Properties
What is it?
Trade name: FLOXIMED International Nonproprietary Name: Ciprofloxacin Dosage form: Ophthalmic ointment Composition: 1 g of FLOXIMED 0.3% ophthalmic ointment contains: Active substance: Ciprofloxacin (as hydrochloride) 3.0 mg; Excipients: anhydrous lanolin, chlorobutanol, soft yellow paraffin. Pharmacotherapeutic group: Antimicrobial agent from the fluoroquinolone group, with a broad spectrum of antibacterial action. Pharmacological properties: Ciprofloxacin has antibacterial (bactericidal) action, is particularly active against Gram-negative bacteria, and has a relatively less pronounced effect on anaerobes. It acts on the following bacteria: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Campilobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloaceae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Salmonella typhi, Serratia marcescens, Shigella flexneri, Shigella sonnei, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Acinetobacter spp., Aeromonas caviae, Aeromonas hydrophilia, Brucella melitensis, Campylobacter coli, Edwardsiella tarda, Enterobacter aerogenes, Haemophilus ducreyi, Klebsiella oxytoca, Legionella pneumophila, Moraxella (Branhamella) catarrhalis, Neisseria meningitides, Pasteurella multicoda, Salmonella enteritidis, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica, Chlamydia trachomatis (moderately sensitive), Mycobacterium tuberculosis (moderately sensitive). Most strains of Pseudomonas cepacia and some strains of Pseudomonas matolphilia, as well as anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile, are resistant to ciprofloxacin. Indications: Local treatment of various infectious diseases of the eye and its adnexa caused by bacteria sensitive to the drug: acute and subacute conjunctivitis, blepharoconjunctivitis, blepharitis, bacterial corneal ulcers with or without hypopyon, bacterial keratitis and keratoconjunctivitis, chronic dacryocystitis and meibomitis. Preoperative prophylaxis in ophthalmic surgery. Treatment of postoperative infectious complications. Treatment and prophylaxis of infectious complications after trauma to the eyeball and its adnexa (with or without foreign body). Contraindications: Hypersensitivity to ciprofloxacin or other drugs of the fluoroquinolone group, glucose-6-phosphate dehydrogenase deficiency, pregnancy and lactation. Side effects: Local reactions: allergic reactions, itching, burning, conjunctival hyperemia and mild pain, nausea are possible; rarely - eyelid edema, photophobia, foreign body sensation in the eyes, unpleasant taste in the mouth after instillation, decreased vision, appearance of crystalline precipitate in patients with corneal ulcers, keratitis, keratopathy, appearance of spots or infiltration on the cornea. Method of administration and dosage: Before administering the drug, it is advisable to determine the sensitivity of the microflora causing the disease to the drug. FLOXIMED ophthalmic ointment 0.3%. Apply to the conjunctival sac (between the posterior surface of the eyelids and the anterior surface of the eyeball). In severe infections, ophthalmic ointment is used 3-4 times a day. The number of applications can be reduced as the symptoms of the disease subside. In mild infections, it is usually prescribed 2 times a day. In combination with eye drops, ophthalmic ointment can be additionally used at night to ensure longer contact with the drug. Overdose: There is no data on overdose of FLOXIMED. Interaction with other drugs: The activity of ciprofloxacin increases when combined with beta-lactam antibiotics, aminoglycosides, vancomycin, clindamycin, and metronidazole. Special instructions: FLOXIMED is for topical use only. If conjunctival hyperemia persists or increases after using eye drops or ophthalmic ointment, the drug should be discontinued and a doctor should be consulted. Wearing soft contact lenses is not recommended during treatment with the drug. When using hard contact lenses, they must be removed before instillation, and the lenses can be reinserted only 15-20 minutes after instillation of the drug. Effect on driving and operating machinery: For patients who experience temporary visual acuity impairment after using FLOXIMED eye drops or ophthalmic ointment, it is not recommended to drive a car or operate complex machinery, machine tools, or other equipment that requires visual acuity. Use in pediatrics: The safety and efficacy of the drug in children have not yet been established. Use during pregnancy and lactation: The use of FLOXIMED during pregnancy and lactation is contraindicated. Dosage form: FLOXIMED ophthalmic ointment 0.3% 5.0 g in an aluminum tube. 1 aluminum tube with a leaflet is placed in a cardboard box. Storage conditions: FLOXIMED ophthalmic ointment 0.3% should be stored at a temperature up to 30ºC, out of reach of children. After opening the tube, the drug should be used within one month! Shelf life: FLOXIMED ophthalmic ointment 0.3% 2 years from the date of manufacture. The drug should not be used after the expiry date. Dispensing from pharmacy: Prescription only. Manufacturer: E.I.P.I.CO Egypt.
