Bausch  Lomb公司宣布Zylet(TM)(loteprednol etabonate0．5／tobramycin 0．3％，氯替泼诺0．5％／托布霉素0．3％眼科用混悬剂)(Ⅰ)的NDA获美国FDA批准，用于治疗类固醇应答性炎性眼科病。这种状况应是皮质类固醇可适用、有浅表性眼科感染或存在感染风险。预计这种处方眼药水最早于2005年第一季度在美国上市，共有3个规格，即2．5、5和10mL。
Loteprednol etabonate（LE）是被称作＂软药＂（soft drug）的皮质甾类药,该类药物虽有很好的抗炎效果,却有相当严重的毒副作用.而LE因在进入血液循环后能迅速失活,使之保留了皮质甾类药物的抗炎效果,却无其常见的不良反应.

Zylet
loteprednol and tobramycin ophthalmic (low teh PRED nall toe bra MYE sin off THAL mick)

What is the most important information I should know about Zylet?
Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

Contact your doctor if your symptoms get worse or if you do not see any improvement in the condition after 48 hours.

If you wear contact lenses, remove them before applying Zylet. Ask your doctor if contact lenses can be reinserted after application of the medication. Zylet may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

What is Zylet?
Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Tobramycin is an antibiotic.

Zylet is used to treat eye inflammation caused by surgery, infection, allergies, and other conditions.

Zylet may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using Zylet?
Do not use tobramycin ophthalmic if you have a viral or fungal infection in the eye. It is used to treat infections caused by bacteria only.

Zylet is in the FDA pregnancy category C. This means that it is not known whether Zylet will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

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

How should I use Zylet?
Use loteprednol and tobramycin eyedrops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using the eyedrops.

Do not use any eyedrop that is discolored or has particles in it.

If you wear contact lenses, remove them before applying Zylet. Ask your doctor if contact lenses can be reinserted after application of the medication. Zylet may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

To apply the eyedrops:
Shake the bottle to be sure the medicine is well mixed. Tilt the head back slightly and pull down on the lower eyelid. Position the dropper above the eye. Look up and away from the dropper. Squeeze out the prescribed number of drops and close the eye. Apply gentle pressure to the inside corner of the eye (near the nose) for about 1 minute to prevent the liquid from draining down the tear duct. If you are using drops in both eyes, repeat the process in the other eye.
Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

Do not stop using this medication suddenly if you have been using it for several weeks or more. Before stopping, your doctor may want to reduce the dose over several days to prevent side effects.

Contact your doctor if your symptoms get worse or if you do not see any improvement in the condition after 48 hours.

Your doctor may want you to have medical evaluations during treatment with Zylet to monitor progress and side effects.

Store Zylet at room temperature away from moisture and heat. Keep the bottle properly capped.

What happens if I miss a dose?
Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and apply the next regularly scheduled dose as directed. Do not use a double dose of this medication.

What happens if I overdose?
An overdose of Zylet is unlikely to threaten life.

If an overdose is suspected, or if the drops have been ingested, contact an emergency room or poison control center for advice.

What should I avoid while using Zylet?
Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in the eye.

Use caution when driving, operating machinery, or performing other hazardous activities. Tobramycin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment with tobramycin ophthalmic. After applying the medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with tobramycin ophthalmic unless otherwise directed by your doctor.

Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.

If you wear contact lenses, remove them before applying Zylet. Ask your doctor if contact lenses can be reinserted after application of the medication. Zylet may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

What are the possible side effects of Zylet?
If you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to Zylet, stop using the medication and seek emergency medical attention.

Serious side effects are not likely to occur with the use of this medication. Rarely, an increase in the pressure inside of the eye, formation of cataracts, or perforation of the cornea have been reported. Talk to your doctor about any possible side effects.

More commonly, some eye burning, stinging, irritation, itching, redness, sensitivity to light, or blurred vision may occur.

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

What other drugs will affect Zylet?
Do not use other eye drops or eye medications during treatment with Zylet without first talking to your doctor.

Drugs other than those listed here may also interact with Zylet. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?
Your pharmacist has additional information about Zylet written for health professionals that you may read.

What does my medication look like?
Loteprednol and tobramycin ophthalmic is available with a prescription under the brand name Zylet. Other brand or generic formulations of this medication may also be available. Ask your pharmacist any questions you have about this medication, especially if it is unfamiliar to you.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.