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Medication Safety Issues
International issues:
Lotemax® may be confused with Lotanax® which is a brand name for terfenadine in the Czech Republic
Pronunciation
(loe te PRED nol)
U.S. Brand Names
Index Terms
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
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.
Special populations:
• Pediatrics: Safety and efficacy have not been established in children.
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
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
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. Store in a cool place. 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. Do not discontinue therapy prematurely. If improvement is not noted within 2 days, notify prescriber. Report persistent vision changes, signs of increased infection, swollen eyelids, extreme itching, or if inflammation does not improve. Pregnancy precaution: Inform prescriber if you are pregnant.
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
Nursing: Physical Assessment/Monitoring
Assess potential for interactions with other prescriptions, OTC medications, or herbal products patient may be taking. Assess therapeutic response and adverse effects. Teach patient proper use, side effects/appropriate interventions, and symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, ophthalmic, as etabonate:
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): $66.13
0.2% (10): $134.27
Suspension (Lotemax)
0.5% (5): $57.32
0.5% (10): $105.32
0.5% (15): $135.41
International Brand Names
Lexi-Comp.com
Last full review/revision May 2009
Content last modified May 2009
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