VoLox Eye Drop

Each mL contains: Levofloxacin hemihydrate equivalent to Levofloxacin 5 mg.
Excipients/Inactive Ingredients: Preservative: Benzalkonium chloride 0.005%.

Levofloxacin exerts a broad-spectrum potent antibacterial activity against organisms causing ophthalmological infections, including gram-positive bacteria, gram-negative bacteria, and anaerobic bacteria. Levofloxacin, an optical isomer of Ofloxacin (l-form), has two times potent antibiotic activity than Ofloxacin.
Pharmacology: Antibacterial activity: Antibacterial activity: Levofloxacin has in vitro broad-spectrum potent antibacterial activity against microorganisms causing ocular infections, including gram-positive bacteria (Staphylococcus sp., Streptococcus sp. [including S. pneumoniae], Micrococcus sp., Enterococcus sp., Corynebacterium sp., etc.), gram-negative bacteria (Pseudomonas sp. Serratia sp., Klebsiella sp., Proteus sp., Acinetobacter sp., Enterobacter sp., etc.), and anaerobic bacteria (Propionibacterium acnes, etc.).
The antibacterial activity of Levofloxacin against standard strains for each bacteria and clinically isolated bacteria identified in patients with external ocular infections was about twice as potent as that of Ofloxacin (in vitro).
Effects on experimental Pseudomonas aeruginosa keratitis in rabbits: Levofloxacin ophthalmic solution was effective in preventing experimental P. aeruginosa keratitis in rabbits.
Mechanism of action: Main mechanism of action of Levofloxacin is to inhibit DNA gyrase activities of bacteria. Its effect is two times greater than that Ofloxacin. There was no difference between MICs and MBCs, indicating its effect being bactericidal. Also bacteriolysis around the MICs was shown in morphological observation.

For topical treatment of external ocular infection such as conjunctivitis caused by Levofloxacin-susceptible strain of Staphylococcus sp., Streptococcus pneumoniae., Micrococcus sp., Enterococcus sp., Corynebacterium sp., Pseudomonas sp., Pseudomonas aeruginosa., Haemophilus sp., (H. influenzae, H. aegypticus [Koch-Weeks bacillus], Moxarella (Branhamella) catarrhalis, Moraxella sp., Morax-Axenfeld bacillus, Serratia sp., Klebsiella sp., Proteus sp., Acinetobacter sp., Enterobacter sp., Propionibacterium acnes.

Usually, instill 1 drop a time 3 times daily. The dosage may be adjusted according to the patient's symptoms.

Patients with a history of hypersensitivity to the ingredient of this product, Ofloxacin, or any quinolone antibiotics.

Benzalkonium chloride which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and / or toxic ulcerative keratopathy. Since this drug contains Benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Contact lenses: Patients should be advised not to wear a contact lens if their eye is red. This drug should not be used to treat contact lens related irritation. The preservative in this drug, Benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling this drug before they insert their contact lenses.

General: In order to avoid emergence of resistant bacteria, bacterial susceptibility should be confirmed and treatment with this drug should be limited to the minimum period required for the eradication of the infection.
The efficacy of this product to Methicillin-resistant Staphylococcus aureus (MRSA) has not been proved. Therefore, other drug having a potent anti-MRSA activity should be administered immediately to patients positively infected with MRSA and not showing any improvement of symptoms with this product.
Use during pregnancy, delivery, or lactation: This product should be used in pregnant women or women who may possibly be pregnant only if the expected therapeutic benefits are judged to outweigh the possible risks associated with the treatment. (The safety of this product during pregnancy has not been established.)
Precautions concerning use: Route administration: ophthalmic use only.
At the time of administration: instruct the patient to be careful not to touch the tip of the bottle to the eye directly in order to avoid the contamination of the drug.

This product should be used in pregnant women or women who may possibly be pregnant only if the expected therapeutic benefits are judged to outweigh the possible risks associated with the treatment. (The safety of this product during pregnancy has not been established.)

The major adverse reactions were eye irritation and eyelid itching.
Clinically significant adverse reactions: Shock, anaphylactoid reaction: since shock anaphylactoid reaction may occur, patients should be carefully observed. If any symptoms such as erythema, rash dyspnoea, decreased blood pressure, and eyelid oedema, etc. are observed, administration should be discontinued and appropriate measures should be taken.
Other adverse reactions: If the following adverse reactions are observed, appropriate measures such as discontinuing administration should be taken: Hypersensitivity: Blepharitis (eyelid redness/oedema, etc.), eyelid dermatitis, itching, rash, urticaria.
Ophthalmic: irritation, corneal lesion such as keratitis superficial diffuse, conjunctivitis (conjunctival injection/oedema, etc.)

Store below 30°C.
Discard the bottle and any remaining solution after 28 days of opening.
Store in the original box, protected from light.
Do not freeze.

Eye Anti-Infectives & Antiseptics

S01AE05 - levofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.

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