Loteprednol / Loteprednol etabonate

Pronunciation: loh-TEP-red-nol et-AB-oh-nate.

Generic name
loteprednol etabonate
Drug class
Ophthalmic corticosteroid (topical anti-inflammatory, ester-based corticosteroid)
Form
Ophthalmic suspension (0.5% and 0.2%), gel (0.5%), and ointment (0.5%)
Route
Topical ophthalmic (eye drops, gel, or ointment)
Legal status
Prescription-only in all markets where it is authorised

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia

Australia: Lotemax (5) · Full directory

What loteprednol etabonate is and how it works

Loteprednol etabonate is a prescription corticosteroid eye drop, gel, or ointment used to reduce inflammation in the eye, either for specific steroid-responsive eye conditions or after eye surgery. (1)

This medicine does not carry a boxed warning, but like all corticosteroid eye medicines, it carries real, well-documented risks with prolonged use: increased eye pressure that can lead to glaucoma and optic nerve damage, cataract formation, slower wound healing after eye surgery, and a higher chance of eye infections (including fungal and viral) because it dampens the eye's local immune response. This is why your eye doctor may check your eye pressure if you use it for 10 days or longer, and why it should not be used if you have certain untreated eye infections.

Mechanism of action: how loteprednol etabonate works

Loteprednol etabonate is a site-specific, ester-based corticosteroid designed to be metabolised rapidly to inactive metabolites after exerting its local anti-inflammatory effect in ocular tissue, which is intended to reduce the systemic and intraocular-pressure side-effect burden compared with older ketone-based ophthalmic corticosteroids, though the real, documented IOP-elevation risk (2% vs 7% with prednisolone acetate in the US data reviewed) remains lower but not absent. (1) (2)

What loteprednol etabonate is used for

Steroid-responsive inflammatory eye conditions

Used to treat steroid-responsive inflammation of the eye, including allergic conjunctivitis, acne rosacea affecting the eye, superficial punctate keratitis, herpes zoster keratitis (the inactive, inflammatory phase), iritis, cyclitis, and selected infective forms of conjunctivitis, when the infective cause is also being treated. It is noted in the US source reviewed as less effective than 1% prednisolone acetate for acute anterior uveitis. (1)

Post-operative inflammation after eye surgery

Used to reduce inflammation after ocular surgery, including cataract surgery. This is the primary licensed indication in the UK, Canada, and Australia, in addition to the broader steroid-responsive-disease indication approved in the US. (2) (4) (5)

Before taking loteprednol etabonate

Do not take / not appropriate for

  • Do not use if you have most viral infections of the cornea or conjunctiva, including active herpes simplex keratitis, vaccinia, or varicella (chickenpox-related eye infection). (all countries) (1) (2)
  • Do not use if you have an untreated fungal, mycobacterial, or (UK) untreated purulent acute or amoebic eye infection. (all countries) (1) (2)
  • Do not use if you are allergic to loteprednol etabonate, any ingredient in the product, or other corticosteroids. (all countries) (1) (2)

Tell your clinician about

  • Any history of glaucoma, elevated eye pressure, or cataracts.
  • Any current or recent eye infection, including cold sores or shingles near the eye.
  • Whether you wear contact lenses.
  • Whether you use other eye drops, especially for glaucoma.
  • Whether you are pregnant, plan to become pregnant, or are breastfeeding.
(1) (2)

How to take loteprednol etabonate

  • Used only in the eye, exactly as your eye doctor directs.
  • Wash your hands before use and avoid letting the dropper tip touch your eye or any other surface.
  • If you wear contact lenses: in the US, soft contact lenses should generally be avoided during treatment because of a preservative in the product; in the UK, remove contact lenses before each dose and you may put them back in about 15 minutes afterward. Follow your own market's product information and your prescriber's guidance.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, use it as soon as you remember unless it is nearly time for your next dose -- do not use two doses at once. Contact your eye doctor if you are unsure or if you miss several doses.

Overdose

An eye-drop overdose is unlikely to cause serious harm beyond temporary eye irritation, but seek medical advice from your eye doctor, pharmacist, or an emergency service if the product is swallowed or if you experience severe eye symptoms after using more than directed. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Blurred vision, burning, stinging, or a feeling of something in the eye.

What to notice: Blurred vision, burning, stinging, or a feeling of something in the eye.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Eye redness (chemosis/injection), discharge, dry eyes, itching.

What to notice: Eye redness (chemosis/injection), discharge, dry eyes, itching.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Sensitivity to light (photophobia).

