Registration number:
Trade name of the drug: Oftaquix
International nonproprietary name: levofloxacin
Dosage form: eye drops
Composition of 1 ml solution:
Active substance:
levofloxacin hemihydrate 5.12 mg, which is equivalent to levofloxacin 5.0 mg
Excipients:
benzalkonium chloride, sodium chloride, hydrochloric acid, sodium hydroxide, water for injection.
Description: light yellow or light greenish yellow solution.
Pharmacotherapeutic group: antimicrobial agent – fluoroquinolone
ATX code: S01AX19
Pharmacological properties
Pharmacodynamics
Levofloxacin is the L-isomer of the racemic drug substance ofloxacin. The antibacterial activity of ofloxacin relates mainly to the L-isomer.
As an antibacterial drug of the fluoroquinolone class, levofloxacin blocks DNA gyrase and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall and membranes.
Effective against:
Gram-negative aerobes:
Branhamella (Moraxella) catarrhalis
Haemophilus influenza
Neisseria gonorrhoeae
Pseudomonas aeruginosa
Gram-positive aerobes:
Staphylococcus aureus
Streptococcus pneumonia
Streptococcus pyogenes
Pharmacokinetics
After instillation into the eye, levofloxacin is well preserved in the tear film. In studies in healthy volunteers, the mean 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 six subjects, levofloxacin concentrations were 2 μg/ml or higher 4 hours after instillation. In four out of six subjects, this concentration remained 6 hours after instillation. The average concentration of levofloxacin when using Oftaquix eye drops 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 mean 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 hour after use is from 0.86 ng/ml on the 1st day to 2.05 ng/ml. 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. Maximum concentrations of levofloxacin were achieved on the 15th day, which is more than 1000 times lower than those concentrations observed after oral administration of standard doses of levofloxacin.
Indications for use
1) Treatment of superficial bacterial infections of the eye of patients aged 1 year and older;
2) Prevention 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.
Directions for use and doses
Locally, into the affected eye.
1-2 drops into the affected eye(s) every two hours up to 8 times a day while awake for the first 2 days, then four times a day from the 3rd to the 5th day. The duration of treatment is determined by the doctor, usually 5 days.
Side effect
Side effects may occur in approximately 10% of patients.
Common side effects (1-10% of patients):
Burning sensation in the eye, decreased visual acuity and the appearance of mucous strands.
Rare side effects (0.1-1% of patients):
Blepharitis, chemosis, papillary growths on the conjunctiva, swelling of the eyelids, discomfort in the eye, itching in the eye, pain in the eye, hyperemia of the conjunctiva, the appearance of follicles on the conjunctiva, dry eye syndrome, erythema of the eyelids, irritation, contact dermatitis, photophobia and allergic reactions. Other reactions reported during clinical trials included headache and rhinitis.
Overdose
The total amount of levofloxacin contained in one vial of eye drops is too small to cause toxic reactions, even after accidental ingestion. After topical application of an excess dose of Oftaquix eye drops, 5 mg/ml, the eye should be rinsed with clean (tap) water at room temperature.
Interaction with other drugs
No specific interaction studies have been conducted with Oftaquix eye drops, 5 mg/ml. Since the maximum plasma concentration of levofloxacin after topical application to the eye is at least 1000 times lower than after standard oral doses, interactions with other drugs characteristic of systemic use are likely to be clinically insignificant.
special instructions
Oftaquix eye drops, 5 mg/ml, should not be administered subconjunctivally or directly into the anterior chamber of the eye.
When using other ophthalmic agents simultaneously, 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 dropper tip and solution, do not touch the eyelids or tissue around the eye with the tip of the dropper.
Release form: eye drops 0.5%.
5 ml in a polyethylene bottle with a dropper tip and a screw cap. Transparent film ring to control the first opening of the bottle. The bottle with instructions for use is placed in a cardboard box.
Storage conditions:
Store at temperatures below 25° C.
Keep out of the reach of children.
Best before date:
3 years.
Use within 1 month. after opening the bottle.
Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies:
On prescription.
Manufacturer and acceptor of quality claims:
JSC Santen, Finland, Tampere, 33720, Nittihaankatu 20
Representative office in Moscow:
119049, st. Mytnaya, 1, office 13.
