FDA label
What is Lotemax used for?
Lotemax contains loteprednol etabonate. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “LOTEMAX 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 advisa...”
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Lotemax, suspension/ drops
Indications and Usage, quoted from the label by Bausch & Lomb Incorporated (NDA020583). Cross-references to other label sections are left out.
LOTEMAX 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.
LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX 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 LOTEMAX and 6% with prednisolone acetate 1%. LOTEMAX should not be used in patients who require a more potent corticosteroid for this indication.
LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular surgery.
Source: DailyMed label, set id f37d74ac-5f9c-40a8-b43b-35148fc66bbe, version 12, effective April 17, 2023. NDC 24208-299, one of 1 listing for this product.
Lotemax, ointment
Indications and Usage, quoted from the label by Bausch & Lomb Incorporated (NDA200738). Cross-references to other label sections are left out.
LOTEMAX® (loteprednol etabonate ophthalmic ointment) 0.5% ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Source: DailyMed label, set id 902a3c6b-2625-44ec-a077-926e012b3176, version 17, effective November 30, 2022. NDC 24208-443, one of 1 listing for this product.
Lotemax, gel
Indications and Usage, quoted from the label by Bausch & Lomb Incorporated (NDA202872). Cross-references to other label sections are left out.
LOTEMAX ®(loteprednol etabonate ophthalmic gel) 0.5% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Source: DailyMed label, set id 9a666065-d467-42b8-8ecd-0ec1de9986d5, version 12, effective October 24, 2024. NDC 24208-503, one of 1 listing for this product.
Questions
What is Lotemax used for?
The FDA label says: “LOTEMAX 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 advisa...”
What drug class is Lotemax?
FDA lists loteprednol etabonate in the Corticosteroid established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Lotemax
- Is Lotemax a controlled substance?Federal schedule
- Generic for LotemaxFDA Orange Book
- What is Loteprednol Etabonate used for?FDA label uses
- Is Loteprednol Etabonate a controlled substance?Federal schedule
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- Generic for InveltysFDA Orange Book
- Corticosteroids listFDA drug class
- NDC 24208-299Lotemax NDC record
- NDC 24208-443Lotemax NDC record
- NDC 24208-503Lotemax NDC record