TobraDex Drops

TobraDex Drops are used for:

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Treating eye infections and associated symptoms, including redness, irritation, and discomfort.

TobraDex Drops are an antibiotic (tobramycin) and a corticosteroid (dexamethasone) combination. The antibiotic works by slowing the growth of, or killing, sensitive bacteria in the eye. The corticosteroid works by reducing inflammatory reactions.

Do NOT use TobraDex Drops if:

• you are allergic to any ingredient in TobraDex Drops
• you have tuberculosis, fungal, or viral (eg, herpes simplex, chickenpox) eye infection

Contact your doctor or health care provider right away if any of these apply to you.

Before using TobraDex Drops:

Some medical conditions may interact with TobraDex Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have thinning of the cornea or the white part of the eye
• if you have diabetes

Some MEDICINES MAY INTERACT with TobraDex Drops. Because little, if any, of TobraDex Drops are absorbed into the blood, the risk of interacting with another medicine is low.

Ask your health care provider if TobraDex Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use TobraDex Drops:

Use TobraDex Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• TobraDex Drops are only for the eye. Do not get it in your nose or mouth.
• Shake well before each use.
• To use TobraDex Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using TobraDex Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• Using TobraDex Drops at the same time each day will help you to remember to use it.
• To clear up your infection completely, use TobraDex Drops for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of TobraDex Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use TobraDex Drops.

Important safety information:

• TobraDex Drops may cause blurred vision. Use TobraDex Drops with caution. Do not drive or perform other possibly unsafe tasks if you cannot see clearly.
• If your symptoms do not improve within a few days or if they get worse, check with your doctor.
• Be sure to use TobraDex Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of TobraDex Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Do not use TobraDex Drops for future eye problems unless directed by your doctor.
• TobraDex Drops should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using TobraDex Drops while you are pregnant. It is not known if TobraDex Drops are found in breast milk. If you are or will be breast-feeding while you use TobraDex Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of TobraDex Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning, or stinging when you first put the medicine in your eye; delayed wound healing.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; itching and swelling of the eyelid; redness or swelling of the eye; second infection; severe eye pain; vision loss.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include flushing; increased tearing; lid itching; redness, swelling; and spots or lesions on the surface of the cornea.

Store TobraDex Drops between 46 and to 80 degrees F (8 and 27 degrees C). Store upright in the original container, tightly closed, and away from heat, moisture, and light. Do not store in the bathroom. Keep TobraDex Drops out of the reach of children and away from pets.

General information:

• If you have any questions about TobraDex Drops, please talk with your doctor, pharmacist, or other health care provider.
• TobraDex Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about TobraDex Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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