Gate DM

Indications

Gate DM 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. Dexamethasone In clinical trials, the most common adverse reaction was ocular discomfort.

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. Dexamethasone:Anti-inflammatory Agents

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 DM is not applicable, half life of Dexamethasone in Gate DM is 190 minutes

Drug Use in Pregnancy

Gatifloxacin: 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 Dexamethasone: Pregnancy: There are no or limited amount of data from the use of Dexamethasone in pregnant woman. Studies in animals have shown reproductive toxicity. Even though, the maximum daily dose (2x 30μl drops x 4 times per day = about 0.240 mg/day dexamethasone) following topical application is much lower than a standard systemic anti-inflammatory dose of about 0.5 to 10mg daily. Dexamethasone is not recommended during pregnancy unless the clinical condition of the woman requires treatment with Dexamethasone. Lactation Systemically administered corticosteroids appear in human milk in quantities that could affect the child being breastfed. However, when instilled topically, systemic exposure is low. It is unknown whether Dexamethasone is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Dexamethasone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

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 Dexamethasone: Paediatric patients The safety and efficacy of this product has not been established in children below 2 years of age.

Drug Use in Geriatric Population

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