Properties
What is it?
International Nonproprietary Name - Levofloxacin Composition 1 ml of the preparation contains: Active substance: 5 mg Levofloxacin (in the form of hemihydrate). Excipients: Sodium chloride, Benzalkonium chloride, Hydrochloric acid, Sodium hydroxide, Purified water. Chemical Name Levofloxacin hemihydrate: (-)–(S)–9–fluoro–2,3–dihydro–3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Pharmacotherapeutic Group Antimicrobial agent from the fluoroquinolone group, for topical use in ophthalmology and otology. Indications for Use Ophthalmology: - Treatment of superficial bacterial infections of the eye caused by microorganisms sensitive to Levofloxacin in patients aged 1 year and older; - Bacterial conjunctivitis; - Corneal ulcer; - Gonococcal and chlamydial diseases of the eye in adults; - Complications after laser and surgical interventions on the eye. Otology: - Otitis externa; - Acute and chronic otitis media; - Prevention of infectious otitis in the pre- and post-operative periods, in case of ear trauma, when removing a foreign body from the external auditory canal accompanied by damage to the ear tissue. Contraindications - Hypersensitivity to Levofloxacin or other components of the preparation; - Hypersensitivity to quinolone-class preparations. Method of Administration and Dosage For topical use only. Ophthalmology: Adults and children aged 1 year and older For the first two days, instill 1-2 drops into the affected eye(s) every 2 hours, 8 times per day. From day 3 to 5, every 4 hours (up to 4 times a day). The duration of treatment is 5 days and mainly depends on the clinical picture, severity of the disease, and bacterial infection. When using several topical ophthalmic preparations simultaneously, it is necessary to observe a 15-minute interval between instillations. To avoid contamination of the solution, the tip of the dropper should not touch the eyelids and surrounding tissues of the eye. Otology: In case of otitis externa: Adults Instill 10 drops into the affected ear once a day for 7 days. Children aged 1 to 12 years Instill 5 drops into the affected ear once a day for 7 days. In case of chronic purulent otitis media (with tympanic membrane perforation): Patients aged 12 years and older Instill 10 drops into the affected ear twice a day for 14 days. For the prevention of infectious otitis: Instill 5 drops into the affected ear twice a day for 10 days. Before instillation into the ear, sanitation of the external auditory canal should be performed. Side Effects In up to 3% of cases – temporary burning sensation in the eye, decreased visual acuity, appearance of mucus in the form of threads; in less than 1% of cases – chemosis, eyelid edema, discomfort in the eye, itching, pain, conjunctival hyperemia, appearance of follicles on the conjunctiva, "dry eye" syndrome, eyelid erythema, tearing, photophobia. Use in Pediatrics The efficacy and safety of the preparation in children under one year of age have not been studied.