Uniflox (Drops) Instructions for Use

Marketing Authorization Holder

Unimed Pharma, s.r.o. (Slovakia)

ATC Code

S03AA (Antimicrobial drugs)

Active Substance

Ofloxacin (Rec.INN registered by WHO)

Dosage Form

Uniflox

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

Dosage Form, Packaging, and Composition

5 ml – plastic dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Antimicrobial agent – fluoroquinolone

Pharmacological Action

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 for Bacteroides urealyticus).

Pharmacokinetics

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

Instillation into the ear in the case of 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 infectious eye diseases (blepharitis, conjunctivitis, keratitis), instill 1-2 drops into the lower conjunctival sac of the affected eye(s) every 2 to 6 hours (2-4 times daily).

For severe infections, the frequency may be increased during initial treatment. Continue therapy for a minimum of 2 days after symptoms have resolved. Do not exceed a 14-day treatment duration.

For ear infections (external otitis, chronic purulent otitis media), instill 10 drops into the affected ear twice daily. The standard treatment course is 10 days.

In pediatric patients ( 1 to 11 years old) with acute otitis media and a tympanostomy tube, instill 5 drops into the affected ear twice daily for 10 days.

Prior to administration, warm the bottle in your hand for several minutes to avoid dizziness. Tilt your head sideways; for ear drops, gently pull the auricle upward and backward to straighten the ear canal.

Avoid direct contact of the dropper tip with the eye, ear, or any surface to prevent contamination. After instillation, apply gentle pressure to the lacrimal sac (for eye drops) for 1-2 minutes or keep the head tilted (for ear drops) to enhance local absorption.

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 possible only 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 operate 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.