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Loteprednol etabonate and tobramycin 5 mg/mL; 3 mg/mL Solution/ Drops — NDC 82260-358-05 (Billing 82260-0358-05)

by Bausch & Lomb Americas Inc. · 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER

This is a package of Loteprednol etabonate and tobramycin 5 mg/mL; 3 mg/mL Solution/ Drops from Bausch & Lomb Americas Inc., marketed since Jan 2026 and currently FDA-listed; retail pharmacies pay about $39.26 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 82260-0358-05
🏷️ FDA NDC (as labeled) 82260-358-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, dropper Cost per mL$39.26 NADAC Per package$196.32 / 5 ml Pack sizes2 compare ↓
Also priced by: Part D plans $45.73/unit — full pricing hub ↓
Main listing for product 82260-358 · Also comes in: 10 mL 82260-358-10
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82260-358-05
Product NDC 82260-358
11-digit billing NDC 82260035805
NCPDP billing unit ML — per mL (volume)
RxCUI 545255
UNII YEH1EZ96K6, VZ8RRZ51VK
Application # NDA050804
SPL Set ID 75df79e9-f064-4f46-9837-8d4d536517a3
Established class (EPC) Aminoglycoside Antibacterial
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-09
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance LOTEPREDNOL ETABONATE; TOBRAMYCIN
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86309902171820
GCN Seq No 058620
GCN 24089
HICL code 026851
Ingredient (HICL) Tobramycin/Lotepred Etab
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6I
Therapeutic class — specific (HIC3) Eye Antibiotic And Glucocorticoid Combinations
AHFS code 08:12.02.00
AHFS class Aminoglycoside Antibiotics
FDB label name TOBRAMYCIN-LOTEPRED 0.3%-0.5%
FDB brand name Tobramycin-Loteprednol
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 058620
  • GCN: 24089
  • GPI-14 (Medi-Span): 86309902171820
  • HICL (First Databank): 026851
  • AHFS class code: 08:12.02.00
  • RxCUI (RxNorm): 545255
Why two NDCs? The FDA registers this code as 82260-358-05 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 82260-0358-05. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial
Drug family (ATC) Other aminoglycosides, Antibiotics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TOBRAMYCIN-LOTEPRED 0.3%-0.5% Ingredient Tobramycin/Lotepred Etab
📗 Our plain-language guide HelloPharmacist
  • It treats eye inflammation that responds to steroids when there is a bacterial infection or a risk of one. The steroid calms inflammation and the antibiotic fights bacteria. Your d...
  • You put one or two drops in the affected eye, usually every four to six hours. Your doctor may have you use it more often at first. Keep the dropper tip from touching anything, and...
  • Eye redness, stinging or burning when the drops go in, and headache are common. Some people have increased eye pressure or small spots of surface damage on the cornea. Call your do...
  • No. This product contains benzalkonium chloride, so you shouldn't wear soft contact lenses while using it.
📖 Read our full Loteprednol Etabonate / Tobramycin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $39.264 $196.32 / 5 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $45.73 $228.67 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Aug 2026 Sep 2026 $39.264 $38.853
▲ Up 1% over the last 2 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
82260-0358-05 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 5 mL in 1 BOTTLE, DROPPER $39.26 / mL $196.32 2026-01-09 — Active
82260-0358-10 82260-358-10 1 BOTTLE, DROPPER in 1 CARTON / 10 mL in 1 BOTTLE, DROPPER — — 2026-01-09 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 carton / 5 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Loteprednol etabonate and tobramycin 5 mg/mL; 3 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Loteprednol etabonate and Tobramycin 5 mg/mL; 3 mg/mL 62332-0801-05 Alembic 1 bottle $39.264 AB Availability likely —
Loteprednol etabonate and tobramycin 5 mg/mL; 3 mg/mLthis 82260-0358-05 Bausch 1 bottle $39.264 AB Availability likely —
Zylet 5 mg/mL; 3 mg/mL 24208-0358-01 Bausch 1 bottle — AB FDA listed —
Loteprednol etabonate and Tobramycin 5 mg/mL; 3 mg/mL 46708-0801-05 Alembic 1 bottle — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBausch & Lomb Americas Inc.
Application holderBAUSCH AND LOMB INC
FDA applicationNDA050804 (NDA AUTHORIZED GENERIC)
Labeler code82260
First marketedJan 2026
Product typeHuman Prescription Drug
Portfolio18 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% is a topical anti-infective and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in 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, and where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation.

They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product (tobramycin) is active against the following common bacterial eye pathogens: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae , Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii , most Proteus vulgaris strains, Haemophilus influenzae , and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Loteprednol Etabonate and Tobramycin Ophthalmic Suspension is a combination of loteprednol etabonate, a corticosteroid, and tobramycin, an aminoglycoside antibacterial, indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

( 1 )

⏱️ Dosage and Administration 128 words ▾

2 DOSAGE AND ADMINISTRATION Apply one or two drops of Loteprednol Etabonate and Tobramycin Ophthalmic Suspension into the conjunctival sac of the affected eye every four to six hours. ( 2.1 )

2.1Recommended Dosing Apply one or two drops of Loteprednol Etabonate and Tobramycin Ophthalmic Suspension into the conjunctival sac of the affected eye every four to six hours. During the initial 24 to 48 hours, the dosing may be increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

2.2Prescription Guideline Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation [see Warnings and Precautions ( 5.3 )].

💊 Dosage Forms and Strengths 34 words ▾

3 DOSAGE FORMS AND STRENGTHS Ophthalmic suspension containing 5 mg/mL (0.5%) loteprednol etabonate and 3 mg/mL (0.3%) tobramycin. Ophthalmic suspension containing 5 mg/mL (0.5%) loteprednol etabonate and 3 mg/mL (0.3%) tobramycin. ( 3 )

⛔ Contraindications 106 words ▾

4 CONTRAINDICATIONS Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, as with other steroid anti-infective ophthalmic combination drugs, 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. ( 4.1 )

4.1Nonbacterial Etiology Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, as with other steroid anti-infective ophthalmic combination drugs, 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.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS 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 a 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. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

( 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 )

5.1Intraocular 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. 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.

5.2Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation.

5.3Delayed 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 a slit lamp biomicroscopy and, where appropriate, fluorescein staining.

5.4Bacterial 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. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

5.5Viral 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).

5.6Fungal 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.

5.7Aminoglycoside Hypersensitivity Sensitivity to topically applied aminoglycosides may occur in some patients. If hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

5.8Risk of Contamination Do not allow the dropper tip to touch any surface, as this may contaminate the suspension.

5.9Contact Lens Wear As with a… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% In a 42-day safety study comparing Loteprednol Etabonate and Tobramycin Ophthalmic Suspension to placebo, ocular adverse reactions included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) and 4% (placebo) of subjects.

Nine percent (9%) of Loteprednol Etabonate and Tobramycin Ophthalmic Suspension subjects reported burning and stinging upon instillation. Ocular reactions reported with an incidence less than 4% include vision disorders, discharge, itching, lacrimation disorder, photophobia, corneal deposits, ocular discomfort, eyelid disorder, and other unspecified eye disorders. The incidence of non-ocular reactions reported in approximately 14% of subjects was headache; all other non-ocular reactions had an incidence of less than 5%.

Loteprednol etabonate ophthalmic suspension 0.2% - 0.5% 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. 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 mm Hg) 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.

Tobramycin ophthalmic solution 0.3% The most frequent adverse reactions to topical tobramycin are hypersensitivity and localized ocular toxicity, including lid itching and swelling and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics.

Secondary Infection The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.

Secondary bacterial ocular infection following suppression of host responses also occurs. Most common adverse reactions reported in patients were injection and superficial punctate keratitis, increased intraocular pressure, burning and stinging upon instillation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with loteprednol etabonate or tobramycin in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rat when administered orally during pregnancy. Loteprednol etabonate produced malformations when administered orally to pregnant rabbits at doses ≥ 0.54 times the recommended human ophthalmic dose (RHOD) and to pregnant rats at doses ≥ 13 times the RHOD.

In pregnant rats receiving oral doses of loteprednol etabonate during the period equivalent to the last trimester of pregnancy through lactation in humans, survival of offspring was reduced at doses ≥ 1.3 times the RHOD. Maternal toxicity was observed in rats at doses ≥ 135 times the RHOD, and a maternal no observed adverse effect level (NOAEL) was established at 13 times the RHOD. Abortions were observed in pregnant rabbits administered tobramycin via subcutaneous injection at 180 times the RHOD.

Tobramycin did not affect fetal development when administered by subcutaneous injection to pregnant rats at doses 450 times the RHOD. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.

Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered loteprednol etabonate by oral gavage on gestation days 6 to 18, to target the period of organogenesis. Loteprednol etabonate produced fetal malformations at doses ≥ 0.1 mg/kg/day (0.54 times the recommended human ophthalmic dose (RHOD) based on body surface area, assuming 100% absorption of loteprednol etabonate). Spina bifida (including meningocele) was observed at doses ≥ 0.1 mg/kg/day, and exencephaly and craniofacial malformations were observed at doses ≥ 0.4 mg/kg/day (2.1 times the RHOD).

At 3 mg/kg/day (16 times the RHOD), loteprednol etabonate was associated with increased incidences of abnormal left common carotid artery, limb flexures, umbilical hernia, scoliosis, and delayed ossification. Abortion and embryofetal lethality (resorption) occurred at doses ≥ 6 mg/kg/day (32 times the RHOD). A NOAEL for developmental toxicity was not established in this study.

The NOAEL for maternal toxicity in rabbits was 3 mg/kg/day. Embryofetal studies were conducted in pregnant rats administered loteprednol etabonate by oral gavage on gestation days 6 to 15, to target the period of organogenesis. Loteprednol etabonate produced fetal malformations, including absent innominate artery at doses ≥ 5 mg/kg/day (13 times the RHOD); and cleft palate, agnathia, cardiovascular defects, umbilical hernia, decreased fetal body weight and decreased skeletal ossification at doses ≥ 50 mg/kg/day (135 times the RHOD).

Embryofetal lethality (resorption) was observed at 100 mg/kg/day (270 times the RHOD). The NOAEL for developmental toxicity in rats was 0.5 mg/kg/day (1.3 times the RHOD). Loteprednol etabonate was maternally toxic (reduced body weight gain) at doses of ≥ 50 mg/kg/day.

The NOAEL for maternal toxicity was 5 mg/kg/day. A peri-/postnatal study was conducted in rats administered loteprednol etabonate by oral gavage from gestation day 15 (start of fetal period) to postnatal day 21 (the end of lactation period). At doses ≥ 0.5 mg/kg/day (1.3 times the RHOD), reduced survival was observed in live-born offspring.

Doses ≥ 5 mg/kg/day (13 times the RHOD) caused umbilical hernia/incomplete gastrointestinal tract. Doses ≥ 50 mg/kg/day (135 times the RHOD) produced maternal toxicity (reduced body weight gain, death), decreased number of live-born offspring, decreased birth weight, and delays in postnatal development. A developmental NOAEL was not established in this study.

The NOAEL for maternal toxicity was 5 mg/kg/day. An embryofetal study was conducted in pregnant rabbits… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with loteprednol etabonate or tobramycin in pregnant women. Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rat when administered orally during pregnancy. Loteprednol etabonate produced malformations when administered orally to pregnant rabbits at doses ≥ 0.54 times the recommended human ophthalmic dose (RHOD) and to pregnant rats at doses ≥ 13 times the RHOD.

In pregnant rats receiving oral doses of loteprednol etabonate during the period equivalent to the last trimester of pregnancy through lactation in humans, survival of offspring was reduced at doses ≥ 1.3 times the RHOD. Maternal toxicity was observed in rats at doses ≥ 135 times the RHOD, and a maternal no observed adverse effect level (NOAEL) was established at 13 times the RHOD. Abortions were observed in pregnant rabbits administered tobramycin via subcutaneous injection at 180 times the RHOD.

Tobramycin did not affect fetal development when administered by subcutaneous injection to pregnant rats at doses 450 times the RHOD. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.

Data Animal Data Embryofetal studies were conducted in pregnant rabbits administered loteprednol etabonate by oral gavage on gestation days 6 to 18, to target the period of organogenesis. Loteprednol etabonate produced fetal malformations at doses ≥ 0.1 mg/kg/day (0.54 times the recommended human ophthalmic dose (RHOD) based on body surface area, assuming 100% absorption of loteprednol etabonate). Spina bifida (including meningocele) was observed at doses ≥ 0.1 mg/kg/day, and exencephaly and craniofacial malformations were observed at doses ≥ 0.4 mg/kg/day (2.1 times the RHOD).

At 3 mg/kg/day (16 times the RHOD), loteprednol etabonate was associated with increased incidences of abnormal left common carotid artery, limb flexures, umbilical hernia, scoliosis, and delayed ossification. Abortion and embryofetal lethality (resorption) occurred at doses ≥ 6 mg/kg/day (32 times the RHOD). A NOAEL for developmental toxicity was not established in this study.

