Oftakwix - instructions for use, dose, side effects, contraindications

As an antibacterial preparation of the class of fluoroquinolones, levofloxacin blocks DNA gyruase and topoisomerase IV, disrupts supercoiling and cross-linking of DNA gaps, inhibits DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes.

Effective with respect to:

Gram-negative aerobes:

Branhamella (Moraxella) catarrhalis

Haemophilus influenzae

Neisseria gonorrhoeae

Pseudomonas aeruginosa

Gram-positive aerobes:

Staphylococcus aureus

Streptococcus pneumoniae

Streptococcus pyogenes

Pharmacokinetics:

After instillation in the eye levofloxacin well preserved in the lacrimal film.

In studies on healthy volunteers, it was shown that the average concentration of levofloxacin in the tear film, measured at 4 and 6 hours after topical application, was 17.0 μg / ml and 6.6 μg / ml, respectively.In five out of six subjects, levofloxacin concentrations were 2 μg / ml and higher 4 hours after instillation. In four out of six subjects, this concentration was preserved 6 hours after instillation.

The average concentration of levofloxacin in the application of eye drops Oftakwix in aqueous humor is statistically significantly higher than the average concentration of ofloxacin (p = 0.0008). In fact, it is approximately twice as high as 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 the blood plasma after 1 hour after application is from 0.86 ng / ml on the 1st day to 2.05 ng / ml. The maximum concentration of levofloxacin in the plasma, equal to 2.25 ng / ml, was detected on the 4th day after two days of application of the drug every 2 hours up to 8 times a day. The maximum concentration of levofloxacin was reached on the 15th day, which is more than 1000 times lower than the concentrations that are noted after oral administration of standard doses of levofloxacin.

Indications:

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

- Prophylaxis of complications after surgical and laser operations on the eye.

Contraindications:

Hypersensitivity to any of the components of the drug or to other quinolones, pregnancy, lactation.

Carefully:

Childhood.

Dosing 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 the waking period during the first 2 days, then four times a day from 3 to 5 days. The duration of treatment is determined by a doctor, usually 5 days.

Side effects:

Side effects can occur in about 10% of patients.

Frequent side effects (1-10% of patients):

Burning in the eye, reduced visual acuity and the appearance of mucous cords.

Rare side effects (0.1-1% of patients):

Blepharitis, chemosis, papillary sprawl on the conjunctiva, edema of the eyelids, unpleasant sensation in the eye, itching in the eye, pain in the eye, conjunctival hyperemia, conjunctival conjunctival follicles, dry eye syndrome, erythema eyelids, irritation, contact dermatitis, photophobia and allergic reaction. Of the other reactions that were noted during clinical trials, there were headache and rhinitis.

Overdose:

The total amount of levofloxacin contained in one bottle of eye drops is too low to cause toxic reactions even after accidental ingestion.After topical administration of an excessive dose of eye drops, Oftakwix, 5 mg / ml, the eye should be rinsed with clean (tap) water at room temperature.

Interaction:

Special studies on the interaction of eye drops Oftakwix, 5 mg / ml, was not 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 orally, interaction with other drugs characteristic of systemic use is most likely clinically insignificant.

Special instructions:

Eye drops Oftakwix, 5 mg / ml, can not be administered subconjunctivally and directly into the anterior chamber of the eye.

With the simultaneous use of other ophthalmic funds, the interval between instillations is at least 15 minutes.

Drops should not be used while wearing hydrophilic (soft) contact lenses, due to the presence of benzalkonium chloride in the drops.

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

Form release / dosage:Eye drops 0.5%.

Packaging:

5 ml in a polyethylene bottle with a dropper tip and a screw cap. Transparent film ring to control the first opening of the vial. The bottle with instructions for use is placed in a cardboard box.

Storage conditions:

Store below 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Use within 1 month. after opening the vial.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001101/08

Date of registration:27.02.2008 / 16.07.2014

Expiration Date:Unlimited

The owner of the registration certificate: Santen, AO Santen, AO Finland

Manufacturer: & nbsp

SANTEN, OY Finland

Representation: & nbspSANTEN AS SANTEN AS Finland

Information update date: & nbsp20.06.2017

Illustrated instructions

Instructions

Oftakwix (Oftaquix)