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Oflomelid 50 g ointment for external use

Release form

Ointment for external use.

Package

50 g.

pharmachologic effect

The combined drug has antimicrobial, anti-inflammatory, local anesthetic, regenerating effects.

Oflomelid has antimicrobial, anti-inflammatory, local anesthetic, and regenerating effects.

Ofloxacin is a broad-spectrum antimicrobial agent from the group of fluoroquinolones. It has a bactericidal effect by blocking DNA gyrase in bacterial cells. Highly active against gram-positive microorganisms: Staphylococcus spp. (including Staphylococcus aureus, Staphylococcus epidermidis), Streptococcus spp.; gram-negative microorganisms: Pseudomonas aeruginosa, Acinetobacter spp., Escherichia coli, Klebsiella spp., Proteus spp., Enterobacter spp., Citrobacter spp.; anaerobes: Propionibacterium acnes; intracellular microorganisms: Chlamydia spp. (including Chlamydia trachomatis), Legionella spp., Mycoplasma spp.

Methyluracil is a tissue repair stimulator. 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 the blockade of sodium channels, which prevents the generation of impulses in the endings of sensory neurons and the conduction of impulses along nerve fibers. When used externally, it dilates blood vessels and does not have a local irritating effect.

The water-soluble hydrophilic (hyperosmolar) base of the ointment is a mixture of polyethylene oxides (polyethylene glycols) with a molecular weight of 400 and 1500, providing a dehydrating (moisture-absorbing) effect on tissue that is 20 times stronger than the hyperosmotic effect of a 10% sodium chloride solution.

Indications

— Infected purulent wounds of various localization and etiology in the first (purulent-necrotic) phase of the wound process, incl. accompanied by severe pain:

— infected burns of II-IV degree;

- bedsores;

- trophic ulcers;

— postoperative and post-traumatic wounds and fistulas;

- wounds after opening abscesses, phlegmons, after surgical treatment of abscessed boils, carbuncles, hidradenitis, suppurating atheromas, lipomas.

Contraindications

- pregnancy;

- lactation period;

- children and adolescents up to 18 years of age;

- hypersensitivity to the components of Oflomelid.

Compound

Active ingredients: ofloxacin 10 mg; dioxomethyltetrahydropyrimidine (methyluracil) 40 mg; lidocaine hydrochloride (in the form of monohydrate) 30 mg;

Excipients: macrogol 1500 (polyethylene oxide 1500, low molecular weight polyethylene glycol 1500), macrogol 400 (polyethylene oxide 400, low molecular weight polyethylene glycol 400), propylene glycol, methyl parahydroxybenzoate (nipagin or methylparaben), propyl parahydroxybenzoate (nipazole or propylparaben)

Directions for use and doses

Oflomelid is used externally, 1 time per day for 1-2 weeks. The maximum daily dose should not exceed 100 g of ointment. The duration of treatment depends on the dynamics of cleansing wounds from purulent exudate and the timing of relief of the inflammatory process.

After standard treatment of wounds and burns, the ointment is applied directly to the wound surface in a thin layer (after which a sterile gauze bandage is applied) or on a gauze bandage, followed by application to the lesion.

Tampons soaked in ointment are loosely filled into the cavities of purulent wounds after surgical treatment, and gauze turundas with ointment are inserted into the fistula tracts.

When treating infected burns, the drug is used daily or 2-3 times a week, depending on the amount of purulent discharge.

Side effects

Possible: allergic reactions.

Storage conditions

In a place protected from light, at a temperature of 15–25 °C.

Best before date

2 years.

Oflomelid 30g ointment

Clinical and pharmacological group

Antibacterial agents

Description

Ointment for external use

Pharmacotherapeutic group

Antimicrobial combination agent

Tradename

Oflomelid®

International nonproprietary name

ofloxacin 1% + methyluracil 4% + lidocaine 3%

Dosage form

ointment for external use.

Compound

per 100 g: active ingredients: ofloxacin - 1 g, dioxomethyltetrahydropyrimidine (methyluracil) -4 g, lidocaine hydrochloride monohydrate (in terms of lidocaine hydrochloride) - 3 g; excipients: methyl parahydroxybenzoate (nipagin or methylparaben), propyl parahydroxybenzoate (nipazoly 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).