The NOAEL for maternal toxicity in rabbits was 3 mg/kg/day. Embryofetal studies were conducted in pregnant rats administered loteprednol etabonate by oral gavage on gestation days 6 to 15, to target the period of organogenesis. Loteprednol etabonate produced fetal malformations, including absent innominate artery at doses ≥ 5 mg/kg/day (13 times the RHOD); and cleft palate, agnathia, cardiovascular defects, umbilical hernia, decreased fetal body weight and decreased skeletal ossification at doses ≥ 50 mg/kg/day (135 times the RHOD).

Embryofetal lethality (resorption) was observed at 100 mg/kg/day (270 times the RHOD). The NOAEL for developmental toxicity in rats was 0.5 mg/kg/day (1.3 times the RHOD). Loteprednol etabonate was maternally toxic (reduced body weight gain) at doses of ≥ 50 mg/kg/day.

The NOAEL for maternal toxicity was 5 mg/kg/day. A peri-/postnatal study was conducted in rats administered loteprednol etabonate by oral gavage from gestation day 15 (start of fetal period) to postnatal day 21 (the end of lactation period). At doses ≥ 0.5 mg/kg/day (1.3 times the RHOD), reduced survival was observed in live-born offspring.

Doses ≥ 5 mg/kg/day (13 times the RHOD) caused umbilical hernia/incomplete gastrointestinal tract. Doses ≥ 50 mg/kg/day (135 times the RHOD) produced maternal toxicity (reduced body weight gain, death), decreased number of live-born offspring, decreased birth weight, and delays in postnatal development. A developmental NOAEL was not established in this study.

The NOAEL for maternal toxicity was 5 mg/kg/day. An embryofetal study was conducted in pregnant rabbits administered 20 or 40 mg/kg/d… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use 153 words ▾

8.4Pediatric Use Two trials were conducted to evaluate the safety and efficacy of Loteprednol Etabonate and Tobramycin Ophthalmic Suspension in pediatric subjects age zero to six years; one was in subjects with lid inflammation and the other was in subjects with blepharoconjunctivitis. In the lid inflammation trial, Loteprednol Etabonate and Tobramycin Ophthalmic Suspension with warm compresses did not demonstrate efficacy compared to vehicle with warm compresses. Patients received warm compress lid treatment plus Loteprednol Etabonate and Tobramycin Ophthalmic Suspension or vehicle for 14 days.

The majority of patients in both treatment groups showed reduced lid inflammation. In the blepharoconjunctivitis trial, Loteprednol Etabonate and Tobramycin Ophthalmic Suspension did not demonstrate efficacy compared to vehicle, loteprednol etabonate ophthalmic suspension, or tobramycin ophthalmic solution. There was no difference between treatment groups in mean change from baseline blepharoconjunctivitis score at Day 15.

There were no differences in safety assessments between the treatment groups in either trial.

🧓 Geriatric Use 18 words ▾

8.5Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.

However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .

Corticosteroids are capable of producing a rise in intraocular pressure. Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent.

The anti-infective component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae .

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius , Moraxella lacunata , Acinetobacter calcoaceticus and some Neisseria species.

12.3Pharmacokinetics In a controlled clinical study of ocular penetration, the levels of loteprednol etabonate in the aqueous humor were found to be comparable between LOTEMAX ® and Loteprednol Etabonate and Tobramycin Ophthalmic Suspension treatment groups. Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ 1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate ophthalmic suspension 8 times daily for 2 days or 4 times daily for 42 days.

This study suggests that limited (<1 ng/mL) systemic absorption occurs with 0.5% loteprednol etabonate.

🧬 Mechanism of Action ~1 min read ▾

12.1Mechanism of Action Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids.

However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 .

Corticosteroids are capable of producing a rise in intraocular pressure. Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent.

The anti-infective component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains. Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae .

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius , Moraxella lacunata , Acinetobacter calcoaceticus and some Neisseria species.

📦 How Supplied / Storage and Handling 99 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% is supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a white polypropylene cap in the following sizes: NDC 82260-358-05 5 mL fill in a 7.5 mL bottle NDC 82260-358-10 10 mL fill in a 10 mL bottle USE ONLY IF IMPRINTED NECKBAND IS INTACT. Storage: Store upright at 15ºC to 25ºC (59ºF to 77ºF). PROTECT FROM FREEZING.

