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Zylet

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Zylet

INDICATIONS

Zylet® is a topical anti-infective and corticosteroid combination 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 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 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 coagulasenegative), including penicillin-resistant strains. Streptococci, including some of the Group Abeta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae, and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

DOSAGE AND ADMINISTRATION

Recommended Dosing

Apply one or two drops of Zylet into the conjunctival sac of the affected eye every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Prescription Guideline

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

Zylet (loteprednol etabonate and tobramycin) Ophthalmic Suspension 0.5%/0.3% contains 5 mg/mL loteprednol etabonate and 3 mg/mL tobramycin.

Storage And Handling

Zylet (loteprednol etabonate and tobramycin) Ophthalmic Suspension is supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a white polypropylene cap in the following sizes:

5 mL (NDC 24208-358-05) in a 7.5 mL bottle
10 mL (NDC 24208-358-10) in a 10 mL bottle

USE ONLY IF IMPRINTED NECKBAND IS INTACT.

Storage: Store upright at 15°-25° C (59°-77° F).

PROTECT FROM FREEZING

Bausch & Lomb Incorporated Tampa, Florida 33637 USA. Revised: 02/2013

Last reviewed on RxList: 3/5/2013
This monograph has been modified to include the generic and brand name in many instances.

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