Oftaquix 5 mg/ml 0.5 ml No. 10 eye drops, tube-drop.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Chemically, levofloxacin is the L-isomer of the racemate of the drug Ofloxacin . the L-isomer of Ofloxacin that has an antibacterial effect .

An antibacterial agent from the pharmacological group of fluoroquinolones , inhibits the activity of type 2 topoisomerase DNA gyrase and topoisomerase of bacterial cells. The action in the cells of gram-negative microorganisms is directed mainly at DNA gyrase , and in gram-positive microorganisms - at topoisomerase of the fourth type.

Active against gram-negative aerobes : Haemophilus influenzae, Branchamella cataralis, Neisseria gonorrhoeae and Pseudomonas aeruginosa; gram-positive aerobes : Streptococcus pneumoniae, Streptococcus pyogenes, Staphyloccocus aureus.

Pharmacokinetics

After use, levofloxacin is well fixed in the tear film. Typically, the average concentration in the blood 60 minutes after use ranges from 0.86-2.05 ng/ml.

The highest concentration of levofloxacin in the blood is recorded on the fourth day after two days of using the drug eight times a day.

Oftaquix 5 mg/ml 0.5 ml No. 10 eye drops, tube-drop.

APPROVED by the Order of the Chairman of the Committee for Control of Medical and Pharmaceutical Activities of the Ministry of Health of the Republic of Kazakhstan From "__" ____20____ No. INSTRUCTIONS for the medical use of the drug OFTAQUIX® Trade name Oftaquix® International nonproprietary name Levofloxacin Dosage form Eye drops 5 mg/ml Composition 1 ml of solution contains the active substance - levofloxacin hemihydrate - 5.12 mg (equivalent to 5.0 mg of levofloxacin); excipients: sodium chloride, hydrochloric acid, sodium hydroxide, water for injection. Description Transparent solution from light yellow to light greenish-yellow color without mechanical inclusions. Pharmacotherapeutic group Drugs for the treatment of eye diseases. Antimicrobial drugs. Levofloxacin. ATC code S01AX19 Pharmacological properties Pharmacokinetics After instillation into the eye, levofloxacin is well preserved in the tear film. The average concentration of levofloxacin in the tear film 4 and 6 hours after topical application is 17.0 μg/ml and 6.6 μg/ml, respectively. The mean levofloxacin concentration of Oftaquix® eye drops in aqueous humor is approximately twice as high as the mean ofloxacin concentration (1139.9 ± 717.1 ng/ml and 621.7 ± 368.7 ng/ml, respectively). The average concentration of levofloxacin in blood plasma 1 hour after use is from 0.86 ng/ml on the 1st day to 2.05 ng/ml on the 15th day. The maximum concentration of levofloxacin in plasma, equal to 2.25 ng/ml, was detected on the 4th day after two days of using the drug every 2 hours up to 8 times a day. The maximum concentration of levofloxacin increased from 0.94 ng/ml on day 1 to 2.15 ng/ml on day 15, which is 1000 times lower than its concentration after oral administration of standard doses of levofloxacin. Bioabsorption is high - from 60 to 100%. Pharmacodynamics Oftaquix®, the active ingredient of which is levofloxacin, is a levorotatory isomer of the racemic substance ofloxacin. The antibacterial activity of ofloxacin is predominantly due to the levorotatory isomer. Mechanism of action As an antibacterial drug of the fluoroquinolone class, levofloxacin selectively inhibits bacterial topoisomerase type II - DNA gyrase and topoisomerase IV. The preferred targets of levofloxacin in gram-negative bacteria are DNA gyrase, and in gram-positive bacteria topoisomerase IV. Effective against the following microorganisms: Aerobic gram-positive: Staphylococcus aureus (MSSA)*, Staphylococcus pneumoniae, Staphylococcus pyogenes, Viridans group streptococci Aerobic gram-negative: Escherichia coli, Branhamella (Moraxella) catarrhalis, Haemophilus influenzae, Pseudomonas aeruginosa (local cultures) Other microorganisms Chlamydia trachomatis (treatment of patients with chlamydial conjunctivitis requires concomitant systemic antimicrobial therapy) Species for which acquired resistance may be a problem Aerobic gram-positive microorganisms: Staphylococcus aureus (MRSA)**, Staphylococcus epidermidis Aerobic gram-negative microorganisms: Pseudomonas aeruginosa (hospital strains) * MSSA = methicillin- sensitive strains of Staphylococcus aureus ** MRSA = methicillin-resistant strains of Staphylococcus aureus Indications for use - treatment of superficial bacterial infections - prevention of complications after surgical and laser operations on the eye Method of administration and dosage Locally - 1-2 drops in one or both affected eyes every 2 hours up to 8 times a day for the first 2 days, then 4 times a day for the next 3-5 days. Usually the duration of treatment is 5 days. In some cases, it is possible to increase the course of treatment to 2 weeks. When using other ophthalmic agents simultaneously, the interval between instillations should be at least 15 minutes. To avoid contamination of the solution, the tip of the dropper should not touch the eyelids or tissues around the eye. The contents of one dropper tube are sufficient for instillation into both eyes. Side effects Side effects may occur in approximately 10% of patients. Side effects are usually mild to moderate, transient, and usually limited to ophthalmic symptoms. Common (³1/100 <1/10) - burning sensation in the eyes - decreased visual acuity - appearance of mucus in the form of strands Rare (³1/1,000 <1/100) - blepharitis, chemosis, conjunctival papillary reaction, eyelid edema, discomfort, itching and eye pain, conjunctival hyperemia, conjunctival follicles, dry eyes, eyelid erythema, photophobia - headache - rhinitis Very rare (³1/10,000, <1/1,000) - extra-ocular allergic reactions, including skin rash Extremely rare (< 1 /10,000), (including individual reports) - anaphylaxis - laryngeal edema Contraindications - hypersensitivity to the active substance - levofloxacin, other quinolones or any excipient - children under 1 year of age Drug interactions Not established Special instructions Oftaquix® eye drops, 5 mg/ ml cannot be administered subconjunctivally. Eye drops should not be instilled directly into the anterior chamber of the eye. Fluoroquinolones for systemic use can cause allergic reactions even after a single use. If an allergic reaction to levofloxacin occurs, you should stop using eye drops. As with all antimicrobial agents, long-term use of Oftaquix® may lead to the growth of resistant microorganisms, including fungi. If infectious manifestations worsen or clinical improvement is not observed after a certain period, it is necessary to stop using the drug and prescribe alternative therapy. Patients who have symptoms of a superficial bacterial eye infection should not wear contact lenses. The safety and effectiveness of the drug in the treatment of corneal ulcers and neonatal gonococcal conjunctivitis have not been studied. Use in the elderly: No dosage change is required. Pregnancy and lactation Oftaquix® eye drops, 5 mg/ml can be used during pregnancy and breastfeeding if the potential benefit to the mother outweighs the possible risk to the infant and fetus. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery In case of any transient visual impairment, the patient should be advised to wait until vision returns to normal and only then drive a car or operate mechanical equipment. Overdose The total amount of levofloxacin contained in one dropper tube of eye drops is too small to cause toxic reactions after accidental ingestion. After topical application of an excess dose of Oftaquix® eye drops, 5 mg/ml, the eyes can be rinsed with clean water at room temperature. Release form and packaging 0.5 ml of solution in a disposable polyethylene dropper tube with a screw cap. 10 dropper tubes are placed in an aluminum foil bag. 1 package, along with instructions for medical use in the state and Russian languages, is placed in a cardboard box. Storage conditions Store at a temperature not exceeding 25°C. Keep out of the reach of children! Shelf life: 2 years After first opening the package with tube droppers, use it within 3 months. Do not use after the expiration date stated on the package. Conditions for dispensing from pharmacies By prescription Manufacturer JSC Santen, Finland, Tampere, 33720 Niittyhaankatu, 20 under license from Daichi Sankyo Co. Ltd., Japan Name and country of the owner of the registration certificate Santen JSC, Finland Address of the organization that accepts claims from consumers regarding product (product) quality in the territory of the Republic of Kazakhstan: Representative office of Santen JSC in Kazakhstan Almaty, st. Zheltoksan, 129/65 sq. 56 Phone number – 250-39-17 Fax number – 250-39-17 Email address

