Дермазин®

General characteristics. Structure:

Cream for external use of 1% 1 g
Active agent:  Sulfadiazinum of silver of 10 mg
excipients: cetyl alcohol; a peanut the oil hydrogenated; polysorbate 60; propylene glycol; methylparahydroxybenzoate; пропилпарагидросибензоат; the water purified.

Pharmacological properties:

Chemotherapeutic means with antimicrobic action for topical administration. It is applied to prevention and treatment of infections at burns.
In a wound Sulfadiazinum of silver dissociates, slowly and evenly releasing silver ions. The ion of silver contacts DNA of bacteria that leads to suppression of their growth and reproduction and does not influence cells of skin and hypodermic fabrics.
Dermasinum possesses a wide antibacterial range of action, it is active concerning almost all microorganisms which can infect burn wounds.

 

MIK of ≤50 mkg/ml                                    of MIK of ≤100 mkg/ml

                            Pseudomonas aeruginosa Enterobacter
                             Pseudomonas maltophilia Klebsiella
                                                      E.cloacea Serratia
                                                          E.coli Acinetobacter
                                                     Proteus Staphylococcus
                                  Morganella morganii Enterococcus spp.
                                           Providencia Clostridium perfringens
                                               Citrobacter Candida albicans
                        Corynebacterium diphteriae Dermatophytes
                         Streptococcus pyogenes Aspergillus fumigatus
                                        Mucor pussilus Aspergillus flavus

 

For Herpes, Herella, Rhizopus nigricans of MIK of ≤10 mkg/ml.
Dermasinum well gets into the centers of a necrosis and exudate. This property of drug is especially important as the antibiotics applied systemically do not affect microorganisms in the zone of a burn necrosis which is switched off from blood circulation.
Pharmacokinetics. At prolonged treatment of extensive burn wounds drug can be absorbed. Serumal concentration of sulfonamide are proportional to the area of a burn wound surface and amount of the applied cream.
After drawing 500–1000 g of 1% of cream of Sulfadiazinum of silver (that corresponds to 5-10 g of Sulfadiazinum of silver) Sulfadiazinum level in a blood plasma makes 2–5 mg/l, and its level in urine — 50–100 mg/l respectively.
Argiriya in connection with system adsorption of silver does not develop.

Indications to use:

Treatment of the infected burns, decubituses, ulcers, superficial wounds with weak exudation. Prevention of development of an infection at burns, wounds, decubituses, ulcers, grazes, small cuts, and also at transplantation of skin.

Route of administration and doses:

The corresponding treatment is appointed right after assessment of the sizes and depth of a wound surface.
After clarification of a surface of a burn Dermasinum is applied on the struck place (or on a sterile gauze napkin which is imposed on a burn surface) with a layer of 2-4 mm. Cream is applied sterile with spatula or a hand (having put on a sterile glove), usually 1 time a day; in hard cases cream is applied by 2 times a day. Before each repeated drawing it is necessary to wash away the remains of a former layer of cream and wound exudate water or solution of an antiseptic agent. It is possible to apply a bandage.
The route of administration and dose of drug do not depend on performing treatment or prevention, and also age of the patient.
Cream does not leave spots on clothes and bed linen.

Features of use:

