pharmacopeia
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Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.

Corticosteroid Hormone ReceptorGlucocorticoid ReceptorLipoxygenase

Indications

Sourced from openFDA
  • Loteprednol etabonate 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. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%.ICD-10: B02.9, H10.9, L70.0, R60.9

Contraindications

Sourced from openFDA
  • Loteprednol etabonate, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol etabonate is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.contraindicated

Dosage & administration

Sourced from openFDA

SHAKE VIGOROUSLY BEFORE USING. 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. 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 (See PRECAUTIONS ). Post-Operative Inflammation: Apply one to two drops of loteprednol etabonate 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.

Warnings & precautions

Sourced from openFDA

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Adverse reactions

Sourced from openFDA

To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2%-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied. Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis and pharyngitis. In a summation of controlled, randomized studies of individuals treated for 28 days or longer with loteprednol etabonate, the incidence of significant elevation of intraocular pressure (≥10 mmHg) was 2% (15/901) among patients receiving loteprednol etabonate, 7% (11/164) among patients receiving 1% prednisolone acetate and 0.5% (3/583) among patients receiving placebo.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic effects: 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 administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity. Loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day.

Approval history

Sourced from openFDA
  • Mar 9, 1998NDANDA020803Bausch And Lomb
  • Mar 9, 1998NDANDA020583Bausch And Lomb
  • Dec 14, 2004NDANDA050804Bausch And Lomb
  • Apr 15, 2011NDANDA200738Bausch And Lomb
  • Sep 28, 2012NDANDA202872Bausch And Lomb Inc
  • Aug 22, 2018NDANDA210565Alcon Labs Inc
  • Feb 22, 2019NDANDA208219Bausch And Lomb Inc
  • Oct 26, 2020NDANDA210933Alcon Labs Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
5,816 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Eye Pain76913%
  2. 2Eye Irritation66311%
  3. 3Off Label Use4748.1%
  4. 4Drug Ineffective4577.9%
  5. 5Vision Blurred4387.5%
  6. 6Ocular Hyperaemia4036.9%
  7. 7Headache3085.3%
  8. 8Fatigue2604.5%
  9. 9Dry Eye2344.0%
  10. 10Nausea2173.7%
  11. 11Lacrimation Increased2143.7%
  12. 12Pain2103.6%
  13. 13Product Dose Omission Issue2033.5%
  14. 14Visual Impairment2013.5%
  15. 15Product Use In Unapproved Indication1893.2%

Literature

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Recent PubMed references pinned to Loteprednol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 67 ClinicalTrials.gov registrations naming Loteprednol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Loteprednol work?
Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
What is Loteprednol used for?
According to FDA labeling, Loteprednol carries indications including: Loteprednol etabonate 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. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Loteprednol?
Loteprednol is classified as Corticosteroids, plain, Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Decreased Leukotriene Activity, Decreased Prostaglandin Activity, Decreased Thromboxane Activity.
What are the contraindications for Loteprednol?
Loteprednol labeling lists contraindications including: Loteprednol etabonate, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol etabonate is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.. Always consult the full prescribing information and a clinician.
Note. Data for loteprednol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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