Loteprednol Etabonate / Tobramycin
Loteprednol etabonate / tobramycin is a prescription eye drop combination of a steroid and an antibiotic used to treat inflammatory eye conditions where bacterial infection is present or likely.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Loteprednol Etabonate / Tobramycin: Patient Information Guide
A plain-language walkthrough of Loteprednol Etabonate / Tobramycin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Loteprednol etabonate / tobramycin eye drops are used for inflammatory eye conditions that need both a steroid and antibiotic protection. Supported uses across available products include:
- Allergic conjunctivitis (eye inflammation from allergies)
- Iritis and cyclitis (inflammation inside the eye)
- Herpes zoster keratitis (eye inflammation related to shingles virus)
- Superficial punctate keratitis (small surface sores on the cornea)
- Acne rosacea affecting the eye
- Chronic anterior uveitis (ongoing inflammation of the eye's middle layer)
- Corneal injury from chemical, radiation, or thermal burns
- Eye injury from penetrating foreign bodies
- Conditions where bacterial infection of the eye surface is present or at high risk
⚙️How it works▾
Loteprednol etabonate is a corticosteroid that works by triggering the production of proteins (called lipocortins) that block the release of arachidonic acid — the raw material the body uses to make inflammatory chemicals like prostaglandins and leukotrienes. By cutting off that supply, the steroid reduces swelling, redness, and irritation in the eye. Tobramycin is an aminoglycoside antibiotic that kills or stops the growth of a wide range of bacteria commonly found in eye infections, including Staphylococci, Streptococci, Pseudomonas aeruginosa, and others.
Because loteprednol etabonate is structurally modified compared to older steroids (it lacks a specific chemical group at position 20), it is broken down locally in the eye. Systemic absorption into the bloodstream is minimal.
💊How it's taken▾
These drops are applied directly into the eye (ophthalmic use only). The typical schedule is one or two drops in the affected eye every four to six hours. During the first 24 to 48 hours, your doctor may increase this to every one to two hours for faster relief. As your eye improves, your doctor will gradually reduce the frequency — it's important not to stop too soon.
- Apply into the conjunctival sac (the pocket behind your lower eyelid)
- Do not allow the dropper tip to touch any surface
- Do not wear soft contact lenses during treatment
- Always follow your prescriber's exact instructions — the initial supply is intentionally limited and requires a doctor visit before a refill is issued
🤒Side effects — in detail▾
The most commonly reported side effects with these eye drops include:
- Eye redness (conjunctival injection)
- Superficial punctate keratitis (tiny surface irritations on the cornea)
- Burning and stinging when the drops are instilled
- Increased intraocular pressure (pressure inside the eye)
- Headache
- Itching, discharge, or eye discomfort
- Sensitivity to light (photophobia)
- Vision changes or corneal deposits (less common)
- Lid itching and swelling (more common with the tobramycin component)
Serious reactions to watch for include significant vision changes, signs of new or worsening infection, or a corneal ulcer that won't heal — contact your doctor right away if any of these occur.
⚠️Warnings & precautions▾
- Eye pressure / glaucoma risk: Prolonged steroid use can raise pressure inside the eye, potentially damaging the optic nerve. If you use this medication for 10 days or longer, your doctor should monitor your eye pressure regularly.
- Cataract risk: Long-term corticosteroid use in the eye can cause a type of cataract called a posterior subcapsular cataract to form.
- Infection masking: Steroids can suppress the eye's immune response, allowing bacterial, viral, or fungal infections to worsen or go unnoticed. If your symptoms don't improve within 2 days, call your doctor.
- Fungal infections: Long-term steroid eye drops can trigger fungal infections of the cornea. Any corneal ulcer that persists should be evaluated for fungal involvement.
- Herpes simplex caution: If you have a history of herpes simplex eye infection, steroids can make it worse or cause it to last longer. Tell your doctor about any history of eye herpes before starting this medication.
- Delayed healing: Steroids can slow healing after cataract surgery or in conditions where the cornea or white of the eye is thinned — and can even cause perforation in severe cases.
- Contact lenses: Do not wear soft contact lenses while using this medication; it contains benzalkonium chloride, which soft lenses can absorb.
🔀What it interacts with▾
The FDA label for these eye drops does not describe specific drug-drug interactions. However, there are important precautions about use in certain conditions:
- Glaucoma medications: Tell your doctor if you already use eye drops for glaucoma — this medication can raise eye pressure and may work against glaucoma treatment
- Soft contact lenses: Benzalkonium chloride in the drops can be absorbed by soft contact lenses, potentially causing eye irritation — remove lenses before applying drops
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Viral eye infections: Do not use if you have most viral diseases of the cornea or conjunctiva, including herpes simplex keratitis (dendritic keratitis), vaccinia, or varicella — this is a contraindication
- Fungal or mycobacterial eye infections: This medication is contraindicated in fungal and mycobacterial (such as tuberculosis-related) eye infections
- Herpes simplex history: Tell your doctor before use — steroids can worsen viral eye infections
- Glaucoma: Use with caution and close monitoring if you have glaucoma or elevated eye pressure
- Recent eye surgery: Steroids can delay healing after cataract surgery — tell your doctor about any recent procedures
- Pregnancy: Animal studies showed birth defects at doses relevant to human use; there are no adequate human studies. Discuss the risks and benefits carefully with your doctor
- Breastfeeding: It is not known whether this medication passes into breast milk; discuss with your doctor before using while breastfeeding
- Children: Clinical trials in children ages 0–6 years did not demonstrate clear efficacy; discuss carefully with your child's doctor
- Older adults: No significant differences in safety or effectiveness have been observed compared to younger adults
- Aminoglycoside allergy: Tell your doctor if you have ever had a reaction to tobramycin or similar antibiotics (aminoglycosides) — discontinue use if an allergic reaction develops
📡Pharmacodynamics — effects in the body▾
The steroid component reduces the hallmark signs of eye inflammation — swelling, blood vessel dilation, and scar formation — by blocking inflammatory chemical pathways. The antibiotic component, tobramycin, is active against a broad range of gram-positive and gram-negative bacteria that commonly cause eye infections. Corticosteroids applied to the eye are also capable of raising intraocular pressure (pressure inside the eye), which is why monitoring is needed with prolonged use.
