Loteprednol Etabonate
Active ingredient
Sold as ALREX · LOTEMAX
- Drug class
- -
- Availability
- Prescription only
- Routes
- Ophthalmic
- Markets covered
- 3
- Products on record
- 9
- FDA reports (12 mo)
- 457
Overview
Loteprednol Etabonate is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| CA Canada | Health Canada | 4 | August 1, 2025 |
| US United States | FDA | 3 | March 26, 2026 |
| GB United Kingdom | MHRA | 2 | May 15, 2026 |
CACanada· Health Canada
4 products
Uses
AND CLINICAL USE................................................................ 3 CONTRAINDICATIONS ..................................................................................... 3 WARNINGS AND PRECAUTIONS....................................................................
4 ADVERSE REACTIONS...................................................................................... 7 DRUG INTERACTIONS .................................................................................... 11 DOSAGE AND ADMINISTRATION ................................................................
11 OVERDOSAGE .................................................................................................. 12 ACTION AND CLINICAL PHARMACOLOGY .............................................. 12 STORAGE AND STABILITY............................................................................
12 SPECIAL HANDLING INSTRUCTIONS ......................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................... 13 PART II: SCIENTIFIC INFORMATION .................................................................
USUnited States· FDA
3 products
Uses
INDICATIONS AND USAGE
Loteprednol etabonate is indicated for the 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 conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%.
The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication.
GBUnited Kingdom· MHRA
2 products
Uses
Treatment of post-operative inflammation following ocular surgery.
How to take
Drug interactions
Known interactions involving Loteprednol Etabonate. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]Health Canada (DPD) · 02320924 · revised August 1, 2025
- [2]FDA DailyMed · 08a091a8-748f-ac… · revised October 26, 2023 [PDF]
- [3]MHRA (UK) · PL179470001 · revised October 28, 2022
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.