HomeNDC LookupIngredientsBrimonidine Tartrate › 60505-0564-01
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Brimonidine Tartrate 1.5 mg/mL Solution/ Drops

by Apotex Corp. · 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-1) / 5 mL in 1 BOTTLE, DROPPER
NDC 60505-0564-01
🏷️ FDA NDC (as labeled) 60505-0564-1 billing pads the package segment with a zero
This package
Contains5 mL in 1 bottle, dropper Cost per mL$10.58 NADAC Per package$52.91 / 5 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $14.51/unit · Part D plans $17.09/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Past resolved recalls for this product (1)
Class II · Mar 1, 2023 · Completed — Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility. (Apotex Corp.) · FDA recall D-0433-2023

🆔 Identity & classification

FDA NDC (as labeled) 60505-0564-1
Product NDC 60505-0564
11-digit billing NDC 60505056401
NCPDP billing unit ML — per mL (volume)
RxCUI 861208
UNII 4S9CL2DY2H
Application # ANDA078479
SPL Set ID 64b21e68-610c-5194-ccb2-9d9f6ff8cda9
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-31
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance BRIMONIDINE TARTRATE
GPI-14 86602020102007
GPI class Brimonidine Tartrate
GCN Seq No 048333
GCN 13752
HICL code 011786
Ingredient (HICL) Brimonidine Tartrate
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 Q6G
Therapeutic class — specific (HIC3) Miotics And Other Intraocular Pressure Reducers
AHFS code 52:40.04.00
AHFS class Alpha-Adrenergic Agonists (52:40)
FDB label name BRIMONIDINE TARTRATE 0.15% DRP
FDB brand name Brimonidine Tartrate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 60505-0564-1 — a 5-4-1 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 package segment → 60505-0564-01. 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 alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Other dermatologicals, Sympathomimetics in glaucoma therapy, Sympathomimetics used as decongestants
How it works Adrenergic alpha-Agonists
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

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA078479 (ANDA)
Labeler code60505
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio304 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 BRIMONIDINE TARTRATE 0.15% DRP Ingredient Brimonidine Tartrate
📗 Our plain-language guide HelloPharmacist
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  • My facial redness seems worse some days after I use the gel — is that normal?
📖 Read our full Brimonidine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Brimonidine Tartrate — tap one for details:

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 $10.582 $52.91 / 5 ml
Medicaid paysCMS SDUD · 12 mo $14.51 $72.53 / 5 ml
Medicare drug plans payPart D · Q2 2026 $17.09 $85.46 / 5 ml
NADAC price history (per mL) — tap or hover for the price & month
Mar 2022 Sep 2022 Jan 2026 Aug 2026 $27.004 $10.175
▼ Down 61% over the last 21 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
Brimonidine Tartrate 1.5 mg/mLthis 60505-0564-01 Apotex 1 bottle $10.582 AT Availability likely
Brimonidine Tartrate 1.5 mg/mL 61314-0144-05 Sandoz 5 ml $10.582 AT Availability likely
Brimonidine Tartrate ophthalmic solution, 0.15% 1.5 mg/mL 62332-0661-05 Alembic 1 bottle $10.582 AT Availability likely
Brimonidine tartrate 1.5 mg/mL 82182-0773-05 Pacific 1 bottle $10.582 AT Availability likely
Alphagan P 1.5 mg/mL 00023-9177-05 Allergan, 1 bottle $39.764 AT Availability likely +276%
Brimonidine Tartrate ophthalmic solution, 0.15% 1.5 mg/mL 46708-0661-05 Alembic 1 bottle AT 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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 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 60505-0564-01, 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
935
Units reimbursed last 4 qtrs
5.9K
Gross reimbursed last 4 qtrs
$86.1K
Avg / prescription
$92.08
Avg / unit
$14.5061
Latest quarter Q4 2025
126Rx
Medicaid pays / mL
$14.5061
gross reimbursed
vs
NADAC / mL
$10.5824
acquisition cost
=
Spread
+$3.9237
+37% 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
15% FFS 85% MCO
Fee-for-service · 136 Rx Managed care · 799 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 615 units · 7.9 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: 290 units · 1.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 420 units · 9.9 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,415 units · 11.3 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 510 units · 5.5 per 100k residents NJ Massachusetts: no data reported MA California: 95 units · 0.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 305 units · 4.9 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 255 units · 2.9 per 100k residents VA Maryland: 300 units · 4.9 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 400 units · 5.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 75 units · 1.1 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 585 units · 12.8 per 100k residents LA Mississippi: no data reported MS Alabama: 120 units · 2.3 per 100k residents AL Georgia: no data reported GA D.C.: 95 units · 14.0 per 100k residents DC Hawaii: no data reported HI Texas: 455 units · 1.5 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.214.0
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 D.C. 14.0 /100k
2 Louisiana 12.8 /100k
3 Illinois 11.3 /100k
4 Oregon 9.9 /100k
5 Washington 7.9 /100k
6 New Jersey 5.5 /100k
7 Arizona 5.4 /100k
8 Missouri 4.9 /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 bottle60505-0564-02 No Medicaid data
1 bottle60505-0564-03 No Medicaid data
Drug total (last 4 qtrs): 935 Rx · 5,935 units · $86,094 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 Brimonidine Tartrate — the program that covers self-administered drugs. 9 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 Brimonidine Tartrate. 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
$23.5M
Claims incl. refills
685K
Beneficiaries
455K
Spend / beneficiary
$51.64
Spend / claim
$34.30
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Brimonidine Tartrate — the ingredient across all brands.