CodeATX

[D06BX]

Pharmacological properties

Oflomelid® is a combination drug that has antimicrobial, anti-inflammatory, local anesthetic, and regenerating effects. The active ingredients are ofloxacin, methyluracil and lidocaine. Ofloxacin is a broad-spectrum antimicrobial agent from the group of fluoroquinolones. It has a bactericidal effect due to the blockade of DNA gyrase in bacterial cells. DNA gyrase is necessary for replication, transcription, repair and recombination of bacterial DNA. Its inhibition leads to unwinding and destabilization of bacterial DNA and, as a result, to 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), Staphylococcus coagulase negative (coagulase-negative staphylococci: Staphylococcus epidermidis, Staphylococcus saprophyticus, Staphylococcus haemoly ticus, Staphylococcus hominis and etc.); gram-negative aerobes - Aeromonas hydrophila, Bordetella spp., Brucella spp., Campylobacterjejuni, Citrobacter spp. (including Citrobacter freundii), Enterobacter spp. (including Enterobacter cloacae, Enterobacteraerogenes, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp. (including Klebsiella pneumonia), Moraxella (Brahamella) catarrhalis, Morganellamorganii, Neisseria gonorrhoeae, Neisseria meningitides, Plesiomonasspp, 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, Vibrioparahaemolyticus), 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 Pseudomonasaeruginosa), Streptococcus spp. (including Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridians) - 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. Has anabolic activity. Accelerates the processes of cellular regeneration in wounds, accelerating the growth and granulation maturation of tissue and epithelialization. Lidocaine has a local anesthetic effect due to the blockade of Na+ channels, which prevents the generation of impulses at the endings of sensory neurons and the conduction of impulses along nerve fibers. When applied externally, it dilates blood vessels and does not have a locally irritating effect. The water-soluble (hydrophilic) and hyperosmolar base of the ointment is a mixture of polyethylene oxides (polyethylene glycols) with a molecular weight 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 20 times stronger than 10% sodium chloride solution and lasts up to 18-20 hours.

Indications for use

Infected wounds of various localization and etiology in the first (purulent-necrotic) phaser wound process, incl. accompanied by severe pain syndrome (infected burns of the II-IV degree, bedsores, trophic ulcers, postoperative and post-traumatic wounds and fistulas, wounds after opening abscesses, phlegmons, post-surgical treatment of abscessed boils, carbuncles, hidradenitis, suppurating atheromas, lipomas, etc.).

Contraindications

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

Use during pregnancy

Contraindicated.

Method of administration and dose

Externally, 1 time per day for 1-2 weeks. After standard treatment of wounds and burns, the ointment is applied directly to the wound surface in a thin layer (after which a sterile gauze bandage is applied) or on a gauze bandage followed by application to the lesion. Tampons soaked in ointment are loosely filled into the cavities of purulent wounds after their surgical treatment, and gauze turundas with ointment are inserted into the fistula tracts. When treating purulent wounds, the ointment is used once a day, when treating burns - 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 cleansing wounds from purulent exudate and the timing of relief of the inflammatory process.

Side effect

Allergic reactions.

Use with other drugs

There have been no cases of drug interactions that would lead to a decrease in the effectiveness and safety of the drugs used.

Release form

Ointments, creams, gels

Release form

Ointment for external use. 30 g, 50 g or 100 g in aluminum tubes. 30 g, 50 g or 100 g in orange glass jars, sealed with plastic lids. 200 g, 400 g in polymer jars with first opening control for the hospital with 5 instructions for use attached. 1000 g in polymer jars with a screw cap for the hospital with 5 instructions for use. 1000 g, 2000 g in orange glass jars, sealed with plastic lids, for hospital use with 5 instructions for use. Each tube or jar of 30 g, 50 g, 100 g with instructions for use in a cardboard pack.

Storage conditions

In a place protected from light at a temperature of 15 to 25 ° C. Keep out of the reach of children.

Best before date

Tubes:4 years. Banks: 4 years. After opening the jar, use within 3 months. Do not use after the expiration date.

Terms of release from pharmacies

on prescription