HomeNDC LookupIngredientsBrimonidine Tartrate › 61314-0143-10
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Brimonidine Tartrate 2 mg/mL Solution, 10 mL

by Sandoz Inc · 10 mL in 1 BOTTLE (61314-143-10)
NDC 61314-0143-10
🏷️ FDA NDC (as labeled) 61314-143-10 billing pads the product segment with a zero
This package
Contains10 mL Cost per mL$0.5858 NADAC Per package$5.86 / 10 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $1.24/unit · Part D plans $1.05/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 →

🆔 Identity & classification

FDA NDC (as labeled) 61314-143-10
Product NDC 61314-143
11-digit billing NDC 61314014310
NCPDP billing unit ML — per mL (volume)
RxCUI 861200
UNII 4S9CL2DY2H
Application # ANDA076254
SPL Set ID dfd85672-fa4b-40e3-ac9c-81b8d9e4ffde
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 2003-09-17
Route OPHTHALMIC
Dosage form SOLUTION
Substance BRIMONIDINE TARTRATE
GPI-14 86602020102010
GPI class Brimonidine Tartrate
GCN Seq No 027882
GCN 36281
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 0.2% EYE DROP
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 61314-143-10 — 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 → 61314-0143-10. 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 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

LabelerSandoz Inc
Application holderSANDOZ INC
FDA applicationANDA076254 (ANDA)
Labeler code61314
First marketedSep 2003
Product typeHuman Prescription Drug
Portfolio387 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 0.2% EYE DROP Ingredient Brimonidine Tartrate
📗 Our plain-language guide HelloPharmacist
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📖 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 $0.586 $5.86 / 10 ml
Medicaid paysCMS SDUD · 12 mo $1.24 $12.41 / 10 ml
Medicare drug plans payPart D · Q2 2026 $1.05 $10.50 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.736 $0.555
▼ Down 14% over the last 24 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 2 mg/mL 70069-0233-01 Somerset 1 bottle $0.509 AT Availability likely save 13%
Brimonidine Tartrate 2 mg/mLthis 61314-0143-10 Sandoz 10 ml $0.586 AT Availability likely
Brimonidine Tartrate 2 mg/mL 70069-0232-01 Somerset 1 bottle $0.586 AT Availability likely
Brimonidine Tartrate 2 mg/mL 24208-0411-05 Bausch 1 bottle $0.820 AT Availability likely +40%
Brimonidine Tartrate 2 mg/mL 70069-0231-01 Somerset 1 bottle $0.820 AT Availability likely +40%
Brimonidine Tartrate 2 mg/mg 71921-0185-05 Florida 5 mg $0.820 AT Availability likely +40%
Brimonidine Tartrate 2 mg/mg 14445-0400-05 Indoco 5 mg AT FDA listed
Brimonidine tartrate 2 mg/mL 42571-0419-56 Micro 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

