Norfloxacin Ophthalmic Solution

NOROXIN® Ophthalmic Solution

MSD

Norfloxacin

Antibacterial

Action And Clinical Pharmacology: Norfloxacin ophthalmic solution is a fluoroquinolone carboxylic acid antibacterial agent for ocular administration. Norfloxacin inhibits bacterial deoxyribonucleic acid synthesis and is bactericidal.

At the molecular level 3 specific actions have been attributed to norfloxacin in the inhibition of E. coli cells: inhibition of the ATP-dependent DNA supercoiling reaction catalyzed by DNA gyrase, inhibition of the relaxation of supercoiled DNA and promotion of double-stranded DNA breakage.

Indications And Clinical Uses: For the treatment of acute superficial infections of the eye and its adnexae (conjunctivitis, blepharoconjunctivitis and blepharitis) when caused by susceptible bacteria in adults and children.

Contra-Indications: Patients with known hypersensitivity to any component of this product or any chemically related quinolone antibacterial agent.

Precautions: General: As with other antibacterial preparations, prolonged use may result in overgrowth of non-susceptible bacteria including fungi. If superinfection or resistance should develop, treatment with norfloxacin ophthalmic solution should be discontinued and appropriate therapy instituted.

Information for the Patient: Patients should be instructed of the following: how to properly use this ophthalmic solution as this is a sterile solution; to avoid contaminating the solution by preventing the dropper tip from touching any surface; to consult a physician, a) unless otherwise informed, if there has been no improvement after 4 days of continuous treatment or if the infection seems to get worse, b) if irritation or sensitization develops, c) before wearing contact lenses.

The preservative (benzalkonium chloride) in Noroxin ophthalmic solution may deposit in soft contact lenses. The lenses should be removed before application of the drops and not be reinserted earlier than 15 minutes after use. Ideally, patients with an eye infection should not wear their contact lenses until their treatment is finished.

Pregnancy: Norfloxacin has not been studied in human pregnancy. Therefore, the ophthalmic solution should be given to a pregnant woman only if clearly needed.

Lactation: It is not known whether norfloxacin is excreted in human milk following ocular administration.

Adverse Reactions: The most frequently reported side effect was local burning or smarting (5.4%). Other drug related side effects were conjunctival hyperemia (0.5%), chemosis (0.3%), photophobia (0.5%) and a bitter taste following instillation.

Dosage And Administration: The recommended dose is 1 or 2 drops of ophthalmic solution in the affected eye(s) 4 times daily. Depending on the severity of the infection, the dosage for the first day of therapy may be increased to 1 or 2 drops every 2 hours during the waking hours.

The usual course of treatment is 7 days.

Availability And Storage: Each mL of sterile, clear, colorless to light yellow ophthalmic solution contains: norfloxacin 3 mg. White, opaque, plastic Ocumeter ophthalmic dispensers of 5 mL with a controlled drop tip. Protect from light. Store at room temperature, below 30°C.

NOROXIN® Ophthalmic Solution MSD Norfloxacin Antibacterial

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Conjunctivitis

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