Instructions for use:
Oftaquix (international name Levofloxacin) is an antimicrobial drug from the group of fluoroquinolones. The drug is intended to eliminate inflammatory processes in the eyes and destroy harmful microorganisms that cannot be treated with penicillin and other antibiotics.
The main active ingredient is Levofloxacin 5.12 mg.
Auxiliary components: benzalkonium chloride, sodium chloride, sodium hydroxide, hydrochloric acid and purified water. Oftaquix is produced in the form of eye drops in 5 ml bottles with a dropper, which are placed in cardboard packaging. Oftaquix drops have a light yellow tint, a uniform consistency and a faint chlorine odor.
Oftaquix eye drops are a broad-spectrum drug with antibacterial, antimicrobial and anti-inflammatory effects. The active ingredient of the drug is aimed at suppressing the synthesis of DNA gyrase and changing the morphology in the cytoplasm, membrane and cellular structures.
Oftaquix acts against various ocular bacteria and microorganisms, including Staphylococcus aureus, Streptococcus agalactiae, Enterobacter cloacae, Enterococcus faecalis, Klebsiella oxytoca, Moraxella catarrhalis, Proteus vulgaris, Bordetella pertussis, Chlamydia pneumoniae, Klebsiella oxytoca, Acinetobacter anitratus, etc.
The active substance levofloxacin has a pronounced antimicrobial effect and suppresses the formation of DNA of microorganisms, and also neutralizes their negative effects on the mucous membrane of the eyes.
Oftaquix has good reviews as a fast-acting drug with a high degree of effectiveness in the treatment of eye diseases caused by gram-positive and gram-negative bacteria.
Oftaquix drops, after application to the mucous membrane of the eyes, may be retained in the tear film. The average concentration of the drug is achieved within 5-7 hours, and the maximum concentration is recorded on the 4th day of use and is 2 μg/ml.
The therapeutic effect of the drug lasts for 6 days after completion of the full course of treatment. The active components of Oftaquix create and maintain blocking from re-infection with eye infections and bacteria for 5-7 days.
Oftaquix drops are indicated for use in various types of superficial eye lesions due to infections, gram-positive and gram-negative bacteria, bacterial corneal ulcers, chronic and acute inflammation of the mucous membrane of the eyes. The drug is prescribed for the treatment of conjunctivitis, blepharitis, keratitis, dacryocystitis and meibomitis.
Oftaquix received positive reviews as an effective drug for the prevention of complications after eye surgery and during the rehabilitation period.
Oftaquix has many good reviews as an effective remedy for the treatment of infectious complications, inflammatory processes and the effects of foreign bodies on the eyeball and adnexa.
According to the instructions, Oftaquix is used topically, instilling the drug into the corner of the eye or onto the affected area of the mucous membrane. For 2-3 days, use 2 drops of the drug in each eye, and then the dosage is increased to 4 drops per day. The duration of treatment should be determined by the attending physician, who throughout the course adjusts the dosage in accordance with the patient’s indications and the type of eye disease. The average duration of treatment is 5-10 days.
According to the instructions, Oftaquix should not be prescribed to pregnant women, as it has side effects on the fetus. If there is a high need for the drug, breastfeeding is canceled.
The Oftaquix instructions prescribe compliance with the interval in taking other ophthalmic drugs. Oftaquix should not be instilled into the anterior chamber of the eye, and these drops are not recommended for use when wearing soft contact lenses.
Oftaquix eye drops are contraindicated for use in cases of individual intolerance and allergic reactions to the components of the drug, pregnancy and lactation, as well as in children under 2 years of age.
With caution, Oftaquix is prescribed to patients with inflammatory lesions of the skin, renal and liver failure, severe cardiovascular diseases and in old age.
Oftaquix can provoke allergic reactions, including burning and itching, urticaria, conjunctivitis and Quincke's edema. Drops can cause the development of blepharitis, swelling of the eyelids, dermatitis, erythema and irritable eye syndrome.
The active substance levofloxacin can have side effects on various body systems. Side effects include:
After a course of treatment with Oftaquix drops, skin reactions may appear, including induration, hyperemia, skin rash, peeling and increased sweating, which usually disappear within 5-7 days.