SHAKE VIGOROUSLY BEFORE USING. After opening, Loteprednol Etabonate and Tobramycin Ophthalmic Suspension can be used until the expiration date on the bottle.

📋 Description 116 words ▾

11 DESCRIPTION Loteprednol Etabonate and Tobramycin Ophthalmic Suspension is a sterile, multiple dose topical anti-inflammatory corticosteroid and anti-infective combination for ophthalmic use. Both loteprednol etabonate and tobramycin are white to off-white powders. The chemical structures of loteprednol etabonate and tobramycin are shown below.

Loteprednol etabonate: Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11 β -hydroxy-3-oxoandrosta-1,4-diene-17 β -carboxylate Tobramycin: Chemical name: O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribo-hexopyranosyl-(1→6)]-2-deoxystreptamine Each mL contains : Actives: Loteprednol Etabonate 5 mg (0.5%) and Tobramycin 3 mg (0.3%). Inactives: Edetate Disodium, Glycerin, Povidone, Purified Water, Tyloxapol, and Benzalkonium Chloride 0.01% (preservative). Sulfuric Acid and/or Sodium Hydroxide may be added to adjust the pH to 5.5 to 6.2.

The suspension is essentially isotonic with a tonicity of 260 to 320 mOsm/kg. chemstructure1 image2

💬 Information for Patients 123 words ▾

17 PATIENT COUNSELING INFORMATION Risk of Contamination This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the suspension. Risk of Secondary Infection Advise patients to consult a physician if pain develops, redness, itching or inflammation becomes aggravated.

Contact Lens Wear As with all ophthalmic preparations containing benzalkonium chloride, advise patients not to wear soft contact lenses when using Loteprednol Etabonate and Tobramycin Ophthalmic Suspension. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA LOTEMAX is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2022 Bausch & Lomb Incorporated or its affiliates 9375703 (FOLDED) 9375603 (FLAT)

🧬 Pharmacokinetics 122 words ▾

12.3Pharmacokinetics In a controlled clinical study of ocular penetration, the levels of loteprednol etabonate in the aqueous humor were found to be comparable between LOTEMAX ® and Loteprednol Etabonate and Tobramycin Ophthalmic Suspension treatment groups. Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ 1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate ophthalmic suspension 8 times daily for 2 days or 4 times daily for 42 days.

This study suggests that limited (<1 ng/mL) systemic absorption occurs with 0.5% loteprednol etabonate.

🧪 Nonclinical Toxicology 150 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate or tobramycin. Mutagenesis Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma TK assay, a chromosome aberration test in human lymphocytes, or in an in vivo mouse micronucleus assay. Impairment of Fertility Oral treatment of female and male rats with 25 mg/kg/day of loteprednol etabonate (67 times the RHOD based on body surface area, assuming 100% absorption) prior to and during mating caused preimplantation loss and decreased the number of live fetuses/live births.

The NOAEL for fertility in rats was 5 mg/kg/day (13 times the RHOD). Subcutaneous administration of male and female rats with tobramycin did not affect mating behavior or cause impairment of fertility at 100 mg/kg/day (450 times the RHOD based on body surface area, assuming 100% absorption).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 147 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate or tobramycin. Mutagenesis Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma TK assay, a chromosome aberration test in human lymphocytes, or in an in vivo mouse micronucleus assay. Impairment of Fertility Oral treatment of female and male rats with 25 mg/kg/day of loteprednol etabonate (67 times the RHOD based on body surface area, assuming 100% absorption) prior to and during mating caused preimplantation loss and decreased the number of live fetuses/live births.

The NOAEL for fertility in rats was 5 mg/kg/day (13 times the RHOD). Subcutaneous administration of male and female rats with tobramycin did not affect mating behavior or cause impairment of fertility at 100 mg/kg/day (450 times the RHOD based on body surface area, assuming 100% absorption).

📄 Package Label / Principal Display Panel 31 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 82260-358-10 Loteprednol Etabonate and Tobramycin Ophthalmic Suspension 0.5%/0.3% (Sterile) FOR TOPICAL OPHTHALMIC USE ONLY (Eye Image) Rx only 10 mL BAUSCH + LOMB 9610603 MA35809A carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82260-0299-05 · Bausch 82260-0361-05 · Bausch →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.