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Loteprednol Drug Information Provided by Lexi-Comp

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Pronunciation

(loe te PRED nol)

Generic Available (U.S.)

No

Index Terms

  • Loteprednol Etabonate

U.S. Brand Names

  • Alrex®
  • Lotemax®

Canadian Brand Names

  • Alrex®
  • Lotemax®

Pharmacologic Category

  • Corticosteroid, Ophthalmic

Pharmacologic Category Synonyms

  • Ophthalmic Corticosteroid
  • Steroid, Ophthalmic

Use: Labeled Indications

Suspension, 0.2% (Alrex®): Temporary relief of signs and symptoms of seasonal allergic conjunctivitis

Suspension, 0.5% (Lotemax®): Inflammatory conditions (treatment of steroid-responsive 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, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation) and treatment of postoperative inflammation following ocular surgery

Pregnancy Risk Factor

C

Lactation

Excretion in breast milk unknown/use caution

Contraindications

Hypersensitivity to loteprednol, other corticosteroids, and any component of the formulation; viral diseases of the cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases of ocular structures

Warnings/Precautions

Concerns related to adverse effects:

• Infection: Steroids may mask infection or enhance existing ocular infection; prolonged use may result in secondary infections due to immunosuppression.

• Ocular effects: Prolonged use may result in glaucoma and injury to the optic nerve. Visual defects in acuity and field of vision may occur. Posterior subcapsular cataracts may form after long-term use. Use with caution in presence of glaucoma (steroids increase intraocular pressure). Perforation may occur with topical steroids in diseases which thin the cornea or sclera. Steroid use may delay healing after cataract surgery. Intraocular pressure should be monitored if this product is used >10 days.

Other warnings/precautions:

• Appropriate use: For ophthalmic use only; patients should be re-evaluated if symptoms fail to improve after 2 days.

Adverse Reactions

>10%:

Central nervous system: Headache

Respiratory: Rhinitis, pharyngitis

1% to 10%: Ocular: Abnormal vision/blurring, burning on instillation, chemosis, dry eyes, itching, injection, conjunctivitis/irritation, corneal abnormalities, eyelid erythema, papillae uveitis

<1%: Cataract formation, changes in visual acuity and/or field defects, global perforation in disease which thins cornea or sclera, increased intraocular pressure, secondary ocular infection

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Mechanism of Action

Corticosteroids inhibit the inflammatory response including edema, capillary dilation, leukocyte migration, and scar formation. Loteprednol is highly lipid soluble and penetrates cells readily to induce the production of lipocortins. These proteins modulate the activity of prostaglandins and leukotrienes.

Pharmacodynamics/Kinetics

Absorption: None

Dosage

Adults: Ophthalmic:

Suspension, 0.2% (Alrex®): Instill 1 drop into affected eye(s) 4 times/day

Suspension, 0.5% (Lotemax®):

Inflammatory conditions: Apply 1-2 drops into the conjunctival sac of the affected eye(s) 4 times/day. During the initial treatment within the first week, the dosing may be increased up to 1 drop every hour. Advise patients not to discontinue therapy prematurely. If signs and symptoms fail to improve after 2 days, re-evaluate the patient.

Postoperative inflammation: Apply 1-2 drops into the conjunctival sac of the operated eye(s) 4 times/day beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period

Administration: Other

Shake well before using.

Monitoring Parameters

Intraocular pressure (if >10 days)

Patient Education

For use in eyes only. Shake well before using. Do not let tip of applicator touch eye; do not contaminate tip of applicator (may cause eye infection, eye damage, or vision loss). Tilt head back, place medication in conjunctival sac, and close eyes. Apply finger pressure at corner of eye for 1 minute following application. May cause temporary sensitivity to bright light, blurring or stinging, changes in visual acuity, headache, runny nose, or sore throat. If improvement is not noted within 2 days, notify prescriber. Report persistent vision changes, signs of infection, swollen eyelids, or inflammation.

Geriatric Considerations

Assess patient's ability to administer eye drops.

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

None reported

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, ophthalmic, as etabonate [drops]:

Alrex®: 0.2% (5 mL, 10 mL) [contains benzalkonium chloride]

Lotemax®: 0.5% (2.5 mL, 5 mL, 10 mL, 15 mL) [contains benzalkonium chloride]

Pricing: U.S. (www.drugstore.com)

Suspension (Alrex)

0.2% (5): $112.99

0.2% (10): $208.00

Suspension (Lotemax)

0.5% (5): $94.99

0.5% (10): $181.00

0.5% (15): $225.98

International Brand Names

  • Alrex (BR, HK)
  • Lotemax (AR, GB, HK, IE, IL, SG, UY)
  • Lotepred (IN)
  • Loterex (MX)
  • Lotesoft (PY, VE)
  • Oftol (CN)

Lexi-Comp.com

Last full review/revision May 2011

Content last modified May 2011

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