Alrex

— THERAPEUTIC CATEGORIES —
  • Ocular allergy/inflammation
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Alrex Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Loteprednol etabonate 0.2%; oph susp; contains benzalkonium chloride.

    Pharmacological Class

    Steroid.

    How Supplied

    Susp—5mL, 10mL

    How Supplied

    Alrex (loteprednol etabonate ophthalmic suspension, 0.2%) is supplied in a plastic bottle with a controlled drop tip in a 5 mL and 10 mL bottle.

    Storage

    Store upright between 15°C to 25°C (59°F to 77°F). Do not freeze.

    Manufacturer

    Bausch & Lomb Inc.

    Alrex Indications

    Indications

    Seasonal allergic conjunctivitis.

    Alrex Dosage and Administration

    Adult

    1 drop into affected eye(s) 4 times daily.

    Children

    Not recommended.

    Alrex Contraindications

    Contraindications

    Ocular fungal, viral, or mycobacterial infections.

    Contraindications

    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.

    Alrex Boxed Warnings

    Not Applicable

    Alrex Warnings/Precautions

    Warnings/Precautions

    Reevaluate if no improvement after 2 days. Prescribe initially and renew after 14 days only after appropriate exam. Corneal or scleral thinning. Glaucoma. History of herpes simplex. Monitor IOP and for secondary infections in prolonged therapy (>10 days). Avoid abrupt cessation. Soft contact lenses (remove, may reinsert 10 minutes after instillation). Pregnancy (Cat.C). Nursing mothers.

    Warnings/Precautions

    • For ophthalmic use. 

    • Prescribe initially and renew after 14 days only after appropriate exam.

    • Reevaluate if signs and symptoms fail to improve after 2 days. Monitor intraocular pressure if used for 10 days or longer.

    • Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Use caution in the presence of glaucoma.

    • Prolonged use may suppress the host response and increase the risk of secondary ocular infections. In those diseases that cause thinning of the cornea or sclera, perforations may occur with the use of steroids. Steroids may mask infection or enhance existing infection in acute purulent conditions of the eye.

    • Use great caution in patients with a history of herpes simplex.

    • The use of long-term local steroid application is prone to fungal infections of the cornea. Consider fungus invasion in any persistent corneal ulceration where a steroid has been used or is in use.

    Pregnancy Considerations

    Teratogenic effects

    • Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Loteprednol etabonate has been shown to be embryotoxic and teratogenic when administered orally to rabbits.

    • Only use during pregnancy if the potential benefit justifies the potential risk to the fetus.

    Nursing Mother Considerations

    • Not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

    • Exercise caution when administering to a nursing woman.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established. 

    Alrex Pharmacokinetics

    Metabolism

    Hepatic. ~98% serum protein bound.

    Elimination

    Fecal.

    Alrex Interactions

    Not Applicable

    Alrex Adverse Reactions

    Adverse Reactions

    Local reactions (eg, blurred vision, burning, itching, dry eye), photophobia, headache, rhinitis, pharyngitis. May mask or exacerbate ocular infections. Prolonged use may increase: IOP, optic nerve damage, visual acuity and field defects, cataract formation, corneal perforation.

    Alrex Clinical Trials

    Clinical Trials

    In two double-masked, placebo-controlled six-week environmental studies of 268 patients with seasonal allergic conjunctivitis, Alrex, when dosed 4 times per day was superior to placebo in the treatment of the signs and symptoms of seasonal allergic conjunctivitis. Alrex reduced bulbar conjunctival injection and itching, beginning approximately 2 hours after instillation of the first dose and throughout the first 14 days of treatment.

    Alrex Note

    Not Applicable

    Alrex Patient Counseling

    Patient Counseling

    • Advise to not allow the dropper tip to touch any surface. 

    • Consult a physician if redness or itching becomes aggravated.

    • Advise not to wear a contact lens if eye is red.

    • Do not use to treat contact lens related irritation.

    • Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least 10 minutes after instilling Alrex before inserting contact lenses.

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