Oftavix, eye drops 0.5% 5 ml

A broad spectrum antimicrobial from the group of fluoroquinolones for use in ophthalmology. It has a bactericidal effect on streptococci and staphylococci (including penicillin resistant), Klebsiella, E. coli, diphtheria corynebacterium, mycobacteria (including tuberculosis), hemophilus bacteria (including ampicillin resistant), mycoplasmas, chlamydia, gonococcus, clostridia etc.

Levofloxacin is the L-isomer of the racemic medicinal substance ofloxacin. The antibacterial activity of ofloxacin refers mainly to the L-isomer. Levofloxacin blocks DNA-gyrease and topoisomerase IV, disrupts superspiralization and cross-linking of DNA breaks, inhibits DNA synthesis and causes deep morphological changes in cytoplasm, cell wall and membranes.

Pharmacokinetics

Levofloxacin persists well in the tear film after instillation into the eye. In studies on healthy volunteers, mean concentrations of levofloxacin in the tear film measured 4 and 6 hours after topical administration were 17.0 mcg/mL and 6.6 mcg/mL, respectively. Five of the six subjects had levofloxacin concentrations of 2 μg/mL or higher 4 h after instillation. In four of the six subjects this concentration was maintained 6 hours after instillation.

The mean concentration of levofloxacin with use of Oftavix eye drops in aqueous humor was statistically significantly (p=0.0008) higher than the mean concentration of ofloxacin (1139.9 ± 717.1 ng/mL and 621.7 ± 368.7 ng/mL, respectively). Mean plasma concentrations of levofloxacin 1 h after administration range from 0.86 ng/mL to 2.05 ng/mL.

The plasma Cmax of levofloxacin equal to 2.25 ng/ml was detected on the fourth day after 2 days of using the drug every 2 hours up to 8 times/day. The Cmax of levofloxacin reached on the fifteenth day was more than 1,000 times lower than the concentration observed after oral administration of standard doses of levofloxacin.

Indications

Oftavix eye drops are used for topical treatment of inflammatory eye diseases in adults and children over 12 months of age caused by pathogens sensitive to the action of levofloxacin.

To prevent complications after surgical and laser operations on the eye.

Active ingredient

Composition

Active ingredient:

Levofloxacin hemihydrate 5.12 mg, which is equivalent to levofloxacin 5.0 mg.

Auxiliary substances:

Benzalkonium chloride;

Sodium chloride;

p> Hydrochloric acid;

Sodium hydroxide;

Injectable water.

How to take, the dosage

Appointed according to the scheme:

The duration of treatment shall be determined by the attending physician; it depends on the severity of symptoms and peculiarities of the clinical course of the disease. The course of treatment in typical cases is 5 days.

Interaction

Special studies on the interaction of Oftavix Eye Drops, 5 mg/ml, have not been conducted.

Because the maximum plasma concentration of levofloxacin after topical application in the eye is at least 1000 times lower than after standard oral doses, the interaction with other drugs typical for systemic use is likely to be clinically insignificant.

Special Instructions

The interval between instillations should be at least 15 minutes when other ophthalmic agents are used concomitantly.

The solution should not be injected under the conjunctiva and into the anterior chamber of the eye. Due to the risk of superinfection and fungal infection, prolonged use is not recommended.

Patients with ocular inflammation should not wear contact lenses.

The content of benzalkonium chloride drops as a preservative may cause eye irritation symptoms.

Transient visual impairment may occur immediately after instillation, so wait before performing sensitive work.

Contraindications

Side effects

Frequently (1-10%): a burning sensation in the eye, decreased visual acuity, the appearance of mucous bands.

Rarely (0.1-1%): blepharitis, chemosis, papillary growths on the conjunctiva, eyelid edema, discomfort in the eye, itching in the eye, pain in the eye, conjunctival hyperemia, appearance of follicles on the conjunctiva, “dry eye” syndrome, eyelid erythema, eye irritation, contact dermatitis, photophobia and allergic reactions.

Others: when in clinical trials – headache, rhinitis

Overdose

The total amount of levofloxacin contained in one bottle of eye drops is too low to cause toxic reactions even after accidental oral administration. After topical application of an excessive dose of Oftavix Eye Drops, 5 mg/ml, the eye should be rinsed with clean (tap) water at room temperature.

Pregnancy use

Contraindicated.

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