Rx Pharmaceuticals

Zylet® (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) FAQs

When can I use Zylet®?

Zylet is indicated for corticosteroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.
Are there any adverse reactions associated with 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%.

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.

See package insert for important safety and full prescribing information.
Why should I consider switching from TobraDex (tobramycin 0.3% and dexamethasone 0.1%) to Zylet®?

Zylet offers patients the proven anti-inflammatory action of loteprednol etabonate with the time-tested antibiotic tobramycin. Loteprednol etabonate has been on the market since 1998 and has recorded a favorable safety profile versus all ketone steroids.
What is the difference between an ester and a ketone steroid?

Loteprednol etabonate is the only ester steroid currently on the market. All other available ocular steroids (dexamethasone, prednisolone, fluorometholone, rimexolone) are ketone steroids. Ketone steroids have long been associated with a variety of ocular side effects, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema, and inflammation, including cataract formation and drug-induced elevated intraocular pressure. While ketone steroids undergo a metabolic breakdown which create metabolites that are "active",  ester steroids are broken down by esterases, into "inactive metabolites" in the eye. The result is that the ketone metabolites have a propensity to remain in the anterior chamber and produce unwanted steroid side effects while the ester steroid metabolites were designed to minimize these side effects.16,17

What preservative is used in Zylet®?

Zylet® contains the preservative benzalkonium chloride 0.01%, which is the same preservative found in TobraDex.

 
What does the vehicle contain?

The inactive ingredients in Zylet® include edetate disodium, glycerin, povidone, purified water, and tyloxapol. These inactive ingredients act as the vehicle for drug delivery and some are known for their lubricating properties which may help with patient comfort when used in the eye. The Zylet suspension also contains the preservative, benzalkonium chloride 0.01%, which is used to inhibit decomposition of the active ingredients. Sulfuric acid and/or sodium hydroxide may be added to adjust the pH to between 5.7 and 5.9.
How vigorously do patients have to shake Zylet® to get it into suspension?

The patients should be instructed to shake Zylet® well before administration. Suspensions should be shaken aggressively at least 10 times.
What is the pH of Zylet®?

The pH is between 5.7 and 5.9. The Zylet vehicle is designed to provide your patients with a soothing, comfortable suspension.
What are the Zylet® commercial fill sizes?

Zylet is supplied in 2.5, 5, and 10 mL fill sizes.
Zylet® is the first corticosteroid/antibiotic combination drug to be approved by the FDA since 1980's. What are the other products in this class that compete with Zylet®?

Combination ophthalmic drugs that are in the same general class as Zylet include:

Corticosteroid/Antibiotic Products:
TobraDex (Alcon)
Cortisporin (Monarch)
Maxitrol (Alcon)
Pred-G (Allergan)
Poly-Pred (Allergan)
NeoDecadron (Merck)

Corticosteroid/Sulfa Products:
Blephamide (Allergan)
FML-S (Allergan)
Vasocidin (Novartis)
Metimyd (Schering)
What's been the early acceptance of Zylet® in the marketplace? In other words, how are sales going?

Zylet has has been well received by eye care professionals in the USA since its launch in early 2005.  Many leading Ophthalmologists and Optometrists are now prescribing it regularly and the product is gaining increased use on a monthly basis.