Top reported reactions

Treatment Failure3,181
Ocular Hyperaemia1,655
Eye Irritation1,649
Eye Pain1,456
Fatigue1,265
Vision Blurred1,230
Intraocular Pressure Increased1,085

Reporter sex

0 reports

Serious outcomes

Death1,214
Disabling550
Life-threatening428
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,341 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
60505-0564-01 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-1) / 5 mL in 1 BOTTLE, DROPPER $10.58 / mL $52.91 2022-01-31 Active
60505-0564-02 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-2) / 10 mL in 1 BOTTLE, DROPPER $10.62 / mL $106.20 2022-03-14 Active
60505-0564-03 1 BOTTLE, DROPPER in 1 CARTON (60505-0564-3) / 15 mL in 1 BOTTLE, DROPPER $11.11 / mL $166.62 2022-01-31 Active

This pack has the lowest per-mL cost of the 3 priced pack sizes ($10.58 NADAC).

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 60505-0564-01?
NDC 60505-0564-01 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 Brimonidine Tartrate 1.5 mg/mL Solution/ Drops?
Bill NDC 60505-0564-01 — the 11-digit billing format is 60505056401. 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 56 words

1 INDICATIONS AND USAGE Brimonidine tartrate ophthalmic solution, 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Brimonidine tartrate ophthalmic solution is an alpha adrenergic agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

⏱️ Dosage and Administration 82 words

2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop of brimonidine tartrate ophthalmic solution in the affected eye(s) three times daily, approximately 8 hours apart. Brimonidine tartrate ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.

One drop in the affected eye(s) three times daily, approximately 8 hours apart. ( 2 )

💊 Dosage Forms and Strengths 32 words

3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) brimonidine tartrate. Ophthalmic solution containing 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) brimonidine tartrate. ( 3 )

Contraindications 83 words

4 CONTRAINDICATIONS Neonates and infants (pediatric patients younger than 2 years old). ( 4.1 ) Hypersensitivity Reactions. ( 4.2 )

4.1Neonates and Infants (Pediatric Patients Younger than 2 Years Old) Brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (pediatric patients younger than 2 years old) [see Use in Specific Populations ( 8.4 )] .

4.2Hypersensitivity Reactions Brimonidine tartrate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.

⚠️ Warnings and Cautions 174 words

5 WARNINGS AND PRECAUTIONS Potentiation of vascular insufficiency. ( 5.1 )

5.1Potentiation of Vascular Insufficiency Brimonidine tartrate ophthalmic solution may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate ophthalmic solution should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

5.2Severe Cardiovascular Disease Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.

5.3Contamination of Topical Ophthalmic Products After Use There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface . Do not touch the tip of the dispensing container to the eye or surrounding structures.

Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Patient Counseling Information ( 17 )] .

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Potentiation of Vascular Insufficiency [see Warnings and Precautions ( 5.1 )] Severe Cardiovascular Disease [see Warnings and Precautions ( 5.2 )] Contamination of Topical Ophthalmic Products after Use [see Warnings and Precautions ( 5.3 )] Neonates and Infants (Pediatric Patients Younger than 2 Years Old) [see Contraindications ( 4.1 )] Most common adverse reactions occurring in approximately 5% to 20% of patients receiving brimonidine ophthalmic solution (0.1% to 0.2%) included allergic conjunctivitis, burning sensation, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or the 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 occurring in approximately 10% to 20% of the subjects receiving brimonidine ophthalmic solution (0.1% to 0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse reactions occurring in approximately 5% to 9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.

Adverse reactions occurring in approximately 1% to 4% of the subjects receiving brimonidine ophthalmic solution (0.1% to 0.2%) included: abnormal taste, allergic reaction, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), insomnia, keratitis, lid disorder, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.

The following reactions were reported in less than 1% of subjects: corneal erosion, hordeolum, nasal dryness, and taste perversion.

