Properties
- Form
- tsvetebi
- Dosage mg
- 0.005
- Pack
- 1
What is it?
Trade name Levoximed, Levoximed International Nonproprietary Name Levofloxacin Levofloxacin Dosage form Eye/ear drops. Description: A clear solution from pale yellow to pale yellow with a greenish tint. Composition 1 ml of the preparation contains: Active substance: 5 mg levofloxacin (in the form of a 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. Pharmacological properties Pharmacodynamics Levoximed is an antimicrobial drug from the fluoroquinolone group. Levofloxacin is the L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of ofloxacin belongs to the L-isomer. Levofloxacin blocks DNA gyrase and topoisomerase IV, disrupts DNA supercoiling and ligation, inhibits DNA synthesis, causes profound morphological changes in bacterial cytoplasm, cell wall, and membranes. Levoximed is active against Gram-negative aerobes: Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa; Gram-positive aerobes: Methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, intracellular microorganisms: Chlamydia trachomatis. Pharmacokinetics After instillation into the eye, levofloxacin is well retained in the tear film. Studies in healthy volunteers showed that the average concentration of levofloxacin in the tear film was 17.0 mcg/ml and 6.6 mcg/ml 4 and 6 hours after topical application. In five out of six volunteers, the levofloxacin concentration was 2 mcg/ml or more 4 hours after instillation. In four out of six subjects, this concentration was maintained 6 hours after instillation. The average concentration of levofloxacin in blood plasma was measured in 15 healthy adult volunteers during 15 days of use of Levoximed eye/ear drops. 1 hour after administration, the average concentration of levofloxacin in blood plasma ranged from 0.86 ng/ml on the first day to 2.05 ng/ml on the 15th day. The maximum plasma concentration of levofloxacin, equal to 2.25 ng/ml, was observed on the fourth day, after 8 administrations per day for 2 days every 2 hours. The maximum concentration of levofloxacin reached on the 15th day was 1000 times lower than the concentration observed after oral administration of standard doses of levofloxacin. 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 postoperative periods, with ear trauma, removal of foreign bodies from the external auditory canal accompanied by damage to ear tissue. Contraindications - Hypersensitivity to levofloxacin or other components of the preparation; - Hypersensitivity to quinolone drugs. Side effects Up to 3% of cases – temporary burning of the eye, decreased visual acuity, mucus formation in the form of threads; Less than 1% of cases – chemosis, eyelid edema, discomfort in the eye, itching, pain, conjunctival hyperemia, follicular formation on the conjunctiva, dry eye syndrome, eyelid erythema, tearing, photophobia. Method of administration and dosage For topical use only. Ophthalmology: Adults and children from 1 year of age and older instill 1-2 drops into the affected eye(s) every 2 hours, 8 times a day. On days 3-5, 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 an interval of 15 minutes between instillations. To avoid contamination of the solution, the tip of the dropper should not touch the eyelids and the tissues around the eye. Otology: For 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. For chronic suppurative 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 instilling Levoximed into the ear, sanitation of the external auditory canal should be performed. Overdose Overdose with the preparation in the form of eye/ear drops is unlikely. Symptoms of overdose are identical to the side effects of the preparation. In case of local overdose of Levoximed eye/ear drops, the eye should be rinsed with clean (tap) water at room temperature. In the presence of pronounced side effects, a doctor's visit is recommended. Also, with intentional or accidental oral intake, symptoms may be identical to side effects. The total amount of levofloxacin contained in one bottle (25 mg) of eye/ear drops is too small to cause toxic reactions even after accidental oral intake. Interaction with other medicinal products After topical application into the eye, the maximum concentration of levofloxacin in plasma is 1000 times lower than after oral administration, so interactions with other medicinal products are unlikely. Special studies on the interaction of Levoximed eye/ear drops have not been conducted. Pregnancy and lactation Pregnancy Due to the lack of clinical trial data on the use of the preparation during pregnancy, Levoximed eye/ear drops can be used only if the expected benefit outweighs the risk associated with the use of the preparation. Lactation Levoximed should be used with caution during lactation. Use in pediatrics The efficacy and safety of the preparation in children under one year of age have not been studied. Effect on ability to drive and operate machinery Due to possible visual disturbances after instillation, it is not recommended to drive vehicles and operate potentially dangerous machinery until vision normalizes. Special instructions Levoximed eye/ear drops should not be administered subconjunctivally; direct instillation into the anterior chamber of the eye should be avoided. Benzalkonium chloride is included in the composition of eye/ear drops as a preservative. It is not recommended to use the preparation while wearing hydrophilic (soft) contact lenses, as this preservative can be absorbed by the lens and cause eye irritation. It is not recommended to wear any type of contact lenses in the presence of symptoms of bacterial conjunctivitis. Dosage form Levoximed eye/ear drops are available in a 5 ml polyethylene bottle with a dropper and a screw-on cap with a tamper-evident ring. The bottle is placed in a cardboard box with instructions for use. Storage conditions Store at a temperature not exceeding 25°C, protected from light, out of reach of children. Shelf life 3 years from the date of manufacture. After opening the bottle, the preparation should be used within 4 weeks. Do not use after the expiry date. Dispensing from pharmacies Pharmaceutical product group II (prescription only). Manufacturer The owner of the trade mark and registration certificate is "World Medicine", Great Britain ("WORLD MEDICINE", GREAT BRITAIN). Manufactured by "Rompharm Company S.R.L.", Otopeni, Eroilor street 1A, Romania. ("Rompharm Company S.R.L.", Otopeni, Eroilor street 1A, Romania).
