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Moxifloxacin Hydrochloride INN

Floromox 400 mg 3X10 Tablet


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, Aminoglycosides, or Tetracyclines antibiotics. Moxifloxacin is active against a wide range of aerobic and anaerobic gram-positive and gram-negative bacteria.

Each ml sterile solution contains Moxifloxacin Hydrochloride USP equivalent to 5 mg Moxifloxacin.

In ophthalmology Moxifloxacin is used to treat conjunctival infections caused by susceptible bacteria and to prevent infection following eye surgeries such as LASIK.

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

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-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection 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.

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. Storage temperature: 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 Moxifloxacin Eye Drops USP 5 mg/ml.