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Loteprednol etabonate

Generic Name
Loteprednol etabonate
Brand Names
Eysuvis, Inveltys, Lotemax
Drug Type
Small Molecule
Chemical Formula
C24H31ClO7
CAS Number
82034-46-6
Unique Ingredient Identifier
YEH1EZ96K6

Overview

Loteprednol Etabonate (LE) is a topical corticoid anti-inflammatory. It is used in ophthalmic solution for the treatment of steroid responsive inflammatory conditions of the eye such as allergic conjunctivitis, uveitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitides. As a nasal spray, it can be used for the treatment and management of seasonal allergic rhinitis. Most prescription LE products, however, tend to be indicated for the treatment of post-operative inflammation and pain following ocular surgery . A number of such new formulations that have been approved include Kala Pharmaceutical's Inveltys - the first twice-daily (BID) ocular corticosteroid approved for this indication, designed specifically to enhance patient compliance and simplified dosing compared to all other similar ocular steroids that are dosed four times daily . Moreover, LE was purposefully engineered to be a 'soft drug', one that is designed to be active locally at the site of administration and then rapidly metabolized to inactive components after eliciting its actions at the desired location, thereby subsequently minimizing the chance for adverse effects .

Background

Loteprednol Etabonate (LE) is a topical corticoid anti-inflammatory. It is used in ophthalmic solution for the treatment of steroid responsive inflammatory conditions of the eye such as allergic conjunctivitis, uveitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, and selected infective conjunctivitides. As a nasal spray, it can be used for the treatment and management of seasonal allergic rhinitis. Most prescription LE products, however, tend to be indicated for the treatment of post-operative inflammation and pain following ocular surgery . A number of such new formulations that have been approved include Kala Pharmaceutical's Inveltys - the first twice-daily (BID) ocular corticosteroid approved for this indication, designed specifically to enhance patient compliance and simplified dosing compared to all other similar ocular steroids that are dosed four times daily . Moreover, LE was purposefully engineered to be a 'soft drug', one that is designed to be active locally at the site of administration and then rapidly metabolized to inactive components after eliciting its actions at the desired location, thereby subsequently minimizing the chance for adverse effects .

Indication

A number of prescription loteprednol etabonate ophthalmic products are specifically indicated for the treatment of post-operative inflammation and pain following ocular surgery .

Associated Conditions

  • Dry Eye Syndrome (DES)
  • Eye Pain
  • Ocular Inflammation

FDA Approved Products

LOTEMAX
Manufacturer:Bausch & Lomb Incorporated
Route:OPHTHALMIC
Strength:5 mg in 1 g
Approved: 2023/02/28
NDC:24208-503
LOTEMAX
Manufacturer:Physicians Total Care, Inc.
Route:OPHTHALMIC
Strength:5 mg in 1 mL
Approved: 2011/03/25
NDC:54868-4278
LOTEMAX
Manufacturer:Bausch & Lomb Incorporated
Route:OPHTHALMIC
Strength:5 mg in 1 mL
Approved: 2023/04/17
NDC:24208-299
Lotemax
Manufacturer:Bausch & Lomb Incorporated
Route:OPHTHALMIC
Strength:5 mg in 1 g
Approved: 2022/11/30
NDC:24208-443
Lotemax SM
Manufacturer:Bausch & Lomb Incorporated
Route:OPHTHALMIC
Strength:3.8 mg in 1 g
Approved: 2023/03/17
NDC:24208-507

Singapore Approved Products

ZYLET® STERILE OPHTHALMIC SUSPENSION
Manufacturer:Bausch & Lomb, Incorporated
Form:SUSPENSION, STERILE
Strength:5 mg/ ml
Online:Yes
Approved: 2009/05/04
Approval:SIN13647P
LOTEMAX STERILE OPHTHALMIC SUSPENSION 0.5%
Manufacturer:BAUSCH & LOMB INC
Form:SOLUTION
Strength:5 mg/ml
Online:Yes
Approved: 2004/10/13
Approval:SIN12601P

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