OFTAKVIKS

Active material: Levofloxacin
When ATH: S01AX19
CCF: Fluoroquinolone antibacterial drug for topical application in ophthalmology
ICD-10 codes (testimony): H10.2, H10.4, H10.5, H16, H16.2, Z29.2
When CSF: 06.17.02.03
Manufacturer: Santen Oy (Finland)

Pharmaceutical form, composition and packaging

Eye drops as a solution of a light yellow or light greenish yellow.

Excipients: benzalkonium chloride, sodium chloride, hydrochloric acid, Sodium hydroxide, water d / and.

5 ml – plastic bottles (1) with a tip-dropper – packs cardboard.

Pharmacological action

Antimicrobial group of fluoroquinolones.

Levofloxacin – L-isomer ratsemicheskoy lekarstvennoy substances ofloxacin. The antibacterial activity of ofloxacin is, mainly, to L-isomer. Levofloxacin blocks DNA gyrase and topoisomerase IV, crosslinking violates supercoiling and DNA breaks, It inhibits the synthesis of DNA, It causes profound morphological alterations in the cytoplasm, cell wall and membranes.

It is active against gram-negative aerobic: Branchamella (Moraxella) cataralis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa; Gram-positive aerobes: Staphyloccocus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.

Pharmacokinetics

After instillation in the eye levofloxacin is well maintained in the tear film. In studies in healthy volunteers have shown, that the average concentrations of levofloxacin in the tear film, measured through 4 and 6 h after topical application of the compositions 17.0 ug / ml 6.6 ug / ml, respectively. Five of the six subjects were concentrations of levofloxacin 2 ug / ml and up through 4 h after instillation. In four of the six subjects retained by the concentration 6 h after instillation.

The average concentration of levofloxacin in the application of eye drops Oftakviks in the aqueous humor was significantly (p = 0.0008) higher than the average concentration of ofloxacin (1139.9 ± 717.1 ng / ml 621.7 ± 368.7 ng / ml). Average concentrations of levofloxacin in plasma 1 h after application – from 0.86 ng / ml to 2.05 ng / ml.

C_max levofloxacin plasma, equal 2.25 ng / ml, It was found on the fourth day after 2 the drug every day 2 h to 8 time / day. C_max levofloxacin, reached on the fifteenth day, was more than 1000 fold lower concentration, notes after oral administration of standard doses of levofloxacin.

Testimony

- Treatment of superficial bacterial infections of the eye in patients 1 and older;

- Prevention of complications after surgery and laser surgery of the eye.

Dosage regimen

Locally, instilled in the affected eye.

During the first two days of the period of wakefulness – every 2 hr from 1-2 a drop in the affected eye, to 8 time / day. On the 3rd to 5th day of treatment – by 1-2 a drop in the affected eye 4 times / day.

The duration of treatment is determined by a physician and is usually 5 Nights.

Side effect

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

Rarely (0.1-1%): .Aloe, xemoz, papillary growths on the conjunctiva, swelling of the eyelids, discomfort in the eye, itchy eyes, eye pain, conjunctival hyperemia, the appearance of follicles in the conjunctiva, dry eye syndrome, эritema century, eye irritation, contact dermatitis, photophobia, and allergic reactions.

Other: during clinical trials – headache, rhinitis.

Contraindications

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug quinolone series;

- Hypersensitivity to the drug.

FROM caution should use the drug in children.

Pregnancy and lactation

Eye drops Oftakviks contraindicated during pregnancy and lactation (breast-feeding).

Cautions

Eye drops Oftakviks subkonyunktivalno can not enter directly into the anterior chamber.

With the simultaneous use of other ophthalmic agents interval between instillation should be at least 15 m.

Due to the presence in the formulation benzalkonium chloride eyedrops should not be used while wearing hydrophilic (soft) contact lenses, because this preservative can be absorbed by them and cause eye irritation.

To avoid contamination of the dropper tip and solution, Do not touch the dropper tip to the periorbital tissues.

Overdose

The total amount of levofloxacin, contained in a bottle of eye drops, too few, to cause toxic reactions even after accidental ingestion. After topical application of excessive doses of eye drops Oftakviks eyes should be rinsed with clean (tap) water at room temperature.

Drug Interactions

Special studies on the interaction of eye drops has not been Oftakviks. Because the maximum concentration in plasma levofloxacin after topical application in the eye at least 1000 times lower, than after ingestion of standard doses inwardly, interactions with other drugs, characteristic for systemic use, probably, clinically insignificant.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.

After opening the bottle shelf life – 1 month.