Ocuflox

Before using ofloxacin eye drops,

• tell your doctor and pharmacist if you are allergic to ofloxacin, benzalkonium chloride, ciprofloxacin (Cipro), enoxacin (Penetrex), levofloxacin (Levaquin), lomefloxacin (Maxaquin), norfloxacin (Noroxin), sparfloxacin (Zagam), cinoxacin (Cinobac), nalidixic acid (NegGram), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin), cyclosporine (Neoral, Sandimmune), and theophylline (Theo-Dur). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using ofloxacin ophthalmic, call your doctor.
• you should know that ofloxacin solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your contact lenses before instilling ofloxacin and put them back in 10 minutes after you instill the medication.

• Ocuflox^®

NOT FOR INJECTION.

OCUFLOX (ofloxacin ophthalmic) solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.

Avoid contaminating the applicator tip with material from the eye, fingers or other source.

Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.

Do not use ofloxacin ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

It is not known whether ofloxacin ophthalmic will harm an unborn baby. Do not use ofloxacin ophthalmic without first talking to your doctor if you are pregnant.

It is also not known whether ofloxacin ophthalmic passes into breast milk. Do not use ofloxacin ophthalmic without first talking to your doctor if you are breast-feeding a baby.

Ophthalmic Use

The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received.

Refer to Warnings for additional adverse reactions.

Read the entire FDA prescribing information for Ocuflox (Ofloxacin Ophthalmic)

Ocuflox is a prescription medication used to treat bacterial infections of the eye, including corneal ulcers and conjunctivitis (pink eye) caused by bacteria. Ocuflox belongs to a group of drugs called fluoroquinolone antibiotics. These drugs work by killing certain bacteria that cause can cause eye infections.

This medication comes in eyedrop form and is typically adminstered into the affected eye(s) 2 to 4 or more times daily.

Common side effects include eye discomfort, tearing, and dryness.

Ocuflox can also cause blurred vision and/or dizziness. Do not drive or operate heavy machinery until you know how Ocuflox affects you.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other antibiotics
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• certain antidepressants
• antipsychotics (medications to treat mental illness)
• cimetidine (Tagamet)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• diuretics ('water pills')
• insulin and oral medications for diabetes such as glyburide (DiaBeta, in Glucovance, Micronase, others)
• certain medications for irregular heartbeat such as amiodarone (Cordarone), quinidine,
• oral or injectable steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), or prednisone (Sterapred)
• procainamide (Procanbid), and sotalol (Betapace, Betapace AF, Sorine)
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others)
• probenecid (in Col-Probenecid, Probalan)
• theophylline (Elixophyllin, Theo-24, Uniphyl, others)

This is not a complete list of Ocuflox drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ocuflox falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

In the U.S.

• Ocuflox

In Canada

• Ofloxacin
• Ophtho-Flox

Available Dosage Forms:

• Solution

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Eye irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature. Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

NOT FOR INJECTION.

Ocuflox® solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

There are rare reports of anaphylactic reaction/shock and fatal hypersensitivity reactions in patients receiving systemic quinolones, some following the first dose, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.

General

As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

The systemic administration of quinolones, including ofloxacin, 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 110 times the maximum recommended daily adult ophthalmic dose) has been associated with these types of effects.

Information for Patients

Avoid contaminating the applicator tip with material from the eye, fingers or other source.

Systemic quinolones, including ofloxacin, have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.

Drug Interactions

Specific drug interaction studies have not been conducted with Ocuflox® ophthalmic solution. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies to determine the carcinogenic potential of ofloxacin have not been conducted.

Ofloxacin was not mutagenic in the Ames test, in vitro and in vivo cytogenic assay, sister chromatid exchange assay (Chinese hamster and human cell lines), unscheduled DNA synthesis (UDS) assay using human fibroblasts, the dominant lethal assay, or mouse micronucleus assay. Ofloxacin was positive in the UDS test using rat hepatocyte, and in the mouse lymphoma assay.

In fertility studies in rats, ofloxacin did not affect male or female fertility or morphological or reproductive performance at oral dosing up to 360 mg/kg/day (equivalent to 4000 times the maximum recommended daily ophthalmic dose).

Pregnancy

Teratogenic Effects

Ofloxacin has been shown to have an embryocidal effect in rats and in rabbits when given in doses of 810 mg/kg/day (equivalent to 9000 times the maximum recommended daily ophthalmic dose) and 160 mg/kg/day (equivalent to 1800 times the maximum recommended daily ophthalmic dose). These dosages resulted in decreased fetal body weight and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day. Ofloxacin has not been shown to be teratogenic at doses as high as 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively.

Nonteratogenic Effects

Additional studies in rats with doses up to 360 mg/kg/day during late gestation showed no adverse effect on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn.

There are, however, no adequate and well-controlled studies in pregnant women. Ocuflox® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

In nursing women a single 200 mg oral dose resulted in concentrations of ofloxacin in milk which were similar to those found in plasma. It is not known whether ofloxacin is excreted in human milk following topical ophthalmic administration. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in infants below the age of one year have not been established.

Quinolones, including ofloxacin, have been shown to cause arthropathy in immature animals after oral administration; however, topical ocular administration of ofloxacin to immature animals has not shown any arthropathy. There is no evidence that the ophthalmic dosage form of ofloxacin has any effect on weight bearing joints.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Ophthalmic Use

The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been received.

Refer to Warnings for additional adverse reactions.