OftaQuixx eye drops 0.5%, 5 ml

Composition

Active ingredient: 

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

Auxiliary substances:

 Benzalkonium chloride;

Sodium chloride;

Hydrochloric acid;

Sodium hydroxide;

Water for injection.

Pharmacological action

A broad-spectrum antimicrobial drug from the group of fluoroquinolones for use in ophthalmology. It has a bactericidal effect on streptococci and staphylococci (including those resistant to penicillin), Klebsiella, Escherichia coli, Corynebacteria diphtheria, mycobacteria (including tuberculosis), hemophilic bacteria (including those resistant to ampicillin), mycoplasmas, chlamydia, gonococci, clostridia, etc.

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

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 17.0 mcg/ml and 6.6 mcg/ml, respectively. In five of the six subjects, levofloxacin concentrations were 2 micrograms / ml or higher 4 hours after instillation. In four of the six subjects, this concentration was preserved 6 hours after instillation.

The average concentration of levofloxacin 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 administration was 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.

Indications

OftaQuixx eye drops are used for topical treatment of inflammatory eye diseases in adults and children older than 12 months caused by pathogenic microorganisms sensitive to the action of levofloxacin.

For the prevention of complications after surgical and laser operations on the eye.

Use during pregnancy and lactation

Contraindicated.

Contraindications

• Hypersensitivity to any of the components of OftaQuixx or to other quinolones.
• It is contraindicated during pregnancy and lactation.

Side Effects

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

Rare (0.1-1%): blepharitis, chemosis, papillary growths on the conjunctiva, eyelid edema, unpleasant sensations 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.

Other: during clinical trials – headache, rin

Interaction

Special studies on the interaction of OftaQuixx eye drops,5 mg / ml, 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 oral doses, the interaction with other drugs characteristic of systemic use is most likely clinically insignificant.

How to take, course of administration and dosage

Assign according to the scheme:

• in the first two days,1-2 drops in the conjunctival sac of the affected eye (s) every 2 hours, if necessary-up to 8 times a day,
• from 3 to 5 days (if necessary and longer) 1-2 drops 4 times a day.

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

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 excessive dose of OftaQuixx eye drops,5 mg/ml, the eye should be rinsed with clean (tap) water at room temperature.

Special instructions

With the simultaneous use of other ophthalmic agents, the interval between instillations should be at least 15 minutes.

The solution should not be injected under the conjunctiva and into the anterior chamber of the eye. Due to the risk of developing superinfection and fungal infection, the drug is not recommended for a long time.

Patients with eye inflammation should not wear contact lenses.

Due to the content of benzalkonium chloride as a preservative in the drops, symptoms of eye irritation may occur.

Immediately after instillation, there may be a temporary deterioration in vision, so you should wait before performing work that requires increased attention.

Form of production

Eye drops

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Levofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Inflammatory eye diseases

Weight

Weight: 17 gr.