🔬Pharmacokinetics — how your body processes it▾
When applied as eye drops, loteprednol etabonate penetrates into the aqueous humor (the fluid inside the front of the eye) at levels comparable to loteprednol alone. Systemic absorption is very low — blood levels of loteprednol etabonate and its primary inactive metabolite remained below detectable limits in studies even with frequent dosing over several weeks. This suggests that very little of the drug reaches the rest of the body after eye application.
📦How to store it▾
Store upright at 15ºC to 25ºC (59ºF to 77ºF). PROTECT FROM FREEZING.
📄 Written from Loteprednol Etabonate / Tobramycin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Loteprednol Etabonate / Tobramycin — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this eye drop treating — is it for infection or inflammation? ▾
How often do I put these drops in, and does it matter what time of day? ▾
Can I wear my contact lenses while using this medication? ▾
What side effects should I just watch for versus which ones mean I need to call my doctor? ▾
Is it safe to use this if I'm pregnant or breastfeeding? ▾
Why can't I just get a refill without seeing the doctor again? ▾
Is Loteprednol Etabonate / Tobramycin available over the counter? ▾
When was Loteprednol Etabonate / Tobramycin first available? ▾
Who makes Loteprednol Etabonate / Tobramycin? ▾
💬 Answers drafted from Loteprednol Etabonate / Tobramycin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Loteprednol Etabonate / Tobramycin comes
Loteprednol Etabonate / Tobramycin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Eye drops
How this form is used
- Loteprednol etabonate and tobramycin eye drops are used for steroid-responsive inflammatory eye conditions where bacterial infection is present or at risk
- Zylet is used for the same steroid-responsive inflammatory ocular conditions where superficial bacterial infection is present or likely
- Both products treat conditions such as allergic conjunctivitis, iritis, cyclitis, herpes zoster keratitis, chronic anterior uveitis, and corneal injury from burns or foreign bodies
- Loteprednol etabonate and tobramycin: apply one or two drops into the conjunctival sac (the pocket inside the lower eyelid) of the affected eye every four to six hours
- Zylet: apply one or two drops into the conjunctival sac of the affected eye every four to six hours; your doctor may increase frequency to every one to two hours during the first 24–48 hours
- Do not allow the dropper tip to touch any surface — this can contaminate the drops
- Do not wear soft contact lenses while using these drops
📊 Loteprednol Etabonate / Tobramycin across the U.S. market
How Loteprednol Etabonate / Tobramycin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Loteprednol Etabonate / Tobramycin is used
A general measure of how commonly Loteprednol Etabonate / Tobramycin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Loteprednol Etabonate / Tobramycin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Loteprednol Etabonate / Tobramycin prescribed? Of the 1,596 medications we measure, Loteprednol Etabonate / Tobramycin ranks #1,355 by Medicaid prescriptions — more than 15% of them.
Utilization by Loteprednol Etabonate / Tobramycin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension
Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 545255
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Loteprednol Etabonate / Tobramycin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 9 listed Loteprednol Etabonate / Tobramycin NDCs with Medicaid activity.
🔍 Compare Loteprednol Etabonate / Tobramycin products
A representative set of FDA-listed product records for Loteprednol Etabonate / Tobramycin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| LOTEPREDNOL ETABONATE 5 mg/mL; TOBRAMYCIN 3 mg/mL | Ophthalmic | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| LOTEPREDNOL ETABONATE 5 mg/mL; TOBRAMYCIN 3 mg/mL | Ophthalmic | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| LOTEPREDNOL ETABONATE 5 mg/mL; TOBRAMYCIN 3 mg/mL | Ophthalmic | Bausch & Lomb Americas Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| LOTEPREDNOL ETABONATE 5 mg/mL; TOBRAMYCIN 3 mg/mL | Ophthalmic | Bausch & Lomb Incorporated | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Loteprednol Etabonate / Tobramycin NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Loteprednol Etabonate / Tobramycin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Loteprednol Etabonate / Tobramycin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Loteprednol Etabonate / Tobramycin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 1009142 1 dose form · 1 strength
-
Dose form (SCDF) Ophthalmic Suspension RxCUI 545254In current FDA listingsClinical drug / strength (SCD) loteprednol etabonate 5 MG/ML / tobramycin 3 MG/MLRxCUI 545255
Look up RxCUI 1009142 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Loteprednol Etabonate / Tobramycin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Loteprednol Etabonate / Tobramycin belongs to the Aminoglycoside Antibacterial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bausch & Lomb Americas Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.