Generic Name

Loteprednol Etabonate

Brand Names
Alrex, Eysuvis, Zylet, Inveltys, Lotemax
FDA approval date: March 09, 1998
Classification: Corticosteroid
Form: Ointment, Suspension, Gel

What is Alrex (Loteprednol Etabonate)?

Eye irritation, redness, and inflammation can make daily life uncomfortable reading, working at a computer, or even stepping outside on a windy day may feel unbearable. Alrex (loteprednol etabonate) is an ophthalmic medication designed to relieve these symptoms and help restore comfort and clarity to the eyes. 

Alrex is a prescription corticosteroid eye drop that helps reduce inflammation caused by seasonal allergic conjunctivitis and other mild eye irritations. Belonging to a class of medications known as corticosteroids, it works by calming inflammation within the eye’s delicate tissues. What makes Alrex unique is that it’s a “soft steroid”, designed to deliver effective anti-inflammatory relief with a lower risk of side effects compared to older steroid eye drops. It’s been widely used for many years as a trusted treatment for allergic eye conditions under the supervision of ophthalmologists and optometrists. 

By easing irritation and redness, Alrex can help patients regain comfort and focus in their daily lives whether it’s working, driving, or simply enjoying time outdoors. 

What does Alrex do? 

Alrex is prescribed to treat eye inflammation caused by allergies, specifically seasonal allergic conjunctivitis, sometimes called “hay fever eyes.” This condition occurs when allergens like pollen, dust, or pet dander trigger an immune reaction in the eyes, causing redness, itching, and tearing. 

The medication is also sometimes used to treat postoperative inflammation after eye surgery or to manage inflammation from other non-infectious causes, as determined by an eye specialist. 

Patients using Alrex typically notice a reduction in redness, swelling, itching, and overall discomfort within several days of consistent use. Clinical studies have shown that loteprednol etabonate is effective in controlling ocular inflammation while maintaining a lower likelihood of increasing intraocular pressure (a common risk with traditional steroid drops) (Mayo Clinic, 2024). 

By addressing the inflammation directly, Alrex helps improve vision clarity and eye comfort, allowing patients to return to their usual routines with less irritation. 

How does Alrex work? 

Alrex contains loteprednol etabonate, a corticosteroid specifically designed for use in the eye. It works by reducing the body’s inflammatory response, a key cause of redness, swelling, and itching in allergic eye conditions. 

When allergens or irritants enter the eye, the immune system releases substances like prostaglandins and cytokines that cause inflammation. Loteprednol blocks the action of these substances, preventing the chain reaction that leads to irritation. 

What sets Alrex apart is its “soft drug” design. Chemically, it’s formulated to become active only where it’s needed (in the eye) and then quickly breaks down into inactive compounds once its job is done. This minimizes the risk of systemic side effects or long-term steroid-related complications, such as increased eye pressure or cataract formation. 

Clinically, this mechanism provides the anti-inflammatory power of a steroid with a lower safety risk, making Alrex a preferred option for patients needing short-term relief from allergic or post-surgical eye inflammation. 

Alrex side effects 

Most patients tolerate Alrex well, especially when used as prescribed for short durations. However, as with any corticosteroid medication, side effects can occur. 

Common side effects may include: 

  • Temporary burning or stinging after application 
     
  • Mild eye irritation or dryness 
     
  • Watery eyes 
     
  • Blurred vision immediately after use 

These effects are usually mild and resolve within minutes. 

Less common but more serious side effects include: 

  • Increased intraocular pressure (eye pressure) 
     
  • Vision changes or seeing halos around lights 
     
  • Eye pain, swelling, or redness that worsens 
     
  • Signs of eye infection, such as discharge or sensitivity to light 

Because corticosteroids can mask the symptoms of infection, it’s essential that Alrex only be used under medical supervision. 

Avoid Alrex if you have viral, fungal, or untreated bacterial eye infections. Use with caution and monitoring if you have a history of glaucoma, cataracts, or ocular herpes simplex.  

Seek immediate medical attention for sudden vision loss, severe pain, or allergic reactions (e.g., eyelid swelling, difficulty breathing). 

