Ophthalmic Corticosteroid (Ester-Class) Pregnancy: US labelling: Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery and limb flexures) when given orally to rabbits during organogenesis at 3 mg/kg/day (35 times the maximum daily clinical dose); the no-observed-effect-level was 0.5 mg/kg/day. Oral treatment of rats during organogenesis also produced teratogenicity and embryotoxicity.

Loteprednol Etabonate 0.5%

Brand names: Lotemax, Eysuvis

Loteprednol etabonate 0.5% eye drops are a topical ophthalmic corticosteroid used to treat ocular surface and anterior segment inflammation, including post-operative inflammation, seasonal allergic conjunctivitis and other steroid-responsive conditions of the eye.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One to two drops into the conjunctival sac of the affected eye

Route: Topical ocular (ophthalmic suspension — SHAKE VIGOROUSLY BEFORE USING)

Frequency: Four times daily (steroid responsive disease). During the initial treatment within the first week, dosing may be increased up to 1 drop every hour if necessary.

Max: Up to 1 drop every hour, during the initial treatment within the first week only, if necessary

STRENGTH PROVENANCE — this page is titled 'Loteprednol Etabonate 0.5%', but the fetched US dosage section does not state a strength; the adverse reactions section of the same label refers to loteprednol etabonate ophthalmic suspension 0.2%–0.5%. The clinician must confirm that this regimen is the 0.5% regimen before publishing. No UK SPC (eMC) record was retrieved in this bundle — the regimen is from US labelling and must be verified against UK labelling. SECOND INDICATION — post-operative inflammation: apply one to two drops into the conjunctival sac of the OPERATED eye four times daily, beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated. Paediatric use: safety and effectiveness in paediatric patients have not been established. No renal or hepatic dose adjustment is stated in the fetched sections. Dose quote — US label DOSAGE AND ADMINISTRATION: 'Steroid Responsive Disease Treatment: Apply one to two drops of loteprednol etabonate into the conjunctival sac of the affected eye four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary.'

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella
Mycobacterial infection of the eye
Fungal diseases of ocular structures
Known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids

Side effects

Elevated intraocular pressure, which may be associated with optic nerve damage and visual acuity and field defects (steroid class effect)
Posterior subcapsular cataract formation
Secondary ocular infection from pathogens including herpes simplex; perforation of the globe where there is thinning of the cornea or sclera
Occurring in 5–15% of patients: abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection and photophobia
Occurring in less than 5%: conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae and uveitis. Non-ocular reactions in less than 15%: headache, rhinitis and pharyngitis

Clinical monograph

How it works

It is an ester ("soft") corticosteroid that binds glucocorticoid receptors to suppress inflammatory mediators, and is designed to be metabolised rapidly to inactive products after exerting its local effect, aiming to lower the intraocular pressure-raising potential compared with ketone steroids.

Prescribing in practice

As with all ocular corticosteroids it can raise intraocular pressure and accelerate cataract formation, and must not be used in untreated viral (herpes simplex), fungal or mycobacterial eye infections where it may worsen the disease.
Reserve for confirmed steroid-responsive inflammation and use for the shortest effective course, tapering rather than stopping abruptly after prolonged use.
Shake the suspension before use and review the diagnosis if there is no improvement, since masked infection or rising pressure may be the cause.

Monitoring

Monitor intraocular pressure and the lens/cornea on slit-lamp examination during any course extended beyond a short period.

Counselling the patient

Shake the bottle well before each dose and do not let the dropper tip touch the eye or skin.
Report any eye pain, worsening redness or blurred vision promptly, as these may signal infection or raised pressure.
Attend the arranged pressure check if you are advised to continue the drops.

Evidence & guidelines

Topical ocular corticosteroids are an established treatment for steroid-responsive ocular inflammation, with class risks of raised intraocular pressure and cataract well documented in the SPC and ophthalmology guidance.

Reference: SPC Lotemax 0.5%; Comstock et al. Ophthalmology 2011; FDA Approval Eysuvis 2020; ESCRS Cataract Surgery Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways