Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension/ Drops — NDC 24208-0295-10 package photo

Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension/ Drops

by Bausch & Lomb Incorporated · 1 BOTTLE, DROPPER in 1 CARTON (24208-295-10) / 10 mL in 1 BOTTLE, DROPPER
NDC 24208-0295-10
🏷️ FDA NDC (as labeled) 24208-295-10 billing pads the product segment with a zero
This package
Contains10 mL in 1 bottle, dropper Cost per mL$4.34 NADAC Per package$43.43 / 10 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $5.49/unit · Part D plans $7.73/unit — full pricing hub ↓
Rx only Generic 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) 24208-295-10
Product NDC 24208-295
11-digit billing NDC 24208029510
NCPDP billing unit ML — per mL (volume)
RxCUI 309683
UNII VZ8RRZ51VK, 7S5I7G3JQL
Application # ANDA064134
SPL Set ID 33de419e-a89b-47e5-952b-87e837f5d531
Established class (EPC) Aminoglycoside Antibacterial; Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
Chemical class Aminoglycosides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1999-10-27
Route OPHTHALMIC
Dosage form SUSPENSION/ DROPS
Substance TOBRAMYCIN; DEXAMETHASONE
GPI-14 86309902801820
GPI class Tobramycin-Dexamethasone
GCN Seq No 007986
GCN 92280
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 TOBRAMYCIN-DEXAMETH OPHTH SUSP
FDB brand name Tobramycin-Dexamethasone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 24208-295-10 — 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 → 24208-0295-10. 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

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB INC
FDA applicationANDA064134 (ANDA)
Labeler code24208
First marketedOct 1999
Product typeHuman Prescription Drug
Portfolio92 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 TOBRAMYCIN-DEXAMETH OPHTH SUSP Ingredient Tobramycin/Dexamethasone
📖 What it is MedlinePlus · NLM

Dexamethasone reduces the irritation, redness, burning, and swelling of eye caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It is sometimes used after eye surgery.

Read the full MedlinePlus article ↗
📗 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII S38J6RZN16
    Hydroxyethyl cellulose is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust product texture, and a film-former to create smooth coatings on tablets.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 0YPR65R21J
    Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
  • UNII O40UQP6WCF
    A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
  • UNII Y27PUL9H56
    Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 $4.343 $43.43 / 10 ml
Medicaid paysCMS SDUD · 12 mo $5.49 $54.90 / 10 ml
Medicare drug plans payPart D · Q2 2026 $7.73 $77.34 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Nov 2022 Feb 2026 Aug 2026 $16.026 $4.156
▼ Down 73% over the last 18 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
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 00574-4031-05 Padagis 5 ml $4.268 AB Availability likely save 2%
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 61314-0647-05 Sandoz 5 ml $4.268 AB Availability likely save 2%
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mLthis 24208-0295-10 Bausch 1 bottle $4.343 AB Availability likely
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1135-00 A-S 2.5 ml AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1136-00 A-S 5 ml AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 50090-1914-00 A-S 1 bottle AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 50090-7267-00 A-S 5 ml AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 63629-9570-01 Bryant 2.5 ml AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 63629-9571-01 Bryant 5 ml AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 63629-9572-01 Bryant 10 ml AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 67296-2174-05 Redpharm 5 ml AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-1821-02 NuCare 1 bottle AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-2418-02 NuCare 1 bottle AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68071-4203-05 NuCare 5 ml AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 68788-4081-05 Preferred 1 bottle AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 70518-3994-00 REMEDYREPACK 5 ml AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 71335-2840-01 Bryant 5 ml AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 71335-2854-01 Bryant 2.5 ml AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 71335-2891-01 Bryant 10 ml AB FDA listed
Tobramycin And Dexamethasone 3 mg/mL; 1 mg/mL 72162-1128-02 Bryant 10 ml AB FDA listed
Tobramycin and dexamethasone 3 mg/mL; 1 mg/mL 80425-0260-01 Advanced 5 ml AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 80425-0366-01 Advanced 5 ml AB FDA listed
Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL 85766-0188-05 Sportpharm 1 bottle AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and 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

