Oflomelid ointment for external use 30 g

Infected wounds of various locations and etiologies in the first (purulent-necrotic) phase of the wound process, including those accompanied by pronounced pain syndrome (infected burns of grades II-IV, pressure ulcers, trophic ulcers, postoperative and post-traumatic wounds and fistulas, wounds after abscess drainage, phlegmon, after surgical treatment of abscessing furuncles, carbuncles, hidradenitis, suppurating atheromas, lipomas, etc.).

For external use, once a day for 1-2 weeks. After standard treatment of wounds and burns, apply the ointment directly to the wound surface in a thin layer (after which a sterile gauze dressing is applied) or to a gauze dressing with subsequent application to the affected area. Use tampons soaked in the ointment to loosely fill the cavities of purulent wounds after surgical treatment, and introduce gauze wicks with the ointment into fistulous tracts.

When treating purulent wounds, the ointment is applied once daily; when treating burns, it is applied daily 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 wound cleansing from purulent exudate and the timeline for resolving the inflammatory process.

Composition per 100 g:
Active ingredients: ofloxacin - 1 g, dioksometiltetrahidropirimidin (methyluracil) - 4 g, lidocaine hydrochloride monohydrate - 3.2 g (calculated as lidocaine hydrochloride - 3 g);
Excipients: methylparaben (nipagin or methylparaben), propylparaben (nipazol 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).

ointment of white or almost white color.

Individual increased sensitivity to the components of the drug; pregnancy; lactation period; pediatric age up to 18 years.

Allergic reactions.

No cases of interaction with medications have been identified that would lead to a decrease in the efficacy and safety of the used drugs.

Oflomelid® is a combined preparation that exhibits antimicrobial, anti-inflammatory, local anesthetic, and regenerative effects. The active ingredients are ofloxacin, methyluracil, and lidocaine.

Ofloxacin is a broad-spectrum antimicrobial agent from the fluoroquinolone group. It exerts a bactericidal effect by blocking DNA gyrase in bacterial cells. DNA gyrase is essential for the replication, transcription, repair, and recombination of bacterial DNA. Its inhibition leads to the unwinding and destabilization of bacterial DNA, resulting in the death of the microbial cell.

Microorganisms highly sensitive to ofloxacin (MIC ≤ 0.5 mg/L):
- Gram-positive aerobes: Staphylococcus aureus methi-S (methicillin-sensitive strains), coagulase-negative Staphylococcus (Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus haemolyticus, Staphylococcus hominis, 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 pneumoniae), Moraxella (Brahamella) catarrhalis, Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, 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;
- Others: 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. (including Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans) - only penicillin-sensitive strains, Ureaplasma urealyticum.

Microorganisms resistant to ofloxacin (MIC > 1 mg/L): Acinetobacter baumannii, most strains of Enterococcus spp., Listeria monocytogenes, Nocardia spp. (including Nocardia asteroids), methicillin-resistant strains of Staphylococcus aureus and Staphylococcus spp. (Staphylococci methi-R), Treponema pallidum.

Methyluracil is a tissue repair stimulator. It has anabolic activity. It accelerates cellular regeneration processes in wounds, promoting tissue growth and granulation maturation, as well as epithelialization.

Lidocaine provides local anesthetic action by blocking Na+ channels, which prevents impulse generation in the endings of sensory neurons and the conduction of impulses along nerve fibers. When applied externally, it dilates blood vessels and does not cause local irritant effects.

The water-soluble (hydrophilic) and hyperosmolar base of the ointment consists of a mixture of polyethylene oxides (polyethylene glycols) with molecular weights of 400 and 1500 (PEO-400 and PEO-1500 or PEG-400 and PEG-1500), providing a dehydrating (moisture-absorbing) and osmotic effect on tissues, which is 20 times more potent than a 10% sodium chloride solution and lasts for 18-20 hours.