Zylet is a topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use. It is indicated for treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Topical ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation. They are also indicated in treating chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The anti-infective drug in Zylet (tobramycin) is active against a wide range of bacterial ocular pathogens, including staphylococci and streptococci, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, H aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus, and some Neisseria species.

Anti-inflammatory efficacy of Zylet can be attributed to its active component, loteprednol etabonate 0.5%. Levels of loteprednol etabonate in the aqueous humor were found to be comparable betweenLotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Zylet treatment groups in a controlled clinical study of ocular penetration.1

Indication

Zylet is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an ant-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumonia. Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumonia, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains Haemophilus influenzae and H. aegypitus, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

IMPORTANT RISK INFORMATION

Zylet is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of the ocular structures. Zylet is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

NOT FOR INJECTION INTO THE EYE

Prolonged use of Zylet is associated with several warnings and precautions, including glaucoma with optic nerve damage, defects in visual acuity, cataract formation, secondary ocular infections, exacerbation or prolongation of viral ocular infections (including herpes simplex), delay in wound healing and increase in bleb formation

If this product is used for 10 days or longer, intraocular pressure should be monitored. The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification. Fungal infections of the cornea may develop with prolonged use of corticosteroids.

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Cross-sensitivity to other aminoglycoside antibiotics may occur.

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. The incidence of clinically significant increases in intraocular pressure ≥ 10 mm Hg from baseline was reported in 3.6% (4/112) of subjects receiving Zylet and 0% (0/56) among subjects receiving placebo. Nine percent (9%) of Zylet subjects reported burning and stinging upon instillation.