LEVOXIMED ear/eye drops

Levoximed (Eye/ear Drops)
(Levofloxacin)

 

COMPOSITION
Each ml contains levofloxacin 5 mg.

THERAPEUTIC INDICATIONS
Ophtalmology:
- Treatment of superficial bacterial infections of eyes, caused by susceptible to levofloxacin microorganisms, in patients at the age from 1 year and older;
- Bacterial conjunctivitis;
- Purulent corneal ulcer;
- Gonorrheal and chlamydial diseases of eyes in adults;
- Prophylaxis of complications after surgical and laser operations in eye.
Otology:
- Otitis externa;
- Acute and chronic otitis media;
- Prophylaxis of infectious otitis before and after surgery, at ear traumas, extraction of foreign body from external auditory meatus, accompanied by ear tissues damage.

CONTRAINDICATIONS
- Hypersensitivity to levofloxacin and other drug components;
- Hypersensitivity to drugs of quinolone group.

ADVERSE EFFECTS
In less than 3% of cases – short time eye burning sense, visual acuity decrement, mucus appearance in the form of strands; in less than 1% of cases – eyelids adhesion, chemosis, papillary conjunctivitis, eyelid edema, unpleasant sensation in eye: itching, pain, hyperaemia of conjunctiva, follicles appearance in conjunctiva, dry eye syndrome, eyelid erythema, lacnmation, photophobia.

DOSAGE AND ADMINISTRATION
Only for local use. Ophtalmology: Adults and children older than 1 year: during first 2 days 1-2 drops are instilled into one/both affected eyes every 2 hours till 8 times per day. During 3-7 days every 4 hours (up to 4 times per day). Treatment duration depends on the severity of disease and evolution of clinical and bacteriological infection. The duration of treatment usually makes 7 days. At concomitant application of several ophthalmologic drugs for local use it is necessary to keep the interval of 15 minutes between instillations. In order to avoid solution contamination, it is not allowed to touch with dropper tip to eyelids and tissues around the eye.
Otology: At otitis externa: Adults: 10 drops are instilled into effected ear 1 times per day during 7 days. Children from 1 year to 12 years old: 5 drops are instilled into effected ear 1 times per day during 7 days. At chronic suppurative otitis media (with perforation of tympanic membrane): patients at the age of 12 years and older 10 drops are instilled into effected ear 2 times per day during 14 days.
At prophylaxis of infectious otitis: 5 drops are instilled into effected ear 2 times per day during 10 days. The sanitization external acoustic meatus should be provided before drops Levoximed instillation into ear. The solution should be instilled into acoustic meatus. The patient lies down, making affected ear upwards and should stay in such position at least 5 minutes after drug instillation. The drops should flow down after instillation into acoustic meatus, pulling off earlap down and backwards. Cotton swab may be placed into acoustic neatus. It is recommended to warm the solution before instillation, holding it in hands for 1-2 minutes.

PREGNANCY AND LACTATION
Due to the absence of data of clinical study concerning the administration of preparation during pregnancy, use of eye/ear drops of levofloxacin is possible if the expected benefit of therapy exceeds the potential risk. It is necessary to use Levoximed carefully during lactation period.

PRECAUTIONS
Eye/ear drops contain benzalkonium chloride as a preservative. The drug should not be applied during hydrophilic (soft) contact lenses wearing, as this preservative may be absorbed and cause eye irritation.

MANUFACTURED FORM
5 ml vial with dropping stopper and screw cap, supplied with guard ring. 1 vial in carton box with packaging leaflet.