Lafrax, eye and ear drops 0.3% 5 ml

Antimicrobial agent of broad spectrum of the group of fluoroquinolones, acts on the bacterial enzyme DNA-gyrase, which provides superspiralization and thus the stability of DNA-bacteria (destabilization of DNA chains leads to their death). It has a bactericidal effect. It is active against microorganisms producing beta-lactamases and rapidly growing atypical mycobacteria.

Sensitive: Staphylococcus aureus (including strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Corynebacterium spp, Micrococcus spp., Bacillus spp., Enterobacteriaceae (Escherichia coli, Citrobacter, Enterobacter spp., Klebsiela spp., Proteus spp, Salmonella spp., Serratia spp., Shigella spp.), Pseudomonas aeruginosa and Pseudomonas species, Haemophilus influenza, Haemophilus ducreyi, Branhamella catarhalis, Neisseria gonorrhoeae, Neisseria menengitidis, Acinetobacter spp,

The drug is also active against Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae and some other mycoplasmas. Clostridium species, Bacteroides species and Peptococcus species are resistant. Resistance of Pseudomonas aeruginosa varies between 15-20% and resistance of Staphylococcus aureus between 5-10%.

Pharmokinetics

Four hours after topical application the average concentration of Ofloxacin in lacrimal fluid exceeds 2 mkg/ml (minimum concentration required for suppression of growth in vitro by 90% for the most common strains of pathogens of infectious eye diseases – MIC90). In the case of intact tympanic membranes, dripping of Ofloxacin into the ear is accompanied by minimal absorption in the middle ear. However, uptake ofloxacin is enhanced with tympanic membrane perforations.

After injection of 0.3% ofloxacin solution in adults with tympanic membrane perforation, the maximum concentration in serum is 10 ng/ml. Maximum serum concentration of ofloxacin after 10 days of regular topical administration is 1000 times lower than when using standard oral doses of ofloxacin.

Indications

Ophthalmology

Bacterial infections of the anterior segment of the eye caused by microorganisms sensitive to Ofloxacin in adults and children aged 1 year and older: corneal ulcers, conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis, dacryocystitis, meibomitis (barley), chlamydial eye infections; prevention and treatment of bacterial infection after eye injuries and surgical procedures.

Ear infections

Lafrax is indicated for the treatment of bacterial infections caused by pathogens sensitive to Ofloxacin in adults and children aged 12 years and older:

– external otitis media, chronic purulent media otitis media, including with perforation of the eardrum;

– Prevention of infectious complications during surgical interventions in adults;

– Outer otitis and acute media otitis with a tympanostomy tube in children from 1 to 11 years old.

The official recommendations on the use of antibacterial drugs should be taken into account.

Active ingredient

Ofloxacin

Composition

1 ml of the drug contains:

Active ingredient:

Ofloxacin 3.0 mg

Excipients:

Sodium dihydrophosphate dihydrate 13.22 mg

Sodium hydrophosphate dihydrate 8.01 mg

Benzalkonium chloride 0.05 mg

Water for injection to 1.0 ml.

How to take, the dosage

Infectious eye diseases.

The drug is put into the conjunctival sac of the sick eye 2-4 times a day. It is not recommended to use the drug for more than 2 weeks.

Ear infections
Adults and children over 12
Frequency of drug administration and duration of treatment shall be determined by the doctor individually. In case of chronic purulent media otitis with chronic tympanic membrane perforation the recommended dosage is 10 drops into the affected ear 2 times a day within 14 days.

Children 1-11 years old

The frequency of application and duration of treatment is determined by the doctor individually.
For treatment of external otitis and acute media otitis with a tympanostomy tube the recommended dosage is 5 drops in the affected ear 2 times a day within 10 days.

Before instillation the bottle should be warmed in the hand for 1-2 minutes to avoid dizziness (possible when using a cold solution). Instillation is performed in the position of the patient lying on his side. After instillation the patient should remain in this position for 5 minutes to facilitate passage of the solution through the external auditory canal. If instillation in the other ear is necessary, proceed in a similar manner.

Contraindications

– Hypersensitivity to the drug components and other quinolone derivatives;

– non-bacterial diseases of the accessory apparatus of the eye, anterior and posterior segment of the eye;

– non-bacterial otitis;

– childhood (up to 1 year);

– pregnancy, period of breast-feeding.

With caution: children.

Application in pregnancy and during breast-feeding.

Side effects

After injection into the conjunctival sac transient burning or discomfort in the eye, conjunctival hyperemia, blurred vision, pain in the eye, a feeling of itching may occur.

If used in the form of ear drops itching and bitter taste in the mouth may occur. Extremely rare: eczema, paresthesia, dizziness, ear pain, a feeling of ringing in the ears, dry mouth are possible.

Overdose

After local administration of an excessive dose of the drug the eyes should be rinsed with clean water at room temperature. There are no data on systemic manifestations of overdose.

Similarities

Floxal, Dancil, Ofloxacin, Ofloxacin-Teva