SANADERM

Sanaderm 10 mg/g cream is a topical prescription medicine containing silver sulfadiazine. The active substance has antibacterial and antifungal activity and is used to prevent or treat infection in selected serious skin injuries.

Sanaderm is intended for application to the skin and wound under medical supervision. It is not a routine cream for every minor burn, redness or skin irritation.

Sanaderm cream – indications, application and precautions

What is Sanaderm used for?

According to the approved Serbian product information, Sanaderm is used:

• to prevent and treat infections associated with second- and third-degree burns;
• for infections associated with venous ulcers;
• for infections associated with pressure ulcers;
• to prevent infection of skin grafts.

Silver sulfadiazine acts against numerous microorganisms that may colonise damaged skin. It does not treat a deep systemic infection and does not replace surgical wound management, appropriate dressings, systemic antibiotics or another procedure prescribed by the doctor.

Sanaderm is not automatically appropriate for a mild first-degree burn, minor redness or ordinary sunburn. A topical antibiotic should be used only when there is a clear medical indication.

How is Sanaderm applied?

• The wound is first cleaned and appropriately treated.
• Sterile gloves should be used during application.
• The cream is applied once or twice daily.
• The usual layer is approximately 1.5 mm thick.
• The entire wound surface should remain covered.
• Reapply the cream if it is accidentally removed.
• Remove the previous layer with water or an antiseptic solution before the next application.

The treated wound may be covered with sterile gauze or a bandage, although this is not always necessary. The doctor or nurse determines the most appropriate dressing method.

Duration of treatment

The doctor determines treatment duration according to the wound, infection risk, response and adverse effects. The wound should be reviewed at regular intervals.

Stopping treatment too early may allow the infection to return. However, the cream should not be continued longer than prescribed, particularly when it is being applied to a large area.

Use in children

Application in children older than two months is generally similar to application in adults, but treatment must be prescribed and supervised by a doctor.

Sanaderm must not be used in premature babies, newborn babies or infants younger than two months because of the risk of kernicterus.

Who must not use Sanaderm?

• people allergic to silver sulfadiazine;
• people allergic to another sulfonamide or an ingredient of the cream;
• premature babies, newborns and infants younger than two months;
• pregnant women, particularly during late pregnancy and near delivery;
• women who are breastfeeding;
• patients with heavily exuding venous or pressure ulcers.

When is particular caution required?

Tell the doctor before treatment if the patient has:

• kidney or liver impairment;
• anaemia or another blood disorder;
• glucose-6-phosphate dehydrogenase deficiency;
• porphyria;
• hypersensitivity to sulfonamides, sulfites or certain preservatives;
• allergy to furosemide, thiazide diuretics, acetazolamide or sulfonylureas.

When Sanaderm is applied to a large area, sulfadiazine may be absorbed into the bloodstream. Monitoring of kidney and liver function, blood-cell counts, serum sulfadiazine and urine crystals may then be required.

Serious skin reactions

Very rare but potentially life-threatening reactions include Stevens–Johnson syndrome and toxic epidermal necrolysis. The greatest risk is during the first weeks of treatment.

A patient who previously developed Stevens–Johnson syndrome or toxic epidermal necrolysis after silver sulfadiazine must never use it again.

Interactions with other medicines

Tell the doctor about all medicines being used, particularly:

• cimetidine, because it may increase the risk of a reduced white-blood-cell count;
• phenytoin, because absorbed sulfadiazine may affect its metabolism;
• methotrexate, because sulfonamides may increase its toxicity;
• other sulfonamide medicines.

Do not independently combine several antiseptics, topical antibiotics, enzymes, balms or cosmetic creams on the wound. Combining products may alter their effects or cause additional irritation.

Pregnancy and breastfeeding

Sanaderm is generally avoided during pregnancy and is particularly contraindicated during late pregnancy and near delivery because of the risk of kernicterus in the newborn.

Earlier use may be considered only when no suitable alternative is available and the doctor determines that the expected benefit outweighs the potential risk.

Sulfadiazine may pass into breast milk. Breastfeeding should therefore be stopped during treatment according to medical advice.

Possible side effects

The most commonly reported reactions include:

• itching, burning or rash at the application site;
• allergic reactions;
• a temporary reduction in white blood cells;
• increased sensitivity to light.

Application to large areas or prolonged use may be associated with:

• kidney impairment and crystals in the urine;
• abnormal liver function;
• headache, dizziness, drowsiness or impaired coordination;
• reduced platelet counts;
• secondary bacterial or fungal infection;
• severe skin reactions.

A grey-brown discolouration of the skin or nails may occur. Prolonged exposure has very rarely been associated with argyria, a persistent dark discolouration caused by silver deposition.

When does the wound require urgent assessment?

Availability and price

Related skin care and education

Products for soothing and supporting the repair of mild superficial burns are available in the Burns category.

Products from this category do not replace Sanaderm for an infected burn, pressure ulcer or venous ulcer. Silicone scar products should be used only after the wound has completely closed unless otherwise instructed by a healthcare professional.

Related blog topic: What to apply to burns and burn blisters?

Composition, appearance and packaging

One gram of cream contains 10 mg of micronised silver sulfadiazine.

Other ingredients are light liquid paraffin, liquid sorbitol 70%, polysorbate 60, sorbitan stearate, cetyl alcohol, stearyl alcohol and purified water.

Cetyl alcohol and stearyl alcohol may cause local skin reactions, including contact dermatitis.

Sanaderm is a uniform white cream supplied in an aluminium tube containing 50 g.

Marketing authorisation holder: Actavis d.o.o. Belgrade.

Storage

Store below 25°C in the original packaging and keep out of the sight and reach of children.

The cream may be used for 30 days after first opening. Return unused medicine to a pharmacy that collects pharmaceutical waste.

Frequently asked questions

Official sources: ALIMS – Patient Information Leaflet | ALIMS – Summary of Product Characteristics.
Marketing authorisation number: 515-01-02001-22-001. Last renewal: 19 April 2023. Product information revised in April 2023. Content checked: July 2026.