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Loteprednol

Generic Name
Loteprednol
Brand Names
Alrex, Lotemax, Zylet
Drug Type
Small Molecule
Chemical Formula
C21H27ClO5
CAS Number
129260-79-3
Unique Ingredient Identifier
Z8CBU6KR16

Overview

No overview information available.

Indication

用于眼科局部炎症。0.2％浓度适用于暂时缓解季节性过敏性结膜炎；0.5％混悬液适用于治疗对类固醇有效的炎症，如结膜炎、角膜、前房炎、过敏性结膜炎、痤疮、酒糟鼻、表浅性点状角膜炎、疱疹、带状疱疹角膜炎、虹膜炎、睫状体炎等可适当减轻水肿和炎症。尚可用于眼科手术后炎症的治疗。

Associated Conditions

  • Chickenpox
  • Conjunctivitis infective
  • Cyclitis
  • Eye infection viral
  • Herpes Zoster Keratitis
  • Inflammation
  • Iritis
  • Ocular Inflammation
  • Rosacea
  • Seasonal Allergic Conjunctivitis
  • Superficial punctate keratitis

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
2022/09/15
NCT05542381
Not Applicable
Recruiting
Virginia Polytechnic Institute and State University
Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial
2022/04/29
NCT05353101
Phase 1
Completed
Second Affiliated Hospital of Nanchang University
Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection
2021/11/29
NCT05136443
Phase 4
Completed
Price Vision Group
DEXTENZA Therapy for Treatment of Allergic Conjunctivitis
2021/01/14
NCT04708821
Phase 4
Completed
Clinical Research Center of Florida
Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
2020/06/05
NCT04418999
Early Phase 1
Completed
Illinois College of Optometry
Topical 0.2% Loteprednol Etabonate vs. Topical 0.1% Dexamethasone in Impending Recurrent Pterygium
2019/08/30
NCT04075227
Phase 4
Completed
Wannisa Suphachearabhan
Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery
2018/05/22
NCT03531697
Phase 1
Completed
Sandoz
Loteprednol vs. Prednisolone and Fluorometholone
2017/04/21
NCT03123614
Phase 4
Completed
University of Utah
Evaluation of the Safety, Systemic Pharmacokinetics, and Tolerability
2017/02/24
NCT03063489
Phase 1
Completed
Bausch Health Americas, Inc.
Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
2016/11/28
NCT02974387
Phase 4
UNKNOWN
Dr Salouti Eye Research Center

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Loteprednol Etabonate Ophthalmic Suspension
Bausch & Lomb Incorporated
国药准字HJ20160346
化学药品
眼用制剂
11/4/2024
Loteprednol Etabonate Ophthalmic Suspension
Bausch & Lomb Incorporated
国药准字HJ20160348
化学药品
眼用制剂
11/4/2024
Loteprednol Etabonate Ophthalmic Suspension
Bausch & Lomb Incorporated
国药准字HJ20160347
化学药品
眼用制剂
11/4/2024
Loteprednol Etabonate Ophthalmic Suspension
Bausch & Lomb Incorporated
国药准字HJ20180059
化学药品
眼用制剂
5/11/2023
Loteprednol Etabonate Ophthalmic Suspension
Bausch & Lomb Incorporated
H20160347
化学药品
眼用制剂
6/11/2020
Loteprednol Etabonate Ophthalmic Suspension
Bausch & Lomb Incorporated
H20160346
化学药品
眼用制剂
6/11/2020
Loteprednol Etabonate Ophthalmic Suspension
Bausch & Lomb Incorporated
H20160348
化学药品
眼用制剂
6/11/2020
Loteprednol Etabonate Ophthalmic Suspension
Bausch & Lomb Incorporated
国药准字HJ20191002
化学药品
眼用制剂
5/11/2023

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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