🏛️
1999
On the market since
Oct 1999
📍
2026
Currently FDA-listed
27 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 24208-0295-10, 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.
📅 Q1 2025 – Q4 2025 · 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
1.2K
Units reimbursed last 4 qtrs
12.6K
Gross reimbursed last 4 qtrs
$69K
Avg / prescription
$55.72
Avg / unit
$5.4898
Latest quarter Q4 2025
180Rx
Medicaid pays / mL
$5.4898
gross reimbursed
vs
NADAC / mL
$4.3428
acquisition cost
=
Spread
+$1.1470
+26% 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
84% FFS 16% MCO
Fee-for-service · 1,039 Rx Managed care · 200 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 240 units · 4.2 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 5,570 units · 28.5 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: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 375 units · 4.0 per 100k residents NJ Massachusetts: no data reported MA California: 4,890 units · 12.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported 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: 630 units · 2.1 per 100k residents TX Florida: 870 units · 3.8 per 100k residents FL
Units reimbursed · per 100k residents
2.128.5
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 New York 28.5 /100k
2 California 12.5 /100k
3 Minnesota 4.2 /100k
4 New Jersey 4.0 /100k
5 Florida 3.8 /100k
6 Texas 2.1 /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 bottle24208-0295-05 22,057 Rx · $783,249
1 bottle24208-0295-25 3,716 Rx · $93,865
1 bottle this page24208-0295-10 1,239 Rx · $69,034
Drug total (last 4 qtrs): 27,012 Rx · 148,036 units · $946,148 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
24208-0295-05 1 BOTTLE, DROPPER in 1 CARTON (24208-295-05) / 5 mL in 1 BOTTLE, DROPPER $4.27 / mL $21.34 1999-10-27 Active
24208-0295-10 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (24208-295-10) / 10 mL in 1 BOTTLE, DROPPER $4.34 / mL $43.43 1999-10-27 Active
24208-0295-25 1 BOTTLE, DROPPER in 1 CARTON (24208-295-25) / 2.5 mL in 1 BOTTLE, DROPPER $4.62 / mL $11.56 1999-10-27 Active

This pack accounts for about 4.6% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 24208-0295-10?
NDC 24208-0295-10 is listed by the FDA — 1 bottle, dropper in 1 carton / 10 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Tobramycin and Dexamethasone 3 mg/mL; 1 mg/mL Suspension/ Drops?
Bill NDC 24208-0295-10 — the 11-digit billing format is 24208029510. 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 214 words

INDICATIONS AND USAGE Tobramycin and dexamethasone 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. 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.

⏱️ Dosage and Administration 83 words

DOSAGE AND ADMINISTRATION One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs.

Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

Contraindications 36 words

CONTRAINDICATIONS Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

⚠️ Warnings 157 words

WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients.

Severity of hypersensitivity reactions may vary from local effects to generalized reactions, such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction does occur, discontinue use. Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.

Intraocular pressure (IOP) should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions and parasitic infections of the eye, steroids may mask infection or enhance existing infection.

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.

🤒 Adverse Reactions ~1 min read

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. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin (tobramycin ophthalmic solution) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema.

These reactions occur in less than 4% of patients. The reactions due to the steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. 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.

Postmarketing Experience: Additional adverse reactions identified from postmarketing use include anaphylactic reaction and erythema multiforme. The following additional adverse reactions have been reported with the individual components listed below: 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. 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. 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.

🤰 Pregnancy 150 words

Pregnancy Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two 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 parenterally 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.

Tobramycin and dexamethasone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

🧒 Pediatric Use 18 words

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

🧓 Geriatric Use 17 words

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

🧬 Clinical Pharmacology 172 words

CLINICAL PHARMACOLOGY Corticoids suppress the inflammatory response to a variety of agents and they probably 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. Dexamethasone is a potent corticoid.

The antibiotic 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 . No data are available on the extent of systemic absorption from tobramycin and dexamethasone ophthalmic suspension; however, it is known that some systemic absorption can occur with ocularly applied drugs.

📦 How Supplied / Storage and Handling 95 words

HOW SUPPLIED Tobramycin and dexamethasone ophthalmic suspension USP, 0.3%/0.1% is supplied in a plastic bottle with a controlled drop tip and pink cap in the following sizes: NDC 24208-295-25 - 2.5 mL NDC 24208-295-05 - 5 mL NDC 24208-295-10 - 10 mL Storage: Store suspension upright at 20°C to 25°C (68°F to 77°F). Shake well before using. Distributed by: Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: August 2023 9090707 (folded) 9090607 (flat) DoNotUse

📋 Description 83 words

DESCRIPTION Tobramycin and dexamethasone ophthalmic suspension USP, 0.3%/0.1% is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. Tobramycin is represented by the following structural formula: Dexamethasone is represented by the following structural formula: Each mL contains: Actives: tobramycin 3 mg (0.3%) and dexamethasone 1 mg (0.1%); Inactives: edetate disodium, hydroxyethyl cellulose, purified water, sodium chloride, sodium sulfate, and tyloxapol. Sulfuric acid and/or sodium hydroxide may be added to adjust pH (5.0 – 6.0).

Preservative: benzalkonium chloride 0.01%. ChemStructure1 ChemStructure2

💬 Information for Patients 29 words

Information for Patients Do not touch dropper tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.

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.