Topical ophthalmic corticosteroid 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

Brand names: Lotemax

Loteprednol etabonate is a topical ophthalmic corticosteroid used to manage ocular inflammation, including postoperative inflammation and steroid-responsive inflammatory 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

No UK SPC (eMC) record was retrieved in this bundle — the regimen below is from US labelling and must be verified against UK labelling. The fetched US dosage section does not state a product strength (the adverse reactions section refers to loteprednol etabonate ophthalmic suspension 0.2%–0.5%), so the clinician must confirm which strength this regimen applies to. 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-based corticosteroid that binds glucocorticoid receptors to suppress inflammatory mediators, and is designed to be metabolised to inactive products to reduce the propensity for steroid-related rises in intraocular pressure.

Prescribing in practice

As with all ocular corticosteroids, prolonged use can raise intraocular pressure, cause cataract and mask or worsen ocular infection, so it must not be used in untreated infective eye conditions.
Treatment should generally be tapered rather than stopped abruptly after prolonged use, and a specialist should oversee extended courses.
Use with caution in patients with a history of herpes simplex keratitis or glaucoma.

Monitoring

Intraocular pressure should be monitored during prolonged therapy, with regular ophthalmic review for cataract and signs of infection.

Counselling the patient

Use only for as long as your clinician advises and do not stop suddenly after a long course without guidance.
Report any eye pain, increasing redness, discharge or visual change promptly.
Attend follow-up appointments so the pressure in your eye can be checked.

Evidence & guidelines

Topical corticosteroids are a long-established treatment for ocular inflammation, with their risks and place in therapy detailed in ophthalmology references and the SPC.

Reference: RCOphth; 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.

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