Microbiology: 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 .

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.

 

Zymasaad solution is sterile ophthalmic solution indicated for the treatment of bacterial conjunctivitis caused by aerobic gram positive or negative bacteria, anaerobic and other microorganisms.

 

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

 

Not For Injection.

In patients receiving systemic quinolones, including gatifloxacin, serious and occasionally fatal hypersensitivity reactions, some following the first dose, have been reported. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema, airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to gatigloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

 

- As with other anti-infectives, 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.

- Gatifloxacin have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first  sign of a rash or allergic reaction.

Pregnancy & Nursing Mothers: Because there are no adequate and well-controlled studies in pregnant women, gatifloxacin solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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.

Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established.

 

The most frequently reported adverse events in the overall study population were conjunctival irritation, increased lacrimation, keratitis, and papillary conjunctivitis. Other reported reactions occurring: chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance.

 

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.

 

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 while awake, up to 8 times daily.

Days 3 through 7: Instill one drop up to four times daily while awake.

 

 ZYMASAAD - Eye drops: A pack of plastic dropper bottle contains 5 mL of a sterile solution that contains Gatifloxacin 0.3% .

 

 Store at 15°-25°C. Protect from light and freezing.