Zylet Side Effects

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

Side Effects of Zylet - for the Consumer

Zylet Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zylet Drops:

Burning or stinging upon using Zylet Drops; mild itching, discomfort, or redness of the eye.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; sensitivity to light; severe or worsening pain or inflammation, redness, swelling, or discharge from the eye or eyelid; unusual tearing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Zylet Side Effects - for the Professional

Zylet

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, the incidence of ocular adverse events reported in greater than 10% of subjects included injection (approximately 20%) and superficial punctate 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 adverse events reported in approximately 14% of subjects was headache; all other non-ocular events 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. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

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.

Side Effects by Body System - for Healthcare Professionals

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) was 2% (15/901) with loteprednol etabonate, 7% (11/164) with 1% prednisolone acetate and 0.5% (3/583) with placebo.

Ocular side effects have been reported the most frequently. They have included injection (20%), superficial punctate keratitis (15%), increased intraocular pressure (10%), and burning and stinging upon instillation (9%). Vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder and other unspecified eye disorders have been reported in less than 4% of patients.

Ocular side effects associated with loteprednol have included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia in 5% to 15% of patients. Conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis have been reported in <5% of patients.

Corticosteroids have also been reported to cause elevated intraocular pressure, optic nerve damage, visual acuity and field defects, cataracts, secondary infections, acute anterior uveitis, perforation of the globe, keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation, and ptosis.

Ocular side effects associated with tobramycin ophthalmic have included eyelid itching and swelling, and conjunctival erythema (<4%).

Nervous system

Nervous system side effects have included headache (14%).

Respiratory

Respiratory side effects associated with loteprednol ophthalmic have included rhinitis and pharyngitis (<15%).

Hypersensitivity

Hypersensitivity side effects associated with tobramycin ophthalmic have included allergic conjunctivitis and blepharitis.

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

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