Composition of the medicinal product Oftaquix
1 ml of Oftaquix contains 5.12 mg of levofloxacin hemihydrate, which corresponds to 5 mg of levofloxacin. The Oftavix vial contains 25.6 mg of levofloxacin hemihydrate, corresponding to 25 mg of levofloxacin.The drug can be used for inflammatory eye lesions caused by microorganisms resistant to the action of aminoglycosides, macrolides and beta-lactam antibiotics, including penicillin and tetracyclines.
After instillation of the drug into the eye, levofloxacin remains in the tear film for a long time. Studies on volunteers showed that the average concentration of levoflaxazine in the tear film 4 and 6 hours after instillation of the drug into the eye was 17.0 μg/ml and 6.6 μg/ml. The concentration of levofloxacin four hours after instillation into the eyes is 2 μg/ml; this concentration of the drug remains in 50% of the subjects six hours after instillation.
The concentration of levofloxacin when using Oftaquix in aqueous humor is higher than the average concentration of ofloxacin. One hour after use, the average concentration of levofloxacin in blood plasma ranges from 0.86 ng/ml to 2.05 ng/ml. The maximum concentration of levofloxacin in blood plasma equal to 2.25 ng/ml was determined on the fourth day, when using the drug for two days every two hours up to eight times a day. The maximum concentration of levofloxacin, which was determined after two weeks, was more than 1000 times lower than the concentration that was determined in the blood after taking the drug orally in standard prescribed doses.
The clinical effect of levofloxacin eye drops in a randomized, double-blind, controlled trial for the treatment of bacterial conjunctivitis was 79% at the end of six days of treatment. Microbiological eradication reached 90%.
Oftaquix cannot be used subconjunctivally or injected into the anterior chamber of the eye. When a doctor prescribes the simultaneous use of several ophthalmic drugs, it is necessary to maintain an interval between installations of different drugs of at least 10-15 minutes.
Since Oftaquix contains benzalkonium chloride as an additional substance, which is absorbed by hydrophilic (soft) contact eye lenses and can cause eye irritation, wearing soft lenses during treatment with the drug is contraindicated.
To prevent infection from entering the dropper tip of the bottle and into the solution during installation of eye drops, it is not recommended to touch the periorbital tissues of the affected eye with the tip of the dropper.
After installation of Oftavix eye drops, a temporary decrease in visual acuity is possible. Therefore, after administering the drug, you need to wait some time until your vision is completely clear and only then start driving a car or working with various mechanisms.
If symptoms of hypersensitivity appear in the form of skin itching, rash, hyperemia, rhinitis and lacrimation, use of the drug should be discontinued.
If the patient's condition worsens, the use of the drug should be discontinued and an alternative method of treating the disease should be prescribed.
Oftaquix can be used to treat elderly patients without dose adjustment.
The drug is not prescribed to children under 1 year of age.
Before prescribing Oftaquix, it is recommended to conduct tests to determine the type of pathogen and its sensitivity to levofloxacin. Periodic testing during treatment with levofloxacin makes it possible to obtain the necessary information about the sensitivity of microorganisms to the drug and the possible development of bacterial resistance.
From the nervous system and sensory organs, headaches, dizziness, increased fatigue, impaired taste and olfactory sensitivity, asthenia, coordination disorders, hallucinations, nervousness, thinking disorders, decreased concentration, sleep disturbances, diplopia, tinnitus, hearing impairment may occur. and vision.
From the cardiovascular system, the development of hypertension, orthostatic hypotension, heart failure, various arrhythmias, blockades, circulatory failure, myocardial infarction, thromboembolism, phlebitis is possible. A blood test determines thrombocytopenia, leukocytosis, leukopenia, lymphopenia, granulocytopenia, lymphadenopathy.
From the respiratory system - the development of sinusitis, rhinitis, asthma, acute respiratory distress syndrome, dry cough, shortness of breath, respiratory failure.
From the gastrointestinal tract - the appearance of nausea, abdominal pain, dyspeptic disorders, vomiting, flatulence, dry mouth, dysphagia, gastroenteritis, colitis, liver dysfunction, jaundice.
From the urinary and reproductive systems, it is possible to develop vaginitis, genital itching, decreased kidney function, increased creatinine in the blood serum, ejaculation disorders and impotence.
From the musculoskeletal system, the development of arthritis and arthrosis, arthralgia, muscle weakness, myalgia, synoviitis, tendonitis, paresthesia, and increased muscle tone is possible.
