Active substanceSulfadiazineSulfadiazine
Similar drugsTo uncover
  • Dermazin®
    cream externally 
    Sandoz d.     Slovenia
  • Sulfargin®
    ointment externally 
    GRINDEX, JSC     Latvia
  • Dosage form: & nbspcream for external use
    Composition:
    1 g of cream for external use contains:
    active substance: silver sulfadiazine 10.0 mg.
    Excipients: cetyl alcohol, peanut butter (hydrogenated), polysorbate-60, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.
    Description:White homogeneous mass.
    Pharmacotherapeutic group:Antimicrobial agent, sulfonamide
    ATX: & nbsp

    J.01.E   Sulfonamides and trimethoprim

    Pharmacodynamics:
    Dermazin is a local chemotherapeutic agent for the prevention and treatment of wound and burn infections ..
    When applied to the surface of a burn sulfadiazine silver decays, slowly and continuously releasing silver ions and sulfonamide, inhibiting the growth and multiplication of bacterial cells. Dermazin cream has a broad spectrum of antibacterial activity, which includes 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 yeast fungi (Candida albicans) and some strains of the herpes virus.
    Dermazin penetrates into necrotic tissues and exudate.
    Indications:
    - treatment and prevention of burn infections, including pre-autodermoplasty;
    - treatment and prevention of infection of trophic ulcers, wounds.
    Contraindications:
    - hypersensitivity to sulfadiazine, other sulfanilamide preparations or any of the components of the drug;
    - pregnancy;
    - the period of breastfeeding;
    - preterm infants and children during the first 2 months after birth;
    - porphyria.
    Carefully:
    - Deficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis);
    - renal and / or liver failure.
    Pregnancy and lactation:
    Data on the use of silver sulfadiazine during pregnancy and during breastfeeding are limited.
    Dermazin® during pregnancy and in the period of breast feeding is contraindicated.
    With systemic use of sulfonamides in newborn children can there is hyperbilirubinemia and nuclear jaundice, because sulfonamides replace bilirubin from plasma albumin.
    Sulfanilamides are excreted in small amounts in breast milk. If you need to use the drug Dermazin® during lactation, you should decide whether to stop breastfeeding.
    Dosing and Administration:
    Outwardly.
    After surgical treatment of the wound, Dermazin® cream is applied a layer 2-4 mm thick on the damaged surface once or twice 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 preparation with water or antiseptic medicines. Dermazin® can be used with or without sterile dressings, the dressings should be changed daily. When changing dressings, pain effects are not observed. Treatment with Dermazin® is 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.
    Side effects:
    According to the World Health Organization (WHO), unwanted the 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 (the frequency of occurrence of phenomena can not be determined on the basis of available data).
    On the part of the organs 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 Dermazin® does not affect the recovery of the number of leukocytes.
    According to post-marketing observations, the following adverse reactions were identified:
    On the part of the organs of hematopoiesis and lymphatic system
    frequency is unknown: increase osmolality of the blood plasma.
    From the immune system
    frequency is unknown: hypersensitivity reactions.
    From the skin and subcutaneous structures
    rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis;
    frequency is unknown: allergic skin reactions such as rash, itching, contact dermatitis, gray staining of the skin under sunlight.
    General disorders and disorders at the site of application
    frequency is unknown: burning sensation or pain.
    Systemic absorption of silver sulfadiazine in very rare cases can cause adverse reactions similar to those in systemic therapy with sulfonamides (skin rash, Stevens-Johnson syndrome, exfoliative dermatitis,multiforme erythema, interstitial nephritis, eosinophilia, eczema, water-electrolyte imbalance, fever, hypoglycemia, purpura, photodermatosis, erythema nodosum, headache, joint pain, folic acid deficiency).
    Overdose:
    With long-term use on a large surface of the body, serum sulfanilamide concentrations may approach the level achieved by systemic application, which increases the risk of adverse reactions characteristic of sulfonamide drugs; in these cases it is recommended to determine the serum silver sulfadiazine concentration.
    Treatment is symptomatic, a copious drink is prescribed (it is recommended to maintain a daily diuresis at 1200-1500 ml or more).
    Argyria does not develop due to increased systemic absorption of silver.
    Interaction:
    Sulfadiazine silver can inactivate enzyme preparations for cleaning the wound with their simultaneous application.
    It is noted that the simultaneous application of cimetidine may increase the incidence of leukopenia.
    With extensive burns, when plasma the concentration of silver sulfadiazine can reach therapeutic values, it must be taken into account that the action other systemic drugs can change.In such cases, control serum concentrations of the drug, kidney function, as well as urinalysis in order to exclude the possible presence of silver sulfadiazine. Sulfadiazine silver can enhance the effect of anticoagulants, oral hypoglycemic drugs from the group of sulfonylureas, methotrexate, sodium thiopental. When used simultaneously with probenecid, indomethacin, phenylbutazone, salicylates, sulfinpyrazone, sulfanilamide action may be enhanced. When used simultaneously with urinary acidifying agents (eg, calcium chloride, ascorbic acid in large doses) it is possible to develop crystalluria.
    Special instructions:
    It is necessary to use with caution the drug Dermazin® in patients with renal insufficiency and damage
    parenchyma of the liver. Patients with deficiency of glucose-6-phosphate dehydrogenase should be under the supervision of a physician. With prolonged use of Dermazin® cream on a large surface of the skin, the blood formula should be monitored because of the possible development of leukopenia.
    When using Dermazin®, Stevens-Johnson syndrome and toxic epidermal necrolysis may develop, especially in the first weeks of use.If symptoms of these diseases occur (progressive skin rash, accompanied by blisters or mucous membrane damage), treatment with the drug should be discontinued. The best results for the treatment of Stevens-Johnson syndrome and toxic epidermal necrolysis are noted in the early diagnosis and immediate discontinuation of any suspected drug. Patients who developed Stevens-Johnson syndrome and toxic epidermal necrolysis with sulfadiazine, it is not recommended to reuse the drug containing sulfadiazine. Parts bodies treated with Dermazin® should be protected from direct sunlight. Avoid contact with eyes.
    Effect on the ability to drive transp. cf. and fur:Not noted.
    Form release / dosage:Cream for external use 1%.
    Packaging:50 mg are placed in an aluminum tube sealed with a membrane on the neck of the tube, sealed with a screwed plastic cap, equipped with a cone-shaped device for puncturing the membrane.
    1 tube is placed in a cardboard box together with instructions for medical use.
    250 grams of cream is placed in a polypropylene jar, the instructions for medical use are glued to the bank.
    Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:
    3 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013945 / 01
    Date of registration:18.09.2008 / 29.12.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp24.03.2017
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