For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.
Composition:
COMPOSITION:
Each gram contains:
Moxifloxacin Hydrochloride IP
Equivalent to Moxifloxacin…………………………………….0.5% w/w
Sterile Ointment Base……………………………………………q.s.
Pharmacotherapeutic Group: Ophthalmologicals, Antinfectives, Fluoroquinolones.
Pharmacology:
Moxifloxacin is a member of the fluoroquinolone class of anti-infectives drugs. Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl ring at the C7 position. 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.
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.
Pharmacokinetics:
Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin 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 400 mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.
DOSAGE AND ADMINISTRATION:
The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Apply half-inch ribbon three times a day on the first two days. For the next five days apply half-inch ribbon two times a day.
CONTRAINDICATIONS:
Moxifloxacin Eye Ointment is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication.
WARNING & PRECAUTIONS:
Moxifloxacin Eye Ointment should not be used for the prophylaxis or empiric treatment of gonococcal conjunctivitis, including gonococcal ophthalmia neonatorum, because of the prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae. Patients with eye infections caused by Neisseria gonorrhoeae should receive appropriate systemic treatment.
The medicinal product is not recommended for the treatment of chlamydia trachomatis in patients less than 2 years of age as it has not been evaluated in such patients. Patients older than 2 years of age with eye infections caused by chlamydia trachomitis should receive appropriate systemic treatment.
PREGNANCY & LACTATION:
Teratogenic Effects
Pregnancy Category C
Since there are no adequate and well-controlled studies in pregnant women, moxifloxacin Eye ointment 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 Eye ointment is administered to a lactating female.
PRESENTATION: Vigoquin Eye Ointment is available in 5 gm tube.
STORAGE: Store in a cool & dry place at a temperature not exceeding 25°C.
Do not freeze.
Keep out of the reach of children.