What to notice: Sensitivity to light (photophobia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache, stuffy or runny nose, sore throat (non-eye related).

What to notice: Headache, stuffy or runny nose, sore throat (non-eye related).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of raised eye pressure or glaucoma — serious

Symptoms: Eye pain, gradual vision changes, or halos around lights, especially with use for 10 days or longer.

Action: Contact your eye doctor -- prolonged use of loteprednol, like other corticosteroid eye medicines, can raise eye pressure and cause glaucoma with optic nerve damage. Your eye doctor may check your eye pressure periodically if you use this medicine for an extended period. (1) (2)

Signs of a new or worsening eye infection — serious

Symptoms: Increasing redness, pain, discharge, or vision changes that do not improve or that worsen during treatment.

Action: Contact your eye doctor promptly -- corticosteroid eye medicines can mask or worsen some eye infections (including fungal and viral infections) with prolonged use. Do not continue treatment on your own if your symptoms change or worsen; your eye doctor needs to reassess you. (1) (2)

Signs of delayed healing after eye surgery — serious

Symptoms: Slow-healing wounds, persistent redness, or unusual swelling after ocular surgery.

Action: Report this to your eye surgeon -- corticosteroids used after eye surgery, including cataract surgery, can delay wound healing; your surgeon will monitor your recovery. (1)

Interactions

  • Other glaucoma (eye pressure-lowering) eye drops: loteprednol may reduce how well these work; your eye doctor will monitor your eye pressure if you use both. (2)
  • Anticholinergic medicines: may adversely affect eye pressure when combined with corticosteroid eye drops; used with caution together. (2)
  • Strong CYP3A inhibitors: may increase the small amount of corticosteroid effect absorbed into the body; used with caution together. (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

US labelling (pre-2015 pregnancy category system) classifies loteprednol as Category C; animal studies at oral doses showed embryotoxic and teratogenic effects, though human data are limited. The UK source reviewed advises against use in pregnancy unless clearly necessary. Discuss with your eye doctor and obstetric care team. (1) (2) (3) (4) (5) (6)

Breastfeeding

It is not known whether topical eye use of loteprednol produces detectable levels in human breast milk. The US source reviewed recommends caution, since systemic corticosteroids are known to appear in breast milk; the UK source reviewed states it is contraindicated during breastfeeding. Discuss with your eye doctor. (1) (2) (3) (4) (5) (6)

Children

Safety and effectiveness have not been established in paediatric patients in the US source reviewed; the UK source reviewed similarly does not recommend paediatric use pending further data. (1) (2) (3) (4) (5) (6)

Elderly

No specific dose adjustment based on age alone is described in the sources reviewed. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Not specifically addressed in the sources reviewed, consistent with this medicine's very low systemic absorption as a topical eye product. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not specifically addressed in the sources reviewed, consistent with this medicine's very low systemic absorption as a topical eye product. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Assessment for active eye infection (viral, fungal, mycobacterial)
  • Baseline eye pressure if there is a history of glaucoma or ocular hypertension

During treatment

  • Intraocular pressure monitoring if used for 10 days or longer.
  • Periodic eye examination for cataract changes with prolonged use.
  • Monitoring for signs of new or worsening eye infection or delayed healing, especially after eye surgery.
(1) (2)

Storage

Store as directed on the product label, typically at room temperature, tightly closed, out of reach of children. Do not use after the labelled expiry date or beyond the discard period after opening stated on your specific product.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and the UK emc SmPC reviewed for this dossier; verify against the current full label before prescribing.

United States

Indication: Steroid-responsive inflammatory eye disease and post-operative inflammation

Dose summary: 1-2 drops 4 times daily (steroid-responsive disease, up to hourly in week 1 if needed); 1-2 drops 4 times daily for up to 2 weeks starting 24h post-op (post-operative inflammation).

Renal context: Not applicable -- topical ophthalmic product with minimal systemic absorption. (1)

United Kingdom / Canada / Australia

Indication: Post-operative inflammation following ocular surgery

Dose summary: 1-2 drops 4 times daily starting 24h post-surgery, not exceeding 2 weeks.

Renal context: Not applicable -- topical ophthalmic product with minimal systemic absorption. (2) (4) (5)

Mechanism of action

Hepatic guidance

Not applicable given minimal systemic absorption from topical ophthalmic use.

Overdose note

No specific antidote is described in the sources reviewed; manage topical overexposure with supportive eye care and seek medical advice if ingested. (1) (2)

Frequently asked questions

Is loteprednol (Lotemax) available in the US, UK, Europe, Canada, Australia, and New Zealand?

