Key facts
- Active ingredient
- Loteprednol Etabonate
- Drug class
- Corticosteroid
- Form
- Topical, Suspension, Drops
- Strength
- Loteprednol Etabonate 0.5%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Sentiss
- What the pharmacy pays
- ~$19.51 per ml — not your price
- FDA application
- ANDA212080
What is Loteprednol Etabonate?
From the FDA label:Loteprednol etabonate is a corticosteroid. Its chemical name is chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Its molecular formula is C 24 H 31 ClO 7 and its chemical structure is: Loteprednol etabonate ophthalmic gel 0.5% contains a sterile, topical corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Each gram contains: ACTIVE: loteprednol etabonate 5 mg (0.5%) INACTIVES: boric acid, edetate disodium dihydrate, glycerin, polycarbophil, propylene glycol, sodium chloride, tyloxapol, water for injection, and sodium hydroxide to adjust to a pH of between 6 and 7 PRESERVATIVE: benzalkonium chloride 0.003% Chemical Structure
How to use
Loteprednol Etabonate is sold in more than one form (Topical, Suspension and Drops), and each is dosed differently. The instructions below come from the FDA label for application ANDA212080 — follow the label that came with the product you were actually prescribed.
Invert closed bottle and shake once to fill tip before instilling drops. Apply one to two drops of loteprednol etabonate ophthalmic gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. Invert closed bottle and shake once to fill tip before instilling drops. ( 2 ) Apply one to two drops of Loteprednol etabonate ophthalmic gel into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period. ( 2 )
Side effects
Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. The most common adverse drug reactions reported in the clinical trials (2 to 5%) were anterior chamber inflammation, eye pain, and foreign body sensation. The most common adverse drug reactions (2 to 5%) were anterior chamber inflammation, eye pain, and foreign body sensation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Important safety information
Intraocular pressure (IOP) increase – Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. ( 5.1 ) Cataracts - Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed healing - The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. ( 5.3 ) Bacterial infections - Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infection. In acute purulent conditions, steroids may mask infection or enhance existing infection. ( 5.4 ) Viral infections - Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.5 ) Fungal infections - Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. ( 5.6 ) 5.1 Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids, including loteprednol etabonate ophthalmic gel, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure should be monitored. 5.2 Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation. 5.3 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. 5.4 Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. 5.5 Viral Infections Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). 5.6 Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal cultures should be taken when appropriate. 5.7 Contact Lens Wear Patients should not wear contact lenses during their course of therapy with loteprednol etabonate ophthalmic gel.
Who should not take Loteprednol Etabonate
Loteprednol etabonate ophthalmic gel is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol etabonate ophthalmic gel is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, in mycobacterial infection of the eye and fungal diseases of ocular structures. ( 4 )
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Loteprednol Etabonate ranks — best-rated corticosteroid for:
Dosage forms
Topical, Suspension and Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Loteprednol Etabonate treat?
- Loteprednol Etabonate (Loteprednol Etabonate) may be used to treat allergic conjunctivitis, bacterial conjunctivitis, viral conjunctivitis, edema, inflammation, iritis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Loteprednol Etabonate work?
- Loteprednol Etabonate is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How much does Loteprednol Etabonate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $19.51 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Pred Forte — about $0.60 on the same basis.
- Is there a coupon or discount for Loteprednol Etabonate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Loteprednol Etabonate. To pay less, Loteprednol Etabonate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Loteprednol Etabonate?
- Loteprednol Etabonate is marketed by Sentiss. You can see Sentiss's full profile, rating, and other products on pharmaranks.
- Is Loteprednol Etabonate a brand-name or generic drug?
- Loteprednol Etabonate is a generic medication; its active ingredient is Loteprednol Etabonate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Loteprednol Etabonate available over the counter?
- No. Loteprednol Etabonate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Loteprednol Etabonate come in?
- Loteprednol Etabonate is currently marketed as topical, suspension and drops, per the FDA's National Drug Code Directory.
- What class of drug is Loteprednol Etabonate?
- Loteprednol Etabonate is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Loteprednol Etabonate FDA-registered?
- Loteprednol Etabonate is on record with the U.S. FDA under application number ANDA212080. You can verify this on its official FDA label.
- Is Loteprednol Etabonate safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Loteprednol Etabonate. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Loteprednol Etabonate?
- Loteprednol Etabonate's side effects are taken directly from its FDA label. From the label: Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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