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Loteprednol


Generic Medicine Info
Indications and Dosage
Ophthalmic
Seasonal allergic conjunctivitis
Adult: For the temporary relief of signs and symptoms: As 0.2% loteprednol etabonate ophthalmic susp: Instil 1 drop into the affected eye(s) 4 times daily.

Ophthalmic
Inflammatory eye disorders
Adult: For the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe: As 0.5% loteprednol etabonate ophthalmic susp: Instil 1-2 drops into the conjunctival sac of the affected eye(s) 4 times daily. Dose may be increased to 1 drop every hour during 1st week of treatment, if necessary. Re-evaluate treatment if signs and symptoms fail to improve after 2 days (refer to specific product guidelines).

Ophthalmic
Postoperative ocular inflammation
Adult: As 0.5% loteprednol etabonate ophthalmic susp or gel: Instil 1-2 drops into the conjunctival sac of the affected eye(s) 4 times daily. As 0.5% loteprednol etabonate ophthalmic ointment: Apply a small amount (approx 1/2 inch ribbon) into the conjunctival sac of the affected eye(s) 4 times daily. All doses are given starting 24 hours following surgery and continued throughout the 1st 2 weeks of the post-operative period.
What are the brands available for Loteprednol in Malaysia?
  • Lotemax
Contraindications
Viral diseases of the cornea and conjunctiva (e.g. epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella), mycobacterial infection of the eye, fungal diseases of ocular structures.
Special Precautions
Patient with glaucoma, acute purulent ocular infections; history of ocular herpes simplex infection. Patients undergoing cataract surgery. Not intended for use in the treatment of ocular herpes simplex. Avoid abrupt withdrawal (particularly in chronic conditions). Pregnancy and lactation.
Adverse Reactions
Significant: Posterior subcapsular cataract formation, visual disturbance; corneal and scleral thinning, elevated IOP or glaucoma, optic nerve damage, defects in visual acuity and vision fields, immunosuppression and increased risk of secondary ocular infections, including fungal infections (prolonged use); delayed healing and increased incidence of bleb formation (when used after cataract surgery); reduced endogenous corticosteroid production; may mask or exacerbate acute purulent ocular infections. Rarely, central serous chorioretinopathy.
Eye disorders: Dry eye, ocular itching, corneal defect, eye discharge, ocular discomfort, epiphora, foreign body sensation in the eyes, conjunctival hyperaemia, chemosis, abnormal vision, keratoconjunctivitis, conjunctivitis, iritis, eye irritation, eye pain, conjunctival papillae, photophobia, uveitis.
General disorders and administration site conditions: Instillation site burning.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Pharyngitis, rhinitis.
Patient Counseling Information
Remove contact lenses before administration and wait for at least 15 minutes before reinsertion.
Monitoring Parameters
Monitor IOP (when used for ≥10 days). Assess for signs and symptoms of infection.
Drug Interactions
Increased risk of elevated IOP with ocular hypotensives and cycloplegics. May increase the risk of systemic adverse reactions with CYP3A4 inhibitors (including cobicistat-containing agents).
Action
Description:
Mechanism of Action: Loteprednol is a nonfluorinated corticosteroid with glucocorticoid activity that inhibits inflammatory responses, including capillary dilation, leucocyte migration, oedema, and scar formation. It readily penetrates cells due to its high lipid solubility, inducing lipocortin production and thereby modulating prostaglandin and leukotriene activity.
Onset: Seasonal allergic conjunctivitis: Within 2 hours.
Pharmacokinetics:
Absorption: Minimally absorbed.
Distribution: Readily penetrates the cornea, followed by the iris or ciliary body and aqueous humour.
Metabolism: Metabolised mainly in the cornea by corneal esterases into carboxylic acid metabolites (inactive). Undergoes rapid metabolism following activation of glucocorticoid receptor.
Chemical Structure

Chemical Structure Image
Loteprednol

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9865442, Loteprednol. https://pubchem.ncbi.nlm.nih.gov/compound/Loteprednol. Accessed Aug. 29, 2025.

Storage
Store between 15-25°C. Do not freeze the ophthalmic susp.
MIMS Class
Eye Corticosteroids
ATC Classification
S01BA14 - loteprednol ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
References
Alrex Sterile Ophthalmic Suspension (Bausch & Lomb [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 30/07/2025.

Brayfield A, Cadart C (eds). Loteprednol Etabonate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/07/2025.

Joint Formulary Committee. Loteprednol Etabonate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 30/07/2025.

Lotemax 0.5% Eye Drops, Suspension (Bausch + Lomb Ireland Limited). MHRA. https://products.mhra.gov.uk. Accessed 30/07/2025.

Lotemax Ointment (Bausch & Lomb Incorporated). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 30/07/2025.

Loteprednol Etabonate Gel (Bausch & Lomb Americas Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 30/07/2025.

Loteprednol Etabonate Suspension/Drops (Amneal Pharmaceuticals NY LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 30/07/2025.

Loteprednol Etabonate. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://www.ahfscdi.com. Accessed 30/07/2025.

Loteprednol. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 30/07/2025.

Disclaimer: This information is independently developed by MIMS based on Loteprednol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2025 MIMS. All rights reserved. Powered by MIMS.com
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