Apdrops DM

Indications

Apdrops DM is indicated for the treatment of Post LASIK & Cataract

Adverse Effects

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

Drug Interactions

Drug-drug interaction studies have not been conducted with Moxifloxacin. 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

Moxifloxacin 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. Dexamethasone ue to its hydrophilic properties, dexamethasone sodium phosphate is barely absorbed by the intact epithelium of the cornea. Following absorption via the eye and the nasal mucosa, dexamethasone sodium phosphate is hydrolyzed in the system to dexamethasone. Afterwards, dexamethasone and its metabolites are mainly eliminated via the kidneys.

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. 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 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. 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

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.