On the skin side, itching, rash, erythema nodosum, skin peeling, ulceration, urticaria, and increased sweating may occur.
Other side effects include local reaction, inflammation and pain at the injection site, chest and back pain, weight loss, hyperthermia, increase or decrease in serum potassium, tissue dehydration, decrease or increase in blood glucose levels, tissue edema face, development of withdrawal syndrome.
These side effects are possible only when taking significant doses of the drug orally, which is impossible when prescribing levofloxacin in a solution for eye drops.
The use of eye drops with levofloxacin may be accompanied by the development of a transient decrease in visual acuity, a burning sensation in the eyes, pain, discomfort and the sensation of a foreign body in the eye, minor fever, headache, inflammation of the pharynx, photophobia, as well as allergic reactions, swelling of the eyelids, a feeling of dryness and itching in the eyes.
Hyperemia of the sclera of the eyes, purulent discharge, itching - all this can be clinical signs of penetration and spread of pathogenic microbes on the mucous membrane of the organ of vision.
Conjunctivitis of bacterial etiology most often develops in children, but adults can also suffer from unpleasant symptoms of this disease. Eye infection can occur when using someone else's face towels or cosmetics; often the sclera becomes inflamed in windy weather and after suffering respiratory diseases.
Unpleasant symptoms force sick people to look for a remedy that can eliminate symptoms in a short time and is safe for the whole body. Such drugs include Oftaquix eye drops; its components have a pronounced antimicrobial effect against a wide group of pathogenic microflora.
Five milliliters of solution is supplied in a plastic bottle (soft polyethylene), 5 ml capacity with a dropper tip (soft polyethylene) and a tan screw cap (hard polyethylene).
1 ml solution:
Clinical and pharmacological group: antibacterial drug of the fluoroquinolone group for topical use in ophthalmology.
Oftaquix drops are indicated for use in various types of superficial eye lesions due to infections, gram-positive and gram-negative bacteria, bacterial corneal ulcers, chronic and acute inflammation of the mucous membrane of the eyes. The drug is prescribed for the treatment of conjunctivitis, blepharitis, keratitis, dacryocystitis and meibomitis.
Oftaquix received positive reviews as an effective drug for the prevention of complications after eye surgery and during the rehabilitation period.
Oftaquix has many good reviews as an effective remedy for the treatment of infectious complications, inflammatory processes and the effects of foreign bodies on the eyeball and adnexa.
The active ingredient in Oftaquix levofloxacin eye drops is the L-isomer of ofloxacin, which belongs to the group of chemical compounds fluoroquinolones that have antibacterial activity.
It has a bactericidal effect (leads to the death of bacteria) due to the suppression of the DNA gyrase enzyme, which catalyzes the DNA supercoiling reaction (deoxyribonucleic acid) of the bacterial cell. Suppression of enzyme activity leads to a decrease in the stability of bacterial DNA with cell death. Levofloxacin is active against a wide range of microorganisms, which include Branchamella (Moraxella) cataralis, Haemophilus influenzae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Staphyloccocus aureus, Streptococcus pneumoniae, Streptococcus pyogenes.
After instilling Oftaquix eye drops into the conjunctival sac, the active substance is distributed in high concentrations in the tear fluid, which envelops the surface of the mucous membrane of the eye in the form of a film. The high concentration is maintained for 4-6 hours. In small amounts, levofloxacin can be absorbed into the systemic circulation.
According to the instructions for use, Oftaquix eye drops are prescribed topically and instilled into the affected eye.
The duration of treatment is determined by the doctor and is usually 5 days.
Contraindications to the use of Oftaquix are: pregnancy; lactation period (breastfeeding); hypersensitivity to quinolone drugs; hypersensitivity to the components of the drug.
The drug should be used with caution in children.
Side effects when using drops:
Oftaquix eye drops are contraindicated during pregnancy and lactation (breastfeeding).
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.
The toxic effect of levofloxacin is possible when taking the drug orally, however, one bottle of Oftaquix levofloxacin eye drops contains a small amount, which cannot lead to the development of toxic reactions even as a result of accidental ingestion of the drug.
When using an excessive dose of Oftaquix topically, the eye should be rinsed with a sufficient amount of clean water at room temperature.
