0000012273 00000 n ... VIGAMOX- moxifloxacin hydrochloride solution/ drops 266 41 0000005927 00000 n 0000004444 00000 n

The No-Observed-Adverse-Effect-Level (NOAEL) for developmental toxicity was 100 mg/kg/day (30 times the human AUC at the recommended human ophthalmic dose).Pregnant cynomolgus monkeys were administered moxifloxacin at doses of 10, 30, or 100 mg/kg/day by intragastric intubation between Gestation Days 20 and 50, targeting the period of organogenesis. 0000001539 00000 n 0000001721 00000 n 0000006178 00000 n 0000014247 00000 n 0000004069 00000 n 0000003007 00000 n 0000012834 00000 n

0000010351 00000 n Instill one drop in the affected eye 3 times a day for 7 days.

0000011507 00000 n

Moxifloxacin ophthalmic solution is for topical ophthalmic use. If superinfection occurs, discontinue use and institute alternative therapy. The mean steady-state CThe antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. Ophthalmic solution containing moxifloxacin 0.5% as base. 0000006762 00000 n Maternal death occurred during gestation at 500 mg/kg/day. 0000005431 00000 n 0000005185 00000 n These events occurred in approximately 1% to 6 % of patients. Moxifloxacin Ophthalmic Solution is for topical ophthalmic use.Moxifloxacin Ophthalmic Solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity(anaphylactic) reactions have been reported, some following the first dose.

0000017198 00000 n 0000002373 00000 n 0000012144 00000 n Wash your hands before and after use. 0000017275 00000 n < xref Use as you have been told, even if your signs get better.

Nonocular adverse events reported at a rate of 1% to 4 % were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. 0000006555 00000 n 0000001858 00000 n HOW SUPPLIED: VIGAMOX™ (moxifloxacin hydrochloride ophthalmic solution) 0.5% is supplied as a sterile ophthalmic solution in Alcon’s DROP-TAINER® dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Follow all instructions closely. Instill one drop in the affected eye 3 times a day for 7 days. Instill one drop in the affected eye 3 times a day for 7 days. 0000006477 00000 n o changes are permitted by any 3rd party other than added notes and mark ups for reuired changes. Contraindications. 3 DOSAGE FORMS AND STRENGTHS. 0000001137 00000 n MOXIFLOXACIN- moxifloxacin hydrochloride monohydrate solution/ drops Lupin Pharmaceuticals, Inc. 1 INDICATIONS AND USAGE. There are no adequate and well-controlled studies with Moxifloxacin Ophthalmic Solution in pregnant women to inform any drug-associated risks.Oral administration of moxifloxacin to pregnant rats and monkeys and intravenously to pregnant rabbits during the period of organogenesis did not produce adverse maternal or fetal effects at clinically relevant doses. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. 0000013131 00000 n Oxygen and airway management should be administered as clinically indicated.As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. DOSAGE FORMS AND STRENGTHS. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. trailer Slight increases in the duration of pregnancy, reduced pup birth weight, and decreased prenatal and neonatal survival were observed at 500 mg/kg/day (estimated 277 times the human AUC at the recommended human ophthalmic dose). 0000012188 00000 n Do not touch the container tip to the eye, lid, or other skin. Drug-drug interaction studies have not been conducted with Moxifloxacin Ophthalmic Solution. ... Instill one drop in the affected eye 3 times a day for 7 days.

Eye Drops Solution Package leaflet: Information for the patient Continued top of next column BBBA5126 Please note that only Artwork Studio is permitted to make changes to the above artwork. 0000019228 00000 n but their clinical significance in ophthalmic infections is unknownWe comply with the HONcode standard for trustworthy health information -

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