6.2Postmarketing Experience The following reactions have been identified during postapproval use of brimonidine tartrate ophthalmic solutions. 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. Bradycardia, depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash, and vasodilation), syncope, and tachycardia.

Apnea, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.

🔄 Drug Interactions ~1 min read

7 DRUG INTERACTIONS Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Use with CNS depressants may result in an additive or potentiating effect. ( 7.2 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.3 ) Monoamine oxidase inhibitors may result in increased hypotension. ( 7.4 )

7.1Antihypertensives/Cardiac Glycosides Because brimonidine tartrate ophthalmic solution may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with brimonidine tartrate ophthalmic solution is advised.

7.2CNS Depressants Although specific drug interaction studies have not been conducted with brimonidine tartrate ophthalmic solution, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.

7.3Tricyclic Antidepressants Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with brimonidine tartrate ophthalmic solution in humans can lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.

7.4Monoamine Oxidase Inhibitors Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

👥 Use in Specific Populations ~3 min read

8 USE IN SPECIFIC POPULATIONS Use with caution in pediatric patients aged 2 years and older. ( 8.4 )

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with brimonidine tartrate ophthalmic solution in pregnant women. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent (see Data).

Because animal reproduction studies are not always predictive of human response, brimonidine tartrate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Data Human Data Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by offspring while breastfeeding.

Animal Data Embryofetal studies were conducted in pregnant rabbits administered brimonidine tartrate by daily oral gavage on gestation days 6 to 18, to target the period of organogenesis. Brimonidine caused miscarriage at 5 mg/kg/day (approximately 70-or 50-times the recommended human ophthalmic dose [RHOD] based on AUC, respectively for brimonidine tartrate 0.15%). The no observed adverse effect level (NOAEL) for developmental toxicity in rabbits was 1 mg/kg/day (approximately 9-and 6-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.15%).

No treatment-related malformations were observed in rabbits. Signs of maternal sedation and fatigue were observed at all dose levels; the lowest observed adverse effect level (LOAEL) for maternal toxicity was 5 mg/kg/day, based on the dose response for these signs. Embryofetal studies were conducted in pregnant rats administered brimonidine tartrate by daily oral gavage on gestation days 6 to 15, to target the period of organogenesis.

The NOAEL for developmental toxicity was 2.5 mg/kg/day (approximately 1,100-and 750-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.15%). No treatment-related malformations were observed in rats. The LOAEL for maternal toxicity was 2.5 mg/kg/day, based on signs of sedation and fatigue.

The maternal NOAEL was 1 mg/kg/day (250-and 180-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.15%). After pregnant rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine and metabolites crossed the placenta and were detectable in fetal blood and organs.

8.2Lactation Risk Summary It is not known whether brimonidine tartrate is excreted in human milk. In animal studies, brimonidine tartrate has been shown to cross the blood-brain barrier and is excreted into breast milk after oral administration to lactating rats (see Data) . Because of the potential for serious adverse reactions, including central nervous system depression and apnea, from brimonidine tartrate ophthalmic solution in nursing infants, brimonidine tartrate ophthalmic solution is not recommended for use during lactation.

Data Animal Data After a single oral dose of 14 C-labeled brimonidine tartrate to lactating rats, brimonidine and metabolites were detected in milk. After male and female rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine crossed the blood-brain barrier. Radiolabel was detected in the cerebellum, cerebrum, and spinal cord.

8.4Pediatric Use Brimonidine tartrate ophthalmic solution is contraindicated in pediatric patients younger than 2 years old [see Contraindications ( 4.1 )] . During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants recei…

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with brimonidine tartrate ophthalmic solution in pregnant women. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. In animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent (see Data).

Because animal reproduction studies are not always predictive of human response, brimonidine tartrate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Data Human Data Limited available data from postmarketing safety reports and published literature with topical use of brimonidine ophthalmic solution in pregnant women are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes including miscarriage, stillbirth, congenital anomaly, and events experienced by offspring while breastfeeding.

Animal Data Embryofetal studies were conducted in pregnant rabbits administered brimonidine tartrate by daily oral gavage on gestation days 6 to 18, to target the period of organogenesis. Brimonidine caused miscarriage at 5 mg/kg/day (approximately 70-or 50-times the recommended human ophthalmic dose [RHOD] based on AUC, respectively for brimonidine tartrate 0.15%). The no observed adverse effect level (NOAEL) for developmental toxicity in rabbits was 1 mg/kg/day (approximately 9-and 6-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.15%).

No treatment-related malformations were observed in rabbits. Signs of maternal sedation and fatigue were observed at all dose levels; the lowest observed adverse effect level (LOAEL) for maternal toxicity was 5 mg/kg/day, based on the dose response for these signs. Embryofetal studies were conducted in pregnant rats administered brimonidine tartrate by daily oral gavage on gestation days 6 to 15, to target the period of organogenesis.

