Ocumox brief prescribing information

Brief Prescribing Information
COMPOSITION:
ADVERSE EFFECTS:
No serious ophthalmic or systemic adverse reactions related to Moxifloxacin were Moxifloxacin Hydrochloride B.P. equivalent to Moxifloxacin . 5 mg.
Preservative: None. 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)
Ocumox ophthalmic solution should not be injected subconjunctivally, nor should
MICROBIOLOGY:
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 PRECAUTIONS:
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.
GRAM-POSITIVE BACTERIA:
GRAM-NEGATIVE BACTERIA:
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 PEDIATRIC USE:
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, even though
OTHER MICROORGANISMS:
oral administration of some quinolones has been shown to cause arthropathy in GERIATRIC USE:
INDICATIONS:
No overall differences in safety and effectiveness have been observed between Ocumox ophthalmic solution is indicated for the treatment of bacterial conjunctivitis
caused by the susceptible strains of the above mentioned organisms.
DOSAGE AND ADMINISTRATION:
CONTRAINDICATIONS:
Instil one drop into the affected eye(s) 3 times a day for 7 days.
Ocumox ophthalmic solution is contraindicated in patients with a history of
hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in
HOW SUPPLIED:
Ocumox ophthalmic solution is available as a sterile solution 5ml in pilfer proof
plastic dropper bottles (Gamma irradiated).

Source: http://ocumox.remingtonpharma.com/images/Ocumox_Prescribing_Info.pdf