Cravit Ophthalmic

Cravit Ophthalmic

levofloxacin

Manufacturer:

Santen

Distributor:

The Glory Medicina
/
DKSH
Full Prescribing Info
Contents
Levofloxacin.
Description
0.5% ophth soln: (See Table 1.)

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1.5% ophth soln: (See Table 2.)

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Action
0.5% ophth soln: 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 (-form) of ofloxacin, has two times more potent antibiotic activity than ofloxacin.
1.5% ophth soln: Levofloxacin hydrate is a fluoroquinone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin hydrate, is the L-isomer of the racemate ofloxacin, has almost two times more potent antibiotic activity than ofloxacin.
Indications/Uses
Indicated bacteria: Susceptible strains of Staphylococcus sp., Streptococcus sp., Streptococcus pneumoniae, Enterococcus sp., Micrococcus sp., Moraxella sp., Corynebacterium sp., Klebsiella sp., Enterobacter sp., Serratia sp., Proteus sp., Morganella morganii, Haemophilus influenzae, Haemophilus aegyptius [Koch-Weeks bacillus], Pseudomonas sp., Pseudomonas aeruginosa, Stenotrophomonas (Xanthomonas) maltophilia, Acinetobacter sp., and Propionibacterium acnes.
Indications: Blepharitis, dacryocystitis, hordeolum, conjunctivitis, tarsadenitis, keratitis (including corneal ulcer), and aseptic treatment during a perioperative period for ocular surgery.
Dosage/Direction for Use
Usually, instill 1 drop a time to the eye 3 times daily. The dosage may be adjusted according to the patient's symptoms.
Contraindications
Patients with a history of hypersensitivity to the ingredient of this product, ofloxacin or any quinolone antibiotics.
Special Precautions
In order to avoid the 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 in Pregnancy 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 treatment. [The safety of this product during pregnancy has not been established.]
Use in Children: 1.5% ophth soln: The safety of this product to low birth weight infants, neonates, infants or children has not been established. (No clinical experience with low birth weight infants, neonates or infants. Limited clinical experience with children.)
Use In Pregnancy & Lactation
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 treatment. [The safety of this product during pregnancy has not been established.]
Adverse Reactions
0.5% ophth soln: Clinically significant adverse reactions ("rarely": <0.1%, occasionally: 5%> ≥0.1%, and no specific designation: ≥5% or incidence unknown).
Shock, anaphylactoid reaction: Since shock and 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. (See Table 3.)

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1.5% ophth soln: Adverse reactions were reported in 7 of 238 patients (2.9%) in clinical trials in Japan. The adverse reactions were eye irritation in 3 patients (1.3%), dysgeusia in 2 patients (0.8%), eye itching in 1 patient (0.4%), and urticaria in 1 patient (0.4%). (At the time of approval).
Clinically significant adverse reactions: Shock, anaphylactoid reaction (incidences unknown): Since shock and anaphylactoid reaction may occur on levofloxacin ophthalmic solution 0.5% (0.5% product), 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 any adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See Table 4.)

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Caution For Usage
1) Route of administration: Ophthalmic use only.
2) 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.
1.5% ophth soln: When more than one ophthalmic drug is used, at least 5 minutes of intervals should be taken.
Storage
Store at 1-30°C under protection from light.
ATC Classification
S01AE05 - levofloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Presentation/Packing
Ophth soln 0.5% (clear, pale to light yellow sterile aqueous ophthalmic solution) x 5 mL. 1.5% (clear, pale to yellow sterile aqueous ophthalmic solution) x 5 mL.
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