ZYLET SUMMARY
Zylet (loteprednol etabonate and tobramycin ophthalmic suspension), is a sterile, multiple dose topical anti-inflammatory corticosteroid and antibiotic combination for ophthalmic use.
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 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 coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-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.
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NEWS HIGHLIGHTS
Published Studies Related to Zylet (Loteprednol / Tobramycin)
Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular
pressure in healthy volunteers. [2008]
ophthalmic suspension... CONCLUSIONS: Loteprednol/tobramycin was significantly less likely to produce
Comparison of tobramycin 0.3%/dexamethasone 0.1% and tobramycin 0.3%/loteprednol
0.5% in the management of blepharo-keratoconjunctivitis. [2007]
In this clinical trial, investigators compared the effectiveness of 2
commercially formulated antibiotic/steroid combinations - tobramycin
0.3%/dexamethasone 0.1% (Tobradex; Alcon, Fort Worth, Tex) and tobramycin
0.3%/loteprednol 0.5% (Zylet; Bausch & Lomb Inc., Rochester, NY) - for rapidly
controlling inflammation in patients with blepharo-keratoconjunctivitis...
Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with
dexamethasone 0.1%/tobramycin 0.3% in the treatment of
blepharokeratoconjunctivitis. [2008]
CONCLUSIONS: LE/T satisfied the condition of non-inferiority to DM/T in
Clinical Trials Related to Zylet (Loteprednol / Tobramycin)
Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis [Recruiting]
This is a Phase IV, single site, randomized, double masked, parallel control clinical trial
of 60 subjects to investigate the variance of efficacy between Lotemax® and Zylet® for
treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy
will be measured by in-vivo confocal microscopy, corneal fluorescein staining, grading of
meibomian gland dysfunction and validated ocular symptom assessment questionnaire.
Reports of Suspected Zylet (Loteprednol / Tobramycin) Side Effects
Condition Aggravated (3),
Eye Pain (3),
Eyelid Oedema (2),
Hypersensitivity (2),
Drug Ineffective (2),
Ocular Hyperaemia (2),
Lacrimation Increased (2),
Wrong Technique in Drug Usage Process (1),
Eye Irritation (1),
Conjunctivitis (1), more >>
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