Zylet

DRUG DESCRIPTION

Zylet (loteprednol etabonate and tobramycin ophthalmic suspension), is a sterile, multiple dose topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below.

Loteprednol etabonate:

Loteprednol etabonate Structural Formula Illustration

C24H31ClO7 Mol. Wt. 466.96

Chemical name: chloromethyl 17?-[(ethoxycarbonyl)oxy]-11?-hydroxy-3-oxoandrosta-1,4diene-17? -carboxylate

Tobramycin:


C18H37N5O9 Mol. Wt. 467.52

Chemical Name: O-3-Amino-3-deoxy-? -D-glucopyranosyl-(1 ? 4)-O- [2,6-diamino-2,3,6-trideoxy-? -D-ribo-hexopyranosyl- (1? 6)] -2-deoxystreptamine

Each mL contains: Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.7-5.9. The suspension is essentially isotonic with a tonicity of 260 to 320 mOsm/kg.

What are the possible side effects of loteprednol and tobramycin ophthalmic (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 loteprednol and tobramycin ophthalmic, 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...

Read All Potential Side Effects and See Pictures of Zylet

What are the precautions when taking loteprednol etabonate and tobramycin (Zylet)?

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...

Read All Potential Precautions of Zylet


Zylet Consumer (continued)

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 immediately 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.

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.


Zylet Patient Information Including Side Effects

Brand Names: Zylet

Generic Name: loteprednol and tobramycin ophthalmic (Pronunciation: LOE te PRED nol and TOE bra MYE sin off THAL mik)

  • What is loteprednol and tobramycin ophthalmic (Zylet)?
  • What are the possible side effects of loteprednol and tobramycin ophthalmic (Zylet)?
  • What is the most important information I should know about loteprednol and tobramycin ophthalmic (Zylet)?
  • What should I discuss with my healthcare provider before using loteprednol and tobramycin ophthalmic (Zylet)?
  • How should I use loteprednol and tobramycin ophthalmic (Zylet)?
  • What happens if I miss a dose (Zylet)?
  • What happens if I overdose (Zylet)?
  • What should I avoid while using loteprednol and tobramycin ophthalmic (Zylet)?
  • What other drugs will affect loteprednol and tobramycin ophthalmic (Zylet)?
  • Where can I get more information?

What is loteprednol and tobramycin ophthalmic (Zylet)?

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

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

Loteprednol and tobramycin ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of loteprednol and tobramycin ophthalmic (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 loteprednol and tobramycin ophthalmic, 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 side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about loteprednol and tobramycin ophthalmic (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 loteprednol and tobramycin ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication. Loteprednol and tobramycin ophthalmic may contain a preservative (benzalkonium chloride), which may cause discoloration of contact lenses.

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