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Tobradex ST tobramycin / dexamethasone 3 mg/mL; .5 mg/mL Suspension/ Drops — NDC 82667-0011-05 package photo

Tobradex ST tobramycin / dexamethasone 3 mg/mL; .5 mg/mL Suspension/ Drops

by Harrow Eye, LLC · 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER
NDC 82667-0011-05
🏷️ FDA NDC (as labeled) 82667-011-05 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle, dropper Cost per mL$46.62 NADAC Per package$233.10 / 5 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $48.13/unit · Part D plans $47.99/unit — full pricing hub ↓
Also comes in: 1 mL 82667-0011-00
Rx only Brand On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 82667-011-05
Product NDC 82667-011
11-digit billing NDC 82667001105
NCPDP billing unit ML — per mL (volume)
RxCUI 849115, 1011080
UNII VZ8RRZ51VK, 7S5I7G3JQL
Application # NDA050818
SPL Set ID 3b99dbb3-ac84-4d0d-b30f-a5db44fdc316
Established class (EPC) Aminoglycoside Antibacterial; Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-31
Route OPHTHALMIC
Dosage form SUSPENSION/ DROPS
Substance TOBRAMYCIN; DEXAMETHASONE
GPI-14 86309902801810
GCN Seq No 066617
GCN 28944
HICL code 039399
Ingredient (HICL) Tobramycin/Dexamethasone
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 TOBRADEX ST 0.3-0.05% EYE DROP
FDB brand name Tobradex St
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 82667-011-05 — 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 → 82667-0011-05. 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.

🏭 Manufacturer & labeler

LabelerHarrow Eye, LLC
Application holderHARROW EYE LLC
FDA applicationNDA050818 (NDA)
Labeler code82667
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio17 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.

🩺 Clinical

Label name TOBRADEX ST 0.3-0.05% EYE DROP Ingredient Tobramycin/Dexamethasone
📗 Our plain-language guide HelloPharmacist
  • It's doing both at once. The dexamethasone in this product is a steroid that calms inflammation — redness, swelling, and discomfort in the eye. The tobramycin is an antibiotic that...
  • What exactly is this eye drop treating — is it for an infection or inflammation?
  • For the eye drops — tilt your head back, gently pull down your lower eyelid to create a small pocket, and instill the drops into that pocket (not directly onto your eyeball). Try n...
  • How do I put in the eye drops or ointment correctly?
📖 Read our full Dexamethasone / Tobramycin guide →
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.

🧪 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.

