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XEMOX STERILE OPHTHALMIC SOLUTION

DESCRIPTION:

XEMOX (moxifloxacin hydrochloride ophthalmic solution) 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin is a fourth generation fluoroquinolone antibacterial agent active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens, atypical microorganisms and anaerobes.

Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position.

C21H24FN3O4HCl Mol.wt.437.9

Chemical Name: 1-Cyclopropyl-6-fluoro-l,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride. Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder.

COMPOSITION

Each ml contains:

Moxifloxacin Hydrochloride B.P. equivalent to Moxifloxacin….…5 mg

Hydroxypropyl Methylcellulose U.S.P. ………5 mg

Preservative: Product is self-preserved.

Inactives: Boric acid, sodium chloride and purified water. May contain hydrochloric acid and / or sodium hydroxide to adjust pH.

CLINICAL PHARMACOLOGY

Pharmacokinetics: Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin drops 3 times a day. The mean steady-state Cmax (2.7 ng/ml) and estimated daily exposure AUC (45 ng•hr/ml) values were 1,600 and 1,000 times lower than the mean Cmax and AUC reported after therapeutic 400mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

Pharmacokinetics: Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin drops 3 times a day. The mean steady-state Cmax (2.7 ng/ml) and estimated daily exposure AUC (45 ng•hr/ml) values were 1,600 and 1,000 times lower than the mean Cmax and AUC reported after therapeutic 400mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines. Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones.
In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 x 10-9 to < 1 x 10-11 for Gram-positive bacteria.

INDICATIONS AND USAGE:

XEMOX Eye Drops are indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Gram-positive bacteria:
Corynebacterium species*
Micrococcus luteus*
Staphylococcus aureus
Staphylococcus epidermidis
Staphylococcus haemolyticus
Staphylococcus hominis
Staphylococcus warneri*
Streptococcus pneumoniae
Streptococcus viridans group
Gram-negative bacteria:
Acinetobacter Iwoffii*
Haemophilus influenza
Haemophilus alconae
Haemophilus parainfluenzae *
Klebsella pneumoniae
Moraxella Catarrhalis
Pseudomonas aeroginosa*
Other microorganisms:
Chlamydia trachomatis
*Efficacy for this organism was studied in fewer than 10 infections.

CONTRAINDICATIONS:

XEMOX ophthalmic solution is contraindicated in patients with a history of hypersensivity to moxifloxacin, to other quinolones, or to any of the components in this medication.

WARNINGS: NOT FOR INJECTION

XEMOX ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

In patients receiving systemically administered quinolones, including moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal,pharyngeal or facial edema), airway obstruction, dyspnea, urticaria,