Oflomelid^® (Ointment) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

Manufactured By

Sintez PJSC (Russia)

Contact Information

SINTEZ PJSC Kurgan Joint Stock Company of Medical Preparations and Products (Russia)

ATC Code

D06BX (Other chemotherapeutic preparations for topical use)

Dosage Form

Oflomelid®

Ointment for external use: tubes 30 g; polymer jars 200 g, 400 g, 1000 g or dark glass jars 1000 g, 2000 g

Dosage Form, Packaging, and Composition

Ointment for external use white or almost white in color.

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, methylparahydroxybenzoate (nipagin or methylparaben), propylparahydroxybenzoate (nipasol or propylparaben).

30 g – aluminum tubes (1) – cardboard packs.
200 g – polymer jars.
400 g – polymer jars.
1000 g – polymer jars.
1000 g – dark glass jars.
2000 g – dark glass jars.

Clinical-Pharmacological Group

A drug with antibacterial, local anesthetic, and tissue regeneration-improving action for external use

Pharmacotherapeutic Group

Combined antimicrobial agent

Pharmacological Action

A combined drug that has antimicrobial, anti-inflammatory, local anesthetic, and regenerative action.

Ofloxacin is a broad-spectrum antimicrobial agent from the fluoroquinolone group. It exerts 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. It has anabolic activity. It accelerates the processes of cellular regeneration in wounds, accelerating tissue growth and granulation maturation and epithelialization.

Lidocaine exerts 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 applied externally, it dilates blood vessels and does not have a local irritant effect.

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

Pharmacokinetics

Pharmacokinetic data for the drug Oflomelid^® are not provided.

Indications

Infected purulent wounds of various locations and etiologies in the first (purulent-necrotic) phase of the wound process, including those accompanied by severe pain syndrome

• Infected burns of II-IV degree;
• Bedsores;
• Trophic ulcers;
• Postoperative and post-traumatic wounds and fistulas;
• Wounds after opening of abscesses, phlegmons, after surgical treatment of abscessed boils, carbuncles, hidradenitis, suppurated atheromas, lipomas.

ICD codes

Dosage Regimen

The drug is applied externally, once a 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 wound cleansing 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 to a gauze bandage followed by application to the lesion.

Tampons soaked with the ointment are used to loosely fill the cavities of purulent wounds after their surgical treatment, and gauze turundas with the ointment are inserted into the fistulous tracts.

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

Adverse Reactions

Possible allergic reactions.

Contraindications

• Pregnancy;
• Lactation period;
• Children and adolescents under 18 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindication: children and adolescents under 18 years of age.

Overdose

Overdose data for the drug Oflomelid^® are not provided.

Drug Interactions

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

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.