INSTRUCTION
(information for patients)
on medical administration of medicinal preparation
LEVOFLOXACIN
Trade name: Levofloxacin.
International non-proprietary name: Levofloxacin.
Description: transparent yellowish green solution.
Composition:
active substance: levofloxacin (as levofloxacin hemihydrates) – 5 mg/ml;
additives: benzalconium chloride, sodium chloride, disodium edentate, hydrochloric acid 1M solution, water for injections.
Drug formulation: solution (eye drops) 5 mg/ml.
Pharmacotherapeutic group: Preparations for treating diseases of eyes. Antibacterial preparations. Fluoroquinolones.
ATX Code: S01AX19.
Pharmacological action
It is an antimicrobial preparation with a wide spectrum bacterial (bactericidal) effect.
The preparation is active against the following microorganisms:
- Aerobic gram positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumonia, Streptococcus pyogenes;
- Aerobic gram negative bacteria: Acinetobacter iwoffii, Haemophilus influenza, Moraxella catarrhalis, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Serratia marcescen);
- Intracellular parasites: Chlamydia trachomatis.
Indications
Treatment of surface bacterial infections of eyes in patients aged 1 year and older.
Prevention of complications after surgical and laser ophthalmological operations.
Mode of administration and dosage
1 – 2 drops of the preparation is instilled into the conjunctival sac of one affected eye or of both every 2 hours (up to eight times per day) during the first 2 days. Then it is instilled every 4 hours (up to 4 times per day) for 3 – 7 days. The treatment duration usually is 5 days. When several ophthalmological local preparations are administered 15 minutes intervals between the instillations should be observed. Do not touch the eyelids and tissues around eyes with the dropper tip in order to avoid the solution contamination. The drops safety and efficiency for treating newborn’s corneal ulcers and gonococcal conjunctivitis are not studied. The dosage for elderly patients does not need changing.
Side effects
The side reactions rate is determined according the following grading: very frequent (≥1/10), frequent (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), occasional <1/10000).
Eyes:
Frequent: eyes burning, vision acuity reduction and appearance of mucus in form of bands.
Rare: blepharitis, chemosis, conjunctival papilla reaction, edema of lids, discomfort, itching and painful eyes, conjunctiva hyperemia, dry eyes, erythema of lids, and photophobia.
Immune system:
Rare: extraocular allergic reactions including skin eruption.
Occasional: anaphylaxia.
Nervous system:
Rare: headache.
Respiratory organs:
Rare: rhinitis.
Occasional: edema of larynx.
Contraindications
Hypersensitivity to levofloxacine or to other quinolones, benzalconium chloride; pregnancy, period of lactation, infancy up to 1 year.
Overdosing
The preparation in form of eye drops overdosing is hardly possible.
Symptoms: irritation of tissues (burning, reddening, edema, colics, lachrymation).
Treatment: Wash the eyes with clean (piped) water of room temperature, in case of evident side effects – symptomatic therapy.
Specificity of administration
Do not administer the preparation subconjunctively, avoid direct instillations in the eye anterior chamber.
The eye drops contain benzalconium chloride as a preservative. Do not administer the preparation while wearing hydrophilic (soft) contact lenses as they can absorb the preservative and the latter can cause irritation of eyes.
Do not wear contact lenses of any type when bacterial conjunctivitis symptoms appear.
Administration during pregnancy and period of lactation. It is contraindicated.
Measures of precaution
Systemic fluoroquinolones can cause allergic reactions (accompanied by the cardiovascular system disturbances, edema of larynx, pharynx and face, labored breathing) even administered once. After an allergic reaction associated with levofloxacin administration has developed the drops instillating should be stopped.
Levofloxacin eye drops administration for a long time can lead to resistant microorganisms and fungi growth. When the clinical picture worsens or is absent the preparation should be cancelled and other therapy should be prescribed.
Impact on driving capacity and managing other potentially dangerous mechanisms. When the drops have been instilled the vision acuity can be disturbed and the person should refuse driving and managing mechanisms till the normal vision restores to the normal.
Interaction with other medicinal agents
The levofloxacin eye drops interaction with other preparations has not been studied. As the plasma levofloxacin maximum concentration when it is administered locally is 1000 times less than after an oral administration interaction with other medicinal agents is hardly possible.
Storage conditions
Keep protected from light exposure at temperature not exceeding 25°C.
Keep away from children.
Keep the opened bottle protected from light exposure at temperature 15°C to 25°C for 4 weeks.
Shelf life
3 years. Do not use after the shelf life specified on the pack has expired.
Packing
1 ml dropping tubes. 2 dropping tubes accompanied by an instruction on the drops administration are put into a cardboard box. 5 ml bottles. Each bottle accompanied by a dropping cover and an instruction on the drops administration are put into a cardboard box.
Terms of sale
On physician’s prescription.
Manufacturer:
Belmedpreparaty RUE
30 Fabritsius Str., 220007 Minsk, Republic of Belarus,
Tel./fax: (+375 17) 220 37 16,
e-mail: medic@belmedpreparaty.com,
http://www.belmedpreparaty.com
I hereby certify the authenticity of the translation with the original document. Translator G.F.Grigorieva.
