Ocumox brief prescribing information
Brief Prescribing Information
No serious ophthalmic or systemic adverse reactions related to Moxifloxacin were
Moxifloxacin Hydrochloride B.P. equivalent to Moxifloxacin . 5 mg.
Product is self - preserved.
Adverse reactions were generally mild and occurred at an incidence similar to
Inactives: Boric acid and sodium chloride.
placebo (vehicle). The most frequently reported event was transient ocular
May also contain hydrochloric acid / sodium hydroxide to adjust pH.
discomfort (burning/stinging) reported at an incidence of 2.9%.Other reportedevents included headache, keratitis, ocular pain, ocular pruritus, ocular hyperemia,
pharyngitis and subconjunctival hemorrhage which were reported at an incidence
Moxifloxacin is a fourth generation fluoroquinolone antibacterial agent active against
a broad spectrum of Gram-positive and Gram-negative ocular pathogens, atypical
WARNINGS: ( NOT FOR INJECTION)
ophthalmic solution should not be injected subconjunctivally, nor should
it be introduced directly into the anterior chamber of the eye.
Moxifloxacin has in vitro
activity against a wide range of Gram-positive and Gram-
negative microorganisms. Moxifloxacin inhibits the topoisomerase II (DNA gyrase)
moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic)
and topoisomerase IV required for bacterial DNA replication,transcription,repair and
reactions have been reported, some following the first dose. Some reactions were
recombination.The C8-methoxy moiety of moxifloxacin also lessens the selection of
accompanied by cardiovascular collapse, loss of consciousness, angioedema
resistant mutants of Gram-positive bacteria compared to the C8-H moiety found in
(including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea,
older fluoroquinolones.Moxifloxacin's bulky C-7 substituent group interferes with the
urticaria and itching. If an allergic reaction to moxifloxacin occurs, discontinue use
quinolone efflux pump mechanism of bacteria.Moxifloxacin is often bactericidal at the
of the drug. Serious acute hypersensitivity reactions may require immediate
concentrations equal to or slightly greater than inhibitory concentrations.
emergency treatment. Oxygen and airway management should be administered as
Fluoroquinolones,including moxifloxacin,differ in chemical structure and mode of
β lactam antibiotics, macrolides and aminoglycosides and therefore, may
As with other anti-infectives, prolonged use may result in overgrowth of non-
susceptible organisms, including fungi. If superinfection occurs, discontinue useand institute alternative therapy. Whenever clinical judgment dictates, the patient
Moxifloxacin has been shown to be active against most strains of the following
should be examined with the aid of magnification, such as slit-lamp biomicroscopy
microorganisms, both in vitro
and in clinical infections.
and, where appropriate, fluorescein staining. Patients should be advised not to wearcontact lenses if they have signs and symptoms of bacterial conjunctivitis.
USE IN PREGNANCY & NURSING MOTHERS:
Since there are no adequate and well-controlled studies in pregnant women,
Moxifloxacin ophthalmic solution should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. Moxifloxacin ophthalmic
solution has not been measured in human milk, although it can be presumed to be
excreted in human milk. Caution should be exercised when Moxifloxacin
ophthalmic solution is administered to a nursing mother.
Staphylococcus warneriStreptococcus mitis
The safety and effectiveness of Moxifloxacin ophthalmic solution in infants below 1
year of age have not been established. There is no evidence that the ophthalmic
administration of Moxifloxacin has any effect on weight bearing joints,
oral administration of some quinolones has been shown to cause arthropathy in
No overall differences in safety and effectiveness have been observed between
ophthalmic solution is indicated for the treatment of bacterial conjunctivitis
caused by the susceptible strains of the above mentioned organisms.
DOSAGE AND ADMINISTRATION:
Instil one drop into the affected eye(s) 3 times a day for 7 days.
ophthalmic solution is contraindicated in patients with a history of
hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in
ophthalmic solution is available as a sterile solution 5ml in pilfer proof
plastic dropper bottles (Gamma irradiated).
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