Silvederm (Aerosol) Instructions for Use

Marketing Authorization Holder

Aldo-Union, S.A. (Spain)

ATC Code

D06BA01 (Sulfadiazine silver)

Active Substance

Sulfadiazine silver (Rec.INN Mod. registered by WHO, modified name)

Dosage Forms

	Silvederm	Aerosol 1% for external use: 50 ml can
		Cream 1% for external use: 50 g tube, 500 g jar

Dosage Form, Packaging, and Composition

Aerosol 1% for external use in the form of a suspension from white to light yellow in color with a slight lavender scent.

Excipients: isopropyl myristate, colloidal silicon dioxide, lavender essence 504, ethanol, 1,1,1,2-tetrafluoroethane (propellant 134a).

50 ml – aluminum cans (1) – cardboard packs.

Cream 1% for external use homogeneous, white or almost white in color.

Excipients: cetyl alcohol, stearyl alcohol, hard paraffin, cetiol V, emulsin B-2, propylene glycol, methylparaben, distilled water.

50 g – plastic tubes (1) – cardboard packs.
500 g – plastic jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial action for external use

Pharmacotherapeutic Group

Antimicrobial agent, sulfonamide

Pharmacological Action

A drug with antibacterial action for external use, a sulfonamide.

Active against gram-positive and gram-negative bacteria, as well as fungi of the genus Candida and dermatophytes.

The bactericidal properties of the drug are due to the activity of silver ions, which are released in the wound as a result of the dissociation of silver sulfadiazine; the release of silver ions occurs gradually (moderate dissociation), ensuring the constancy of the antibacterial action. The bactericidal activity of silver ions is complemented by the bacteriostatic action of sulfadiazine (also released during the dissociation of silver sulfadiazine).

The cream is characterized by moderate osmotic activity and does not possess necrolytic properties.

Pharmacokinetics

When the cream is applied to a damaged skin surface (burns or wounds), absorption of the active substances of the drug is possible – up to 1% of silver ions and up to 10% of sulfadiazine from the total amount of silver sulfadiazine salt applied to the wound.

Indications

Prevention and treatment of purulent wounds and burns with mild exudation, trophic ulcers, bedsores in adults and children over 1 year of age, including:

• Treatment of fresh burn surfaces for infection prevention;
• Treatment of wound and burn surfaces in the first phase of the wound process with mild exudation;
• Treatment of wounds and burns of I-IIIA degree in the second and third phase of the wound process;
• Treatment of trophic ulcers, bedsores, long-term non-healing wounds, including stump wounds.

ICD codes

Dosage Regimen

The cream or aerosol is applied externally after surgical treatment of the wound and removal of necrotic tissues.

The cream is applied to the damaged surface in a thin layer (2-4 mm) – under a bandage or by the open method.

The aerosol is sprayed onto the damaged surface – under a bandage or by the open method.

The bandage is changed 1-2 times/day or less frequently. The duration of treatment is up to 3 weeks.

Adverse Reactions

Local reactions rarely – burning, pain (usually resolve on their own within 5-10 minutes after bandage application).

Systemic reactions with prolonged use of the drug on extensive burn surfaces, changes in the peripheral blood picture (leukopenia), dyspeptic symptoms and allergic reactions characteristic of sulfonamide drugs are possible.

Contraindications

• Pregnancy;
• Lactation (breastfeeding);
• Children under 1 year of age;
• Hypersensitivity to sulfonamides.

Use in Pregnancy and Lactation

Silvederm is contraindicated for use during pregnancy and lactation (breastfeeding).

Pediatric Use

The drug is contraindicated in children under 1 year of age.

Special Precautions

Silvederm should not be used to treat deep purulent wounds and burn surfaces with abundant exudation.

Overdose

Data on overdose of Silvederm are not provided.

Drug Interactions

Data on drug interactions of Silvederm are not provided.

Storage Conditions

The drug should be stored in a dry place, protected from light, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.