To avoid hit of drug in eyes.
Cream Dermasinum should be applied with care at patients with hypersensitivity to sulfonamides (because of possible emergence of allergic reactions); with inborn deficit glyukozo-6-fosfatdegidrogenazy (as after use of cream on big surfaces there can be a hemolysis); with renal failures or a liver (there can be cumulation; control of level of sulfonamide in plasma is necessary for such patients).
Do not apply at patients with a porphyria.
If treatment provides prolonged use of cream Dermasinum on big sites of skin, control of indicators of blood as emergence of a leukopenia, thrombocytopenia and eosinophilia is possible is necessary. At treatment of massive wounds of concentration of Sulfadiazinum in a blood plasma can reach therapeutic levels. System side effects of sulfonamides can develop. Therefore it is recommended to control concentration of Sulfadiazinum in plasma, function of kidneys, and also to investigate urine as emergence of a crystalluria is possible.
As well as at use of other local antimicrobic means, as a result of treatment by Sulfadiazinum of silver superinfection can develop.
The fervescence connected with undesirable side effects is very seldom possible.
Cream contains methylparahydroxybenzoate and пропилпарагидроксибензоат which can become the reason of allergic reaction. Dermasinum contains peanut butter. Patients with hypersensitivity to a peanut or soy should not use this drug. Also it contains propylene glycol which can cause irritation of skin.
Use during pregnancy and feeding by a breast. Sulfadiazinum of silver should not be applied during pregnancy if it is not caused by urgent need, especially in the first 3 months of pregnancy and before childbirth.
It is known that sulfonamides increase risk of bilirubinovy encephalopathy at children of chest age therefore cream use Dermasinum contraindicated when feeding a breast of children at the age of 2 months. If the age of the child — is more senior than 2 months, the decision on the feeding continuation/termination by a breast or therapies it is necessary to accept advantage/risk taking into account a ratio.
Children. Cream use Dermasinum contraindicated at premature and newborn in the first 3 months of life because of possible developing of bilirubinovy encephalopathy after sulphonamide therapy. The recommended doses of cream and a route of administration at children are aged more senior than 3 months do not differ from those for adults.
Influence on ability to manage vehicles or to work with mechanisms. There are no data.

Side effects:

On the basis of assessment of side effects they were classified according to the frequency of manifestations: very often (≥1/10), it is frequent (≥1/100 and <1/10), sometimes (≥1/1000 and <1/100), is rare (≥1/10 000 and <1/1000), is very rare (<1/10 000), unspecified (it is impossible to estimate according to the available data).
From system of blood: often — a leukopenia.
From skin and hypodermic fabric: seldom — irritation of skin, an itch, a burning sensation, pain when drawing, rash, coloring of skin in gray color (an argiriya — the pigmentation caused by silver adjournment), a photosensitization; very seldom — a skin necrosis; unspecified — a hyperpegmentation.
The Tranzitorny leukopenia usually does not demand the therapy termination by Dermasinum or acceptances of other special measures. Monitoring of indicators of blood is recommended.
When putting cream Dermasinum on big surfaces (high doses), especially after heavy burns, there were messages on the side reactions established at oral administration of Sulfadiazinum such as nausea, vomiting, diarrhea, glossitis, joint pain, headache, confusion of consciousness, spasm, anemia, thrombocytopenia, eosinophilia, medicamentous fever, dysfunction and necrosis of a liver, intersticial nephrite and crystalluria. Frequency of these side effects is not established as they are given in spontaneous messages.

Interaction with other medicines:

Sulfadiazinum of silver can inactivate fermental drugs for clarification of a wound at their simultaneous use.
At simultaneous use with Cimetidinum the frequency of development of a leukopenia increases.

Contraindications:

Hypersensitivity to Sulfadiazinum of silver or any other component of drug; porphyria; period of pregnancy and feeding by a breast; age up to 3 months (because of a possibility of development of a kernicterus).

Overdose:

Prolonged use of drug on big sites of skin (high doses) can result in system side effects of sulfonamides and increase in level of silver in plasma. However it is normalized after the treatment termination by silver Sulfadiazinum. At patients with heavy burns at prolonged treatment cream noted substantial increase of osmolarity of plasma. The raised resorption of the propylene glycol drug which is a part through the struck derma can be the cause of it.
In case of overdose therapy by drug needs to be stopped and carried out a symptomatic treatment. If necessary it is necessary to control function of kidneys and indicators of blood. The soaked-up silver Sulfadiazinum easily is removed by means of haemo - and peritoneal dialysis.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity of the drug Дермазин® 3 of year.

Issue conditions:

According to the recipe

Packaging:

External use cream, 1%. On 50 g of cream in an aluminum tuba, on 1 tuba in a cardboard pack. On 250 g of cream in a polypropylene can, to bank paste the instruction on a medical use.