Reviews report satisfaction with the results of treatment with the drug for the vast majority of patients who used Oftaquix as prescribed by a doctor. Among the disadvantages, the most often noted is the high price of this drug.
In terms of the active substance and therapeutic effect of Oftaquix eye drops, the drugs Signicef and Levofloxacin are similar.
The average price of OFTAQUIX, drops in pharmacies (Moscow) is 245 rubles.
The drug is available with a prescription.
Store at a temperature not exceeding 25 °C. Keep away from children. Shelf life – 3 years (after opening the bottle – 1 month).
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Treatment of infectious ophthalmological diseases is carried out using antibacterial agents.
This group of drugs is also necessary in the postoperative period, when the risk of tissue infection increases. Effectively eliminate unpleasant symptoms, which are expressed in purulent discharge from the conjunctiva, itching, pain, antibiotic medications.
One of them is Oftaquix .
Antibiotics, actively used in the fight against pathogenic bacteria, are used internally and locally.
Oftaquix is available in the form solution light yellow or light green with a yellow tint.
Eye drops have a local effect, practically not being absorbed into the main bloodstream.
The basis of the composition is levofloxacin hemihydrate.
1 ml of medicinal liquid contains 5.12 mg (or 5 mg of levofloxacin).
Auxiliary components improve the absorption of levofloxacin.
For these purposes, the following are used in production:
The medicinal solution is packaged in 5 ml droppers made of polyethylene. The neck of the container is equipped with a tip, which makes the procedure more comfortable.
You can buy an ophthalmic product in a network of pharmacies or by placing an order in an online pharmacy.
The cost of the medicine varies in the range 207-229 rubles.
How much the medicine costs can be found on the reference website in the RLS system, where all drugs that have been registered in the Russian Federation are listed.
The pronounced antimicrobial effect of levofloxacin is used in the treatment of bacterial infections of the eye and after surgical interventions on the tissues of the organ of vision (using or surgical intervention).
In this case, the patient’s age does not play a special role; the use of medications is allowed from one year of age.
The basis of the composition is levofloxacin, which copes with different types of microorganisms:
Eye drops are effective in cases that have developed for unknown reasons. The mechanism of action of the active substance of Oftaquix is so effective that the medicine is prescribed in cases where ampicillin and penicillin are powerless.
The dynamics of improvement can be noted after 2-3 days after starting eye drops. After using the drops for five days, not a trace remains of the characteristic symptoms.
Oftaquix is a popular prophylactic drug that allows you to avoid complications and secondary infections after surgery.
Among the main benefits the drug – the absence of allergic reactions to the components used in production (allergy to drops is extremely rare).
The ophthalmic solution is intended for introduction into the eye cavity by instillation.
The active component has a local effect; a negligible amount of the chemical compound penetrates into the bloodstream.
The manufacturer in the annotation offers the following rules for using eye drops:
The duration of treatment depends on the complexity of the disease and the bacteriological dynamics of the infection. But in any case, the duration of use of the drug should not exceed 15 days.
During the study of the drug, no negative manifestations were identified in elderly patients. This indicates that the medicine can be used for preventive and therapeutic purposes without changing the dosage specified in the instructions.
The manufacturer indicates the presence of some contraindications to the use of Oftaquix eye drops. They mainly relate to the period of pregnancy and lactation, predisposition to allergies to quinolone group drugs.
Before using an ophthalmic product, you should familiarize yourself with the list of components of the composition. If you have hypersensitivity to one or more substances, you should discard the solution.
If the drug is prescribed to patients childhood, the treatment regimen and dosage should be strictly followed. If you detect the slightest disturbances or symptomatic manifestations, you should immediately report them to your doctor.
The effects of Oftaquix eye drops have been tested on animals.
Based on the results of the research, the fact of penetration of the active substance into the placental zone and breast milk was revealed.
Therefore, patients who are carrying or breastfeeding a child are not prescribed an ophthalmic agent.
The risk of developing side effects is minimized, and the drug also has few contraindications. Thanks to these factors, the medicine can be used from early childhood (from 1 year).
According to average statistical data, side effects are recorded in approximately 10% of patients who are treated with Oftaquix eye drops. Of this amount, most of it is due to burning in the eye and decreased clarity of vision.
The appearance of mucous strands is also possible.
Other manifestations are quite rare:
