Gaforin

Gatifloxacin.

Each ml contains: Gatifloxacin Sesquihydrate equivalent to 3 mg of Gatifloxacin.
Excipients/Inactive Ingredients: Preservative: Benzalkonium Chloride.

Pharmacology: GAFORIN is an 8-methoxy fluoroquinolone antiinfective for topical ophthalmic use.
The antibacterial action of Gatifloxacin results from inhibition of DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
Resistance to Gatifloxacin in vitro develops via multiple-step mutations. Resistance to Gatifloxacin in vitro occurs at a general frequency of between 1x10^-7 to 10^-10.

GAFORIN is indicated for the treatment of external infections of the eye such as bacterial conjunctivitis and bacterial keratitis caused by susceptible microorganisms to Gatifloxacin such as: Aerobic Gram-positive Bacteria: Corynebacterium propinquum, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis, Streptococcus pneumoniae.
Aerobic Gram-negative Bacteria: Haemophilus influenzae.

Bacterial conjunctivitis: Days 1 and 2: 1 drop in the affected eye(s) (while awake) every 2 hours up to 8 times daily.
Days 3-7: 1 drop in the affected eye(s) (while awake) up to 4 times daily.
Bacterial keratitis: 1 drop every 1 hour in the affected eye(s) (start while awake until before sleep). If any improvement occurs after 3 days, instill every 2 hours. Subsequently if any improvement occurs after 3 days, instill every 3 hours until the eye(s) look normal.
Use within 4 weeks after opening.

Hypersensitivity to Gatifloxacin, to other quinolones, or to any of the components in this medication.

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 in 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 contact lenses if their eye is red. This drug should not be used to treat contact lenses-related irritation. The preservative in this drug, Benzalkonium Chloride, may be absorbed by soft contact lenses and whose eyes are not red should be instructed to wait at least 10 minutes after instilling this drug before they insert contact lenses.
Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs discontinue use and institute alternative therapy.
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Avoid contaminating the applicator tip with material from the eye, fingers or other source.
Discontinue use immediately and contact the physician at the first sign of a rash or allergic reactions.
Gatifloxacin solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Caution should be exercised when Gatifloxacin is administered to nursing mothers.
Safety and effectiveness in infants below the age of one year have not been established.
In patients receiving systemic quinolones, including Gatifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to Gatifloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

Gatifloxacin solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Caution should be exercised when Gatifloxacin is administered to nursing mothers.

The most frequently reported adverse reactions were conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis. These reactions occurred in 5-10% of patients.
Other reported reactions occurring in 1-4% of patients were chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance.

Specific drug interactions studies have not been conducted with GAFORIN eye drops. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.

Keep in a cool place (15°-25°C), away from light.
Protect from freezing.

Eye Anti-Infectives & Antiseptics

S01AE06 - gatifloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.

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