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Dosage form: & nbspointment for external use
Composition:

For 100 g of ointment:

Active substances:

Fusidic acid (fusidine-sodium)

2 grams

Dioxomethyltetrahydropyrimidine (methyluracil)

1 g

Excipients:

Sodium pyrosulphuric acid (sodium disulfite)

0.05 g

Povidone (polyvinylpyrrolidone low molecular weight medical)

0.5 g

Lanolin (anhydrous lanolin)

25 grams

Petrolatum

71,25

Purified water

0.2 g

Note. The amount of fusidine sodium is indicated for a substance with an activity of 900 U / mg. In the case of a greater or lesser activity of fusidine sodium, the amount of the substance is changed accordingly.

Pharmacotherapeutic group:antimicrobial agent
ATX: & nbsp
  • Other antimicrobials
  • Pharmacodynamics:

    Sodium fusidate (fusidin sodium) is a fusidic acid sodium salt, an antibiotic that exhibits high specific antimicrobial activity against Staphylococcus spp. (including those resistant to penicillins, streptomycin, chloramphenicol, erythromycin), Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus spp., Moraxella spp. and Corynebacterium spp.

    Has a high antimicrobial activity against Staphylococcus epidermidis (methicillin-resistant and methicillin-sensitive); less Streptococcus spp. (incl. Streptococcus pneumoniae).

    Inactive for Escherichia coli, Salmonella spp., Proteus spp. and other gram-negative bacteria, as well as protozoa and fungi.

    Dioxomethyltetrahydropyrimidine is a stimulator of cellular regeneration, has anabolic and anti-catabolic activity, shortens the healing time for wounds.

    Pharmacokinetics:

    Sodium fusidate when applied externally penetrates deeply into the skin in the area of ​​affected areas. Dioxomethyltetrahydropyrimidine when applied topically in the form of an ointment is not practically absorbed into the systemic circulation.

    Indications:Ointment is used to treat purulent-inflammatory skin diseases caused by microorganisms sensitive to fusidate sodium: surface folliculitis, furunculosis, pyoderma, impetigo, hydradenitis, deep wounds and abrasions caused by microorganisms sensitive to fusidate sodium; burns I-III-IV degree as an antimicrobial and regenerating agent in the second phase of the wound process, sycosis, infected wounds and ulcerous surfaces.
    Contraindications:

    - Individual intolerance to the components of the ointment;

    - pregnancy, the period of breastfeeding;

    - Children under 18 years of age (due to lack of data);

    - leukemia (leukemia, especially myeloid), lymphogranulomatosis, hemoblastosis, malignant bone marrow diseases.

    Dosing and Administration:

    Outwardly.

    After removal of pus and necrotic masses, ointment is applied a thin layer 1-2 times a day, with burns - 2-3 times a week.

    The duration of treatment depends on the form and severity of the disease.

    With extensive wound processes, it is possible to combine the ointment with the intake of sodium fusidate inside. In such cases, the dose of sodium fusidate is prescribed by a doctor.

    The average duration of therapy with ointment is 10-14 days, it is possible to extend the course to 3 weeks.

    Side effects:

    Allergic reactions are rare (> 0.01% and <0.1%).

    Very rarely (<0.01%), there may be a local irritant effect in the form of redness and itching, which usually does not require withdrawal of the drug.

    If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions are noted, you should inform the doctor immediately.

    Overdose:Over the period of post-marketing use of the drug, no cases of overdose have been observed.
    Interaction:

    There is an increase in the effect of the ointment when combined with the use of ointment and sodium fusidate tablets.

    The effect of the ointment increases when combined with antibiotics (semisynthetic penicillins, tetracyclines, macrolides). The route of administration of an antibiotic is not critical.

    Form release / dosage:

    Ointment for external use.

    Packaging:

    15 g, 25 g or 150 g in an aluminum tube or in a polymer tube.

    The tube with instruction for use is placed in a pack of cardboard.

    0.5 kg, 0.93 kg, 2 kg or 3 kg in a glass can with a screw neck of BV type with a cap screwed on plastic and a cardboard seal with a double-sided polyethylene coating or a plastic sheathed or polymer canister (for hospitals).

    For 4 cans (0.5 kg, 0.93 kg, 2 kg) or 1 bank (3 kg) with application instructions for the number of packages enclosed in a box of corrugated three-layer cardboard.

    Storage conditions:
    At a temperature not higher than 15 ° С.
    Keep out of the reach of children.
    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-001791
    Date of registration:08.07.2011
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia
    Information update date: & nbsp03.03.2016
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