🏛️
2003
On the market since
Sep 2003
📍
2026
Currently FDA-listed
23 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 61314-0143-10, 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
13.5K
Units reimbursed last 4 qtrs
149.9K
Gross reimbursed last 4 qtrs
$186K
Avg / prescription
$13.79
Avg / unit
$1.2409
Latest quarter Q4 2025
3.1KRx
Medicaid pays / mL
$1.2409
gross reimbursed
vs
NADAC / mL
$0.5858
acquisition cost
=
Spread
+$0.6551
+112% 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
38% FFS 62% MCO
Fee-for-service · 5,181 Rx Managed care · 8,307 Rx
State Medicaid map
Alaska: 140 units · 19.1 per 100k residents AK Maine: 380 units · 27.2 per 100k residents ME Washington: 840 units · 10.8 per 100k residents WA Idaho: 220 units · 11.2 per 100k residents ID Montana: 120 units · 10.6 per 100k residents MT North Dakota: no data reported ND Minnesota: 1,700 units · 29.6 per 100k residents MN Wisconsin: 1,625 units · 27.5 per 100k residents WI Michigan: 8,025 units · 80.0 per 100k residents MI New York: 27,600 units · 141 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 110 units · 2.6 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 120 units · 13.1 per 100k residents SD Iowa: 790 units · 24.6 per 100k residents IA Illinois: 7,805 units · 62.2 per 100k residents IL Indiana: 5,020 units · 73.2 per 100k residents IN Ohio: 9,540 units · 81.0 per 100k residents OH Pennsylvania: 10,515 units · 81.1 per 100k residents PA New Jersey: 7,740 units · 83.3 per 100k residents NJ Massachusetts: 13,990 units · 200 per 100k residents MA California: 11,840 units · 30.4 per 100k residents CA Utah: no data reported UT Colorado: 140 units · 2.4 per 100k residents CO Nebraska: 355 units · 17.9 per 100k residents NE Missouri: 740 units · 11.9 per 100k residents MO Kentucky: 1,260 units · 27.8 per 100k residents KY West Virginia: 880 units · 49.7 per 100k residents WV Virginia: 5,340 units · 61.3 per 100k residents VA Maryland: 4,625 units · 74.8 per 100k residents MD Connecticut: 3,590 units · 99.3 per 100k residents CT Rhode Island: 2,230 units · 204 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,220 units · 17.1 per 100k residents TN North Carolina: 3,930 units · 36.3 per 100k residents NC South Carolina: 2,690 units · 50.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 1,195 units · 26.1 per 100k residents LA Mississippi: no data reported MS Alabama: 525 units · 10.3 per 100k residents AL Georgia: 2,790 units · 25.3 per 100k residents GA D.C.: 3,465 units · 510 per 100k residents DC Hawaii: no data reported HI Texas: 935 units · 3.1 per 100k residents TX Florida: 2,595 units · 11.5 per 100k residents FL
Units reimbursed · per 100k residents
2.4510
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. 510 /100k
2 Rhode Island 204 /100k
3 Massachusetts 200 /100k
4 New York 141 /100k
5 Connecticut 99.3 /100k
6 New Jersey 83.3 /100k
7 Pennsylvania 81.1 /100k
8 Ohio 81.0 /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.
5 ml61314-0143-05 52,706 Rx · $568,798
1 ml this page61314-0143-10 13,488 Rx · $185,992
15 ml61314-0143-15 9,232 Rx · $156,091
Drug total (last 4 qtrs): 75,426 Rx · 627,694 units · $910,881 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
61314-0143-05 5 mL in 1 BOTTLE (61314-143-05) $0.8201 / mL $4.10 2003-09-17 Active
61314-0143-10 You're viewing this 10 mL in 1 BOTTLE (61314-143-10) $0.5858 / mL $5.86 2003-09-17 Active
61314-0143-15 15 mL in 1 BOTTLE (61314-143-15) $0.5086 / mL $7.63 2003-09-17 Active

You're viewing one of 3 pack sizes for this product.

Per mL, this pack runs about 15% above the cheapest pack (15 mL, $0.5086 vs $0.5858 NADAC).

This pack accounts for about 18% of this product's recent Medicaid fills; most go to the 5 ml pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 61314-0143-10?
NDC 61314-0143-10 contains 10 mL — 10 ml in 1 bottle.
What is the difference between NDC 61314-0143-10 and NDC 61314-0143-05?
Both are Brimonidine Tartrate 2 mg/mL Solution — the drug itself is identical. NDC 61314-0143-10 is the 10 mL package, while NDC 61314-0143-05 is the 5 ml package. Per-mL NADAC also differs: $0.5858 here vs $0.8201 for the 5 ml pack.
What NDC number is used to bill for this package of Brimonidine Tartrate 2 mg/mL Solution?
Bill NDC 61314-0143-10 — the 11-digit billing format is 61314014310. 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 85 words

1 INDICATIONS AND USAGE Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.

Brimonidine tartrate ophthalmic solution, 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )

⏱️ Dosage and Administration 83 words

2 DOSAGE AND ADMINISTRATION The recommended dose is one drop of brimonidine tartrate ophthalmic solution, 0.2% 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 20 words

3 DOSAGE FORMS AND STRENGTHS Solution containing 2 mg/mL brimonidine tartrate. Solution containing 2 mg/mL brimonidine tartrate. ( 3 )

Contraindications 84 words

4 CONTRAINDICATIONS Neonates and infants (under the age of 2 years). ( 4.1 )

4.1Neonates and Infants (under the age of 2 years) Brimonidine tartrate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years) [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 [see Adverse Reactions ( 6.1 ) and ( 6.2 )].

⚠️ Warnings and Cautions 187 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 [see Patient Counseling Information ( 17 )].

5.4Use with Contact Lenses The preservative in brimonidine tartrate ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling brimonidine tartrate ophthalmic solution to insert soft contact lenses.