The NOAEL for developmental toxicity was 2.5 mg/kg/day (approximately 1,100-and 750-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.15%). No treatment-related malformations were observed in rats. The LOAEL for maternal toxicity was 2.5 mg/kg/day, based on signs of sedation and fatigue.

The maternal NOAEL was 1 mg/kg/day (250-and 180-fold the RHOD based on AUC, respectively for brimonidine tartrate 0.15%). After pregnant rats received a single oral dose of 14 C-brimonidine tartrate, brimonidine and metabolites crossed the placenta and were detectable in fetal blood and organs.

🧒 Pediatric Use 131 words

8.4Pediatric Use Brimonidine tartrate ophthalmic solution is contraindicated in pediatric patients younger than 2 years old [see Contraindications ( 4.1 )] . During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. In a well-controlled clinical study conducted in pediatric glaucoma patients aged 2 to 7 years old, the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50% to 83% in pediatric patients aged 2 to 6 years old) and decreased alertness.

In pediatric patients aged 7 years and older (greater than 20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of pediatric patients on brimonidine tartrate ophthalmic solution 0.2% discontinued from the study due to somnolence.

🧓 Geriatric Use 19 words

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

🆘 Overdosage 76 words

10 OVERDOSAGE Limited information exists on accidental ingestion of brimonidine in adults; the only adverse reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine tartrate ophthalmic solution as part of medical treatment of congenital glaucoma or by accidental oral ingestion [see Use in Specific Populations ( 8.4 )]. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

🧬 Clinical Pharmacology 143 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brimonidine tartrate ophthalmic solution is a relatively selective alpha-2 adrenergic receptor agonist with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow.

12.3Pharmacokinetics Absorption After ocular administration of either a 0.1% or 0.2% solution, plasma concentrations peaked within 0.5 to 2.5 hours and declined with a systemic half-life of approximately 2 hours. Distribution Brimonidine was approximately 29% bound to plasma proteins in healthy subjects. Elimination Metabolism In humans, brimonidine is extensively metabolized by the liver.

Excretion Urinary excretion is the major route of elimination of brimonidine and its metabolites. Approximately 87% of an orally-administered radioactive dose of brimonidine was eliminated within 120 hours, with 74% found in the urine.

🧬 Mechanism of Action 52 words

12.1Mechanism of Action Brimonidine tartrate ophthalmic solution is a relatively selective alpha-2 adrenergic receptor agonist with a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow.

📦 How Supplied / Storage and Handling 82 words

16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine Tartrate Ophthalmic Solution is supplied sterile, in white opaque LDPE ophthalmic bottles with white translucent LDPE ophthalmic droppers and purple opaque ophthalmic HDPE plastic caps as follows: 0.15% 5 mL in 5 mL bottle NDC 60505-0564-1 10 mL in 11 mL bottle NDC 60505-0564-2 15 mL in 15 mL bottle NDC 60505-0564-3 Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room temperature]. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

📦 Storage and Handling 24 words

Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room temperature]. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN

📋 Description 142 words

11 DESCRIPTION Brimonidine Tartrate Ophthalmic Solution, 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist for topical ophthalmic use. The structural formula of brimonidine tartrate is: 5-bromo-6-(2-imidazolin-2-ylamino) quinoxaline D-tartrate; MW= 442.22 In solution, brimonidine tartrate ophthalmic solution has a clear, greenish-yellow color. It has an osmolality of 250 to 350 mOsmol/kg and a pH of 6.6 to 7.4 (0.15%).

Brimonidine tartrate appears as white to slightly yellowish powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of Brimonidine Tartrate Ophthalmic Solution contains the active ingredient brimonidine tartrate 0.15% (1.5 mg/mL) with the inactive ingredients boric acid; calcium chloride dihydrate; carboxymethylcellulose sodium; magnesium chloride; potassium chloride; sodium borate; sodium chloride; sodium chlorite (0.08 mg/mL) as a preservative; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH. structure.jpg

💬 Information for Patients ~1 min read

17 PATIENT COUNSELING INFORMATION Handling the Container Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions ( 5.3 )]. Always replace the cap after using.

If solution changes color or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle. When to Seek Physician Advice Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.

Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Potential for Decreased Mental Alertness As with other similar medications, brimonidine tartrate ophthalmic solution may cause fatigue and/or drowsiness in some patients. Caution patients who engage in hazardous activities of the potential for a decrease in mental alertness.

The trademarks referenced herein are owned by their respective companies. Manufactured by: Manufactured for: Apotex Inc. Apotex Corp.

Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: October 2025

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.