Zylet Side Effects

Generic name: loteprednol / tobramycin ophthalmic

Note: This document contains side effect information about loteprednol / tobramycin ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Zylet.

Some side effects of Zylet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to loteprednol / tobramycin ophthalmic: ophthalmic suspension

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.

For Healthcare Professionals

Applies to loteprednol / tobramycin ophthalmic: ophthalmic suspension

Ocular

Randomized studies involving patients treated with loteprednol etabonate therapy for 28 days or longer revealed the incidence of significant elevation in intraocular pressure (10 mmHg or greater) was 2% (15/901) with loteprednol etabonate, 7% (11/164) with 1% prednisolone acetate, and 0.5% (3/583) with placebo.

Very common (10% or more): Injection (about 20%), superficial punctate keratitis (about 15%), increased intraocular pressure (10%); Loteprednol ophthalmic (5% to 15%): Abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, photophobia
Common (1% to 10%): Burning and stinging upon instillation (9%); Less than 4%: Vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, other unspecified eye disorders; Loteprednol ophthalmic (less than 5%): Conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, uveitis; Tobramycin ophthalmic (less than 4%): Localized ocular toxicity including eyelid itching and swelling, conjunctival erythema
Frequency not reported: Secondary infections (including fungal infections of the cornea, bacterial ocular infections); Ophthalmic steroids: Elevated intraocular pressure (may be associated with infrequent optic nerve damage), visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infections from pathogens including herpes simplex, perforation of the globe where there is thinning of the cornea or sclera, acute anterior uveitis, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, ptosis

Nervous system

Very common (10% or more): Headache (about 14%)

Other

Common (1% to 10%): Other (unspecified) non-ocular side effects (less than 5%)

Hypersensitivity

Common (1% to 10%): Tobramycin ophthalmic: Hypersensitivity (less than 4%)
Rare (less than 0.1%): Tobramycin ophthalmic: Allergic conjunctivitis and blepharitis (at least 1 case)

A case of allergic conjunctivitis and blepharitis associated with tobramycin ophthalmic ointment has been reported. Hypersensitivity was confirmed by patch testing.

Respiratory

Very common (10% or more): Loteprednol ophthalmic: Rhinitis (less than 15%), pharyngitis (less than 15%)

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