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Moxifloxacin HCL
0.5%
Loteprednol Etabonate
0.5%
Dosage Form & Strength
TID
Apdrops LP is indicated for the treatment of Bacterial conjunctivitis & Post ocular surgery
Apdrops LP is contrainidicated in Hypersensitivity to the ingredients of this drug
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. Loteprednol The most common ocular adverse event, reported in 27%, is anterior chamber inflammation. Other common adverse events, with an incidence of 4-5%, are conjunctival hyperemia, corneal edema, and eye pain.
Moxifloxacin: 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
Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA gyrase and topoisomerase IV required for bacterial DNA replication, repair, and recombination
Loteprednol Results from oral and ocular administration of loteprednol in normal volunteers have shown that there are low or undetectable concentrations of either unchanged material or the metabolite. Results from a bioavailability study established that plasma concentrations of loteprednol etabonate following ocular administration of one drop in each eye of loteprednol eight times daily for 2 days or four times daily for 42 days were below the limit of quantitation (1 ng/mL) and detection (500 pg/mL) at all sampling times. In the same study, plasma cortisol concentrations were measured and no evidence of adrenal cortex suppression was observed. All cortisol measurements were within normal range. 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.
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. Loteprednol: Pregnancy For Loteprednol no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown and Lotemax should not be used in pregnancy unless clearlynecessary. Breastfeeding It is not known whether loteprednol etabonate is excreted in human milk. Excretion of loteprednol etabonate in breastmilk has not been investigated in animal studies. Therefore, the use of loteprednol etabonate is contraindicated inlactating women.
Moxifloxacin: Use in hepatic and renal impairment No dosage adjustment is necessary.
Moxifloxacin: Use in hepatic and renal impairment No dosage adjustment is necessary.
Moxifloxacin: Paediatric patients No dosage adjustment is necessary. Loteprednol: Paediatric Population Loteprednol should not be used in the paediatric age group until further data become available.
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. Loteprednol: Adults and elderly One to two drops four times daily beginning 24 hours after surgery and continuing throughout the post-operative period. The duration of treatment should not exceed 2 weeks.
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