Mostly, but not everywhere. It is confirmed authorised in the US, UK, Canada, and Australia, and via national (not EU-wide) procedures in at least Lithuania, Slovenia, Slovakia, and Latvia within the European Union. New Zealand is a genuine exception: there is no Medsafe marketing authorisation for loteprednol, and it can only be supplied there under Section 29 of the Medicines Act 1981, an unapproved-medicine pathway for an individual patient under a prescriber's care. (1) (2) (3) (4) (5) (6)

Does loteprednol have a boxed warning?

No. A direct review of the current US FDA label confirms loteprednol does not carry a boxed warning. It does carry real, standard corticosteroid-class ophthalmic precautions -- raised eye pressure/glaucoma risk, cataract risk, delayed wound healing, and increased infection risk with prolonged use -- which are documented on this page, but none of these rises to boxed-warning level in the label reviewed. (1)

Why does my eye doctor want to check my eye pressure while I use this?

Because prolonged use of loteprednol, like other corticosteroid eye medicines, carries a real risk of raising eye pressure, which can lead to glaucoma and optic nerve damage if not caught early. Regulators recommend eye-pressure monitoring if the medicine is used for 10 days or longer. (1) (2)

What is the mechanism of action of loteprednol etabonate?

Loteprednol etabonate is a site-specific, ester-based corticosteroid designed to be metabolised rapidly to inactive metabolites after exerting its local anti-inflammatory effect in ocular tissue, which is intended to reduce the systemic and intraocular-pressure side-effect burden compared with older ketone-based ophthalmic corticosteroids, though the real, documented IOP-elevation risk (2% vs 7% with prednisolone acetate in the US data reviewed) remains lower but not absent. (1) (2)

What is the generic name of Loteprednol / Loteprednol etabonate?

The generic name is loteprednol etabonate. (1) (2)

What class of drug is loteprednol etabonate?

Loteprednol / Loteprednol etabonate is classed as: Ophthalmic corticosteroid (topical anti-inflammatory, ester-based corticosteroid). (1) (2)

References

  1. LOTEMAX (loteprednol etabonate ophthalmic suspension, 0.5%) -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Bausch & Lomb · United States · dated 2025-01-01 · accessed 2026-07-30 · source 1
  2. Lotemax 0.5% w/v Eye Drops, Suspension -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Summary of Product Characteristics · United Kingdom · dated 2026-01-01 · accessed 2026-07-30 · source 2
  3. Loteprednol -- list of nationally authorised medicinal products (PSUSA/00001913/202405)European Medicines Agency (EMA) -- list of nationally authorised medicinal products (periodic safety update single assessment, PSUSA-00001913) · European Union · dated 2024-05-01 · accessed 2026-07-30 · source 3
  4. LOTEMAX (loteprednol etabonate ophthalmic suspension/gel) -- Product MonographHealth Canada -- Product Monograph and Drug Product Database (DPD) · Canada · dated 2023-01-01 · accessed 2026-07-30 · source 4
  5. Lotemax loteprednol etabonate 0.5% eye drop suspension -- ARTG entry 202525Therapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) · Australia · dated 2014-01-16 · accessed 2026-07-30 · source 5
  6. Loteprednol/Lotemax supply in New Zealand under Section 29 of the Medicines Act 1981 (unapproved medicine); Pharmac application historyNew Zealand regulatory context -- Medsafe unapproved-medicines framework and Pharmac funding-application history · New Zealand · dated 2026-07-30 · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient loteprednol etabonate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Lotemax5 mg/mL, 5 mg/g · bausch & lomb incorporated
  • Inveltys10 mg/mL · alcon laboratories, inc.
  • Eysuvis2.5 mg/mL · alcon laboratories, inc.
  • Alrex2 mg/mL · bausch & lomb incorporated
  • Lotemax SM3.8 mg/g · bausch & lomb incorporated

United Kingdom

  • Lotemax 0.5% w/v Eye Drops, Suspension (2)emc current smpc confirmed · 0.5% w/v (0.19 mg per drop) · Bausch & Lomb U.K. Limited

Canada

  • LOTEMAX
  • ALREX

Australia

  • Lotemax (5)tga artg registered confirmed · 0.5% eye drop suspension · Bausch & Lomb Australia Pty Ltd
View brands in additional countries.

European Union

Lotemax / Loterex (national brands vary) (3)

This page provides general reference information about loteprednol/loteprednol etabonate and is not a substitute for advice from the eye doctor (ophthalmologist or optometrist) or prescriber managing your treatment. All dosing and treatment decisions should be made with your eye-care prescriber.

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