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Therapeutic Category
- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Single Dose Ophthalmic Solutions
- Composition : Each 1 ml of sterile eye drop solution contains: 5.12 mg Levofloxacin Hemihydrate equivalent to 5 mg Levofloxacin. Each one single dose (0.3 ml) contains 1.5 mg of levofloxacin.
- Active Substance : Levofloxacin (Hemihydrate)
Mechanism of action:
As a fluoroquinolone antibacterial agent, levofloxacin inhibits bacterial type II topoisomerases—DNA gyrase and topoisomerase IV. Levofloxacin preferentially targets DNA gyrase in Gram-negative bacteria and topoisomerase IV in Gram-positive bacteria.
Pharmacokinetics:
After ocular instillation, levofloxacin is well maintained in the tear-film.
As yet, the plasma concentrations of levofloxacin reached after application to infected eyes are not known.
Indications:
levofloxacin eye drops are indicated for the topical treatment of bacterial external ocular infections in patients ≥1 year of age caused by levofloxacin susceptible microorganisms.
levofloxacin eye drops are indicated in adults, children aged ≥1 year to 12 years and adolescents aged 12 to 18 years.
Contraindication:
In patients hypersensitive to levofloxacin or any other quinolone and any of the excipients .
Side effects:
Nervous system disorders:
Uncommon : Headache.
Eye disorders
Common : Ocular burning, decreased vision and mucous strand.
Uncommon: Lid matting, chemosis, conjunctival papillary reaction, lid oedema, ocular discomfort, ocular itching, ocular pain, conjunctival injection, conjunctival follicles, ocular dryness, lid erythema, and photophobia.
No corneal precipitates were observed in clinical studies.
Respiratory, thoracic and mediastinal disorders:
Uncommon : Rhinitis.
Warnings And Precautions For Use:
levofloxacin eye drops must not be injected sub-conjunctivally. The solution should not be introduced directly into the anterior chamber of the eye.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If worsening of infection occurs, or if a clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy.
Patients with external bacterial ocular infections should not wear contact lenses.
Systemic fluoroquinolones have been associated with hypersensitivity reactions, even following a single dose. If an allergic reaction to levofloxacin occurs, discontinue the medication.
Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including levofloxacin, particularly in older patients and those treated concurrently with corticosteroids. Therefore, caution should be exercised and treatment with levofloxacin eye drop should be discontinued at the first sign of tendon inflammation.
Pediatric population:
The special warnings and precautions for use are the same in adults and children aged ≥1 year.
Pregnancy:
There are no adequate data from the use of levofloxacin in pregnant women. The potential risk for humans is unknown.
levofloxacin eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Breastfeeding:
Levofloxacin is excreted in human milk. However, at therapeutic doses of levofloxacin eye drops no effects on the suckling child are anticipated. levofloxacin eye drops should be used during lactation only if the potential benefit justifies any potential risk to the nursing child.
Effects on ability to drive and use machines:
levofloxacin eye drops have minor influence on the ability to drive and use machines.
If there are any transient effects on vision, the patient should be advised to wait until this clears before driving or operating machinery.
Drug interaction:
Specific drug interaction studies have not been conducted with levofloxacin eye drops.
Since maximum plasma concentrations of levofloxacin after ocular administration are at least 1000 times lower than those reported after standard oral doses, interactions mentioned for systemic use are unlikely to be clinically relevant when using levofloxacin eye drops.
Posology:
For all patients instill one to two drops in the affected eye(s) every two hours up to 8 times per day while awake for the first two days and then four times daily on days 3 through 5.
If different topical ocular medications are used concomitantly, at least a 15-minute interval is required between instillations.
The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection. The usual treatment duration is 5 days.
Safety and efficacy in the treatment of corneal ulcer and ophthalmia neonatorum has not been established.
levofloxacin eye drops is not recommended for use in children below age 1 year due to a lack of data on safety and efficacy.
Use in the elderly:
No adjustment of dosage is required.
Pediatric population:
The posology is the same in adults and children aged ≥1 year.
The safety and efficacy of levofloxacin eye drops in children aged ≥1 year have been established.
The safety and efficacy of levofloxacin eye drops in children < 1 year have not yet been established.
Method of administration
Ocular use. For single use only.
The contents of one single-dose container are sufficient for both eyes.
The eye drops, solution should be used immediately after first opening the single dose container.
The used single dose container should be discarded.
Overdose:
The total amount of levofloxacin in the provided amount of single-dose container of eye drops is too small to induce toxic effects after an accidental oral intake. If considered necessary, the patient can be observed clinically and supportive measures can be undertaken. After a local overdose with levofloxacin eye drops, the eyes can be flushed with clean (tap) water at room temperature.