💲 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 $46.620 $233.10 / 5 ml
Medicaid paysCMS SDUD · 12 mo $48.13 $240.63 / 5 ml
Medicare drug plans payPart D · Q2 2026 $47.99 $239.95 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $46.722 $46.620
Flat over the last 9 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tobradex ST 3 mg/mL; .5 mg/mLthis 82667-0011-05 Harrow 1 bottle $46.620 Availability likely
Tobradex ST 3 mg/mL; .5 mg/mL 71776-0035-01 Eyevance 1 bottle FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2009
First FDA approval
Feb 2009
📍
2026
Currently FDA-listed
17 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Aug 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 13, 2009 RLD RS ⏳ ~1.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 7795316 — method of use (U-1082)
US 8101582 — method of use (U-1082)
US 8450287 — drug product
2009 2011 2013 2015 2017 2019 2021 2023 2025 2027
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (3)
PatentTypeUse codeExpires
US 7795316 ↗ Method of use U-1082 Aug 3, 2028
US 8101582 ↗ Method of use U-1082 Dec 19, 2027
US 8450287 ↗ Drug product Dec 19, 2027
Common questions
Is there a generic version of TOBRADEX ST 0.3-0.05% EYE DROP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for TOBRADEX ST 0.3-0.05% EYE DROP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Aug 2028 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 82667-0011-05, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q2 2025 – Q1 2026 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1K
Units reimbursed last 4 qtrs
5.2K
Gross reimbursed last 4 qtrs
$249.8K
Avg / prescription
$246.81
Avg / unit
$48.1251
Latest quarter Q1 2026
267Rx
Medicaid pays / mL
$48.1251
gross reimbursed
vs
NADAC / mL
$46.6196
acquisition cost
=
Spread
+$1.5055
+3% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
60% FFS 40% MCO
Fee-for-service · 610 Rx Managed care · 402 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 335 units · 4.3 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 635 units · 3.2 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 580 units · 8.5 per 100k residents IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: 975 units · 13.9 per 100k residents MA California: 1,255 units · 3.2 per 100k residents CA Utah: no data reported UT Colorado: 295 units · 5.0 per 100k residents CO Nebraska: no data reported NE Missouri: 210 units · 3.4 per 100k residents MO Kentucky: no data reported KY West Virginia: 130 units · 7.3 per 100k residents WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: 325 units · 9.0 per 100k residents CT Rhode Island: no data reported RI Arizona: 450 units · 6.1 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.213.9
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 13.9 /100k
2 Connecticut 9.0 /100k
3 Indiana 8.5 /100k
4 West Virginia 7.3 /100k
5 Arizona 6.1 /100k
6 Colorado 5.0 /100k
7 Washington 4.3 /100k
8 Missouri 3.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page82667-0011-05 1,012 Rx · $249,769
1 bottle82667-0011-00 No Medicaid data
Drug total (last 4 qtrs): 1,012 Rx · 5,190 units · $249,769 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Tobradex St — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Tobradex St. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$616.3K
Claims incl. refills
2.4K
Beneficiaries
2.2K
Spend / beneficiary
$276.24
Spend / claim
$252.06
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
82667-0011-00 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER 2025-03-31 Active
82667-0011-05 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER $46.62 / mL $233.10 2025-03-31 Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 82667-0011-05?
NDC 82667-0011-05 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 Tobradex ST tobramycin / dexamethasone 3 mg/mL; .5 mg/mL Suspension/ Drops?
Bill NDC 82667-0011-05 — the 11-digit billing format is 82667001105. 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~1 min read

1 INDICATIONS AND USAGE TOBRADEX ST ophthalmic suspension is 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. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe 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 is active against the following common bacterial eye pathogens: Staphylococci , including S. aureus and S. epidermidi s (coagulase-positive and coagulase-negative), including penicillin-resistant isolates.

Streptococci , including some Group A and other 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 isolates, Haemophilus influenzae, H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus , and some Neisseria species . TOBRADEX ST is a topical antibiotic 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.

( 1 ).

⏱️ Dosage and Administration 220 words

2 DOSAGE AND ADMINISTRATION Instill one drop into the conjunctival sac(s) every 4 to 6 hours. ( 2.1 ) During the initial 24 to 48 hours, dosage may be increased to one drop every 2 hours. ( 2.1 ) Frequency should be decreased gradually as warranted by improvement in clinical signs, but care should be taken not to discontinue therapy prematurely. ( 2.1 )

2.1Initiation and Continuation of Treatment Evaluate intraocular pressure (IOP) prior to the initial prescription and renewal of the medication order [see Warnings and Precautions (5.1) ] . Perform ophthalmic examination with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining, prior to the initial prescription and renewal of the medication order. Re-evaluate the patient if signs and symptoms fail to improve after 2 days [see Warnings and Precautions (5.4 , 5.5) ] .

Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation.

2.2Recommended Dosage Instill one drop into the conjunctival sac(s) every 4 to 6 hours. During the initial 24 to 48 hours, the dosage may be increased to one drop every 2 hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Shake well before use.

