The instruction for use of medicine for experts
the Trade name
the International unlicensed
name Silver Sulphathiazole
A dosage form
Cream of 2%, 15 g or 40 g
of 1 g of cream contains
active agent – sulphathiazole silver salt 20.0 mg
excipients: propilparagidroksibenzoat, methylparahydroxybenzoate, liquid paraffin, cetostearyl alcohol, white vaseline, sodium lauryl sulfate, glycerin diphosphate potassium, phosphate sodium, water for injections
White or white with a shade from pink to light gray homogeneous soft mass.
Antimicrobial drugs for external use. Streptocides.
The code of automatic telephone exchange D06BA02
Pharmacokinetics Which Is Contained properties in drug silver salt of sulphathiazole possesses small degree of solubility in fats therefore at topical administration the concentration of drug in a wound remains at the constant level. Thanks to the minimum resorption, drug has no toxic effect. Only the insignificant amount of silver salt of sulphathiazole gets into the general blood stream then is exposed in a liver to acetylation.
With urine it is removed in the form of inactive metabolites and partially in not changed look. Absorption of sulphathiazole increases after use of drug on extensive sites of the affected skin.
Argosulfan cream – the antibacterial drug for external use promoting healing of wounds (burn, trophic, purulent, etc.), provides effective protection of wounds against infection, stops pain and burning in a wound, reduces treatment time, and time of preparation of a wound for skin transplantation, in many cases leads to wound healing that excludes need of performing transplantation.
The streptocide which is a part of cream – sulphathiazole, is antimicrobial bacteriostatic means, it possesses a wide range of antibacterial action concerning gram-positive and gram-negative bacteria. The mechanism of antimicrobial effect of sulphathiazole consists in oppression of growth and reproduction of microbes as a result of competitive antagonism with paraaminobenzoic acid and oppressions of a digidropteroatsintetaza. It leads to disturbance of synthesis of dihydrofolic acid, and, finally, its active metabolite – the tetragidrofiliyevy acid necessary for synthesis of purines and pyrimidines of a microbic cell. The ions of silver which are present at drug strengthen several dozen times antibacterial effect of streptocide – they slow down growth and division of bacteria by linking with deoxyribonucleic acid of a microbic cell. Besides, ions of silver weaken the sensibilizing properties of streptocide.
Thanks to the hydrophilic basis of cream having optimum rn and containing a large amount of water the local analgeziruyushchy action is provided and the humidity in the field of a wound increases. All this promotes good tolerance of drug and acceleration of wound healing.
– burns of all degrees and various origin (including thermal, solar, chemical, electric current, beam)
– trophic ulcers of a shin of various genesis (including at chronic venous insufficiency, an obliterating endarteritis, disturbances of blood supply in diabetes, an ugly face, etc.)
– purulent wounds
– home accidents (cuts, grazes)
– the infected dermatitis, simple contact dermatitis
– the complicated impetigo
– microbic eczema
– strepto – and a staphyloderma.
The route of administration and doses
use Drug outwardly as by an open method, and with use of occlusive bandages.
After clarification and surgical treatment apply drug with observance of conditions of sterility 2-3 mm thick on a wound 2-3 times a day. A wound during treatment all has to be covered with cream. If a part of a wound opens, it is necessary to apply cream in addition. Imposing of an occlusive bandage – is possible, but is not obligatory.
Cream is applied to a complete wound healing or till the moment when the surface of a wound is prepared for skin transplantation. In case of use of drug on contaminated wounds exudate can appear. Before use of cream it is necessary to wash a wound of 0.1% with aqueous solution of a chlorhexidin, 3% aqueous solution of boric acid or other antiseptic agent.
The maximum daily dose – 25 g.
The maximum course of treatment – 60 days.
At children 2 months of change of a dosage are more senior it is not required.
– skin allergic reactions
– the irritation which is shown burning in the place of use of cream (sometimes)
– desquamative dermatitis
– a leukopenia (in case of prolonged use).
– hypersensitivity to sulphathiazole and other streptocides
– congenital insufficiency glyukozo-6-fosfatdegidrogenazy
– premature children and newborns up to 2 months of life (in connection with risk of developing a kernicterus)
is not recommended to apply Medicinal interactions in a combination with other medicines to external use.
Folic acid and its structural analogs (for example, Procainum) are capable to weaken antimicrobial effect of sulphathiazole.
Against the background of prolonged use on extensive sites of skin it is necessary to control sulphathiazole level in blood serum, especially in cases of diseases of kidneys and a liver.
It is necessary to be careful at use for patients in a state of shock in extensive burns because of impossibility of collecting the full allergological anamnesis.
Not to apply at premature, 2 months owing to strengthening of jaundice of newborns are younger than newborns and children.
Argosulfan the cream applied outwardly does not cause darkening of skin and linen.
Pregnancy and a lactation
Are absent the corresponding clinical trials and it is not recommended to use drug during pregnancy. Drug can be used only when the expected advantage for mother exceeds possible risk for a fruit (for example, the surface of a burn exceeds 20% of a body surface).
It is not recommended to apply during feeding by a breast.
Influence on ability to control of vehicles and to service of moving mechanisms
Drug does not limit psychophysical activity and ability to control of motor transport and to service of the machine equipment.
Cases of overdose are noted.
A form of release and packing
On 15 g or 40 g of 2% of cream in aluminum tubas. Each tuba is placed in a cardboard pack with the instruction for use.
To Store storage conditions at a temperature not higher than + 250C. Not to freeze.
To store out of children’s reach!
An expiration date
not to use medicine after its expiry date.
the Jelfa Pharmaceutical Plant A Producer. Lake
of ul. W .Pola 21, 58 – 500 Jelenia Góra, Poland