Oftakvix eye drops 0.5% 5 ml (Levofloxacin)

Latin name

Oftaquix

Release form

Eye drops

Packaging

5 ml - polyethylene bottles (1) with a dropper tip - packs of cardboard.

Pharmacological action

Antimicrobial drug from the group of fluoroquinolones.

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

Active against gram-negative aerobes: Branchamella (Moraxella) cataralis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa gram-positive aerobes: Staphyloccocus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.

Pharmacokinetics

After instillation into the eye, levofloxacin is well preserved in the tear film. Studies in healthy volunteers showed that the average concentrations of levofloxacin in the tear film, measured 4 and 6 hours after topical application, were 17.0 μg / ml and 6.6 μg / ml, respectively. Five out of six subjects had levofloxacin concentrations of 2 μg / ml or higher 4 hours after instillation. In four out of six subjects, this concentration persisted 6 hours after instillation.

The average concentration of levofloxacin when using Oftakvix eye drops in aqueous humor was statistically significantly (p = 0.0008) higher than the average concentration of ofloxacin (1139.9 ± 717.1 ng / ml and 621.7 ± 368.7 ng / ml, respectively). The average concentration of levofloxacin in blood plasma 1 h after application is from 0.86 ng / ml to 2.05 ng / ml.

Cmax of levofloxacin in plasma, 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. Cmax of levofloxacin achieved on the fifteenth day was more than 1000 times lower than the concentration observed after oral administration of standard doses of levofloxacin.

Indications

Treatment of superficial bacterial infections of the eyes of patients aged 1 year and older.

Prevention of complications after surgical and laser operations on the eye.

Contraindications

Hypersensitivity to any of the components of Oftakviks or to other quinolones.

Contraindicated in pregnancy and lactation.

Use during pregnancy and lactation

Contraindicated.

Composition

1 vial contains:

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

Excipients: Benzalkonium chloride Sodium chloride Hydrochloric acid Sodium hydroxide Water for injection.

Dosage and Administration

Locally, in the affected eye.

1-2 drops in the affected eye (a) every two hours up to 8 times a day during wakefulness for the first 2 days, then four times a day from 3 to 5 days. The duration of the course of treatment is determined by the doctor, usually 5 days.

Side effects

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

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, follicles on the conjunctiva, dry eye syndrome, erythema of the eyelids, irritation eyes, contact dermatitis, photophobia and allergic reactions.

Other: during clinical trials - headache, rin

Drug interaction

Special studies on the interaction of ophthalmic optic drops, 5 mg / ml, have not been performed. Since the maximum concentration of levofloxacin in plasma after topical application in the eye is at least 1000 times lower than after taking standard doses inside, interaction with other drugs characteristic of systemic use is likely to be clinically insignificant.

overdose

The total amount of levofloxacin contained in one vial of eye drops is too small to cause toxic reactions, even after accidental ingestion. After topical application of an overdose of Ophtakviks eye drops, 5 mg / ml, the eye should be rinsed with clean (tap) water at room temperature.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

The Expiration of

is 3 years. Use within 1 month after opening the vial.

Deystvuyuschee substances

Levofloxacin

dosage form

Dosage

form drops of the eye

Santen, France



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