Side effects

• most often occur: a burning sensation in the eye area, decreased visual acuity, identification of mucous strands;
• less frequently appear: blepharitis , growths in the form of papillae on the conjunctiva, swelling of the eyelids, chemosis , discomfort in the eye area, pain or itching in the eye area, development of follicles on the conjunctiva, contact dermatitis , hyperemia erythema eyelids , dry eye syndrome , photophobia, eye irritation and allergic reactions;
• other reactions: rhinitis and headache .

special instructions

These eye drops cannot be used subconjunctivally or injected into the anterior chamber of the eyeball.

When using other ophthalmic agents together, the interval between their use should be more than 15 minutes.

This medication should not be used while wearing hydrophilic contact lenses.

To prevent contamination of the dropper and the drug solution, the tip of the dropper of the bottle should not come into contact with the periorbital tissues.

Antiviral eye drops: indications for use

Antimicrobial drugs for the treatment of the visual apparatus are prescribed when inflammatory processes caused by the presence of viruses are detected. The main diseases that can be caused by bacterial organisms (viruses) include:

• uveitis;
• conjunctivitis;
• keratoconjunctivitis;
• keratitis;
• iridocyclitis;
• neuritis.

In addition, antiviral agents for the eyes can be used to eliminate diseases caused by adenoviruses, piconaviruses, cytomegaloviruses, enteroviruses and herpes viruses. Before prescribing the drops, the specialist conducts an examination to identify the causative agent of the pathology.

Oftaquix's analogs

Level 4 ATX code matches:
Dancil

Oftadek

Signitsef

Vitabact

Okomistin

Tsiprolet

The most common analogues: L-Optic Rompharm, Signicef, OD-Levox, Zimaxid, Oftalmodek, Povisep, Ciborat-Oftan, Posiformin.

Oftaquix price, where to buy

In Russia, the price of Oftaquix eye drops is 207-242 rubles, in Ukraine it starts from 130 hryvnia.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

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Antibacterial drops for children

Ophthalmologists approach the prescription of antibacterial drugs for the eyes of children with special attention, since some of them have a number of side effects. Most often, doctors combine several weak-acting drugs, which may include:

• "Maxitrol" - drops that have a bacteriostatic effect and at the same time destroy pathogenic microorganisms.
• Vigamox is a product made from the antibiotic moxifloxacin. It directly affects bacteria at the cellular level, blocking their reproduction.
• "Vitabact" - contains the active component picloxidine, which has an antibacterial and antimicrobial effect. Easily tolerated by children over 1 year of age and does not cause discomfort.