Ciprofloxacin eye and ear drops 3 mg/ml bottle complete with dropper cap 5 ml

• active ingredient: ciprofloxacin;
• 1 ml of solution contains 3 mg of ciprofloxacin;
• Excipients: benzalkonium chloride; disodium edetate (Trilon B); sodium chloride; purified water.

Hypersensitivity to ciprofloxacin or to other quinolones, or to any of the components of the drug.

Side effects observed after the use of ciprofloxacin in the eye

Nervous system: common: dysgeusia; uncommon: headache; rare: dizziness.

Ophthalmological disorders: common: corneal deposits, ocular discomfort, ocular hyperaemia; uncommon: keratopathy, corneal infiltrates, corneal discolouration, photophobia, visual acuity reduced, eyelid oedema, blurred vision, eye pain, dry eye, eye swelling, eye itching, foreign body sensation in the eye, lacrimation increased, eye discharge, eyelid margin scaling, eyelid exfoliation, conjunctival oedema, eyelid erythema; uncommon: ocular toxicity, punctate keratitis, keratitis, conjunctivitis, corneal dysfunction, corneal epithelial defect, diplopia, ocular hypoaesthesia, asthenopia, eye irritation, eye inflammation, conjunctival hyperaemia.

Gastrointestinal: Infrequent: nausea; Rare: diarrhea, abdominal pain.

Adverse reactions reported with ciprofloxacin in the ear

Nervous system: infrequent: tearfulness, headache.

From the side of the organs of hearing and labyrinth: infrequent: ear pain, ear congestion, otorrhea, ear itching; frequency unknown: ringing in the ears.

Skin and subcutaneous tissue disorders: uncommon: dermatitis.

General disorders and administration site conditions: uncommon: hyperthermia.

Corneal ulcers

Ciprofloxacin should be administered at the following intervals, including at night:

• on the 1st day, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every 15 minutes for the first 6 hours, then 2 drops every 30 minutes for the first day;
• on the 2nd day, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every hour;
• From day 3 to day 14, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every 4 hours.

In case of corneal ulcer, treatment may last more than 14 days; the dosage regimen and duration of treatment are determined by the doctor.

Bacterial superficial infections of the eye and its adnexa

The standard dose is 1–2 drops in the conjunctival sac(s) of the affected eye(s) 4 times daily.

For severe infections, the dose may be 1–2 drops every 2 hours for the first two days during the daytime.

Typically, treatment lasts 7–14 days.

After instillation, tight eyelid closure or nasolacrimal occlusion is recommended. This reduces systemic absorption of drugs administered into the eye, which reduces the likelihood of systemic side effects.

In case of concomitant therapy with other topical ophthalmic drugs, an interval of 10–15 minutes should be observed between their use.

Use in children

The dosage for children over 1 year of age is the same as for adults.

Ciprofloxacin is known to be clinically and microbiologically effective for the treatment of bacterial conjunctivitis in neonates and infants under 1 month of age when administered 3 times daily for 4 days.

Use in liver and kidney dysfunction

The use of ciprofloxacin in this category of patients has not been studied.

To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the tip of the dropper bottle.

Application in otology

For adults, the dose is 4 drops of the drug into the ear canal twice a day.

For patients who require the use of ear plugs, the dose can be doubled only for the first use (i.e. 6 drops for children and 8 drops for adults).

In general, the duration of treatment should not exceed 5–10 days. In some cases, treatment may be extended, but in this case it is recommended to check the sensitivity of the local flora.

In case of concomitant therapy with other topical medications, an interval of 10–15 minutes should be observed between their application.

Use in children

The dose is 3 drops of the drug in the ear canal twice a day. The safety and efficacy of ciprofloxacin have been studied in children aged 1 to 12 years. The safety and efficacy in children under 1 year of age have not been established.

Use during pregnancy or breastfeeding

It is advisable to avoid using the medicine during pregnancy.

Ciprofloxacin has been found in breast milk after oral administration. It is not known whether ciprofloxacin is excreted in breast milk after topical application to the eye or ear. Caution should be exercised when used in nursing mothers.

Children

Eye drops

It is known that the safety and efficacy of eye drops were determined in 230 children aged 0 to 12 years. No serious adverse reactions associated with the use of the drug were reported in this category of patients.

Ear drops

It is known that the safety and efficacy of the ear drops were determined in 193 children aged 1 to 12 years. No serious adverse reactions associated with the use of the drug were reported in this category of patients.

Safety and effectiveness in children under 1 year of age have not been established.

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug has no or negligible influence on the ability to drive or use machines. Temporary blurred vision or other visual disturbances may impair the ability to drive or use machines. If blurred vision occurs during instillation, the patient should wait until the vision clears before driving or using machines.

There is no data on the effect of ear drops on the ability to drive or use other mechanisms.

Given the characteristics of this drug, intended for external use, no toxic effects are expected when used in ophthalmology/otology at recommended doses, as well as in the event of accidental ingestion of the contents of one bottle.

Since ciprofloxacin has low systemic concentrations when applied topically to the eye or otolaryngology, interactions with other drugs are unlikely. If several topical eye medications are used simultaneously, wait at least 5 minutes between their applications. Ophthalmic ointments should be applied last.

Store in the original packaging at a temperature not exceeding 25 °C.

Do not refrigerate.

Keep out of reach of children.