Gate P

Indications

Gate P is indicated for the treatment of Ocular Infections with Inflammation

Adverse Effects

Gatifloxacin 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 hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance. Prednisolone Prolonged treatment with corticosteroids in high dosage is occasionally associated with cataract. The systemic effects of steroids are possible following the use of Prednisolone, but are, however, unlikely due to the reduced absorption of topical eye drops.

Drug Interactions

Gatifloxacin: Specific drug interaction studies have not been conducted with Gatifloxacin ophthalmic solution. 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

Mechanism of Action

Gatifloxacin : Gatifloxacin is a fluoroquinolone antibacterial. Gatifloxacin is an 8-methoxyfluoroquinolone with a 3-methylpiperazinyl substituent at C7. 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. Prednisolone: Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

Serum Gatifloxacin levels were below the lower limit of quantification (5 ng/mL) in all subjects, so the half life of Gatifloxacin in Gate P is not applicable, half life of Prednisolone in Gate P is 30 minutes

Drug Use in Pregnancy

Pregnancy Risk Summary: There are no available data on the use of Gatifloxacin in pregnant women to inform a drug-associated risk Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Gatifloxacin and any potential adverse effects on the breastfed child from Gatifloxacin Prednisolone: Pregnancy There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals cancause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There maytherefore be a very small risk of such defects in the human foetus. Therefore this product should be used with cautionduring pregnancy only if the potential benefit outweighs the potential risk to the foetus. Breast-feeding It is not known whether topical administration of Prednisolone could result in sufficient systemic absorption to producedetectable quantities in breast milk. Therefore, use is not recommended in women breast- feeding infants.

Drug Use in Pediatric Population

Pediatric Use The safety and effectiveness of (gatifloxacin ophthalmic solution) 0.3% have been established in all ages. Use of gatifloxacin ophthalmic solution is supported by evidence from adequate and well controlled studies of gatifloxacin ophthalmic solution in adults, children and neonates

Drug Use in Geriatric Population

Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.