Apdrops

Dosage in Special Population

Pregnancy Category C: Used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Caution should be exercised when administered to a nursing mother.

Indications

Apdrops is indicated for the treatment of Bacterial Conjunctivitis

Contraindications

Apdrops is contrainidicated in Hypersensitivity to the ingredients of this drug

Adverse Effects

The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.

Drug Interactions

Drug-drug interaction studies have not been conducted with Moxifloxacin solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes

Mechanism of Action

Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and topoisomerase IV required for bacterial DNA replication, repair, and recombination

Pharmacokinetics

Following topical ocular administration, moxifloxacin was absorbed into the systemic circulation. Plasma concentrations of moxifloxacin were measured in 21 male and female subjects who received bilateral topical ocular doses of the medicinal product 3 times a day for 4 days. The mean steady-state Cmax and AUC were 2.7 ng/ml and 41.9 ng·hr/ml, respectively. These exposure values are approximately 1,600 and 1,200 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

Drug Use in Pregnancy

Moxifloxacin: Pregnancy There are no adequate data from the use of Moxifloxacin in pregnant women. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible. The medicinal product can be used during pregnancy. Breastfeeding It is unknown whether moxifloxacin/metabolites are excreted in human milk. Animal studies have shown excretion of low levels in breast milk after oral administration of moxifloxacin. However, at therapeutic doses of Moxifloxacin no effects on the suckling child are anticipated. The medicinal product can be used during breastfeeding. Fertility Studies have not been performed to evaluate the effect of ocular administration of Moxifloxacin on fertility.

Drug Use in Renal Impairment

Moxifloxacin: Use in hepatic and renal impairment No dosage adjustment is necessary.

Drug Use in Hepatic Impairment

Moxifloxacin: Use in hepatic and renal impairment No dosage adjustment is necessary.

Drug Use in Pediatric Population

Moxifloxacin: Paediatric patients No dosage adjustment is necessary.

Drug Use in Geriatric Population

Moxifloxacin: Use in adults including the elderly (≥ 65 years) The dose is one drop in the affected eye(s) 3 times a day. The infection normally improves within 5 days and treatment should then be continued for a further 23 days. If no improvement is observed within 5 days of initiating therapy, the diagnosis and/or treatment should be reconsidered. The duration of treatment depends on the severity of the disorder and on the clinical and bacteriological course of infection.