Properties
- Form
- tsvetebi
- Dosage mg
- 0.003
- Pack
- 1
What is it?
Trade name: Ciprofloxacin International Nonproprietary Name - Ciprofloxacin Dosage form: 0.3% eye drops Composition: Active substance: Ciprofloxacin hydrochloride – 3.3 mg (equivalent to 3 mg ciprofloxacin); Excipients: Sodium chloride 9 mg; Benzalkonium chloride – 0.05 mg; Water for injection – up to 1 ml. Description: A clear, colorless, pale yellow or yellowish-green liquid. Pharmacotherapeutic group – Antimicrobial agent, fluoroquinolone. Pharmacological action Pharmacokinetics A broad-spectrum antimicrobial agent, a fluoroquinolone derivative, inhibits bacterial DNA gyrase, disrupts DNA synthesis, bacterial growth, and division; causes pronounced morphological changes and rapid death of bacterial cells. Low toxicity to macroorganism cells is explained by the absence of DNA gyrase in them. With Ciprofloxacin, parallel resistance to other antibiotics not belonging to the gyrase inhibitor group does not develop, which makes it effective against bacteria resistant to, for example, aminoglycosides, penicillins, cephalosporins, tetracyclines, and many other antibiotics. In vitro, Ciprofloxacin is highly active against most aerobic Gram-positive bacteria, including Pseudomonas aeruginosa. The drug is also active against Gram-positive bacteria (Staphylococcus, Streptococcus). Anaerobic bacteria are less sensitive or resistant to Ciprofloxacin. Resistance develops very slowly, since, on the one hand, practically no persistent microorganisms remain after the action of Ciprofloxacin, and on the other hand, bacterial cells lack enzymes that inactivate it. Pharmacokinetics When used topically, Ciprofloxacin enters the systemic circulation. Plasma concentrations of Ciprofloxacin vary from undetectable values to 4.7 ng/ml. Indications for use Infections caused by microorganisms sensitive to Ciprofloxacin: - Corneal ulcer; - Superficial bacterial infections of the eyes; Prevention and treatment of bacterial infections after eye trauma and surgery. Contraindications Hypersensitivity to the components of the drug and other fluoroquinolones. The efficacy and safety of the drug in children under one year of age have not been established. Method of administration and dosage Adults and children from 1 year of age: - For corneal ulcer, instill 2 drops every 15 minutes for 6 hours on the first day, then 2 drops every half hour until the end of the day. On the second day, instill 2 drops every hour. From the 3rd to the 14th day – 2 drops every 4 hours. Treatment can be continued after 14 days if no recurrent epithelialization of the cornea is observed; - For superficial bacterial infections of the eyes, usually 1-2 drops are used every 4 hours; in severe infections – 1-2 drops every 2 hours (during wakefulness) for the first 2 days, in subsequent days – 1-2 drops every 4 hours. In both cases, the duration of treatment should not exceed 21 days. Side effects Locally: burning, itching, discomfort, foreign body sensation in the eyes, conjunctival hyperemia, tearing, peeling of the skin of the eyelid margins, decreased visual acuity, visual disturbances, photophobia, keratitis, keratopathy, allergic reactions, appearance of spots on the cornea, corneal infiltration, nausea, rarely – hypersensitivity reactions; with corneal ulcer, the appearance of white crystalline precipitate is possible (24 hours – 7 days after the start of treatment). Dissolution of the precipitate may be observed immediately after the start of treatment or within 13 days. With topical use of fluoroquinolones, in very rare cases, generalized rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria may develop. Overdose There is no data on overdose with topical use of the drug. In case of overdose, it is necessary to wash the eyes with warm water. Interaction with other drugs No specific studies have been conducted with Ciprofloxacin eye drops. However, it should be taken into account that with combined systemic use of some fluoroquinolones (including Ciprofloxacin): - With theophylline, an increase in theophylline concentration in blood plasma is possible; - With warfarin, an increase in the anticoagulant effect of warfarin is possible; - With cyclosporine, a temporary increase in serum creatinine levels is possible. Special instructions Clinical studies on the use of the drug in children under one year of age (especially newborns) are limited. In some patients receiving systemic fluoroquinolones, serious hypersensitivity reactions have been observed. The use of the drug should be discontinued if any signs of allergic reactions appear. Do not inject the drug subconjunctivally or into the anterior chamber of the eye. Prolonged use of the drug may lead to the development of non-specific, including fungal infections. During treatment with the drug, the use of contact lenses is not recommended. Use during pregnancy and lactation The use of the drug during pregnancy is possible if the expected effect outweighs the potential risk to the fetus. It is unknown whether the drug is excreted in breast milk. Caution should be exercised when using the drug in nursing mothers. Effect on ability to drive and use machinery For patients who temporarily lose visual acuity after application, it is not recommended to drive or operate complex machinery, equipment, or any complex devices that require clear vision immediately after instillation. Shelf life 2 years. Do not use after the expiry date indicated on the packaging. Storage conditions Store at a temperature of 15-30°C, protected from light and out of reach of children. Dosage form 10 ml in a polyethylene dropper bottle. Dispensing conditions from pharmacies Pharmaceutical product group: III, available without a prescription Manufacturer Closed Joint Stock Company "Liquor", Armenia
