FLOMOX

Eye Drops




Executive Summary



One of the New, 4th Generation Fluoroquinolones

Excellent invitro-activity against Gram-negative organisms that fluoroquinolones are known to treat.

Expanded activity against Gram- positive organisms including resistant Gram- positive organisms.

Moxifloxacin has tremendous activity as monotherapy against numerous organisms which are difficult to treat.

Able to treat keratitis caused by the organisms resistant to the earlier generation of Fluoroquinolones



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Flomox
Eye Drops

Composition : Each ml solution contains Moxifloxacin 5 mg as Moxifloxacin Hydrochloride INN. Preservative: Benzalkonium Chloride 0.01%
Description: Moxifloxacin is a fourth-generation 8- methoxy fluoroquinolone antibacterial agent having an enhanced broad-spectrum activity against Gram-positive bacteria and Gram-negative bacteria. It is also active against atypical microorganisms, Mycobacterium and anaerobes. It works by stopping the life cycle of bacteria.

Mechanism of Action: Moxifloxacin inhibits bacterial enzyme topoisomerase II (DNA gyrase) and topoisomerase IV. Topoisomerases are essential enzymes which play a crucial role in the replication and repair of bacterial DNA. This mechanism is lethal to susceptible bacteria.

Indications: Flomox eye drops are indicated in the treatment of a variety of ocular infections caused by susceptible bacteria. Such as-
î Conjunctivitis î Blepharitis î Blepharo-conjunctivitis î Corneal ulcer î Dacryocystitis î Traumatic ocular injuries î Meibomianitis î Keratitis î Eliminate conjunctival microorganisms prior to ocular surgery & î In the treatment of postoperative infections

Dosage & administration: Instill one drop in the affected eye(s) 3 times a day for 7 days.

Contraindications: Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other quinolones or to any of the components of the preparation.

Pediatric Use: The safety and effectiveness of Moxifloxacin ophthalmic solution in infants below 1 year of age has not been established. There is no evidence that the ophthalmic administration of Moxifloxacin solution has any effect on weight bearing joints.

Use in pregnancy: Moxifloxacin should be used during pregnancy only if the potential benefit justifies against the potential risk to the fetus.

Use in lactation : 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 Solution is administered to nursing mothers.

Side effects: The most frequently reported ocular side effects were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage and tearing. These events occurred in approximately 1-6% of patients.


Precaution: In patients receiving systemically administered quinolones, including Moxifloxacin, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported 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 the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment.

Drug interaction: Drug-drug interaction studies have not been conducted with Moxifloxacin solution. In vitro studies indicate that Moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that Moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes

Package quantities: Flomox Eye Drops are supplied in 5 ml Polyethylene bottle

Storage: Keep in a dry & cool place, Protect from light. Keep out of the reach of children.
Ref: Product Management Department, Opso Saline Ltd., Bangladesh.