Ketogate

Indications

Ketogate 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. Ketorolac The most frequent adverse reactions reported by up to 40% of patients participating in clinical trials have been transient stinging and burning on instillation.

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. Ketorolac: Ketorolac trometamol is a non-steroidal anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity. Ketorolac trometamol inhibits the cyclo-oxygenase enzyme essential for biosynthesis of prostaglandins. Ketorolac has been shown to reduce prostaglandin levels in the aqueous humour after topical ophthalmic administration.

Pharmacokinetics

Serum Gatifloxacin levels were below the lower limit of quantification (5 ng/mL) in all subjects, so the half life of Gatifloxacin in Ketogate is not applicable, Ketoroalc plasma concentration is negligible, so the half life of Ketorolac in Ketogate is not applicable

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 Ketorolac Pregnancy There are no adequate data from the use of eye drops containing ketorolac trometamol in pregnant women. Studies in animals have shown reproductive toxicity. Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/ or postnatal development. Although a very low systemic exposure is expected after the use of ketorolac eye drops, Ketorolac trometamol 0.5% w/v eye drops is not recommended during pregnancy. Breast-feeding Ketorolac trometamol 0.5% w/v eye drops, solution should not be used during breast-feeding. Ketorolac trometamol is excreted in human milk after systemic administration. Fertility There are no adequate data from the use of ketorolac trometamol on fertility in humans.

Drug Use in Pediatric Population

Gatifloxacin: 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 Ketorolac: Paediatric population There is no relevant use of Ketorolac trometamol 0.5% w/v eye drops, solution in the paediatric population in the indication: For the prophylaxis and reduction of inflammation following cataract surgery.

Drug Use in Geriatric Population

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