Expiration date: 02/2025

The composition and form of issue:

Eye drops, 0.5%. 1 ml contains:

active substance:

levofloxacin hemihydrate 5 a, 12 mg

(equivalent to the content of levofloxacin 5 mg) 

excipients: benzalkonium chloride sodium chloride hydrochloric acid sodium hydroxide water for injections 

in bottles, PE with tips-droppers, screw caps and transparent plastic rings for the first autopsy, 5 ml in a cardboard pack 1 bottle.

Description pharmaceutical form:

The solution is light yellow or light greenish-yellow color.

Pharmacokinetics:

After instillation into the eyes of levofloxacin is well maintained in the tear film.

In studies in healthy volunteers have shown that the average concentration of levofloxacin in the tear film, measured after 4 and 6 h after topical application, were 17 and 6, 6 µg/ml, respectively. Five of the six subjects, the concentration of levofloxacin was 2 µg/ml and above after 4 h after instillation. Four of the six subjects this concentration remained after 6 h after instillation.

The average concentration of levofloxacin in the application of eye drops, Oftaquix in watery moisture is statistically significantly higher mean concentration of ofloxacin (p=0, 0008). In fact it is approximately twice higher than average concentration of ofloxacin— (1139, 9±717, 1) ng/ml (621, 7±368, 7) ng/ml, respectively.

The average concentration of levofloxacin in plasma in the 1st day after 1 hour after application, from 0, 86 to 2, 05 ng/ml Cmax of levofloxacin in plasma, is 2, 25 ng/ml, detected at 4 days following 2 days of the drug every 2 hours up to 8 times a day. Cmax of levofloxacin was achieved on the 15th day, which is more than 1000 times lower than those concentrations which are observed after ingestion of standard doses of levofloxacin.

Description pharmacological action:

Levofloxacin is the L-isomer of the racemic drug substance ofloxacin. Antibacterial activity of ofloxacin is primarily to L-isomer.

As an antibacterial drug class fluoroquinolones, levofloxacin does DNK-girazu and topoisomerase IV, violates supercoiling and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in cytoplasm, cell wall and membranes.

Effective against gram (Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa) and gram-positive aerobic bacteria (Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes).

Indications:

• surface bacterial eye infection in patients aged 1 year and older
  
• prevention of complications after surgical and laser operations on the eyeball.
  

Contraindications:

• hypersensitivity to any component of the drug or other hinolonam
  
• pregnancy
  
• lactation.
  

Caution: for adults only.

Side effects:

Side effects may occur in about 10% of patients.

Common side effects (1-10% patients) burning sensation in the eye, decreased visual acuity and the appearance of the mucous strands.

Rare side effects (0, 1-1% of patients) blepharitis, chemosis, papillary growths on the conjunctiva, swelling of the eyelids, discomfort in your eye, itchy eye, eye pain, conjunctival hyperemia, appearance of follicles in the conjunctiva, dry eye, erythema of the eyelids, irritation, contact dermatitis, photophobia and allergic reactions.

Other reactions observed during clinical trials: headache and rhinitis.

Drug interactions:

Special studies on interaction of eye drops, Oftaquix (5 mg/ml) was carried out. Since the Cmax of levofloxacin in plasma after topical application in the eye at least 1000 times lower than after taking standard doses inside, interaction with other drugs, typical for systemic use, most likely clinically insignificant.

Method of application and dose:

Locally, in the affected eye.

1-2 drops in affected eye every 2 hours up to 8 times day during wakefulness within the first 2 days, then 4 times a day from the 3rd to 5th day. The duration of treatment is determined by a physician, usually 5 days.

Overdose:

The total number of levofloxacin contained in one bottle of eye drops, too small to cause toxic reactions even after casual intake. After local application of excessive doses of eye drops, Oftaquix (5 mg/ml), the eyes should be rinsed with clean (tap) water at room temperature.

Precautions:

Eye drops, Oftaquix (5 mg/ml), you cannot enter directly into the subconjunctival and anterior chamber of the eye.

While the use of other ophthalmic means the interval between instillations — a minimum of 15 min.

Drops should not be used while wearing hydrophilic (soft) contact lenses in connection with the presence of droplets of benzalkonium chloride.

To avoid contamination of the dropper tip and solution, the dropper tip should not touch the eyelids and tissues around the eyes.

Storage conditions:

Use within 1 month after opening the bottle.