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Pronunciation |
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(loe
te PRED
nol) |
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U.S. Brand
Names |
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Alrex™; Lotemax® |
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Generic
Available |
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No |
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Synonyms |
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Loteprednol Etabonate |
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Pharmacological Index |
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Corticosteroid, Ophthalmic |
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Use |
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0.2% suspension (Alrex™): Temporary relief of signs
and symptoms of seasonal allergic conjunctivitis
0.5% suspension (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 |
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Pregnancy Risk
Factor |
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C |
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Contraindications |
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Viral diseases of the cornea and conjunctiva; mycobacterial infection of the
eye; fungal diseases of ocular structures; hypersensitivity to loteprednol and
any ingredients; hypersensitivity to other corticosteroids |
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Warnings/Precautions |
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For ophthalmic use only; patients should be re-evaluated if symptoms fail to
improve after 2 days. Intraocular pressure should be monitored if this product
is used >10 days. 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. Steroids may mask
infection or enhance existing infection. Steroid use may delay healing after
cataract surgery. |
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Adverse
Reactions |
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10% to 15%:
Central nervous system: Headache
Respiratory: Rhinitis, pharyngitis
5% to 10%: Ocular: Abnormal vision/blurring, burning on instillation,
chemosis, dry eyes, itching, injection
<5%: Ocular: Conjunctivitis/irritation, corneal abnormalities, eyelid
erythema, papillae uveitis
<1%: Ocular: Increased intraocular pressure, changes in visual acuity
and/or field defects, cataract formation, secondary ocular infection, global
perforation in disease which thins cornea or sclera |
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Mechanism of
Action |
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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. |
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Pharmacodynamics/Kinetics |
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Plasma levels following intraocular administration were not
detectable |
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Usual Dosage |
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Adults: Ophthalmic:
0.5% suspension (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 |
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Administration |
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Shake well before using |
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Monitoring
Parameters |
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Intraocular pressure (if >10 days) |
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Mental Health: Effects
on Mental Status |
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None reported |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Solution: Store in a cool place. Tilt head back, place medication in
conjunctival sac, and close eyes. Apply finger pressure at corner of eye for 1
minute following application. Do not allow tip of applicator to touch eye or any
contaminated surface. |
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Dosage Forms |
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Suspension, ophthalmic, as etabonate:
0.5% (Lotemax®): 2.5 mL, 5 mL, 10 mL, 15 mL
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