Universal reference book for medicines
Product name: DERMASIN ® (DERMAZIN ® )

Active substance: sulfadiazine silver

Type: Antibacterial agent for external use

Manufacturer: LEK dd (Slovenia)
Composition, form of production and packaging
Cream for external use 1%
in the form of a homogeneous mass of white.

1 g

sulfadiazine silver 10 mg

Excipients: cetyl alcohol, peanut oil (hydrogenated), polysorbate 60, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

50 g - aluminum tubes (1) - packs of cardboard.

250 g - polypropylene cans.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Antimicrobial drug for external use, sulfonamide.
When applied to the surface of the burn, sulfadiazine silver breaks up, slowly and continuously releasing silver ions and sulfonamide, which inhibits the growth and multiplication of bacterial cells.
Dermazin has a broad spectrum of antibacterial activity, including virtually all types of microbes that cause infection of burns and other wounds on the skin surface (including Pseudomonas aeruginosa, Escherichia coli, Proteus spp., Staphylococcus spp., Streptococcus spp., Klebsiella spp., Enterobacter spp.), As well as yeast fungi (Candida albicans) and some strains of the herpes virus.

Sulfadiazine silver penetrates into necrotic tissues and exudate.

PHARMACOKINETICS

Data on the pharmacokinetics of Dermazin are not available.

INDICATIONS

- treatment and prevention of burn infections (including pre-autodermoplasty);

- treatment and prevention of infection of trophic ulcers, wounds.

DOSING MODE

Dermazin can be used with or without bandages.
The drug is intended only for application to the skin.
After surgical treatment of the burn surface, the cream is applied to it with a layer 2-4 mm thick.
The drug should be applied 1-2 times / day.
Treatment should be continued until the wound surface is completely healed.

The method of applying the cream is the same for the treatment of burns and trophic ulcers.
Dressings should be changed daily.
SIDE EFFECT

Local reactions: rarely - a burning sensation, itching.

On the part of the hematopoiesis system: in some cases development of transient leukopenia (predominantly a decrease in the number of neutrophils) in patients treated with sulfadiazine of silver was noted.
The maximum decrease in the level of leukocytes is observed on the 2-4 days after the start of treatment. Then their level is normalized within 2-3 days, while continuing treatment with sulfatiazine silver does not affect the process of recovery of the number of leukocytes.
There are separate reports on the development of skin necrosis, erythema multiforme, skin pigmentation disorders, interstitial nephritis.

The degree of absorption of silver sulfadiazine depends on the size of the surface of the burn and the degree of tissue damage.
In rare cases, it is possible to develop any adverse reactions characteristic of sulfonamides: hematopoietic disorders (including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia), skin and allergic reactions (including Stevens-Johnson syndrome and exfoliative dermatitis), dyspeptic phenomena, hepatitis, hepatocellular necrosis, reactions from the central nervous system, toxic nephrosis.
CONTRAINDICATIONS

- Children's age up to 2 months;

- premature newborn children;

- the period of childbirth;

- hypersensitivity to the components of the drug;

- Hypersensitivity to sulfonamides.

PREGNANCY AND LACTATION

Dermazin should not be used during pregnancy, except when the potential benefit of using it to save life exceeds the possible harm to the fetus.
The use of sulfonamides increases the risk of hyperbilirubinemia, therefore, do not prescribe Dermazin especially in the third trimester of pregnancy and during childbirth. The exception is cases where the potential benefit to the patient's survival is greater than the existing risk to the fetus.
It is not known whether silver sulfadiazine is excreted in human breast milk.
However, other sulfonamides in milk are detected. In addition, all sulfonamides increase the risk of hyperbilirubinemia. In connection with the possibility of developing serious side effects in an infants with the use of sulfonamides in a nursing mother, if it is necessary to use the drug during lactation, the question of stopping breastfeeding should be addressed, taking into account the degree of significance of treatment for the mother.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution, prescribe the drug to patients with impaired renal function due to possible cumulation of the drug due to delayed excretion.
It is necessary to decide whether to continue therapy, considering the possible consequences of its withdrawal and the benefits when continuing. In the case of continuing treatment should monitor the concentration of sulfadiazine in the serum.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution, prescribe the drug to patients with impaired hepatic function due to possible cumulation of the drug due to delayed excretion.
It is necessary to decide whether to continue therapy, considering the possible consequences of its withdrawal and the benefits when continuing. In the case of continuing treatment should monitor the concentration of sulfadiazine in the serum.
SPECIAL INSTRUCTIONS

With caution should prescribe the drug to patients with increased sensitivity to sulfonamides because of the possibility of developing cross-sensitivity.

As with the use of other local antimicrobials, the treatment with sulfadiazine silver may develop superinfection.

Use with caution in patients with congenital insufficiency of glucose-6-phosphate dehydrogenase because of the risk of hemolysis.

With caution, prescribe the drug to patients with impaired liver and kidney function due to possible cumulation of the drug due to delayed excretion.
It is necessary to decide whether to continue therapy, considering the possible consequences of its withdrawal and the benefits when continuing. In the case of continuing treatment should monitor the concentration of sulfadiazine in the serum.
When Dermazin is applied to burn wounds of a large area, the concentration of sulfadiazine in the serum can reach therapeutic levels when ingested.
In this case, it is necessary to monitor serum concentrations, monitor renal function, and monitor the possible content of sulfadiazine in the urine.
With prolonged use of Dermazin on a large surface of the skin should monitor the blood formula because of the possible development of leukopenia, thrombocytopenia or eosinophilia.

The drug should not be used in porphyria.

Avoid contact with eyes.

Impact on the ability to drive vehicles and manage mechanisms

There was no evidence of Dermazin's influence on the ability to drive vehicles and control mechanisms.

OVERDOSE

Symptoms: with long-term use on a large surface of the body, the concentrations of sulfadiazine in the serum can approach the level reached by systemic administration, which increases the risk of adverse reactions characteristic of sulfonamides.

Argyria does not develop due to increased systemic absorption of silver.

Treatment: symptomatic therapy, determination of serum sulfanilamide concentration, abundant drinking (it is recommended to maintain a daily diuresis at 1200-1500 ml or more).

DRUG INTERACTION

Sulfadiazine silver can inactivate enzyme preparations to clean the wound while they are being used simultaneously.

It was noted that with the simultaneous use of cimetidine, the risk of developing leukopenia increases.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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