Dermazin cream 1%, 50 g

Х treatment and prevention of burn infections, including before autodermoplasty;
Х treatment and prevention of infection of trophic ulcers, wounds.

Outwardly.
After surgical treatment of the wound, DermazinЃ cream is applied in a layer 2-4 mm thick on the damaged surface once or twice a day until the wound surface is completely healed.
Before each reapplication of the cream, it is necessary to remove the previous layer of the drug with water or antiseptic drugs.
DermazinЃ can be used with or without sterile dressings, dressings should be changed daily. No pain effects are observed when changing dressings.
DermazinЃ treatment 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.

1 g of cream for external use contains:
Active substance: silver sulfadiazine 10.0 mg.
Excipients: cetyl alcohol, peanut oil (hydrogenated), polysorbate-60, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Х hypersensitivity to sulfadiazine, other sulfa drugs, or any of the components of the drug;
Х pregnancy;
Х period of breastfeeding;
Х premature infants and babies during the first 2 months after birth;
Х porphyria.

Carefully

Х Deficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis);
Х renal and / or hepatic impairment.

Trade name of the drug

DermazinЃ

International non-proprietary name

sulfadiazine

Dosage form

cream for external use.

Composition

1 g of cream for external use contains:
Active substance: silver sulfadiazine 10.0 mg.
Excipients: cetyl alcohol, peanut oil (hydrogenated), polysorbate-60, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Description

White homogeneous mass.

Pharmacotherapeutic group

antimicrobial agent, sulfonamide.

ATX code : D06BA01

Pharmacological properties

DermazinЃ is a local chemotherapeutic agent for the prevention and treatment of wound and burn infections.
When applied to the burn surface, silver sulfadiazine decomposes, slowly and continuously releasing silver and sulfonamide ions, inhibiting the growth and reproduction of bacterial cells. DermazinЃ cream has a wide spectrum of antibacterial activity, including virtually all types of microbes that cause infection of burns and other wounds on the skin surface: Pseudomonas aeruginosa, Escherichia coli, Proteus sp., Staphylococcus spp., Streptococcus spp., Klebsiella sp., Enterobacter sp. as well as yeasts (Candida albicans) and some strains of the herpes virus.
DermazinЃ penetrates into necrotic tissues and exudate.

Indications for use

Х treatment and prevention of burn infections, including before autodermoplasty;
Х treatment and prevention of infection of trophic ulcers, wounds.

Contraindications

Х hypersensitivity to sulfadiazine, other sulfa drugs, or any of the components of the drug;
Х pregnancy;
Х period of breastfeeding;
Х premature infants and babies during the first 2 months after birth;
Х porphyria.

Carefully

Х Deficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis);
Х renal and / or hepatic impairment.

Application during pregnancy and during breastfeeding

Data on the use of silver sulfadiazine during pregnancy and during breastfeeding are limited. The use of the drug DermazinЃ during pregnancy and during breastfeeding is contraindicated.
With the systemic use of sulfonamides in newborns, hyperbilirubinemia and kernicterus may occur, since sulfonamides replace bilirubin from plasma albumin.
Sulfonamides are excreted in small amounts in breast milk. If it is necessary to use the drug DermazinЃ during lactation, the question of stopping breastfeeding should be resolved.

Method of administration and dosage

Outwardly.
After surgical treatment of the wound, DermazinЃ cream is applied in a layer 2-4 mm thick on the damaged surface once or twice a day until the wound surface is completely healed.
Before each reapplication of the cream, it is necessary to remove the previous layer of the drug with water or antiseptic drugs.
DermazinЃ can be used with or without sterile dressings, dressings should be changed daily. No pain effects are observed when changing dressings.
DermazinЃ treatment 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.

