Composition :
1 ml of the solution contains
Gatifloxacin IP 0.3% w/v + Hydroxypropylmethyl Cellulose IP 0.25% w/v + Benzalkonium Chloride Solution IP 0.02% w/v, Sterile Aqueous Base q.s.

Description :
LUGAT(gatifloxacin ophthalmic solution) 0.3% is a sterile ophthalmic solution. It is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.

Indications :
Gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis, keratitis, pre & post operatively to control the infection.

Dosage and Administration :
The recommended dosage regimen for the treatment of bacterial conjunctivitis is:
Days 1 and 2: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily.
Days 3 through 7: Instill one drop up to four times daily while awake.
LUGAT is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerobic Gram-Positive Bacteria:
Cornyebacteriumpropinquum, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis, Streptococcus pneumoniae
Aerobic Gram-Negative Bacteria:
Haemophilus influenza

Contraindications :
LUGAT is contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.

Warning and Precautions :
NOT FOR INJECTION.
LUGAT solution should not be injected sub-conjunctively, nor should it be introduced directly into the anterior chamber of the eye. 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.

Adverse Effects :
The most frequently reported adverse events in the overall study population were conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis. These events occurred in approximately 5-10% of patients. Other reported reactions occurring in 1-4% of patients were chemosis, conjunctival haemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid oedema, headache, red eye, reduced visual acuity and taste disturbance.

CLINICAL PHARMACOLOGY :
Mechanism of Action :
The mechanism of action of fluoroquinolones including gatifloxacin is different from that of aminoglycoside, macrolide, and tetracycline antibiotics. Therefore, gatifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to gatifloxacin. There is no cross-resistance between gatifloxacin and the aforementioned classes of antibiotics. Cross-resistance has been observed between systemic gatifloxacin and some other fluoroquinolones. Gatifloxacin has been shown to be active against most strains of the following organisms both in vitro and clinically, in conjunctival infections as described below:
Aerobes, Gram-Positive: Cornyebacteriumpropinquum* Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis* Streptococcus pneumoniae
Aerobes, Gram-Negative: Haemophilus influenza.

USE IN SPECIFIC POPULATIONS :
Pregnancy Teratogenic Effects :
As there are no adequate and well-controlled studies in pregnant women, LUGAT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers :
Gatifloxacin is excreted in the breast milk of rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when gatifloxacin is administered to a nursing woman.
Paediatric Use :
Safety and efficacy in paediatric patients below the age of one year have not been established.
Geriatric Use :
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Packaging :
5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml solution.

Storage Conditions :
In dry place protected from light at a temperature below 25°С. Do not freeze. After instillation the vial should be tightly closed. Keep out of reach of children.

Shelf-Life :
15 months after opening the vial it is suitable for use within 1 month.
Do not use after the expiration date stated on the package