Each mL contains Moxifloxacin Hydrochloride 5.45 mg eq. to Moxifloxacin 5 mg.
Pharmacology: Pharmacodynamics: Moxifloxacin is a fluoroquinolone anti-infective agent. Moxifloxacin inhibits DNA synthesis in susceptible organism via inhibition of topoisomerases II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of DNA. Moreover, Topoisomerase IV is an enzyme to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
Pharmacokinetics: For topical application of moxifloxacin 0.5% ophthalmic solutions to the eye, the drug is absorbed systematically and low moxifloxacin concentration are attained in plasma.
In a study in healthy adult who received bilateral topical ocular doses of moxifloxacin 0.5% ophthalmic solutions 3 times a day. The mean steady-state Cmax and estimated daily exposure AUC values were 1,600 and 1,000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.
For treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria including Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae and Streptococcus viridans group; Gram-negative bacteria including Acinetobacter lwoffii*, Haemophilus influenzae and Haemophilus parainfluenzae*; Other organism including Chlamydia trachomatis.
* Efficacy for this organism was studied in fewer than 10 infections.
Recommended Dose: For Bacterial Conjunctivitis: Adults and children 1 year of age or older: Instill 1 drop into affected eye(s) 3 times daily for 7 days.
Mode of Administration: Moxifloxacin ophthalmic solution is for topical use only. The solution should not be injected subconjunctivally and should not be introduced directly into the anterior chamber of the eye.
The limited holding capacity of the conujnctival sac for ophthalmic products practically precludes any overdosing of the medicinal product.
The total amount of moxifloxacin in a single container is too small to induce adverse effects after accidental ingestion.
Contraindicated in patient with known hypersensitivity to moxifloxacin, other quinolones, or any component in the formulation.
Contraindicated in patients who are hypersensitive to moxifloxacin and other quinolone antibiotics.
If using this medication, the patient who have red eyes, edema, rashes, pain, muscle pain, tendon pain have been occurred, discontinue use of this medication and inform the doctor.
This medication may cause liver and kidney damage.
Contact lenses: Contact lenses should not be worn if any signs or symptoms of bacterial conjunctivitis are present.
Superinfection: Prolong use of this medication may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, ophthalmic solution should be discontinued and appropriate therapy instituted.
Use in Children: Safety and efficacy have not been established in infants younger than 1 year of age. Although systemic quinolones have been associated with arthropathy in immature animals, there is no evidence that administration of moxifloxacin ophthalmic solution has any effect on weight bearing joints.
Use in Elderly: No overall differences in safety and efficacy of moxifloxacin ophthalmic solution have been observed between geriatric and younger adults.
Pregnancy: Pregnancy category C. Safety for use during pregnancy has not been established.
Lactation: Although distribution of moxifloxacin into milk following ophthalmic administration has not been studied, it is presumed that drug is distributed into human milk. Caution is advised if moxifloxacin ophthalmic solution is used in a breast-feeding mother.
Ocular adverse reactions reported in approximately 1-6% of patients include conjunctivitis, decreased visual acuity, ocular dryness, keratitis, ocular discomfort/pain/pruritus, ocular hyperemia, subconjunctival hemorrhage, and tearing.
Adverse systematic effects reported in approximately 1-4% of patients include fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
In vitro studies indicate that moxifloxacin does not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2C9, 2C19, 2D6 or 3A4. Moreover, no formal drug interaction studies have been performed using moxifloxacin ophthalmic solution.
Store below at temperature 30°C. Discard 30 days after first opening.
S01AE07 - moxifloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Ophth soln 0.5% w/v (clear, light yellow, sterile) x 5 mL x 1's.