Dermazine, cream 1% 50 g

Dermazine is a broad spectrum antibacterial.

Blocks folate synthesis in the microbial cell (sulfadiazine) and the activity of enzymes – primarily SH-containing (Ag).

Indications

Burns, sores, deep wounds.

Active ingredient

Composition

Active substance:

Silver sulfadiazine10 mg;

Auxiliary substances:

Cetyl alcohol;

Hydrogenated peanut oil;

Polysorbate 60;

Propylene glycol;

methylparahydroxybenzoate;

propylparahydroxybenzoate;

purified water

How to take, the dosage

After surgical treatment of the wound Dermazine® cream is applied in a 2-4 mm layer on the damaged surface 1-2 times a day until the wound surface is completely healed. Before each reapplication of the cream the previous layer of the preparation should be removed by water or antiseptic drugs.

Dermazine® can be used with or without sterile dressings, the dressings should be changed daily.

There are no painful effects when the dressings are changed.

The treatment with Dermazine® Cream is continued until the wound surface is completely healed.

The method of application of the cream is the same for the treatment of burns and trophic ulcers.

Interaction

The incidence of leukopenia may increase with concomitant use of cimetidine.

Silver sulfadiazine may inactivate enzymatic wound cleansing drugs when used concomitantly.

In the treatment of extensive burns, when plasma concentrations of silver sulfadiazine reach therapeutic values, it should be taken into account that the effect of drugs used systemically may change.

Special Instructions

Avoid getting the drug in the eyes. Dermazine cream should be used with caution in patients with hypersensitivity to sulfonamides (because of possible allergic reactions); with congenital deficiency of glucose-6-phosphate dehydrogenase (in treatment of minor superficial burns); with renal or hepatic disorders (cumulation may occur; for such patients plasma levels of sulfonamide should be controlled).

Do not use in patients with porphyria.

Dangerous skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with sulfadiazine.

The greatest risk of these reactions is in the first weeks of treatment. At the first manifestations of hypersensitivity (progressive skin rash, often with vesicles and mucous membrane lesions) the drug should be discontinued. Only with minor superficial burns can the cream be used alone. Patients with deeper burns should always consult a doctor before starting treatment.

Burns affecting 2% or more of the body surface area (approximately 1 palm of the patient corresponds to 1% of their body surface area), as well as burns affecting the eyes, ears, face, hands, feet and/or crotch require medical evaluation.

Consultation with a physician is necessary for skin wounds containing foreign material that cannot be removed; deep puncture wounds; animal bites; wounds with significant redness, sudden development of edema and wounds accompanied by fever. If treatment requires long-term use of Dermazine cream on large areas of skin, blood values should be monitored as leukopenia, thrombocytopenia and eosinophilia are possible.

When treating massive wounds, plasma concentrations of sulfadiazine may reach therapeutic levels. Systemic sulfonamide side effects may develop. Therefore, it is recommended to monitor plasma sulfadiazine concentrations, renal function, and urine tests regarding the occurrence of crystalluria.

As with other topical antimicrobials, superinfection may develop during treatment. Very rarely, an increase in body temperature is possible, which is associated with undesirable side effects. Excipients methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions, including delayed, in some cases – bronchospasm. Dermazine contains peanut oil.

Patients with hypersensitivity to peanut or soybean should not use this drug. Propylene glycol, which is part of the drug, may cause skin irritation. Cetyl alcohol may also cause local skin reactions (e.g., contact dermatitis).

Children.

Due to the risk of nuclear jaundice, silver sulfadiazine should not be used in premature infants, newborns and children less than 3 months of age. Because the efficacy and safety of the drug in children over 3 months of age have not been determined, it is recommended that patients in this age group be prescribed the drug after consultation with their physician.

The ability to affect the reaction rate when driving vehicles or operating other mechanisms.

There are no data regarding adverse effects.

Contraindications

Hypersensitivity, glucose-6-phosphate dehydrogenase deficiency, pregnancy.

Side effects

Itching, burning sensation. With prolonged use on large surfaces, systemic effects typical of sulfonamides are possible.

Overdose

In case of overdose of the cream, side effects associated with the systemic use of all sulfonamides are possible.

Prolonged use of silver sulfadiazine at high doses may cause elevated plasma silver levels.

However, these levels normalize after discontinuation of treatment.

In patients with severe burns, a significant increase in plasma osmolarity has been noted with long-term treatment.

The reason for this may be increased resorption of propylene glycol, a component of the drug, through the affected skin.

The treatment is symptomatic.

When necessary, renal function and blood parameters should be monitored.

Absorbed sulfadiazine is easily excreted by hemo- and peritoneal dialysis.

Similarities