Oflomelid® (Oflomelide®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspointment for external use
Composition:

Per 100 g:

active substances: ofloxacin 1 g, dioxomethyltetrahydropyrimidine (methyluracil) 4 g, lidocaine hydrochloride monohydrate (in terms of lidocaine hydrochloride) 3 g;

Excipients: methylpiperoxybenzoate (nipagine or methylparaben), propyl parahydroxybenzoate (nipazole or propylparaben), propylene glycol, macrogol-1500 (low molecular weight polyethylene glycol-1500, polyethylene oxide-1500), macrogol-400 (low molecular weight polyethylene glycol-400, polyethylene oxide-400).

Description:Ointment is white or almost white.
Pharmacotherapeutic group:Antimicrobial combination
ATX: & nbsp
  • Other antimicrobials
    • Pharmacodynamics:

    Ofmelid® is a combined preparation, antimicrobial, anti-inflammatory, locally anesthetic, regenerative. Active substances are ofloxacin, methyluracil and lidocaine.

    Ofloxacin is a broad-spectrum antimicrobial agent from the group of fluoroquinolones. Has a bactericidal effect due to blockade of DNA-gyrase in bacterial cells. DNA-gyrase is necessary for replication, transcription, repair and recombination of bacterial DNA. Its inhibition leads to the unwinding and destabilization of bacterial DNA and, as a result, to the death of the microbial cell.

    Microorganisms highly sensitive to ofloxacin (IPC ≤0.5 mg / l):

    - Gram-positive aerobes - Staphylococcus aureus methi-S (methicillin-sensitive strains), Staphylococcus coagulase negative (coagulase-negative staphylococci: Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus haemolyticus, Staphylococcus hominis and etc.);

    - Gram-negative aerobes - Aeromonas hydrophila, Bordetella spp., Brucella spp, Campylobacter jejuni, Citrobacter spp. (including Citrobacter freundii), Enterobacter spp. (including Enterobacter cloacae, Enterobacter aerogenes, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumonia), Moraxella (Brahamella) catarrhalis, Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitides, Plesiomonas spp, Proteus spp. (Proteus mirabilis, Proteus vulgaris (indole + and indole -)), Providencia spp., Salmonella spp., Serratia (including Serratia marcescens), Shigella spp. (including Shigella sonnei), Vibrio spp. (including Vibrio cholerae, Vibrio parahaemolyticus), Yersinia spp. (including Yersinia enterocolitica);

    - anaerobes - Clostridium perfringens, Helicobacter pylori, Propionibacterium acnes;

    - other - Chlamydia trachomatis, Legionella spp., Mycoplasma spp. (including Mycoplasma hominis).

    Microorganisms moderately sensitive to ofloxacin:

    Acinetobacter spp. (including Acinetobacter calcoaceticus), Bacteroides fragilis, Bacteroides urealyticus, Chlamydia psittaci, Gardnerella vaginalis, Enterococcus faecalis, Mycobacterium tuberculosis, Mycobacterium leprae, anaerobic Gram-positive cocci (Peptococcus spp., Peptostreptococcus spp., Pseudomonas spp. (including Pseudomonas aeruginosa), Streptococcus spp. (incl. Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridians) - only penicillin-sensitive strains, Ureaplasma urealyticum.

    Microorganisms, resistant to ofloxacin (IPC > 1 mg / L):

    Acinetobacter baumannii, most strains Enterococcus spp., Listeria monocytogenes, Nocardia spp, (incl. Nocardia asteroids), methicillin-resistant strains Staphylococcus aureus and Staphylococcus spp. (Staphylococci methi-R), Treponema pallidum.

    Methyluracil stimulator of tissue repair. Has anabolic activity. Accelerates the processes of cellular regeneration in wounds, accelerating the growth and granulation maturation of tissue and epithelization.

    Lidocaine has a local anesthetic effect due to blockade Na +channels, which prevents the generation of pulses in the endings of sensitive neurons and impulses along nerve fibers. With external application dilates blood vessels, does not have a locally irritating effect. The water-soluble (hydrophilic) and hyperosmolar basis of the ointment is a mixture of polyethylene oxides (polyethylene glycols) with a molecular mass of 400 and 1500 (PEO-400 and PEO-1500 or PEG-400 and PEG-1500), providing a dehydrating (moisture-absorbing) and osmotic effect on the tissue that 20 times greater than the action of 10% sodium chloride solution and lasts up to 18-20 hours.

    Indications:

    Infected wounds of different localization and etiology in the first (purulent-necrotic) phase of the wound process, incl. accompanied by severe pain syndrome (infected burns II-IV sores, decubitus ulcers, trophic ulcers, postoperative and post-traumatic wounds and fistulas, wounds after opening abscesses, phlegmon, after surgical treatment of abscessed boils, carbuncles, hydradenites festered with ather, lime, etc.).

    Contraindications:

    Individual hypersensitivity to the components of the drug, pregnancy, lactation, children under 18 years.

    Dosing and Administration:

    Externally, once a day for 1-2 weeks.

    After the standard treatment of wounds and burns, the ointment is applied directly to the wound surface with a thin layer (after which a sterile gauze dressing is applied) or a gauze dressing with subsequent application to the lesion. Tampons impregnated with ointment loosely fill the cavities of purulent wounds after their surgical treatment, and gauze turuns with ointment are injected into the fistulous passages.

    When treating purulent wounds, ointment is used once a day, when treating burns - every day or 2-3 times a week, depending on the amount of purulent discharge.

    The maximum daily dose should not exceed 100 g.

    The duration of treatment depends on the dynamics of the purification of wounds from purulent exudate and the timing of arresting the inflammatory process.

    Side effects:Allergic reactions.
    Interaction:

    There were no cases of interaction with drugs that would lead to a decrease in the effectiveness and safety of the drugs used.

    Form release / dosage:

    Ointment for external use.

    Packaging:

    For 30 g, 50 g or 100 g in tubes of aluminum.

    For 30 g, 50 g or 100 g in cans of orange glass, ukuporennyh covers plastic.

    200 g, 400 g in polymer cans with the control of the first opening.

    200 g, 400 g in polymer cans with the control of the first opening for Hospital with the application of 5 instructions for use.

    1000 g in polymer cans with a screw cap for hospital, with 5 instructions for application.

    By 1000 g, 2000 g in cans of orange glass, ukuporennyh covers plastic, for the hospital with the application of 5 instructions for application.

    Each tuba or can of 30 g, 50 g, 100 g 200 g, 400 g with instructions for use in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    Tubes: 4 years.

    Banks: 4 years. After opening the cans, use within 3 months.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007163/09
    Date of registration:10.09.2009 / 18.04.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:MS-VITA, LLC MS-VITA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.06.2017
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