Ocuflox (Ofloxacin)




Antibacterial Agent

Action And Clinical Pharmacology: The primary mechanism of action of ofloxacin appears to be the specific inhibition of DNA gyrase (topoisomerase II). This enzyme is responsible for the negative supercoiling of bacterial DNA and consequently for its topological configuration, governing functions such as RNA transcription, protein synthesis, DNA replication and repair functions.

Indications And Clinical Uses: For the treatment of conjunctivitis when caused by susceptible strains of the following bacteria: Gram-positive bacteria: S. aureus, S. epidermidis, S. pneumoniae. Gram-negative bacteria: H. influenzae.

Contra-Indications: In patients with a history of hypersensitivity to ofloxacin or to any of the components of this medication. A history of hypersensitivity to other quinolones also contraindicates use of ofloxacin.

Manufacturers’ Warnings In Clinical States: Ofloxacin ophthalmic solution is not for injection into the eye.

Precautions: General: Prolonged use of ofloxacin ophthalmic solution may result in overgrowth of nonsusceptible organisms, including fungi. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

In patients receiving systemic quinolone therapy, serious and occasionally fatal hypersensitivity (anaphylatic) reactions, some following the first dose, have been reported. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylatic reactions may require immediate emergency treatment with epinephrine. Oxygen, i.v. steroids and airway management, including intubation, should be administered as clinically indicated.

The systemic administration of quinolones has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species. Ofloxacin, administered systemically at 10 mg/kg/day in young dogs (equivalent to 150 times the maximum recommended daily adult ophthalmic dose), has been associated with these types of effects.

Pregnancy: There have been no adequate and well-controlled studies performed in pregnant women. Since systemic quinolones have been shown to cause arthropathy in immature animals, ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: Because ofloxacin taken systemically is excreted in breast milk, and there is potential for harm to nursing infants, a decison should be made whether to temporarily discontinue nursing during therapy or not to administer the drug, taking into account the importance of the drug to the mother.

Children: Safety and effectiveness of ofloxacin in children have not been established.

Geriatrics: No comparative data are available with topical ofloxacin therapy in this age category versus other age groups.

Drug Interactions: Specific drug interaction studies have not been conducted with ofloxacin ophthalmic solution. Interactions between ofloxacin and caffeine have not been detected. Systemic use of ofloxacin with nonsteroidal anti-inflammatory drugs has shown that the risk of CNS stimulation and convulsive seizures may increase. A pharmacokinetic study in 15 healthy males has shown that the steady-state peak theophylline concentration increased by an average of approximately 9% and the AUC increased by an average of approximately 13% when oral ofloxacin and theophylline were administered concurrently.

Adverse Reactions: Ophthalmic Use of Ofloxacin: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions were ocular redness, stinging, itching, photophobia, tearing and dryness. One report of dizziness, one report of headache and one spontaneous report of toxic epidermal necrolyis have also been received.

Systemic Effects of Ofloxacin: As with all topical ophthalmic drugs, the potential exists for systemic effects. Ofloxacin used systemically has rarely been associated with serious side effects. Serious reactions reported for systemic dosing of ofloxacin include convulsions and increased intracranial pressure. For the oral dosage form of ofloxacin, gastrointestinal symptoms, mainly nausea/vomiting, pain/discomfort, diarrhea and anorexia, were reported most frequently, followed by CNS events (such as dizziness and headaches) and dermatological or hypersensitivity reactions. Photophobia was reported rarely in clinical trials with systemic ofloxacin and phototoxicity has been reported with other drugs in this class.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: In the event of accidental ingestion of 10 mL of ofloxacin ophthalmic solution 0.3%, only 30 mg of ofloxacin would be ingested. Although this amount may not be clinically significant in terms of overdosage, there could be an increased potential for systemic reactions.

A topical overdosage of ofloxacin ophthalmic solution is considered a remote possibility. Discontinue medication if heavy or protracted use is suspected. In the event of a topical overdose, flush the eye with a topical ocular irrigant.

Dosage And Administration: 1 to 2 drops every 2 to 4 hours for the first 2 days, and then 4 times daily in the affected eye(s) for 8 days.

If superinfection occurs or if clinical improvement is not noted with 7 days, discontinue use and institute appropriate therapy.

Patients should be advised to avoid contamination of the dropper tip.

Use while wearing contact lenses: The use of ofloxacin ophthalmic solution while wearing contact lenses has not been studied. Therefore, its use is not recommended while the lens is on the eye.

Availability And Storage: Each bottle contains: ofloxacin 0.3% as a sterile, ophthalmic solution. Nonmedicinal ingredients: benzalkonium chloride 0.005% (as preservative), sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust the pH and purified water. Plastic dropper bottles of 5 and 10 mL. Ofloxacin ophthalmic solution is sterile in the unopened package, and is stable for 24 months when stored at 15 to 25°C.

OCUFLOX Allergan Ofloxacin Antibacterial Agent

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