🤒 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 (under the age of 2 years) [see Contraindications ( 4.1 )] Most common adverse reactions occurring in approximately 10 to 30% of patients receiving brimonidine ophthalmic solution 0.2% included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. • Adverse reactions occurring in approximately 10-30% of the subjects (in descending order): oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus. • Adverse reactions occurring in approximately 3-9% of the subjects (in descending order): corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain. • Adverse reactions reported < 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.

6.2Postmarketing Experience The following reactions have been identified during postmarketing use of brimonidine tartrate ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions, or a combination of these factors, include: • Bradycardia; conjunctivitis; hypersensitivity; hypotension; iritis; keratoconjunctivitis sicca; lacrimation increased; miosis; nausea; skin reactions (including erythema, eyelid pruritus, rash, and vasodilation); and tachycardia. • Apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence 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 ~2 min read

8 USE IN SPECIFIC POPULATIONS Use with caution in children ≥ 2 years of age. ( 8.4 )

8.1Pregnancy Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved AUC exposure values 375-fold higher or 19-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution, 0.2%, one drop in one eye, twice daily.

There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. 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.

8.3Nursing Mothers It is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the potential for serious adverse reactions from brimonidine tartrate ophthalmic solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Brimonidine tartrate ophthalmic solution is contraindicated in children under the age of 2 years [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. The safety and effectiveness of brimonidine tartrate have not been studied in children below the age of 2 years.

In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution, 0.2% dosed three times daily were somnolence (50-83% in patients ages 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age (greater than 20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of patients on brimonidine tartrate ophthalmic solution, 0.2% discontinued from the study due to somnolence.

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

8.6Special Populations Brimonidine tartrate ophthalmic solution has not been studied in patients with hepatic impairment. Brimonidine tartrate ophthalmic solution has not been studied in patients with renal impairment. The effect of dialysis on brimonidine pharmacokinetics in patients with renal failure is not known.

🤰 Pregnancy 139 words

8.1Pregnancy Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved AUC exposure values 375-fold higher or 19-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate ophthalmic solution, 0.2%, one drop in one eye, twice daily.

There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. 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.

🧒 Pediatric Use 143 words

8.4Pediatric Use Brimonidine tartrate ophthalmic solution is contraindicated in children under the age of 2 years [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. The safety and effectiveness of brimonidine tartrate have not been studied in children below the age of 2 years.

In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution, 0.2% dosed three times daily were somnolence (50-83% in patients ages 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age (greater than 20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of 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 Very 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 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 138 words

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brimonidine tartrate ophthalmic solution, 0.2% 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 a 0.2% solution, plasma concentrations peaked within 1 to 4 hours and declined with a systemic half-life of approximately 3 hours. Distribution The protein binding of brimonidine has not been studied. 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 53 words

12.1Mechanism of Action Brimonidine tartrate ophthalmic solution, 0.2% 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 61 words

16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate ophthalmic solution, 0.2% is supplied sterile in white opaque LDPE plastic dropper bottles with tips with purple polypropylene caps as follows: 5 mL in 8 mL bottle NDC 61314-143-05 10 mL in 10 mL bottle NDC 61314-143-10 15 mL in 15 mL bottle NDC 61314-143-15 Storage: Store between 15° to 25°C (59° to 77°F).

📋 Description 120 words

11 DESCRIPTION Brimonidine tartrate ophthalmic solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It has a molecular weight of 442.24 as the tartrate salt and is water soluble (34 mg/mL) at pH 6.5.

The structural formula is: In solution, brimonidine tartrate ophthalmic solution, 0.2% has a clear, greenish-yellow color. It has an osmolality of 280-330 mOsml/kg and a pH of 5.6-6.6. Each mL of brimonidine tartrate ophthalmic solution, 0.2% contains: Active: brimonidine tartrate 0.2% (2 mg/mL).

Preservative: benzalkonium chloride 0.005% (0.05 mg). Inactives: citric acid; polyvinyl alcohol; purified water; sodium chloride and sodium citrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. chemical

💬 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 Contact Lenses Advise patients that contact lenses should be removed prior to instillation of brimonidine tartrate ophthalmic solution and may be reinserted 15 minutes following its administration. 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. Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc.

Princeton, NJ 08540 300069995-0525

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.