💊 Dosage Forms and Strengths 35 words

3 DOSAGE FORMS AND STRENGTHS TOBRADEX ST ophthalmic suspension 0.3%/0.05% contains 3 mg/mL tobramycin and 0.5 mg/mL dexamethasone. TOBRADEX ST ophthalmic suspension contains 0.3% (3 mg/mL) tobramycin and 0.05% (0.5 mg/mL) dexamethasone. ( 3 )

Contraindications 111 words

4 CONTRAINDICATIONS TOBRADEX ST, 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. ( 4.1 ) Hypersensitivity to any component of the medication ( 4.2 )

4.1Nonbacterial Etiology TOBRADEX ST, 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.

4.2Hypersensitivity Hypersensitivity to a component of the medication.

⚠️ 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 ).

Sensitivity to topically applied aminoglycosides may occur. ( 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, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. ( 5.5 ) 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.

( 5.7 ) Vision Blurred : Vision may be temporarily blurred following dosing with TOBRADEX ST. Care should be exercised in operating machinery or driving a motor vehicle. ( 5.8 )

5.1Intraocular Pressure 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, intraocular pressure (IOP) should be monitored.

5.2Aminoglycoside Sensitivity Sensitivity to topically applied aminoglycosides may occur.

5.3Cataracts Use of corticosteroids may result in posterior subcapsular cataract formation.

5.4Delayed 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.

5.5Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. 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 reevaluated.

5.6Viral 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).

5.7Fungal 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.

5.8Vision Blurred Vision may be temporarily blurred following dosing with TOBRADEX ST. Care should be exercised in operating machinery or driving a motor vehicl…

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS Most common adverse reactions to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. The reactions due to the steroid component are increases in IOP with possible development of glaucoma. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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. Exact incidence figures are not available.

The most frequent adverse reactions to topical ocular tobramycin (TOBREX ® ) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia. These reactions occur in less than 4% of patients. The reactions due to the steroid component are: increased IOP with possible development of glaucoma, and infrequent optic nerve disorder; subcapsular cataract; and impaired healing [see Warnings and Precautions (5.1 , 5.3 , 5.4) ] .

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 [see Warnings and Precautions (5.7) ] . 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. Non-ocular adverse events occurring at an incidence of 0.5% to 1% included headache and increased blood pressure. The following additional adverse reactions have been reported with the individual components below: Aminoglycosides: Neurotoxicity, ototoxicity, and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy.

Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson's disease, because of their potential effect on neuromuscular function. Dexamethasone: Cushing's syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of TOBRADEX ST. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Additional adverse reactions identified from postapproval use include, anaphylactic reaction, and erythema multiforme.

👥 Use in Specific Populations ~1 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Corticosteroids have been shown to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in 2 groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy.

Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day (equivalent to human doses of 16 and 32 mg/kg/day, respectively) and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation.

Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism. TOBRADEX ST ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Nonclinical Toxicology (13.1) ] .

8.3Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when TOBRADEX ST is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

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

🤰 Pregnancy 165 words

8.1Pregnancy Corticosteroids have been shown to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in 2 groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy.

Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day (equivalent to human doses of 16 and 32 mg/kg/day, respectively) and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation.

Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism. TOBRADEX ST ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Nonclinical Toxicology (13.1) ] .

🧒 Pediatric Use 19 words

8.4Pediatric Use Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

🧓 Geriatric Use 18 words

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

🧬 Clinical Pharmacology ~1 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dexamethasone is a potent corticoid. Corticoids suppress the inflammatory response to a variety of agents and they can delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant.

Tobramycin is an antibacterial drug. It inhibits the growth of bacteria by inhibiting protein synthesis. Tobramycin is included in this combination product to provide action against susceptible bacteria [see Microbiology (12.4) ] .

12.3Pharmacokinetics In a multi-center, double-masked, parallel-group, randomized, single-dose pharmacokinetic study in male and female cataract surgery patients, mean dexamethasone concentrations following administration of TOBRADEX ST were similar to dexamethasone concentrations following administration of TOBRADEX (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.1%. Aqueous humor concentrations reached a mean peak of 33.7 ng/mL 2 hours following single-dose administration of TOBRADEX ST. No data are available on the extent of systemic absorption of tobramycin from TOBRADEX ST ophthalmic suspension.

