Levofloxacin - instructions for use, dosage, side effects, contraindications

Excipients: Benzalkonium chloride - 0.04 mg, sodium chloride - 9 mg, disodium edetate - 0.1 mg, hydrochloric acid solution 1 M - to pH 6.4, water for injection - up to 1 ml.

Description:Transparent yellowish-green liquid.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.12 Levofloxacin

Pharmacodynamics:

Antimicrobial drug from the group of fluoroquinolones, the left-handed isomer of ofloxacin. It has a wide spectrum of antibacterial (bactericidal) action. Inhibits bacterial DNA gyrase and topoisomerase IV, enzymes responsible for the replication, transcription, repair and recombination of bacterial DNA. Causes profound morphological changes in the cytoplasm, cell wall and bacterial membrane.

A drug active with respect to microorganisms:

- aerobic gram-positive bacteria: Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Groups C/F), Streptococcus (Group G), Viridans group streptococci.

- aerobic gram-negative bacteria: Acinetobacter Waffle, Haemophilus influenzae, Serratia marcescens.

Pharmacokinetics:

After instillation into the eye levofloxacin well preserved in the lacrimal film. After a single application of eye drops, the concentration of levofloxacin in the lacrimal film is 17.0 μg / ml and 6.6 μg / ml at 4 and 6 hours, respectively. The maximum concentration of levofloxacin, equal to 2.25 ng / ml, is observed on the 4th day after 2 daily applications every 2 hours (8 times a day). With long-term use in the form of eye drops, the concentration of levofloxacin in the blood plasma is 0.94 ng / ml and 2.15 ng / ml on days 1 and 15, respectively, which is 1000 times lower than the concentrations when administered in standard recommended doses.

Indications:

Treatment of infections of the anterior part of the eye caused by microorganisms sensitive to levofloxacin.

Contraindications:

Hypersensitivity to the components of the drug; pregnancy, lactation, children under 1 year.

Pregnancy and lactation:

The drug is contraindicated in pregnancy.

If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:

Locally. The drug is instilled in the conjunctival sac by 1-2 drops of solution in one or both of the affected eyes every 2 hours (up to 8 times a day) during the first 2 days. Then every 4 hours (up to 4 times a day) for 3-7 days. The duration of treatment is 5-7 days.With the simultaneous use of several ophthalmic preparations for topical application, a 15-minute interval between instillations should be observed.

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

Recommendations for the use of vials with dropper caps: Before using the drug, remove the aluminum cap from the bottle, remove the rubber stopper and close the bottle with a dropper, previously released from the package. Then remove the cap from the cap-dropper, turn the bottle, drip the required number of drops of the drug. After applying the bottle, return to the vertical position and put the cap on the lid-dropper.

Recommendations for the use of a tube-dropper (t / k): Before using the product, remove the protective cap, cut off the membrane of the neck of the body with scissors, without damaging the threaded part. Turn the body t / k with the drug throat down and gently move the body t / k, using it as a pipette. After the application of the recommended dose for a prescription by the doctor or the dose specified in the instructions for use of the medicinal product,Turn the torsion bar upside down and screw on the protective cap.

Side effects:

Often (1 - 10 %): short-term burning in the eye, red eyes, decreased visual acuity.

Infrequently (0,1-1 %): the appearance of mucus in the form of strands.

Rarely (0.1-0.01%): blepharitis, chemosis, papillary growth and the appearance of follicles on the conjunctiva, dry eye syndrome, erythema eyelids, itching and pain in the eye, photophobia, allergic reactions, headache, rhinitis.

Because the drug contains benzalkonium chloride, it is possible to develop contact dermatitis and eye irritation.

Overdose:

An overdose of the drug in the form of eye drops is unlikely.

Symptoms: irritation of the eye tissues (burning, redness, swelling, lacrimation).

Treatment: rinse with clean (tap) water at room temperature, symptomatic therapy.

Interaction:

Special studies of the interaction of levofloxacin in the form of eye drops were not conducted. Since the maximum concentration of levofloxacin in plasma after topical application 1000 times less than with oral intake, the effects of interaction with other drugs are unlikely.

Special instructions:

Drops should not be used when wearing soft contact lenses due to the presence in the preservative drops of benzalkonium chloride, which can be absorbed by contact lenses and have an adverse effect on the eye tissue and cause discoloration of the contact lenses.

Effect on the ability to drive transp. cf. and fur:In the case of a transient reduction in visual acuity after instillation, it is not recommended to drive or work with potentially dangerous mechanisms until it is restored.

Form release / dosage:Eye drops 0.5%.

Packaging:

1 ml per tube - droppers.

On 2 tubes - droppers together with the instruction on application place in a pack a cardboard.

5 or 10 ml in the glass bottles.

Each bottle together with a lid-dropper and instructions for use in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

After opening, the vial should be stored for 4 weeks.

Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LSR-008567/10

Date of registration:23.08.2010 / 04.03.2015

Expiration Date:Unlimited

The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus

Manufacturer: & nbsp

BELMEDPREPARATY, RUP Republic of Belarus

Information update date: & nbsp07.03.2018

Illustrated instructions

Instructions

Levofloxacin (Levofloxacin)