Each mL of ophthalmic solution contains levofloxacin 5 mg.
Cravit Ophth Soln has a pH of 6.2-6.8 and osmotic pressure ratio of 1-1.1.
Pharmacology: Levofloxacin, an optical isomer of ofloxacin (l-form), has 2 times more potent antibiotic activity than ofloxacin.
Mechanism of Action: The main mechanism of action of levofloxacin is to inhibit DNA gyrase activities of bacteria. Its effect is 2 times greater than that of ofloxacin. There was no difference between minimum inhibitory concentrations (MICs) and minimum bactericidal concentrations (MBCs), indicating its effect being bactericidal. Also bacteriolysis around MICs was shown in morphological observation.
Microbiology: Antibacterial Activity: Levofloxacin exerts a broad-spectrum potent antibacterial activity against organisms causing ophthalmological infections, including gram-positive bacteria [Staphylococcus sp, Streptococcus sp, (including S. pneumoniae), Micrococcus sp, Enterococcus sp, Corynebacterium sp, etc], gram-negative bacteria [Pseudomonas sp, (including P. aeruginosa), Haemophilus sp, Moraxella (Branhamella) catarrhalis, Moraxella sp, Serratia sp, Klebsiella sp, Proteus sp, Acinetobacter 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.
The following infections caused by levofloxacin-susceptible strains of Staphylococcus sp, Streptococcus sp, Streptococcus pneumoniae, Micrococcus sp, Enterococcus sp, Corynebacterium sp, Pseudomonas sp, P. aeruginosa, Haemophilus sp [H. influenzae, H. aegyptius, (Koch-Weeks bacillus)], Moraxella (Branhamella) catarrhalis, Moraxella sp (Morax-Axenfeld bacillus), Serratia sp, Klebsiella sp, Proteus sp, Acinetobacter sp, Enterobacter sp, Propionibacterium acnes: Blepharitis, hordeolum, dacryocystitis, conjunctivitis, tarsadenitis, keratitis, corneal ulcer and postoperative infections.
For ophthalmic use only.
Usually, instil 1 drop at a time, 3 times daily. The dosage may be adjusted according to the patient's symptoms.
Administration: At the time of administration, the patient should be instructed not to touch the tip of the bottle directly to the eye in order to avoid contamination of Cravit Ophth Soln.
History of hypersensitivity to levofloxacin or to any of the ingredients of Cravit Ophth Soln, ofloxacin or any quinolone antibiotics.
In order to avoid the emergence of resistant bacteria, bacterial susceptibility should be confirmed and treatment with Cravit Ophth Soln should be limited to minimum period required for the eradication of infection.
The efficacy of Cravit Ophth Soln to methicillin-resistant Staphylococcus aureus (MRSA) has not been proven. Therefore, other drugs having a potent anti-MRSA activity should be administered immediately to patients positively infected with MRSA and not showing any improvement of symptoms with Cravit Ophth Soln.
Use in pregnancy: Cravit Ophth Soln 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 treatment. The safety of Cravit Ophth Soln during pregnancy has not been established.
Cravit Ophth Soln 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 treatment. The safety of Cravit Ophth Soln during pregnancy has not been established.
Clinically significant adverse reactions (rare: <0.1%; occasionally: >5%, ≥0.1%; and no specific designation: ≥5% or unknown incidence).
Shock, Anaphylactoid Reaction: Since shock and anaphylactoid reactions may occur, patients should be carefully observed. If symptoms eg, erythema, rash, dyspnoea, decreased blood pressure and eyelid oedema, etc are observed, administration should be discontinued and appropriate measure should be taken.
Others: If the following adverse reactions are observed, appropriate measures eg, discontinuing administration should be taken.
Hypersensitivity: Occasionally: Blepharitis (eyelid redness/oedema, etc), eyelid dermatitis, itching. Rare: Urticaria. Unknown Incidence: Rash.
Ophthalmic: Occasionally: Irritation, corneal lesion eg, superficial diffuse keratitis. Rare: Conjunctivitis (conjunctival injection/oedema, etc), eye pain.
Store at room temperature (1-30°C). Protect from light.
S01AE05 - levofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Cravit ophth soln 0.5%
5 mL x 1's
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