfonamides may increase the possibility of kernicuterus

Special precautions: Avoid prolonged use.

Dosages/ Overdosage Etc:

Indications:

Prevention and treatment of sepsis in second and third degree burns.

Dosage:

Apply with a sterile gloved hand once or twice daily.

Patient Information:

1.Apply under sterile conditions once or twice daily to a thickness of approx.

1/16 inch to the clean and debrided wound

2.Cover the burn areas with silver sulfadizine at all times

3. Whenever necessary reapply the cream to the areas from which it has been removed

by patient activity

4. Reapply immediately after hydrotherapy

5. Dressing are not required , but may be used if individual patient requirement

makes them necessary

Ref - USP PDI Vol II 17th Edition (1997)

SILVER SULPHADIAZINE - TOPICAL

1.Allergies-

Tell your doctor if you have ever had any unusual or allergic reaction to

silver sulfadiazine or any of the following. Also tell your healthcare care

professional if you are allergic to any other substances such as foods,

preservatives or dyes.

Acetazolamide

Antidiabeics

Diclorphenamide

Furosemide

Methozolamide

Sulfonamide

Thiazide diuretics

2.Pregnancy-

Studies have not been done in humans. However, sulfa medicine may increase

the chance of liver problems in new born infants. Silver Sulfadiazine has not

shown to cause birth defects or other problems in rabbits treated with 3 to 10 times

the usual amount of silver sulfadiazine.

3. Breast-feeding-

It is not known whether silver sulfadiazine applied to the skin and/or burns

passes into breast milk. However, caution is recommended when using this

medicine in nursing women.

4.Children-

Use is not recommended in premature or new born infants up to 1 month of

age. Although there is no specific information comparing use of silver

sulfadiazine in children with use in other age groups, this medicine

is not expected to cause different side effects or problems than it does

in adults.

5.Older adults-

There is no specific information comparing use of silver sulfadizine

in the elderly with use in other age groups.

6. Other medicines-

Tell your doctor if you are using any of the following medicines -

Collagensase or

Papain or

Sutilains - silver sulfadizine may prevent these enzymes from working

properly

7. Other medical problems-

Make sure you tell your doctor if you have any other medical problems

especially-

Blood problems or

Glucose -6-phosphate dehydrogenase deficiency- (G6PD enzyme)-

use of this medicine may cause blood problems or make them worse.

Kidney disease or

Liver disease - in persons with these conditions use may result

in higher blood levels of this medicine, a smaller dose may be

needed

Porphyria- Use of this medicine may result in a severe attack of

porphyria

Pharmacology/ Pharmacokinetics:

Pharmacology:

Silver sulphadiazine acts only on cell membranes and cell wall to produce its bactericidal effect. Silver is slowly released from the preparation in concntrations that are toxic to bacteria.

Pharmacokinetics:

While less than 1% of silver is absorbed, upto 10% of the sulfadiazine is absorbed. Serum concentration of 10 to 20mcg/ml have been reported when extensive areas are involved.

Pregnancy and lactation:

Use during pregnancy only if clearly indicated

Lactation-

Not known whether silver sulphadizine is excreted in breast milk. Decide depending on the relative importance to the mother weighing the potential risks involved

Children-

Safety not established

Silver sulphadiazine ( * ) - @ - Burn preparation- (Oct 2004)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation