Properties
What is it?
Instructions for use Kinoftal 0.3% Eye/Ear Drops Trade name of the preparation: Kinoftal International Nonproprietary Name: Ciprofloxacin. Description: Transparent solution. Composition: The solution contains: Active substance – Ciprofloxacin (in the form of hydrochloride) – 3 mg/ml; Excipients: Sodium acetate trihydrate, Disodium edetate, Mannitol, Benzalkonium chloride, Glacial acetic acid, Purified water. Dosage form: Eye/Ear Drops (0.3% solution). Pharmacotherapeutic group: Preparations for ophthalmology and otology – anti-infective agent. Pharmacological action Pharmacodynamics Kinoftal 0.3% contains a fluoroquinolone – Ciprofloxacin. The preparation inhibits the bacterial enzyme DNA gyrase, which disrupts DNA replication and bacterial cellular protein synthesis. Ciprofloxacin acts in vitro against Gram-positive and Gram-negative organisms: anaerobes are less susceptible. In ophthalmology, Ciprofloxacin is active against Gram-positive aerobic bacteria: Corynebacterium accolens, Corynebacterium auris, Corynebacterium propinquum, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Staphylococcus aureus (methicillin susceptible – MSSA), Staphylococcus hominus, Staphylococcus saprophyticus, Staphylococcus varneri, Streptococcus pneumoniae, Streptococcus viridans Group; Gram-negative aerobic bacteria: Acinetobacter species, Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Serratia marcescens. Species for which acquired resistance may be problematic: Staphylococcus aureus (methicillin resistant - MRSA), Staphylococcus epidermidis (methicillin resistant-MRSE), Staphylococcus lugdunensis. Resistant bacteria: Corynebacterium jeikeium. In otorhinolaryngology, Ciprofloxacin is active against Staphylococcus aureus (methicillin-susceptible; MSSA) and Pseudomonas aeruginosa. Species for which acquired resistance may be problematic: Staphylococcus aureus. Indications for use In ophthalmology: Kinoftal 0.3% is used for the treatment of corneal ulcers and various infectious diseases of the eye and its adnexa caused by bacteria sensitive to the preparation. In otorhinolaryngology: Kinoftal 0.3% is used for acute external otitis. Method of administration and dosage In ophthalmology: Adults, newborns (0-27 days), infants and young children (28 days to 23 months), children (2-11 years) and adolescents (12-16 years). Corneal ulcer: - On the first day: 2 drops in the affected eye every 15 minutes for 6 hours, and then 2 drops in the affected eye every 30 minutes for the remainder of the day; - On the second day: 2 drops in the affected eye every 1 hour; - From the 3rd to the 14th day – 2 drops every 4 hours. If the patient requires treatment for more than 4 days, the dosage of the preparation will be determined by the doctor. Infectious eye diseases: For mild to moderately severe infections, eye drops – 1-2 drops in the conjunctival sac of the affected eye (or both eyes) every 4 hours, for severe infections – 2 drops every hour. The maximum recommended duration of therapy is 21 days. For children over 1 year of age, the preparation is prescribed in the same dosage as for adults. In otorhinolaryngology: Adults: Recommended dose: 4 drops of Kinoftal 0.3% twice a day. For patients using ear tampons, the first dose is doubled (e.g., 6 drops for children and 8 drops for adults). The maximum recommended duration of therapy is 5-10 days. Children over one year of age: The recommended dose is 3 drops of Kinoftal 0.3% twice a day. Safety and efficacy in children under 1 year of age have not been established. Method of administration Do not touch the eye or the external ear with the tip of the pipette. When using other ophthalmic preparations, the interval between their administration should be 5 minutes. During treatment with the preparation, it is not recommended to wear soft contact lenses. When wearing hard contact lenses, they should be removed before instillation and put back on 15 minutes after instillation of the preparation. In otorhinolaryngology, it is recommended to shake the bottle well before use. After instillation, the patient should lie on the side opposite the affected ear for approximately 5 minutes. Side effects In ophthalmology: Hypersensitivity, headache, dizziness, corneal deposits, eye discomfort, conjunctival hyperemia, keratopathy, punctate keratitis, photophobia, decreased visual acuity, eyelid edema, blurred vision, eye pain, eye itching, lacrimation, eyelid dryness, conjunctival edema, keratitis, conjunctivitis, diplopia, asthenopia, stye, ear pain, rhinitis, nausea, diarrhea, abdominal pain, dermatitis. In otorhinolaryngology: Headache, ear pain, ear discharge, otorrhea, ear itching, tinnitus, dermatitis. Contraindications Hypersensitivity to the components of the preparation. Use during pregnancy and lactation The use of the preparation during pregnancy and lactation (breastfeeding) is possible only when the potential benefit to the mother outweighs the potential risk to the fetus and child. Effect on ability to drive and operate machinery The preparation has no or negligible effect on the ability to drive and operate machinery. Temporary blurred vision or other visual disturbances may affect the ability to drive and operate machinery. The use of eye drops can cause transient blurred vision. Until this effect disappears, patients should not drive or operate machinery. Special instructions The use of Ciprofloxacin eye drops is not recommended for gonococcal or chlamydial ophthalmia in newborns, due to the lack of data on the use of the preparation in this group of patients. The safety and efficacy of Ciprofloxacin ear drops have been established in controlled clinical trials in pediatric patients aged 1 year and older. There is limited data for patients under 1 year of age. When using Ciprofloxacin eye drops, the possibility of rhinopharyngeal passage should be considered, which can lead to an increase in the degree and frequency of bacterial resistance. Serious anaphylactic reactions, in rare cases fatal, including after the first dose, have been observed in patients receiving systemic therapy with quinolones. Some of these reactions were accompanied by cardiovascular collapse, fainting, laryngeal and facial edema, tingling, dyspnea, itching, and urticaria. Only a few patients had a history of hypersensitivity. The use of the preparation should be immediately discontinued in case of skin rash or any other allergic reactions. In case of hypersensitivity reaction to Ciprofloxacin, emergency assistance may be required, including artificial ventilation of the lungs. Prolonged therapy with antibacterial agents may lead to overgrowth of non-susceptible microorganisms, including fungal flora. In case of development of superinfection, additional antibacterial therapy should be prescribed. There are reports of tendonitis in elderly patients with systemic use of fluoroquinolones in combination with glucocorticosteroids, so at the first sign of tendonitis, the intake of the preparation should be discontinued. Patients with corneal ulcers have experienced the appearance of white crystalline precipitate, which represents residues of the preparation. The precipitate does not limit the further use of Ciprofloxacin and does not affect the therapeutic effect of the preparation. The appearance of the precipitate is observed from 24 hours to 7 days before the start of therapy, and its absorption occurs both immediately after formation and within 13 days from the start of therapy. Wearing contact lenses is not recommended during treatment with the preparation. The preparation contains benzalkonium chloride, which can be absorbed by contact lenses and cause their discoloration, as well as eye irritation. Before using the preparation, contact lenses should be removed and put back on no earlier than 15 minutes after using the preparation. Frequent medical observation is recommended when instilling into the ear, for timely implementation of other therapeutic measures (systemic use of antibiotics, surgical intervention, etc.). Overdose In case of overdose with local application of Kinoftal 0.3%, rinse the eyes with an excess stream of warm water. In case of accidental oral ingestion of the preparation, overdose symptoms are unlikely to occur, as the preparation is not toxic. Interaction with other medicinal products Interactions of Ciprofloxacin drops with other drugs during simultaneous use have not been identified. There are reports that systemic use of some quinolones increases the concentration of theophylline in blood plasma, affects caffeine metabolism, and potentiates the action of oral anticoagulants (including warfarin and its derivatives). There are reports of a temporary increase in creatinine levels in blood plasma in patients with simultaneous systemic use of cyclosporine and Ciprofloxacin. Storage conditions Store in the manufacturer's packaging at a temperature not exceeding 25°C. Keep out of reach of children. Shelf life: 3 years. Do not use after the expiry date indicated on the packaging. After opening the bottle, eye drops should be used within 4 weeks. Packaging: 5 ml in a dropper bottle, sealed with a polyethylene cap. One bottle with instructions for use in a cardboard box. Dispensing category: Pharmaceutical product group III, available without a prescription. Manufacturer: K.O. Rompharm Company, Romania.
