Pharmacological properties

Pharmacodynamics. Sulfadiazinum of silver has antimicrobic effect on gram-positive and gram-negative microbes and mushrooms (candida, phycomycetes and aspergillus spp., dermatophytes). the activity of ointment sulfargin is caused by a vysobozhdeniye of ions of silver in a wound as a result of moderate dissociation of Sulfadiazinum of silver, than long antimicrobic action which supplements Sulfadiazinum (streptocide) is reached. ions of silver are adsorbed on a surface of microbic cells and render so-called oligodynamic bacteriostatic and bactericidal action. ointment does not possess nekrolitichesky and mutagen action, is characterized by moderate osmotic activity.

Pharmacokinetics. At topical administration about 1% of ions of silver and up to 10% of Sulfadiazinum of total amount of the ointment applied on a wound can be soaked up. The most part of the soaked-up silver is removed with bile. The soaked-up Sulfadiazinum does not collect in an organism and is quickly emitted with kidneys.

Indication

Treatment and prevention of the infected burns, decubituses, ulcers, superficial wounds with weak exudation, grazes; transplantation of skin.

by

for topical administration outwardly.

After removal of necrotic fabrics ointment is applied a thin layer (2–4 mm) on the damaged surface usually by 1–2 times a day, under a sterile bandage or an open way. In hard cases ointment is applied to 4 times a day. It is important that the damaged sites of skin were covered with an ointment layer all the time.

Before each subsequent putting ointment the damaged surface needs to wash 0.9% with solution of sodium of chloride or solution of an antiseptic agent for removal of residues of ointment and wound exudate.

Ointment is applied to a complete wound healing or till the moment when the surface of a wound is prepared for the corresponding surgical intervention.

Route of administration and a dose of ointment do not depend on age of the patient, but depend on the size and depth of defeat of a wound surface. The maximum single dose — 300 g

At use of ointment on an extensive surface should control function of kidneys and a liver and blood indicators (maintenance of uniform elements of blood). The patient should give plentiful alkaline drink.

Contraindication

Hypersensitivity to silver Sulfadiazinum, streptocides or any excipient which is a part of ointment; genetic deficit glyukozo-6-fosfatdegidrogenazy (at use on extensive surfaces there can be a hemolysis); purulent wounds and burn wounds with plentiful exudation it (is inexpedient); porphyria; premature children, newborns and children aged up to 3 months (in connection with danger of developing of a kernicterus).

Side effects

Local reactions. seldom ointment can have local irritative effect (short burning, pain) which takes place in 5–10 min. at hypersensitivity there can be allergic reactions, including rash, burning, an itching, reddening, allergic rhinitis, allergic oh, a photosensitization, skin necrosis, a hyperpegmentation, contact dermatitis. at long-term treatment or treatment of big surfaces of skin there can be an argiriya — as a result of accumulation of silver in fabrics the skin can get slightly grayish coloring.

System reactions. At long-term treatment of extensive burn surfaces in blood plasma there can be such concentration of streptocides which are comparable to the concentration which are reached at system use. There can be side reactions, characteristic of streptocides: nausea, vomiting, diarrhea, glossitis, joint pain, dysfunctions and necrosis of a liver, headache, medicamentous fever, confusion of consciousness, spasm, crystalluria, interstitial nephrite, leukopenia, thrombocytopenia, eosinophilia.

Special instructions

Should avoid hit of ointment in eyes.

With care should be applied at:

• hypersensitivity to sulfonamides (because of possibility of allergic reactions);
• congenital deficit glyukozo-6-fosfatdegidrogenazy (after use of ointment on big surfaces the hemolysis is possible);
• a renal failure and a liver (there can be cumulation; control of level of sulfonamide in blood plasma is necessary for such patients).

Should avoid use of ointment for patients with a porphyria.

As well as at topical administration of other medicaments with antimicrobic action, at intake of Sulfadiazinum of silver the superinfection can also develop.

ointment Excipients, methylparaben (E218) and propylparaben (E216), can cause allergic reactions (including the slowed-down type), in some cases — a bronchospasm.

cetostearyl alcohol and propylene glycol can cause local skin reactions (for example contact dermatitis); propylene glycol can cause irritation of skin.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Data on adverse influence are absent.

Use during pregnancy or feeding by a breast. It is not necessary to apply during pregnancy or feeding by a breast.

Knows that sulfonamides increase risk of bilirubinovy encephalopathy at babies therefore use of ointment is contraindicated when feeding by a breast. In need of use of ointment during feeding it is necessary to pass with a breast to alternative feeding of the child.

Children. Due to danger of developing of a kernicterus it is impossible to apply silver Sulfadiazinum at premature children, newborns and children aged up to 3 months

Interaction

Sulfadiazinum of silver can inactivate the means fermentno cleaning a wound therefore at the same time it is not recommended to use these drugs.

Simultaneous use of Cimetidinum can cause the increased frequency of development of a leukopenia.

At overdose of ointment the emergence of the side effects connected with system use of all streptocides is possible

(see side effects).

At patients with heavy burns at prolonged use noted substantial increase of osmolarity of blood plasma. The raised resorption of propylene glycol which is a part of drug, through the affected skin can be the cause of it.

symptomatic treatment. If necessary it is necessary to control function of kidneys and indicators of blood. The soaked-up Sulfadiazinum easily is removed at haemo - and peritoneal dialysis.

Storage conditions

At a temperature not above 25 °C. not to store in the fridge and the freezer.