Active substance
Loteprednol etabonate
- SFDA 3
- US FDA 21
- Health Canada 4
- US price lines 11
- Safety 4
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LOTEMAX 0.5% GEL | 0.5 % | eye gel · Ophthalmic use | 1 Bottle | SAR 64.10 | NCE · Prescription | Bausch & Lomb, Incorporated | Valid |
| Lotemax | 0.5 % | Eye drops, suspension · Ophthalmic use | 1 Multidose container | SAR 44.00 | NCE · Prescription | Bausch & Lomb, Incorporated | Valid |
| Lotrell | 0.5 % | Eye drops, suspension · Ocular use | 1 Dropper Container | SAR 44.00 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
Indications — CHI Daman Drug Formulary
HERPESVIRAL KERATITIS, ZOSTER KERATITIS, SUPERFICIAL KERATITIS, ADENOVIRAL CONJUNCTIVITIS; NON-INFECTIOUS UVEITIS; SJOGREN'S SYNDROME
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LOTEMAX | 0.5% | suspension/drops · ophthalmic | BAUSCH AND LOMB | Prescription | 9 Mar 1998 |
| ALREX | 0.2% | suspension/drops · ophthalmic | BAUSCH AND LOMB | Prescription | 9 Mar 1998 |
| LOTEMAX | 0.5% | ointment · ophthalmic | BAUSCH AND LOMB | Prescription | 15 Apr 2011 |
| LOTEMAX | 0.5% | gel · ophthalmic | BAUSCH AND LOMB INC | Prescription | 28 Sep 2012 |
| INVELTYS | 1% | suspension/drops · ophthalmic | ALCON LABS INC | Prescription | 22 Aug 2018 |
| LOTEMAX SM | 0.38% | gel · ophthalmic | BAUSCH AND LOMB INC | Prescription | 22 Feb 2019 |
| LOTEPREDNOL ETABONATE | 0.5% | suspension/drops · ophthalmic | SENTISS | Prescription | 17 Apr 2019 |
| EYSUVIS | 0.25% | suspension/drops · ophthalmic | ALCON LABS INC | Prescription | 26 Oct 2020 |
| LOTEPREDNOL ETABONATE | 0.5% | gel · ophthalmic | SENTISS | Prescription | 10 Feb 2021 |
| LOTEPREDNOL ETABONATE | 0.5% | suspension/drops · ophthalmic | SUN PHARM | Prescription | 26 Feb 2021 |
| LOTEPREDNOL ETABONATE | 0.2% | suspension/drops · ophthalmic | SENTISS | Prescription | 12 Apr 2023 |
| LOTEPREDNOL ETABONATE | 0.2% | suspension/drops · ophthalmic | LUPIN | Prescription | 26 Dec 2023 |
| LOTEPREDNOL ETABONATE | 0.5% | suspension/drops · ophthalmic | LUPIN | Prescription | 24 Apr 2024 |
| LOTEPREDNOL ETABONATE | 0.2% | suspension/drops · ophthalmic | PADAGIS US | Prescription | 10 Jul 2024 |
| LOTEPREDNOL ETABONATE | 0.2% | suspension/drops · ophthalmic | AMNEAL | Prescription | 13 Dec 2024 |
| LOTEPREDNOL ETABONATE | 0.5% | suspension/drops · ophthalmic | PADAGIS US | Prescription | 29 Jan 2025 |
| LOTEPREDNOL ETABONATE | 0.5% | suspension/drops · ophthalmic | AMNEAL | Prescription | 20 May 2025 |
| LOTEPREDNOL ETABONATE | 0.38% | gel · ophthalmic | LUPIN | Prescription | 30 Jun 2025 |
| LOTEMAX | 0.5% | suspension/drops · ophthalmic | PHARMOS | Discontinued | 9 Mar 1998 |
| LOTEPREDNOL ETABONATE | 0.5% | gel · ophthalmic | SUN PHARM | Discontinued | 9 Aug 2023 |
| LOTEPREDNOL ETABONATE | 0.5% | gel · ophthalmic | HIKMA PHARMS | Discontinued | 29 Nov 2023 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ALREX | 02320924 | 0.2 % / W/V | SUSPENSION · OPHTHALMIC | BAUSCH & LOMB INC |
| LOTEMAX | 02321114 | 0.5 % / W/V | SUSPENSION · OPHTHALMIC | BAUSCH & LOMB INC |
| LOTEMAX GEL | 02435853 | 0.5 % / W/W | GEL · OPHTHALMIC | BAUSCH & LOMB INC |
| LOTEMAX OINTMENT | 02421941 | 0.5 % / W/W | OINTMENT · OPHTHALMIC | BAUSCH & LOMB INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ALREX 0.2% EYE DROPS | $58.04442 | per ML | 23 Sep 2026 |
| US NADAC | ALREX 0.2% EYE DROPS | $58.01 | per ML | 22 Jul 2026 |
| US NADAC | EYSUVIS 0.25% EYE DROPS | $61.51166 | per ML | 23 Sep 2026 |
| US NADAC | INVELTYS 1% EYE DROP | $103.11071 | per ML | 23 Sep 2026 |
| US NADAC | LOTEMAX 0.5% EYE OINTMENT | $99.7438 | per GM | 23 Sep 2026 |
| US NADAC | LOTEMAX 0.5% OPHTHALMIC GEL | $49.66158 | per GM | 23 Sep 2026 |
| US NADAC | LOTEMAX SM 0.38% OPHTH GEL | $49.48461 | per GM | 23 Sep 2026 |
| US NADAC | LOTEPREDNOL ETABONATE 0.2% DRP | $30.71714 | per ML | 23 Sep 2026 |
| US NADAC | LOTEPREDNOL ETABONATE 0.5% DRP | $10.47371 | per ML | 23 Sep 2026 |
| US NADAC | LOTEPREDNOL ETABONATE 0.5% DRP | $21.199 | per ML | 23 Sep 2026 |
| US NADAC | LOTEPREDNOL ETABONATE 0.5% DRP | $17.16787 | per ML | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 25 Oct 2021 ZYLET — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 8 Dec 2020 LOTEMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 24 Apr 2020 INVELTYS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 20 Jul 2018 LOTEMAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations
Combinations containing Loteprednol etabonate
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.