Levofloxacin Ophthalmic

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• drainage or crusting of your eye;
• severe eye irritation after using the eye drops;
• feeling like there is something in your eye;
• vision problems, increased light sensitivity;
• the first sign of any skin rash, no matter how mild; or
• fever, or any signs of a new infection.

Common side effects may include:

• mild eye irritation or discomfort;
• blurred vision;
• headache;
• nausea, diarrhea, upset stomach;
• throat irritation; or
• unusual or unpleasant taste in the mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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:

• Headache.
• Burning.
• Feeling that something is in the eye.
• Eye is bothered by bright light.
• Throat 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.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Generic: 0.5% (5 mL)

Hypersensitivity to levofloxacin, other quinolones, or to any component of the formulation.

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning, headache, foreign body sensation in eye, sensitivity to light, pharyngitis, or bad taste. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use levofloxacin ophthalmic to treat any eye condition that has not been checked by your doctor.

The number of times per day that you use this medicine may change throughout your treatment. Follow your doctor's dosing instructions very carefully.

Wash your hands before using the eye drops.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

An overdose of levofloxacin ophthalmic is not likely to cause life-threatening symptoms.

Temporary blurred or decreased vision, temporary stinging/burning/pain in the eyes, feeling as if something is in the eye, fever, headache, sore throat, or sensitivity of the eyes to light may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.