Rx Pharmaceuticals

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

Zylet® is a unique, combination ophthalmic suspension product that combines the proven anti-inflammatory power of loteprednol etabonate, with the broad-spectrum anti-infective agent, tobramycin.  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 and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.  Zylet® is the first FDA approved anti-inflammatory/anti-infective ophthalmic combination since the 1980's.  It has been over 16 years since the US FDA has approved a New Drug Application (NDA) for a combination anti-inflammatory/anti-infective agent so Zylet offers both clinicians and patients an important new treatment option.1 With the use of loteprednol as the anti-inflammatory component in the formulation, Zylet offers both power and protection for a wide range of patients - including those patients previously known to be at risk for glaucoma or ocular hypertension, or those who may react unfavorably with a steroid-induced rise in intraocular pressure. Zylet is truly the smart combination!

Zylet is the first and only ophthalmic corticosteroid/antibiotic combination to contain an "ester" corticosteroid (loteprednol etabonate).2 This ester steroid provides important and significant benefits versus older therapies which contain "ketone" class corticosteroid agents, particularly with respect to side effects such as steroid-induced, elevated intraocular pressure.3,4 The unique loteprednol etabonate mechanism of action translates to proven performance and enhanced protection characterized by a high affinity for the corticosteroid receptor;5 corneal penetration augmented by high lipid solubility;3,6 and a predictable transformation to an inactive metabolite,3 which reduces the risk of clinically significant intraocular pressure elevations.3,7

As with other steroid anti-infective ophthalmic combination drugs, Zylet is contraindicated in most viral diseases of the cornea and conjunctiva and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prolonged use of corticosteroids may result in glaucoma, as well as increase the hazard of secondary ocular infections. The incidence of adverse events reported by subjects treated with Zylet included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. NOT FOR INJECTION INTO THE EYE. Steroids should be used with caution in the presence of glaucoma. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. If this product is used for 10 days or longer, intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients.

See package insert for important safety and full prescribing information.

 

Key Benefits

Zylet - A Smart Combination

  • Combination therapy 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 and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.3
  • The first FDA approved anti-inflammatory/anti-infective ophthalmic combination since the 1980's.1
  • Corticosteroid efficacy suitable for a wide range of patients, including those who are steroid responders, who have ocular hypertension or glaucoma.3,8-12
  • Broad array of FDA approved indications.3
  • Soothing and comfortable formulation with glycerin and povidone.3

Corticosteroid Power-Loteprednol Etabonate 0.5%

  • Clinical studies of loteprednol etabonate 0.5% ophthalmic suspension report proven efficacy in the treatment of anterior chamber inflammation following cataract surgery, acute anterior chamber uveitis, and giant papillary conjunctivitis, as well as in the prophylaxis of seasonal allergic conjunctivitis.13
  • Single-step metabolism means limited systemic absorption (1ng/mL) following administration.7,13,14,15
  • Exerts site-specific action, providing a low propensity for raising intraocular pressure and, therefore, a decreased risk of steroid-induced glaucoma.7,13,14
  • In a comparison clinical trial with prednisolone acetate 1.0%, in known steroid responders, the mean IOP elevations that loteprednol etabonate 0.5% induced were neither statistically nor clinically significant after 6 weeks of usage.4
  • Moreover, in other studies, significant increases in intraocular pressure were found with dexamethasone, but not with loteprednol etabonate.13,16
  • Absence of a ketone group on the number 20 carbon position has been theorized as possibly providing a lower risk of steroid-induced cataract formation.2,17,18,19
  • High lipid solubility, augmenting corneal and cell penetration.2,3,13
  • The first and only next generation ester corticosteroid for optimum control of inflammation.2

Antibiotic Power - Tobramycin 0.3%

  • Broad-spectrum aminoglycoside antibiotic with over 20 years of real world proven experience.20,21,22
  • Proven broad-spectrum (Gram-positive and Gram-negative) antibiotic efficacy against the following common eye pathogens. 2,3
    • 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 
    • Proteus vulgaris (most strains)
    • Haemophilus influenzae 
    • Moraxella lacunta 
    • Acinetobacter calcoaceticus 
    • Haemophilus aegyuptius 
    • Neisseria (some species)

 

As with other steroid anti-infective ophthalmic combination drugs, Zylet is contraindicated in most viral diseases of the cornea and conjunctiva and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prolonged use of corticosteroids may result in glaucoma, as well as increase the hazard of secondary ocular infections. The incidence of adverse events reported by subjects treated with Zylet included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. NOT FOR INJECTION INTO THE EYE. Steroids should be used with caution in the presence of glaucoma. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. If this product is used for 10 days or longer, intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients.

See package insert for important safety and full prescribing information.

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Indications

Zylet® has been approved for the following indications:3

  • Steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or the 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.
  • 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 (see package insert for full prescribing information).

 

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Contents

Active Ingredients

  • Loteprednol Etabonate 0.5%
  • Tobramycin 0.3%

 Inactive Ingredients

  • Edetate Disodium
  • Glycerin
  • Povidone
  • Purified Water
  • Tyloxapol
  • Benzalkonium Chloride 0.01% (preservative)
  • Sulfuric Acid and /or Sodium Hydroxide maybe added to adjust the pH to 5.7% - 5.9%. The suspension is essentially isotonic with a tonicity of 260 to 320 m0smol/kg.

  

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Safety Information

As with other steroid/anti-infective ophthalmic combination drugs, 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 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. Prolonged use of corticosteroids may result in glaucoma, as well as increase the hazard of secondary ocular infections. The incidence of adverse events reported by subjects treated with Zylet included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. NOT FOR INJECTION INTO THE EYE. Steroids should be used with caution in the presence of glaucoma. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. If this product is used for 10 days or longer, intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients.

See package insert for important safety and full prescribing information.

 

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Package Size

Available in 3 convenient sizes:

  • 2.5 mL in a 7.5 mL bottle
  • 5 mL in a 7.5 mL bottle
  • 10 mL in a 10 mL bottle

 

See package insert for important safety and full prescribing information.
 

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