Zylet 0.3-0.5% Ophthalmic Drops, 5ml

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

TOBRAMYCIN/LOTEPREDNOL - OPHTHALMIC SUSPENSION

(TOE-bra-MYE-sin/LOE-te-PRED-nol)

COMMON BRAND NAME(S): Zylet

USES: This medication is used to treat conditions involving swelling (inflammation) of the eyes and to treat or prevent bacterial eye infections. This product contains tobramycin, an antibiotic that works by stopping the growth of bacteria. It also contains loteprednol, an anti-inflammatory corticosteroid that works by reducing swelling, redness, and itching. This medication treats/prevents only bacterial eye infections. It will not work for other types of eye infections and may worsen them (e.g., infections caused by viruses, fungi, mycobacteria). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: This medication is applied to the eye(s) as directed by your doctor. To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface. Shake the bottle well before each dose. Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to manufacturer\'s directions, and check with your doctor before you begin using them again. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps if your dose is for more than 1 drop and for your other eye if so directed. Repeat as often as directed by your doctor. Your dosage is based on your medical condition and response to therapy. Do not rinse the dropper. Replace the dropper cap after each use. If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye. Do not use this medication more often than prescribed or for longer than 2 weeks unless directed by your doctor. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue to use this medication for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too soon may allow bacteria to continue to grow, which may result in a return of the infection. Inform your doctor if your condition does not improve in 2 days.

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes may occur when this medication is applied. Headache may also occur during treatment with this medication. If any of these effects persist or worsen, notify 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. Use of this medication for prolonged/repeated periods may result in a new fungal eye infection and may increase your risk for other eye problems (e.g., glaucoma, cataracts, delayed wound healing). Do not use this medication for longer than prescribed. Tell your doctor right away if any of these unlikely but serious side effects occur: new or worsening eye symptoms (e.g., discharge, swelling, redness), vision problems, eye pain. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to tobramycin or loteprednol; or to aminoglycoside antibiotics (e.g., gentamicin, neomycin); or to corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma). After you apply this drug, your vision may become temporarily unstable. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aminoglycoside antibiotics (e.g., intravenous amikacin, gentamicin, tobramycin). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Throw away the unused medication after treatment is completed. Do not use it later for another infection unless your doctor tells you to. If you use this medication for 10 days or longer, eye exams should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store the bottle upright at room temperature away from heat and moisture. Do not freeze. Do not store in the bathroom. Throw away this medication and do not use it if the solution turns brown or cloudy or contains particles. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised June 2018. Copyright(c) 2018 First Databank, Inc.