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standards of non-Merck sources.
Pronunciation
(loe te PRED nol)
Generic Available (U.S.)
No
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Ointment, 0.5% (Lotemax®): Treatment of postoperative inflammation and pain following ocular surgery
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
Pregnancy Considerations
Loteprednol was shown to be teratogenic in animal reproduction studies when administered orally. The amount of loteprednol absorbed systemically following ophthalmic administration is not known.
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 (including epithelial herpes simplex keratitis, vaccinia, and varicella); mycobacterial infection of the eye; fungal diseases of ocular structures
Warnings/Precautions
Concerns related to adverse effects:
• Immunosuppression: Prolonged use of corticosteroids (including ophthalmic preparations) may increase the incidence of secondary infection, mask acute infection (including fungal infections), or prolong or exacerbate viral infections. Corticosteroids should not be used to treat ocular herpes simplex; use caution in patients with a history of ocular herpes simplex. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
• 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.
Special populations:
• Contact lens wearers: Patients should be advised to not wear contact lenses during treatment.
• Pediatrics: Do not use ointment in children following ocular surgery; may interfere with amblyopia treatment.
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 (2% to <15%)
Ocular: Anterior chamber inflammation (ointment 25%), abnormal vision/blurring (5% to 15%), burning on instillation (5% to 15%), chemosis (5% to 15%), discharge (5% to 15%), dry eyes (5% to 15%), epiphora (5% to 15%), foreign body sensation (5% to 15%), itching (5% to 15%), photophobia (5% to 15%)
Respiratory: Pharyngitis (<15%), rhinitis (<15%)
1% to 5%: Ocular: Conjunctival hyperemia, conjunctivitis/irritation, corneal abnormalities, corneal edema, eyelid erythema, pain, 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, optic nerve damage, secondary ocular infection
Metabolism/Transport Effects
None known.
Drug Interactions
There are no known significant interactions.
Storage
Store at 15°C to 25°C (59°F to 77°F); do not freeze.
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: Minimal
Dosage
Adults: Ophthalmic:
Ointment, 0.5% (Lotemax®): Apply ~1/2 inch ribbon into the conjunctival sac of the affected eye(s) 4 times/day beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period
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 suspension well before using.
Monitoring Parameters
Intraocular pressure (if >10 days)
Patient Education
For use in eyes only. Shake suspension 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.
Ointment, ophthalmic, as etabonate:
Lotemax®: 0.5% (3.5 g)
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)
Ointment (Lotemax)
0.5% (3.5): $145.99
Suspension (Alrex)
0.2% (5): $119.99
0.2% (10): $227.99
Suspension (Lotemax)
0.5% (5): $117.80
0.5% (10): $230.62
0.5% (15): $310.00
International Brand Names
Lexi-Comp.com
Last full review/revision November 2011
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