Oftaquix eye drops 0.5%, 5 ml

• Treatment of superficial bacterial eye infections in patients 1 year of age and older;

• prevention of complications after surgical and laser eye surgery.

Topically, instilled into the affected eye.

During the first two days during the waking period - every 2 hours, 1-2 drops into the affected eye, up to 8 times / day. From the 3rd to the 5th day of treatment - 1-2 drops in the affected eye 4 times / day.

The duration of the course of treatment is determined by the doctor and is usually 5 days.

Eye drops in the form of a solution of light yellow or light greenish-yellow color.

1 ml

levofloxacin hemihydrate 5.12 mg,

which corresponds to the content of levofloxacin 5 mg

Excipients: benzalkonium chloride - 0.05 mg, sodium chloride - 9 mg, hydrochloric acid - qs, sodium hydroxide - qs, water d / i - up to 1 ml.

• Pregnancy;

• lactation period (breastfeeding);

• hypersensitivity to quinolone drugs;

• hypersensitivity to the components of the drug.

  The drug should be used with caution in childhood.

pharmachologic effect

Antimicrobial drug from the group of fluoroquinolones. Levofloxacin is the L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of ofloxacin is mainly related to the L-isomer. Levofloxacin blocks DNA gyrase and topoisomerase IV, disrupts supercoiling and stitching of DNA breaks, inhibits DNA synthesis, and 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. In studies on healthy volunteers, it was shown that the average concentrations of levofloxacin in the tear film, measured 4 and 6 hours after topical application, were 17 ?g / ml and 6.6 ?g / ml, respectively. In five out of six subjects, levofloxacin concentrations were 2 ?g / ml and higher 4 hours after instillation. In four out of six subjects, this concentration remained 6 hours after instillation. The average concentration of levofloxacin in aqueous humor with Oftaquix eye drops is statistically significant (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 hour 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, reached on the fifteenth day, was more than 1000 times lower than the concentration observed after oral administration of standard doses of levofloxacin.

Side effect

Side effects can occur in about 10% of patients. Often (1-10%): a burning sensation in the eye, decreased visual acuity, the appearance of mucous cords. Rarely (0.1-1%): blepharitis, chemosis, papillary growths on the conjunctiva, eyelid edema, discomfort in the eye, itching in the eye, eye pain, conjunctival hyperemia, the appearance of follicles on the conjunctiva, dry eye syndrome, eyelid erythema, eye irritation , contact dermatitis, photophobia and allergic reactions. Others: during clinical trials - headache, rhinitis.

Application during pregnancy and lactation

Oftaquix eye drops are contraindicated during pregnancy and lactation (breastfeeding).

Application in children

The drug should be used with caution in childhood.

special instructions

Oftaquix eye drops should not be administered subconjunctivally and directly into the anterior chamber of the eye. With the simultaneous use of other ophthalmic agents, the interval between instillations should be at least 15 minutes. Due to the presence of benzalkonium chloride in the drug, eye drops should not be used while wearing hydrophilic (soft) contact lenses. To avoid contamination of the dropper tip and solution, do not touch the periorbital tissue with the dropper tip.

Overdose

The total amount of levofloxacin contained in one bottle of eye drops is too small to cause toxic reactions even after accidental ingestion. After topical application of an excess dose of Oftaquix eye drops, the eyes should be rinsed with clean (tap) water at room temperature.

Drug interactions

Special studies on the interaction of Oftaquix eye drops have not been conducted. Since the maximum plasma concentration of levofloxacin after topical application in the eye is at least 1000 times lower than after taking standard doses by mouth, the interaction with other drugs typical for systemic use is most likely clinically insignificant.