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Moxifloxacin Hydrochloride INN
|NAME||STRENGTH||PACK SIZE||DOSAGE FORM|
|Floromox ED||0.5% w/v||5 ml||Eye drops|
Floromox (Moxifloxacin) is a fourth-generation fluoroquinolone approved for ophthalmic use as Moxifloxacin ophthalmic solution 0.5 % (w/v). The antibacterial action of Moxifloxacin results from inhibition of the Topoisomerase II (DNA gyrase) and Topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. There is no cross-resistance between Moxifloxacin and Macrolides, Amino glycosides, or Tetracycline’s antibiotics. Moxifloxacin is active against a wide range of aerobic and anaerobic gram-positive and gram-negative bacteria.
Floromox Eye Drops: Each ml sterile solution contains Moxifloxacin Hydrochloride USP equivalent to 5 mg Moxifloxacin.
Indications And Uses
In ophthalmology Moxifloxacin is used to treat conjunctival infections caused by susceptible bacteria and to prevent infection following eye surgeries such as LASIK.
Dosage And Administration
Instill one drop in the affected eye 3 times a day for 7 days. Method of administration Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop and then close your eye. Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
The most frequently reported ocular undesirable 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. Nonocular undesirable effects reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.
As with other anti-infective, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super infection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. * If an allergic reaction to Moxifloxacin occurs, discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.
Use In Pregnancy Lactation
Since there are no adequate and well-controlled studies in pregnant women, Moxifloxacin solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 solution is administered to a lactating female.
Drug-drug interaction studies have not been conducted with Moxifloxacin ophthalmic solution.
An overdose of this medication is unlikely to threaten life. Overdose should be flushed from eyes with warm water.
Protect from light & keep in cool and dry place. Store within 25°C.
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.
Floromox Eye Drops: Each plastic dropper bottle contains 5 ml sterile eye drops.