THERAPEUTIC INDICATIONS:
-
treatment of superficial bacterial eye infections in patients over 8 years of age.
Download instructions for use
Composition
1 ml of the solution contains
- active substance - levofloxacin hemihydrate - 5.12 mg (equivalent to 5.0 mg of levofloxacin);
- excipients: benzalkonium chloride, sodium chloride, hydrochloric acid, sodium hydroxide, water for injection.
Pharmaceutical form
Eye drops, 5 mg/ml
Pharmacotherapeutic group
Sense organs. Ophthalmologicals. Antimicrobials. Fluoroquinolones. Levofloxacin.
ATC code S01AE05
Indications
- treatment of superficial bacterial eye infections in patients over 8 years of age.
Contraindications
- hypersensitivity to the active substance - levofloxacin, other quinolones or any excipient;
- children under 8 years of age.
Posology and method of administration
Topically - 1-2 drops in one or both affected eyes every 2 hours up to 8 times a day during the first 2 days, then 4 times a day for the next 3-5 days. Usually the duration of treatment is 5 days. With the concomitant use of other ophthalmic agents, 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 and tissues around the eye.
Adverse reactions
Side effects can occur in about 10% of patients. Side effects are usually mild to moderate, transient, and usually limited to ophthalmic symptoms.
Common (³1/100 <1/10):
- eye burning;
- decreased vision;
- mucous discharge from the eyes in the form of strands.
Uncommon (³1/1,000 <1/100):
- blepharitis, chemosis, conjunctival papillary reaction, eyelid edema, eye discomfort, itching and pain, conjunctival hyperemia, conjunctival follicles, dry eyes, erythema eyelid, photophobia;
- headache;
- rhinitis.
Rare (³1/10,000, <1/1,000):
- extra-ocular allergic reactions, including skin rash.
Very rare (< 1/10,000), (including individual reports):
- anaphylaxis;
- laryngeal edema.
Overdose
Overdose of the product in the form of eye drops is unlikely
Symptoms: tissue irritation (burning, redness, swelling, tears, lacrimation).
Treatment: rinse with clean (tap) water at room temperature, in the presence of pronounced side effects - symptomatic therapy.
Use during pregnancy or breastfeeding
Levofloxacin-DF Eye Drops, 5 mg/ml may be used during pregnancy and lactation if the potential benefit to the mother exceeds the possible risk to the infant and fetus.
Pediatric population
Do not use in children under 8 years of age.
Special warnings
Levofloxacin-DF Eye Drops, 5 mg/ml should not 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, discontinue use of the eye drops.
As with all antimicrobials, long-term use of Levofloxacin-DF can lead to the growth of resistant microorganisms, including fungi. If there is a worsening of infectious manifestations or no clinical improvement after a certain period, it is necessary to stop using the product and prescribe an alternative therapy.
Levofloxacin-DF eye drops, 5 mg/ml contain benzalkonium chloride as a preservative, which may cause irritation, and should not be used while wearing hydrophilic (soft) contact lenses, as the preservative may be absorbed by them and cause eye irritation. Iritis is possible; remove contact lenses before use and wait at least 15 minutes after instillation. Patients should not use contact lenses if they have symptoms of a superficial bacterial eye infection.
Benzalkonium chloride discolors soft contact lenses.
Safety and efficacy of the product in the treatment of corneal ulcer and gonococcal conjunctivitis in newborns have not been studied.
Elderly: No dosage adjustment is required.
Effects on ability to drive and use machines
In the case of any transient visual impairment, the patient should be advised to wait until vision has normalized before driving a motor vehicle or operating mechanical equipment.
Presentation and package
5 ml of the product in plastic dropper bottles, sealed with tamper-proof caps. Each bottle has a label made of label or writing paper. One bottle with instructions for use in the state and Russian languages are placed in a carton pack made of chrome-ersatz.
Storage conditions
Store below 25°С.
Keep out of the reach of children.
Shelf life
3 years
The period of use of the product after opening the bottle is 28 days.
Manufacturer
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.
Marketing authorization holder
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.
Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:
"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,
Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.