Side effect

According to the World Health Organization (WHO), undesirable effects are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, < 1/100), rarely (? 1/10000, <1/1000) and very rarely (<1/10000); frequency is unknown (frequency of occurrence cannot be determined from available data).
From the side of hematopoiesis and lymphatic system
infrequently: leukopenia (in 3-5% of patients), characterized mainly by a decrease in the number of neutrophils; the maximum decrease in the level of leukocytes is observed on the 2-4th day after the start of treatment, then their level is normalized within 2-3 days, while the continuation of treatment with DermazinЃ does not affect the process of restoring the number of leukocytes.
According to post-marketing observations, the following adverse reactions were identified:
On the part of the hematopoietic and lymphatic system, the
frequency is unknown: an increase in blood plasma osmolality.
On the part of the immune system, the
frequency is unknown: hypersensitivity reactions.
On the part of the skin and subcutaneous structures, it is
very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis;
frequency not known: allergic skin reactions such as rash, itching, contact dermatitis, gray skin discoloration on exposure to sunlight.
General disorders and disorders at the site of application, the
frequency is unknown: burning sensation or pain.
Systemic absorption of silver sulfadiazine in very rare cases can cause side reactions similar to those during systemic sulfonamide therapy (skin rash, Stevens-Johnson syndrome, exfoliative dermatitis, erythema multiforme, interstitial nephritis, eosinophilia, eczema, imbalance in water and electrolyte balance, fever , hypoglycemia, purpura, photodermatosis, erythema nodosum, headache, joint pain, folic acid deficiency).

Overdose

With prolonged use on a large surface of the body, serum sulfonamide concentrations may approach the level achieved with systemic use, which increases the risk of developing adverse reactions characteristic of sulfa drugs; in these cases, it is recommended to determine the serum concentration of silver sulfadiazine.
Treatment is symptomatic, an abundant drink is prescribed (it is recommended to maintain daily urine output at a level of 1200 - 1500 ml or more).
Argyria due to increased systemic absorption of silver does not develop.

Interaction with other medicinal products

Silver sulfadiazine can inactivate enzymatic preparations for wound cleansing when used simultaneously.
It is noted that the simultaneous use of cimetidine can increase the incidence of leukopenia.
With extensive burns, when the plasma concentration of silver sulfadiazine can reach therapeutic values, it must be borne in mind that the effect of other systemic drugs may change. In such cases, it is necessary to monitor the serum concentrations of the drug, renal function, as well as urine analysis in order to exclude the possible presence of silver sulfadiazine.
Silver sulfadiazine can enhance the effect of anticoagulants, oral hypoglycemic drugs from the sulfonylurea group, methotrexate, sodium thiopental.
With simultaneous use with probenecid, indomethacin, phenylbutazone, salicylates, sulfinpyrazone, the effect of sulfonamide may be enhanced.
With simultaneous use with urine acidifying agents (for example, calcium chloride, ascorbic acid in large doses), crystalluria may develop.

special instructions

It is necessary to use DermazinЃ with caution in patients with renal failure and damage to the liver parenchyma.
Patients with glucose-6-phosphate dehydrogenase deficiency should be monitored by a physician.
With prolonged use of DermazinЃ cream on a large surface of the skin, the blood count should be monitored due to the possible development of leukopenia.
When using the drug DermazinЃ, Stevens-Johnson syndrome and toxic epidermal necrolysis may develop, especially in the first weeks of using the drug.
If symptoms of these diseases occur (progressive skin rash, accompanied by blisters or damage to the mucous membrane), treatment with the drug should be discontinued. The best results in the treatment of Stevens-Johnson syndrome and toxic epidermal necrolysis are with early diagnosis and immediate discontinuation of any suspected drug.
Patients who have developed Stevens-Johnson syndrome and toxic epidermal necrolysis during treatment with sulfadiazine are not recommended to re-use the drug containing sulfadiazine.
The parts of the body treated with DermazinЃ should be protected from direct sunlight.
Avoid contact with eyes.

Influence on the ability to concentrate : not observed.

Release form

Cream for external use 1%; 50 g of cream in an aluminum tube, 1 tube each together with instructions for medical use in a cardboard box. 250 g of cream are placed in a polypropylene jar, instructions for medical use are glued to the jar.

Storage conditions

At a temperature not higher than 25 ? C.
Keep out of the reach of children.

Shelf life

3 years.
Do not use after the expiration date.

Conditions of dispensing from pharmacies

On prescription.