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Zylet

Last reviewed on RxList: 6/27/2017
Zylet Side Effects Center

Last reviewed on RxList 6/27/2017

Zylet (loteprednol etabonate and tobramycin) is a combination of a corticosteroid and an antibiotic used to treat eye inflammation caused by surgery, infection, allergies, and other conditions. Common side effects of Zylet include stinging, burning, irritation, itching, discomfort, or redness of the eyes for 1 to 2 minutes when this medication is applied. Other side effects of Zylet include headache, sensitivity of the eyes to light, or blurred vision.

The recommended dose of Zylet is one or two drops applied into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Do not use other eye drops or eye medications during treatment with Zylet ophthalmic unless directed by your doctor. Other drugs may also interact with Zylet ophthalmic. Tell your doctor all prescription or over-the-counter medicines or supplements you use. During pregnancy, Zylet should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Zylet (loteprednol etabonate and tobramycin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Zylet Consumer Information

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.

Read the entire detailed patient monograph for Zylet (Loteprednol Etabonate and Tobramycin)

Zylet Professional Information

SIDE EFFECTS

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.

Zylet:

In a 42 day safety study comparing Zylet to placebo, ocular adverse reactions included injection (approximately 20%) and superficial punctuate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Zylet) and 4% (placebo) of subjects. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation.

Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders.

The incidence of non-ocular reactions reported in approximately 14% of subjects was headache; all other non ocular reactions had an incidence of less than 5%.

Loteprednol etabonate ophthalmic suspension 0.2% - 0.5%:

Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure ( ≥ 10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.

Tobramycin ophthalmic solution 0.3%:

The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.

Secondary Infection:

The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids.

The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs.

Read the entire FDA prescribing information for Zylet (Loteprednol Etabonate and Tobramycin)

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© Zylet Patient Information is supplied by Cerner Multum, Inc. and Zylet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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