Alrex dosage 

Alrex is an ophthalmic suspension (eye drop). Shake the bottle well before use. Apply drops to the affected eye(s) as directed by your healthcare provider, usually for a short period during active inflammation. Do not stop abruptly without medical advice. 

Proper use tips: 

  • Wash hands before and after use. 
  • Avoid touching the dropper tip. 
  • Remove contact lenses before using Alrex and wait 10 minutes before reinserting. 

Doctors may advise regular eye pressure checks, particularly for long-term Alrex users or those with a glaucoma history, to ensure safe and effective treatment. Older adults typically tolerate Alrex well, but extended use of any corticosteroid should be limited to reduce ocular side effect risks.. 

Does Alrex have a generic version? 

Yes. Loteprednol etabonate ophthalmic suspension (0.2%) is the generic version of Alrex and is FDA-approved. The generic formulation contains the same active ingredient, strength, and dosage form as Alrex, ensuring equivalent effectiveness and safety. 

Generic loteprednol (0.2%) is a cost-effective, widely available option for mild allergic eye conditions, offering the same therapeutic benefits as Alrex. Lotemax (0.5%) is for more severe inflammation. 

Conclusion 

Alrex (loteprednol etabonate) offers targeted, effective relief for eye inflammation caused by allergies or mild irritation. Its “soft steroid” design makes it a trusted choice for patients who need the benefits of corticosteroid therapy with reduced risk of side effects. 

Alrex alleviates eye redness, itching, and swelling, restoring comfort and clarity. While generally safe, use under an eye care professional’s guidance for effective, low-risk treatment, balancing powerful relief with safety. 

References 

  1. Mayo Clinic. (2024). Loteprednol (ophthalmic route) description and precautions. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Loteprednol ophthalmic: Uses and side effects. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. U.S. Food and Drug Administration (FDA). (2023). Approved Drug Products: Loteprednol etabonate (Alrex). Retrieved from https://www.accessdata.fda.gov 
     
  1. National Institutes of Health (NIH). (2024). Corticosteroids in ocular inflammation management. Retrieved from https://www.nih.gov 

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Brand Information

    Alrex (loteprednol etabonate)
    1DESCRIPTION
    ALREX
    Loteprednol etabonate is represented by the following structural formula:
    Alrex chemical formula
    Chemical Name:
    Each mL contains:
    ACTIVE: Loteprednol Etabonate 2 mg (0.2%);
    INACTIVES: Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg.
    PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
    2CLINICAL PHARMACOLOGY
    Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A
    Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent. It is highly lipid soluble which enhances its penetration into cells. Loteprednol etabonate is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon
    Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ
    2.1Clinical Studies:
    In two double-masked, placebo-controlled six-week environmental studies of 268 patients with seasonal allergic conjunctivitis, ALREX, when dosed four times per day was superior to placebo in the treatment of the signs and symptoms of seasonal allergic conjunctivitis. ALREX provided reduction in bulbar conjunctival injection and itching, beginning approximately 2 hours after instillation of the first dose and throughout the first 14 days of treatment.
    3INDICATIONS AND USAGE
    ALREX ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.
    4CONTRAINDICATIONS
    ALREX, as with other ophthalmic corticosteroids, 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. ALREX is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
    5WARNINGS
    Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma.
    Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.
    Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.
    6ADVERSE REACTIONS
    Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.
    Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied.
    Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis.
    In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mm Hg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo. Among the smaller group of patients who were studied with ALREX, the incidence of clinically significant increases in IOP (≥10 mm Hg) was 1% (1/133) with ALREX and 1% (1/135) with placebo.
    To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
    7DOSAGE AND ADMINISTRATION
    SHAKE VIGOROUSLY BEFORE USING.
    8HOW SUPPLIED
    ALREX
    1. NDC 24208-353-05 5 mL in a 7.5 mL bottle
    2. NDC 24208-353-10 10 mL in a 10 mL bottle
    9Storage:
    Store upright between 15°C to 25°C (59°F to 77°F). DO NOT FREEZE.
    10Principal Display Panel
    carton
    9537903
    NDC 24208-353-10
    Alrex®
    loteprednol etabonate
    ophthalmic suspension, 0.2%

    FOR OPHTHALMIC USE ONLY

    Sterile
    Rx only

    10 mL
    Alrex has been selected.