Optimox

Optimox

moxifloxacin

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Moxifloxacin.
Description
Each mL contains Moxifloxacin HCL equiv to Moxifloxacin 5mg/ml (0.5%).
Indications/Uses
Optimox Sterile Eye Drops / Sterile Eye Ointment is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of following organisms: Aerobic gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group.
Aerobic Gram-negative microorganisms: Acinetobacter iwoffii, Haemophilus influenzae, Haemophilus parainfluenzae.
Dosage/Direction for Use
For Eye Drops: One drop in the affected eye 3 times per day for 7 days.
Contraindications
Moxifloxacin is contraindicated in patients with history of hypersensitivity to Moxifloxacin, to other quinolones or to any of components in the medication.
Special Precautions
Prolonged use may result in overgrowth of non-susceptible organisms, including fungi like with other anti-infectives.
Use in Pregnancy: Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus as there are no adequate and well-documented studies in pregnant women.
Use in Lactation: Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin sterile eye drops & sterile eye ointment is administered to a lactating mother.
Use in Children: The safety and effectiveness of Moxifloxacin sterile eye drops & sterile eye ointment in infants below one year of age was not proven earlier. However, several latest clinical studies show that the drug can be used safely in children even younger than one month of age.
Use in the Elderly: No overall differences in safety and effectiveness have been observed between elderly and younger patients.
Use In Pregnancy & Lactation
Use in Pregnancy: Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus as there are no adequate and well-documented studies in pregnant women.
Use in Lactation: Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Moxifloxacin sterile eye drops & sterile eye ointment is administered to a lactating mother.
Side Effects
The most frequently reported ocular side effects were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, sub-conjunctival hemorrhage and tearing. These events occurred in approximately 1-6% of patients.
Drug Interactions
Drug-drug interaction studies have not been conducted with Moxifloxacin Hydrochloride. 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 isoenzymes.
MIMS Class
ATC Classification
S01AE07 - moxifloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Presentation/Packing
Eye drops (sterile) 0.5% x 5 mL x 1's.
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