Sulfargin®

Excipient(s): cetostearyl alcohol, propylene glycol, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216).

For a full list of excipients, see section 6.1.

White or almost white ointment with specific odour.

Prophylaxis and treatment of infection in burns. Additional treatment of infected skin ulcers and bedsores. An aid to the prophylaxis of infection in skin graft donor sites and extensive abrasions.

4.2     Posology and method of administration

For cutaneous use.

Following the removal of necrotic tissue thin layer of the ointment (2...4 mm) is applied over the affected skin area once or twice daily and covered with sterile bandage or left open. The ointment may also be applied to sterile bandage which is then laid to the affected surface. Maximum single amount to apply is 300 g. Treatment lasts up to 3 weeks.

When applying to large skin areas patient's renal and hepatic functions and blood levels should be monitored. A large amount of alkaline liquid should be given to patient.

Silver sulfadiazine should not be used in premature infants and newborn infants during the first 3 months of life (see section 4.3).

4.3     Contraindications

Hypersensitivity to silver sulfadiazine, to any of the excipients or other sulphonamides, genetic glucose-6-phosphate dehydrogenase deficiency (applying to large areas could result in haemolysis). Because of risk of kernicterus silver sulfadiazine should not be used on premature infants and newborn infants during the first 3 months of life. Silver sulfadiazine should not be used in pregnancy and lactation.

SULFARGIN 10 mg/g ointment is not recommended for use in deep festering ulcers and burn wounds that are very exudative.

4.4     Special warnings and precautions for use

Silver sulfadiazine should be used with caution in patient with hepatic and renal impairment.

In case of long-term treatment with silver sulfadiazine or if the medication is applied on large‑area burns, the blood count must be regularly monitored because of risk of leucopenia, trombocytopenia or eosinophilia.

Patients with porphyria should avoid using the medication.

As in case other locally applied antimicrobial preparations, a superinfection could develop when using silver sulfadiazine.

Sulfargin ointment contains methylparahydroxybenzoate (E 218) and propylparahydroxybenzoate (E 216), which may cause allergic reactions (possibly delayed) and exceptionally, bronchospasm.

Ointment contains also cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis) and propylene glycol, which may cause skin irritation.

4.5     Interaction with other medical products and other forms of interaction

As silver sulfadiazine may inactivate enzymatic debriding agents, their concomitant use is not recommended.

4.6     Fertility, pregnancy and lactation

Safety of use of silver sulfadiazine in pregnancy has not been established. Silver sulfadiazine should not be used in pregnancy and lactation (see section 4.3).

4.7     Effects on ability to drive and use machines

Not relevant.

4.8     Undesirable effects

The adverse reactions are presented according to MedDRA system organ classes and MedDRA frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated form the available data).

Local reactions

Skin and subcutaneous tissue disorders

Rare: allergic skin reactions (rash, burning, itching, redness).

Very rare: local irritant effect (short-term itching, pain), which usually disappears in 5...10 minutes.

Systemic reactions

Sulphonamide concentration in serum could raise to a level attributable to systemic therapy when applied to large area wounds over prolonged periods. In such cases adverse reactions typical of sulphonamides could occur:

Gastrointestinal disorders

Common: nausea, vomiting, diarrhoea, glossitis.

Musculoskeletal and connective tissue disorders

Not known: joint pain.

Hepatobiliary disorders

Rare: hepatic impairment.

Nervous system disorders

Rare: headache, spasmodic fits.

Psychiatric disorders

Not known: distraction.

Renal and urinary disorders

Rare: crystaluria, renal impairment.

Blood and lymphatic system disorders

Rare: leucopenia, thrombocytopenia, eosinophilia.

Skin and subcutaneous tissue disorders

Rare: argyria (a slate-grey skin may develop due to deposition of silver in tissues). Usually occurs if used for prolonged periods of time or applied on large skin areas.

Immune system disorders

Rare: allergical cold or allergical asthma.

4.9     Overdose

When applied to large area wounds over prolonged periods the sulphonamide concentration in serum could raise to a level attributable to systemic therapy, therefore all adverse reactions similar to systemic use of sulphonamides are possible to occur (see 4.8). Treatment is symptomatic.

Pharmacotherapeutic group: chemotherapeutics for topical use, sulphonamides, silver sulfadiazine,

АТС code: D06BA01

Silver sulfadiazine has antimicrobial activity against grampositive and gramnegative bacteria and fungi (Candida, Phycomycetes and Aspergillus spp, dermatophytes). Effect of the preparation is based on silver ions releasing in the wound as a result of moderate dissociation of silver sulfadiazine, by means with what a long-term antimicrobial activity is achieved which is supplemented by sulfadiazine (sulphonamide). Silver ions adsorbate on the surface of bacteria cells and produce sc oligodynamical bacteriostatic and bactericidal action. The preparation does not have necrolytic and mutagenic effect. SULFARGIN has moderate osmotic activity.

5.2     Pharmacokinetic properties

Up to 1% of silver ions and 10% of sulfadiazine may be absorbed from locally applied ointment. Most of the absorbed silver is excreted in bile. Absorbed sulfadiazine does not cumulate in body and is subject to rapid renal excretion.

5.3     Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.

Paraffin liquid, propylene glycol, cetostearyl alcohol, glycerol monostearate 40-55, polysorbate 80, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216) and water purified.

6.2     Incompatibilities

See section 4.5.

6.3     Shelf life

50 g of ointment in aluminium tube: 2 years

500 g of ointment in plastic jar: 1 year

6.4     Special precautions for storage

Do not store above 25 °C.

Do not refrigerate or freeze.

Keep the plastic jar (500 g) tightly closed in order to protect from light.

6.5     Nature and contents of container

50 g of ointment in aluminium tube, 500 g of ointment in plastic jar.

Not all pack sizes may be marketed.

6.6     Special precautions for disposal

No special requirements.