Dermazine, cream 1%, 50g

Composition

Active ingredient:

silver sulfadiazine 10 mg;

Auxiliary substances:

cetyl alcohol;

hydrogenated peanut butter;

polysorbate 60;

propylene glycol;

methyl parahydroxybenzoate;

propyl parahydroxybenzoate;

purified water

Pharmacological action

Dermazin is a broad-spectrum antibacterial agent.

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

Indications

Burns, bedsores, deep wounds.

Contraindications

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

Side effects

Itching, burning sensation. Prolonged use on large surfaces may result in systemic effects that are characteristic of sulfonamides.

Interaction

When used concomitantly with cimetidine, the incidence of leukopenia may increase.

Silver sulfadiazine can inactivate wound-cleansing enzyme preparations when used simultaneously.

In the treatment of extensive burns, when the concentration of silver sulfadiazine in the blood plasma reaches therapeutic values, it should be borne in mind that the effect of drugs used systemically may change.

How to take, course of use and dosage

Externally.

After surgical treatment of the wound Dermazin® the cream is applied in a layer 2-4 mm thick on the damaged surface 1-2 times a day until the wound surface is completely healed. Before each repeated application of the cream, it is necessary to remove the previous layer of the drug with water or antiseptic drugs.

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

When changing bandages, there are no pain effects.

Treatment with Dermazin ® 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.

Overdose

If the cream is overdosed, side effects associated with the systemic use of all sulfonamides may occur.

Long-term use of high doses of silver sulfadiazine may cause an increase in plasma silver levels.

However, these levels return to normal after discontinuation of treatment.

In patients with severe burns, a significant increase in plasma osmolarity was observed during long-term treatment.

The reason for this may be increased resorption of propylene glycol, which is part of the drug, through the affected skin.

Treatment is symptomatic.

If necessary, kidney function and blood counts should be monitored.

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

Special instructions

Avoid contact with eyes. Dermazin cream should be used with caution in patients with hypersensitivity to sulfonamides (due to the possible occurrence of allergic reactions); with congenital glucose-6-phosphate dehydrogenase deficiency (in the treatment of minor superficial burns); with impaired renal or hepatic function (accumulation may occur; for such patients, monitoring of the level of sulfonamide in blood plasma is necessary).

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 such reactions occurs in the first weeks of treatment. At the first signs of hypersensitivity (progressive skin rash, often with blisters and mucosal lesions), the drug should be discontinued. Only with minor superficial burns, the cream can be applied independently. Patients with deeper burns should always consult their doctor before starting treatment.

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

Consultation with a doctor is necessary for skin wounds containing foreign materials that cannot be removed; for deep puncture wounds; animal bites; for wounds with significant redness, sudden development of edema and wounds accompanied by fever. If the treatment involves prolonged use of Dermazin cream on large areas of the skin, it is necessary to monitor blood parameters, since leukopenia, thrombocytopenia and eosinophilia may occur.

In the treatment of massive wounds, plasma concentrations of sulfadiazine can reach therapeutic levels. Systemic side effects of sulfonamides may occur. Therefore, it is recommended to monitor the concentration of sulfadiazine in the blood plasma, kidney function, and also to examine the urine for 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 can cause allergic reactions, including delayed ones, in some cases — bronchospasm. Dermazin contains peanut butter.

Patients with hypersensitivity to peanuts or soy should not take this medicine. Propylene glycol, which is part of the drug, can cause skin irritation. Cetyl alcohol can also cause local skin reactions (for example, contact dermatitis).

Children.

Due to the risk of nuclear jaundice, silver sulfadiazine should not be used in premature infants, newborns, and children under 3 months of age. Since the efficacy and safety of the drug in children aged 3 months and older have not been determined, it is recommended to prescribe the drug to patients of this age category after consulting a doctor.

Ability to influence the reaction rate when driving vehicles or working with other mechanisms.

There are no data on negative impacts.

Form of production

Cream for external use

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

3 years

Active ingredient

Silver Sulfadiazine

Conditions of release from pharmacies

By prescription

Dosage form

cream

Description

Children as prescribed by a doctor, Children over 2 months of age

Indications

Minor skin injuries, Trophic ulcers, Purulent wounds, Burns