Universal reference book for medicines
Name of the preparation: OFLOMELID ® (OFLOMELID)

Active substance: dioxomethyltetrahydropyrimidine, lidocaine, ofloxacin

Type: The drug with antibacterial, locally anesthetic and tissue regeneration-improving action for external use

Manufacturer: MS-VITA (Russia) produced SYNTHESIS (Russia)
Composition, form of production and packaging
Ointment for external use
white or almost white.

1 g

ofloxacin 10 mg

dioxmethyltetrahydropyrimidine (methyluracil) 40 mg

lidocaine hydrochloride (in the form of monohydrate) 30 mg

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

30 g - aluminum tubes (1) - cardboard packs.

200 g - polymer cans.

400 g - polymer cans.

1000 g - polymer cans.

1000 g - cans of dark glass.

2000 g - cans of dark glass.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Combined drug, antimicrobial, anti-inflammatory, locally anesthetic, regenerative effect.

Ofloxacin is a broad-spectrum antimicrobial agent from the group of fluoroquinolones.
Has bactericidal action due to blockade of 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 - a 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 of sodium 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 (hyperosmolar) basis of the ointment is a mixture of polyethylene oxides (polyethylene glycols) with a molecular mass of 400 and 1500, providing a dehydrating (moisture-absorbing) effect on the tissue, 20 times greater than the strength of the hyperosmotic effect of 10% sodium chloride solution.

PHARMACOKINETICS

Data on the pharmacokinetics of Oflomelid ® are not available.

INDICATIONS

Infected purulent wounds of different localization and etiology in the first (purulent-necrotic) phase of the wound process, incl.
accompanied by severe pain syndrome:
- infected burns of II-IV degree;

- pressure sores;

- trophic ulcers;

- postoperative and post-traumatic wounds and fistulas;

- wounds after dissection of abscesses, phlegmon, after surgical treatment of abscessed boils, carbuncles, hydradenites, festering with atheroma, lipomas.

DOSING MODE

The drug is used externally, 1 time / 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 the purification of wounds from purulent exudate and the timing of arresting the inflammatory process.
After the standard treatment of wounds and burns, the ointment is applied directly to the wound surface with a thin layer (afterwards, a sterile gauze bandage is applied) or a gauze bandage with subsequent application to the lesion site.

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.

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

SIDE EFFECT

Possible: allergic reactions.

CONTRAINDICATIONS

- Pregnancy;

- lactation period;

- children and adolescence under 18;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

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

APPLICATION FOR CHILDREN

Contraindication: children and adolescence under 18 years.

OVERDOSE

Data on the overdose of Oflomelid ® are not available.

DRUG INTERACTION

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from light at a temperature of 15 ° C to 25 ° C.
Shelf life - 2 years.
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