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ZYLET (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension)



Important Safety Information | Prescribing Information  





A one-two combo in the treatment of blepharitis and other ocular inflammatory conditions with a risk of infection

  • An ophthalmic suspension formulated with loteprednol etabonate 0.5% and tobramycin 0.3%1
  • Formulated with the known moisturizing ingredients povidone and glycerin1,2

ZYLET treats a wide range of ocular inflammatory conditions with a risk of infection1,3,4

Blepharitis is a common and persistent ocular condition

 

  • In a survey of 204 eye care professionals, it was reported that blepharitis is seen in 37% to 47% of their patients5
  • Affects adult age groups 18 and older6
  • Recurrent condition with symptoms including6,7:
    • Lid hyperemia and inflammation
    • Itching/burning eyelid
    • Crusting of the lid margin
    • Foreign body sensation
    • Excessive tearing
    • Symptoms are usually worse in the morning



INDICATIONS AND USAGE

ZYLET (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension) 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 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.

IMPORTANT SAFETY 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 infections of the eye and fungal diseases of ocular structures.
  • Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, and defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored.
  • Use of corticosteroids may result in posterior subcapsular cataract formation.
  • The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as a slit lamp biomicroscopy and, where appropriate, fluorescein staining.
  • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infections. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
  • Employment of corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and exacerbate the severity of many viral infections of the eye (including herpes simplex).
  • Fungal infections of the cornea are particularly prone to develop coincidentally with long-term, local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
  • Most common adverse reactions reported in patients were injection and superficial punctate keratitis, increased intraocular pressure, and burning and stinging upon instillation.

Please click here for Prescribing Information about ZYLET.

* Source: WK Pharmaceutical Audit. Month ending October, 2016.

References: 1. ZYLET [prescribing information]. Tampa, FL: Bausch & Lomb Incorporated; 2013. 2. Guillon M, Maissa C, Pouliquen P, Delval L. Effect of povidone 2% preservative-free eye drops on contact lens wearers with computer visual syndrome: pilot study. Eye Contact Lens. 2004;30(1):34-39. 3. Reed KK. How to manage bacterial eye infections. Review of Optometry. May 2011. http://www.revoptom.com/continuing_education/tabviewtest/lessonid/107608/dnnprintmode/true/skinsrc/. Accessed January 7, 2014. 4. Contact Lens-Induced Acute Red Eye (CLARE). Living Library. Association of Optometric Contact Lens Educators. http://www.aocle.org/livingL/clare.html. Accessed January 3, 2014. 5. Lemp MA, Nichols KK. Blepharitis in the United States 2009: a survey-based perspective on prevalence and treatment. Ocul Surf. 2009;7(2 suppl):S1-S14. 6. Lindsley K, Matsumura S, Hatef E, Akpek EK. Interventions for chronic blepharitis. Cochrane Database Syst Rev. 2012;5:CD005556. 7. Blepharitis. American Optometric Association. http://www.aoa.org/patients-and-public/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/blepharitis?sso=y. Accessed July 7, 2015.

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