Following multiple-dose (4 times a day for 2 days) bilateral ocular administration of TOBRADEX (tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension) in healthy male and female volunteers, peak plasma concentrations of dexamethasone were less than 1 ng/mL and occurred within 2 hours post dose across all subjects.

12.4Microbiology The antibiotic component (tobramycin) in the combination is included to provide action against susceptible bacteria. In vitro studies have demonstrated that tobramycin is active against susceptible isolates of the following bacteria: Staphylococcus aureus (includes penicillin-resistant isolates), Staphylococcus epidermidis (includes penicillin-resistant isolates), Streptococci , including some Group A other beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae . Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Haemophilus aegypticus, Klebsiella pneumoniae, Moraxella lacunata, Morganella morganii, Neisseria perflava, Neisseria sicca, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa.

In vitro bacterial studies demonstrate that in some cases bacteria resistant to gentamicin are susceptible to tobramycin.

🧬 Mechanism of Action 85 words

12.1Mechanism of Action Dexamethasone is a potent corticoid. Corticoids suppress the inflammatory response to a variety of agents and they can delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant.

Tobramycin is an antibacterial drug. It inhibits the growth of bacteria by inhibiting protein synthesis. Tobramycin is included in this combination product to provide action against susceptible bacteria [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 91 words

16 HOW SUPPLIED/STORAGE AND HANDLING TOBRADEX ST is supplied as a 2.5 mL or 5 mL suspension in a 4 mL or 8 mL natural polyethylene DROP-TAINER ® bottle with a natural polyethylene dispenser tip and a pink polypropylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the bottle. 2.5 mL NDC 82667-011-00 5 mL NDC 82667-011-05 Storage Store at 2°C to 25°C (36°F to 77°F).

Protect from light. After opening, TOBRADEX ST can be used until the expiration date on the bottle.

📦 Storage and Handling 26 words

Storage Store at 2°C to 25°C (36°F to 77°F). Protect from light. After opening, TOBRADEX ST can be used until the expiration date on the bottle.

📋 Description 143 words

11 DESCRIPTION TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05% is a sterile, isotonic, white, aqueous antibiotic and steroid suspension with a pH of approximately 5.7 and an osmolality of approximately 290 mOsm/kg. The chemical name of tobramycin is 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-deoxy- L-streptamine. It has a molecular formula of C 18 H 37 N 5 O 9 and a molecular weight of 467.52 g/mol.

The chemical structure is: The chemical name of dexamethasone is 9-fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione. It has a molecular formula of C 22 H 29 FO 5 and a molecular weight of 392.47 g/mol. The chemical structure is: Each mL of TOBRADEX ST contains: Actives: tobramycin 3 mg and dexamethasone 0.5 mg.

Preservative: benzalkonium chloride 0.1 mg. Inactives: edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), propylene glycol, purified water, sodium chloride, sodium sulfate, tyloxapol, and xanthan gum. Chemical Structure Chemical Structure

💬 Information for Patients 127 words

17 PATIENT COUNSELING INFORMATION Storage and Handling Instruct the patient to store the bottle upright and away from light. Shake well before using [see Dosage and Administration (2.1) and How Supplied/Storage and Handling (16) ] . Avoid Contamination Instruct the patient not to touch dropper tip to any surface, as this may contaminate the contents [see Warnings and Precautions (5.9) ] .

Contact Lens Wear Advise the patient that contact lenses should not be worn during the use of this product [see Warnings and Precautions (5.10) ] . Ability to Drive and Use Machines Advise the patient that vision may be temporarily blurred following dosing with TOBRADEX ST. Care should be exercised in operating machinery or driving a motor vehicle [see Warnings and Precautions (5.8) ] .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.