Medically reviewed by Drugs.com. Last updated on Aug 9, 2019.
(loe te PRED nol)
- Loteprednol Etabonate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, Ophthalmic, as etabonate:
Lotemax: 0.5% (5 g) [contains benzalkonium chloride, edetate disodium dihydrate, propylene glycol]
Lotemax SM: 0.38% (5 g) [contains benzalkonium chloride, edetate disodium dihydrate, propylene glycol]
Ointment, Ophthalmic, as etabonate:
Lotemax: 0.5% (3.5 g)
Inveltys: 1% (2.8 mL) [contains benzalkonium chloride, edetate disodium dihydrate]
Suspension, Ophthalmic, as etabonate:
Alrex: 0.2% (5 mL, 10 mL)
Lotemax: 0.5% (5 mL, 10 mL, 15 mL)
Generic: 0.5% (5 mL, 10 mL, 15 mL)
Brand Names: U.S.
- Lotemax SM
- Corticosteroid, Ophthalmic
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.
Metabolized to inactive carboxylic acid metabolites
Onset of Action
Seasonal allergic conjunctivitis: Reduction of symptoms seen within 2 hours of instillation
Use: Labeled Indications
Seasonal allergic conjunctivitis (0.2% suspension): Temporary relief of signs and symptoms of seasonal allergic conjunctivitis
Postoperative inflammation/pain (0.38% gel; 0.5% suspension/ointment/gel; 1% suspension): Treatment of postoperative inflammation and pain following ocular surgery
Ophthalmic inflammatory conditions (0.5% suspension): Treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (eg, 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)
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
Seasonal allergic conjunctivitis: Ophthalmic: 0.2% suspension: Instill 1 drop into affected eye(s) 4 times daily.
Steroid-responsive inflammatory conditions: Ophthalmic: 0.5% suspension: 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. Advise patients not to discontinue therapy prematurely. If signs and symptoms fail to improve after 2 days, re-evaluate the patient.
Postoperative inflammation/pain: Ophthalmic:
0.38% gel: Apply 1 drop into the conjunctival sac of the affected eye(s) 3 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
0.5% ointment: Apply ~1/2 inch ribbon into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
0.5% gel, 0.5% suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
1% suspension: Instill 1 to 2 drops into the affected eye(s) twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.
Refer to adult dosing.
Postoperative inflammation and pain: Infants, Children, and Adolescents: Ophthalmic: 0.5% gel (Lotemax): Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 times daily beginning postoperative day 1 and continuing throughout the first 2 weeks of the postoperative period; trials in young pediatric patients (mean age: 3 years) were conducted following cataract surgery.
For topical ophthalmic use only; to avoid contamination, do not touch dropper or tube tip to eyelids or other surfaces. Remove contacts prior to administration. Contact lenses should not be worn when using loteprednol 0.38% gel or 0.5% ophthalmic gel, ointment, or suspension. However, contact lenses may be reinserted 15 minutes following administration of loteprednol 1% ophthalmic suspension or ≥10 minutes following administration of loteprednol 0.2% ophthalmic suspension. When used for the treatment of seasonal allergic conjunctivitis, do not wear contacts if eyes are red.
Gel: While bottle is closed, invert and shake once to fill tip prior to instilling drops.
Suspension: Shake well before using.
Store at 15°C to 25°C (59°F to 77°F); do not freeze.
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Central nervous system: Foreign body sensation of eye (2% to 15%), headache (2% to <15%)
Endocrine & metabolic: Chemosis (5% to 15%)
Local: Application site burning (5% to 15%)
Ophthalmic: Anterior chamber inflammation (2% to 25%), blurred vision (5% to 15%), epiphora (5% to 15%), eye discharge (5% to 15%), eye pruritus (5% to 15%), injected sclera (5% to 15%), photophobia (5% to 15%), visual disturbance (5% to 15%), xerophthalmia (5% to 15%)
Respiratory: Pharyngitis (<15%), rhinitis (<15%)
1% to 10%:
Dermatologic: Erythema of eyelid (<5%)
Ophthalmic: Conjunctival hyperemia (4% to 5%), corneal edema (4% to 5%), eye pain (1% to 5%), conjunctivitis (<5%), corneal changes (<5%), eye discomfort (<5%), eye irritation (<5%), keratoconjunctivitis (<5%), uveitis (<5%), increased intraocular pressure (2%), posterior capsule opacification (1%)
Miscellaneous: Papilla (<5%)
Concerns related to adverse effects:
• Cataracts: Use of corticosteroids may result in posterior subcapsular cataract formation. Use following cataract surgery may delay healing and increase the incidence of bleb formation.
• Corneal thinning: Various ophthalmic disorders, as well as prolonged use of corticosteroids, may result in corneal and scleral thinning. Continued use in a patient with thinning may result in perforation.
• Glaucoma: Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) and/or glaucoma; damage to the optic nerve; and defects in visual acuity and fields of vision. Use with caution in patients with glaucoma; monitor IOP in any patient receiving treatment for ≥10 days.
• Immunosuppression: Prolonged use of corticosteroids (including ophthalmic preparations) may increase the incidence of secondary ocular infections (including fungal infections). Acute purulent ocular infections may be masked or exacerbated with use. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
• Herpes simplex: Corticosteroids should not be used to treat ocular herpes simplex; may exacerbate the severity of the infection. Use extreme caution in patients with history of herpes simplex.
• Contact lens wearers: Some preparations may contain benzalkonium chloride, which may be absorbed by contact lenses. Contact lenses should not be worn when using loteprednol 0.38% gel or 0.5% ophthalmic gel, ointment, or suspension. However, contact lenses may be reinserted 15 minutes following administration of loteprednol 1% ophthalmic suspension or ≥10 minutes following administration of loteprednol 0.2% ophthalmic suspension.
• Pediatric: Avoid use of ointment in children following amblyopia treatment since ointment consistency may hinder ability to see out of treated eye.
Dosage form specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).
• Acute anterior uveitis: More potent steroids may be required for this indication.
• Appropriate use: For ophthalmic use only; patients should be re-evaluated if symptoms fail to improve after 2 days. Initial prescription and renewal of medication after 14 days should be made by healthcare provider only after examination with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate). Avoid contamination; do not touch tip of applicator or let tip of applicator touch eye.
Intraocular pressure (if >10 days of treatment); signs and symptoms of infection
Adverse events have been observed in animal reproduction studies following oral administration. The amount of loteprednol absorbed systemically following ophthalmic administration is not known but expected to be <1 ng/mL. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache, burning, itching, dry eyes, blurred vision, foreign body sensation in eye, rhinorrhea, or pharyngitis. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: ophthalmic steroids