Lafrax (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

S03AA (Antimicrobial drugs)

Active Substance

Ofloxacin (Rec.INN registered by WHO)

Dosage Form

Lafrax

Eye and ear drops 0.3%: 5 ml dropper bottle 1 pc.

Dosage Form, Packaging, and Composition

Eye and ear drops as a clear, light yellow or greenish-yellow solution.

Excipients: sodium dihydrogen phosphate dihydrate – 13.22 mg, disodium hydrogen phosphate dihydrate – 8.01 mg, benzalkonium chloride – 0.05 mg, water for injections – up to 1 ml.

5 ml – high-density polyethylene dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group for topical use in ophthalmology and ENT practice

Pharmacotherapeutic Group

Agents for the treatment of eye and ear diseases; antimicrobial agents

Pharmacological Action

A broad-spectrum antimicrobial drug from the fluoroquinolone group. The bactericidal action is associated with the blockade of the DNA gyrase enzyme in bacterial cells.

Highly active against most gram-negative microorganisms: Escherichia coli, Salmonella spp., Proteus spp., Morganella morganii, Shigella spp., Klebsiella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., Chlamydia spp.

Active against some gram-positive microorganisms, in particular Staphylococcus spp., Streptococcus spp.

Moderately sensitive to ofloxacin are Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp.

Microorganisms producing beta-lactamase are sensitive to ofloxacin.

Not sensitive are anaerobic bacteria (except Bacteroides urealyticus).

Pharmacokinetics

4 hours after topical application, the average concentration in the tear fluid exceeds 2 µg/ml.

Instillation into the ear with an intact tympanic membrane is accompanied by minimal absorption into the middle ear. However, absorption increases with perforations of the tympanic membrane.

Indications

Blepharitis; stye; conjunctivitis; dacryocystitis; keratitis; corneal ulcer; chlamydial eye infection; prevention and treatment of bacterial infections after eye injuries and surgical interventions; external otitis, chronic purulent otitis media, including with perforation of the tympanic membrane; prevention of infectious complications during surgical interventions in adults; external otitis and acute otitis media with a tympanostomy tube in children from 1 to 11 years old.

ICD codes

Dosage Regimen

For acute, uncomplicated bacterial eye infections (e.g., conjunctivitis, blepharitis), instill 1 to 2 drops into the affected eye(s) every 2 to 4 hours while awake for the first 2 days.

For moderate to severe eye infections (e.g., keratitis, corneal ulcer), apply 1 to 2 drops into the affected eye(s) every 30 to 60 minutes initially, gradually reducing frequency to every 4 to 6 hours as clinical improvement is observed.

For post-operative prophylaxis or following eye injury, use 1 drop into the affected eye(s) 2 to 4 times daily for 7 to 10 days, or as directed.

For external otitis in adults and children (1 year and older), instill 10 drops into the affected ear twice daily for 10 days.

For chronic suppurative otitis media with perforated tympanic membrane, administer 10 drops into the affected ear twice daily for 14 days.

Prior to ear instillation, warm the bottle in your hands for 1-2 minutes to avoid dizziness. Lie on your side with the affected ear upward during administration and remain in this position for 5 minutes.

Do not allow the dropper tip to contact any surface to avoid contamination.

The maximum recommended treatment duration for eye conditions is 2 weeks unless otherwise directed by a physician.

Adverse Reactions

Local reactions: transient burning or discomfort in the eye, conjunctival hyperemia, blurred vision, eye pain, itching sensation, ear pain, ringing sensation in the ears, dry mouth.

Systemic reactions: eczema, paresthesia, dizziness.

Contraindications

Non-bacterial diseases of the eye adnexa, anterior and posterior segments of the eye; non-bacterial otitis; pregnancy; lactation (breastfeeding); children’s age (under 1 year).

Use in Pregnancy and Lactation

Use during pregnancy is only possible if the intended benefit to the mother outweighs the potential risk to the fetus. It is not recommended for use during lactation (breastfeeding).

Pediatric Use

Use is contraindicated in children under 1 year of age.

Special Precautions

It is not recommended to wear contact lenses during use.

Sunglasses should be worn (due to the possible development of photophobia) and prolonged exposure to sunlight should be avoided.

Effect on ability to drive vehicles and machinery

After application (after instillation into the conjunctival sac), visual acuity is temporarily impaired, which must be taken into account when driving a car and working with machinery.

Drug Interactions

During use, it should be taken into account that magnesium, aluminum, iron, and zinc reduce the absorption of ofloxacin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.