Anti-Biotic and Combinations

MOXIEYE-K

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MOXIEYE-K

Anti-Biotic and Combinations


Moxifloxacin & Ketorolac Tromethamine Ophthalmic Solution 0.5% w/v & 0.5% w/v

COMPOSITION
Each ml contains : Moxifloxacin Hydrochloride IP equivalent to Moxifloxacin 5 mg, Ketorolac Tromethamine IP 5 mg, Benzalkonium Chloride Solution IP (as Preservative) 0.01% v/v, Sterile Aqueous Base q.s It contains HPMC solution as lubricant

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INTRODUCTION
MOXIEYE-K is a sterile multidose topical anti-inflammatory NSAID and antibiotic combination for ophthalmic use. MOXIEYE-K contains Moxifloxacin HCI 0.5% w/v and Ketorolac Tromethamine 0.5% w/v.Moxifloxacin is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.Ketorolac is a member of the pyrrolopurrole group of nonsteroidal anti-inflammatory drugs (NSAIDS).

INDICATIONS
NSAID responsive inflammatory ocular conditions for which a NSAID is indicated and where superficial bacterial ocular infection or the risk of bacterial ocular infection exists and where the inherent risk of NSAID use in certain infective conjunctivitis is accepted to obtain a diminution in edema and flammation.Topical NSAID like ketorolac tromethamine is indicated for the treatment of postoperactive inflammation in patients who have undergone cataract extraction. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

DIRECTIONS
Instill one drop in the affected eye 3 times a day or as directed by the physician

WARNINGS
NOT FOR INJECTION.
MOXIEYE-K solution should not be injected subconjunctivaly, 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) reations 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, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically incidiacted.

SIDE EFFECTS
The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular
hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occured in approdimately 1-6% of patients.
Nonocular adverse events reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash and rhinitis.

PACKING
5 ml vial with dispensing plug and screw cap, all polypropylene.

Storage :
Store at temperature not exceeding 25 C and protect from light.

Medicine :
Keep out of reach of children.
Use the solution within one month after opening the container.
For external use only.

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