Pronunciation: LOE-te-PRED-nol ET-a-BOE-nate
Class: Ophthalmic corticosteroid
- Suspension, ophthalmic 0.2%
- Ointment, ophthalmic 0.5%
- Suspension, ophthalmic 0.5%
Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary and fibroblast proliferation, collagen deposition, and scar formation associated with inflammation. The mechanism of ocular corticosteroids is not known.
Systemic absorption after ocular instillation of loteprednol suspension is below the limit of quantitation (less than 1 ng/mL).
Undergoes extensive metabolism to inactive carboxylic acid metabolites.
Indications and Usage
Treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe ( Lotemax suspension); treatment of inflammation and pain associated with ocular surgery ( Lotemax suspension/ointment); relief of the signs and symptoms of seasonal allergic conjunctivitis ( Alrex ).
Most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infection of the eye; fungal disease of ocular structures; hypersensitivity to any component of the product.
Dosage and AdministrationPostoperative Inflammation
Adults Lotemax suspension
Ophthalmic Instill 1 to 2 drops into the conjunctival sac of the operated eye(s) 4 times daily beginning 24 h after surgery and continuing throughout the first 2 wk of the postoperative period.Lotemax ointment
Ophthalmic Apply a small amount (approximately ½-inch ribbon) into the conjunctival sac(s) 4 times daily beginning 24 h after surgery and continuing throughout the first 2 wk of the postoperative period.Seasonal Allergic Conjunctivitis
Ophthalmic Instill 1 drop into the affected eye(s) 4 times daily.Steroid-Responsive Inflammatory Conditions
Adults Lotemax suspension
Ophthalmic Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 times daily. During the initial treatment within the first week, the dosing may be increased up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely.
- Shake suspension vigorously before using.
Store between 59° and 77°F. Do not freeze.
None well documented.
Anterior chamber inflammation (25%); abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, injection, itching, photophobia (5% to 15%); conjunctival hyperemia, corneal edema, eye pain (4% to 5%); conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, uveitis (less than 5%); elevated IOP, which may be associated with optic nerve damage; perforation of the globe where there is thinning of the cornea or sclera; posterior subcapsular cataract formation; secondary ocular infection from pathogens, including herpes simplex; visual acuity and field defects.
Pharyngitis, rhinitis (less than 15%).
Monitor IOP if used for more than 10 days. Reevaluate the patient if signs and symptoms fail to improve after 2 days.
Category C .
Safety and efficacy not established.
Prolonged use may suppress the host response, increasing the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection.
Posterior subcapsular cataract formation may occur.
Prolonged use may increase the risk of fungal infections of the cornea.
Prolonged use may result in glaucoma with damage to the optic nerve and defects in visual acuity and fields of vision. Use with caution in the presence of glaucoma.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
Use may prolong the course and exacerbate the severity of many ocular viral infections, including herpes simplex. Use with caution in patients with a history of herpes simplex.
Healing may be delayed and risk of bleb formation may be increased.
Systemic absorption is minimal following ocular instillation.
- Instruct patients on the proper method of ophthalmic ointment application into the conjunctival sac and suspension instillation.
- Advise patients to consult their health care provider if pain develops or if redness, itching, or inflammation becomes aggravated.
- Advise patients not to wear contact lenses when using loteprednol ointment or 0.5% suspension.
- Advise patients not to wear contact lenses during therapy if their eyes are red. Instruct patients using soft contact lenses whose eyes are not red to wait at least 10 min after loteprednol 0.2% suspension instillation before inserting contact lenses.
- Instruct patients to wash hands prior to using loteprednol.
- Inform patients to tell their health care provider if symptoms do not improve within 2 days.
- Advise patients not to touch the eyelid or surrounding areas with the tip of the tube or to allow the dropper tip to touch any surface because this may contaminate the product.
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