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Brimonidine Tartrate 1.5 mg/mL Solution, 10 mL — NDC 61314-0144-10 package photo

Brimonidine Tartrate 1.5 mg/mL Solution, 10 mL

by Sandoz Inc · 10 mL in 1 BOTTLE (61314-144-10)
NDC 61314-0144-10
🏷️ FDA NDC (as labeled) 61314-144-10 billing pads the product segment with a zero
This package
Contains10 mL Cost per mL$10.62 NADAC Per package$106.20 / 10 ml Pack sizes3 compare ↓
Also priced by: Medicaid pays $14.89/unit · Part D plans $17.09/unit — full pricing hub ↓
Rx only Brand 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) 61314-144-10
Product NDC 61314-144
11-digit billing NDC 61314014410
NCPDP billing unit ML — per mL (volume)
RxCUI 861208
UNII 4S9CL2DY2H
UPC 0361314144058
Application # NDA021764
SPL Set ID b1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-10-02
Route OPHTHALMIC
Dosage form SOLUTION
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 61314-144-10 — 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 → 61314-0144-10. 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 applicationNDA021764 (NDA)
Labeler code61314
First marketedOct 2010
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 TARTRATE 0.15% DRP Ingredient Brimonidine Tartrate
📗 Our plain-language guide HelloPharmacist
  • Brimonidine eye drops are used to lower the pressure inside your eye — what doctors call intraocular pressure. High eye pressure is a key risk factor for glaucoma-related vision da...
  • What exactly is brimonidine eye drops used for?
  • The usual routine is one drop in the affected eye or eyes, three times a day — roughly 8 hours apart, so think morning, afternoon, and evening. If you use other eye drops too, wait...
  • The most common ones are eye redness, itching, a burning or stinging sensation, and dry mouth. Some people also notice drowsiness or blurred vision. These are usually manageable, b...
📖 Read our full Brimonidine Ophthalmic 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 $10.620 $106.20 / 10 ml
Medicaid paysCMS SDUD · 12 mo $14.89 $148.85 / 10 ml
Medicare drug plans payPart D · Q2 2026 $17.09 $170.92 / 10 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $27.892 $10.256
▼ Down 55% 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 1.5 mg/mL 60505-0564-01 Apotex 1 bottle $10.582 AT Availability likely +0%
Brimonidine Tartrate ophthalmic solution, 0.15% 1.5 mg/mL 62332-0661-05 Alembic 1 bottle $10.582 AT Availability likely +0%
Brimonidine tartrate 1.5 mg/mL 82182-0773-05 Pacific 1 bottle $10.582 AT Availability likely +0%
Brimonidine Tartrate 1.5 mg/mLthis 61314-0144-10 Sandoz 10 ml $10.620 AT Availability likely
Alphagan P 1.5 mg/mL 00023-9177-05 Allergan, 1 bottle $39.764 AT Availability likely +274%
Brimonidine Tartrate ophthalmic solution, 0.15% 1.5 mg/mL 46708-0661-05 Alembic 1 bottle AT FDA listed
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2010
On the market since
Oct 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

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

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

🗺️ 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 61314-0144-10, 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
241
Units reimbursed last 4 qtrs
2.5K
Gross reimbursed last 4 qtrs
$37.7K
Avg / prescription
$156.26
Avg / unit
$14.8851
Latest quarter Q4 2025
56Rx
Medicaid pays / mL
$14.8851
gross reimbursed
vs
NADAC / mL
$10.6204
acquisition cost
=
Spread
+$4.2647
+40% 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
100% MCO
Fee-for-service · 0 Rx Managed care · 241 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: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported 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: 1,160 units · 9.2 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported 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: 420 units · 4.8 per 100k residents VA Maryland: 950 units · 15.4 per 100k residents 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.815.4
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 Maryland 15.4 /100k
2 Illinois 9.2 /100k
3 Virginia 4.8 /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 ml61314-0144-05 1,529 Rx · $136,281
1 ml this page61314-0144-10 241 Rx · $37,659
15 ml61314-0144-15 178 Rx · $45,666
Drug total (last 4 qtrs): 1,948 Rx · 14,790 units · $219,606 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
61314-0144-05 5 mL in 1 BOTTLE (61314-144-05) $10.58 / mL $52.91 2010-10-02 Active
61314-0144-10 You're viewing this 10 mL in 1 BOTTLE (61314-144-10) $10.62 / mL $106.20 2010-10-02 Active
61314-0144-15 15 mL in 1 BOTTLE (61314-144-15) $11.11 / mL $166.62 2010-10-02 Active

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

This pack effectively ties for the lowest per-mL cost of the 3 priced pack sizes ($10.62 NADAC).

This pack accounts for about 12% 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 61314-0144-10?
NDC 61314-0144-10 contains 10 mL — 10 ml in 1 bottle.
What is the difference between NDC 61314-0144-10 and NDC 61314-0144-05?
Both are Brimonidine Tartrate 1.5 mg/mL Solution — the drug itself is identical. NDC 61314-0144-10 is the 10 mL package, while NDC 61314-0144-05 is the 5 ml package. Per-mL NADAC also differs: $10.62 here vs $10.58 for the 5 ml pack.
What NDC number is used to bill for this package of Brimonidine Tartrate 1.5 mg/mL Solution?
Bill NDC 61314-0144-10 — the 11-digit billing format is 61314014410. 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 54 words

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

⏱️ Dosage and Administration 102 words

2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop of brimonidine tartrate ophthalmic solution, 0.15% in the affected eye(s) three-times daily, approximately 8 hours apart. Brimonidine tartrate ophthalmic solution, 0.15% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart. • Instill one drop in the affected eye(s) three-times daily ( 2 ). • If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart ( 2 ).

💊 Dosage Forms and Strengths 24 words

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

Contraindications 95 words

4 CONTRAINDICATIONS • Neonates and infants (pediatric patients younger than 2 years old) ( 4.1 ). • Hypersensitivity to any component of this product ( 4.2 ).

4.1Neonates and Infants (Pediatric Patients Younger than 2 Years Old) Brimonidine tartrate ophthalmic solution, 0.15% 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, 0.15% is contraindicated in patients with hypersensitivity to any component of this product [see Adverse Reactions ( 6.1 ) and ( 6.2 )].

⚠️ Warnings and Cautions 137 words

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

5.1Potentiation of Vascular Insufficiency Brimonidine tartrate ophthalmic solution, 0.15% may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate ophthalmic solution, 0.15% 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.

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Neonates and Infants (Pediatric Patients Younger than 2 Years Old) [see Contraindications ( 4.1 )] • 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 )] Most common adverse reactions are allergic conjunctivitis, conjunctival hyperemia, and eye pruritis ( 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 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 included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritis. Adverse reactions occurring in approximately 5 to 9% of the subjects included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.

Adverse reactions occurring in approximately 1 to 4% of subjects included: allergic reaction, arthralgia, arthritis, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, chest pain, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, diabetes mellitus, 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, insomnia, joint disorder, keratitis, lid disorder, osteoporosis, 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 adverse reactions were reported in less than 1% of subjects: corneal erosion, nasal dryness, and taste perversion.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of brimonidine tartrate ophthalmic solution. 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, iritis, miosis, skin reactions (including erythema, eyelid pruritis, rash, and vasodilation), and tachycardia. • Apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.

🔄 Drug Interactions ~1 min read

7 DRUG INTERACTIONS • Concomitant use with systemic beta-blockers may potentiate systemic beta-blockade ( 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 ).

7.1Anti-hypertensives / Cardiac Glycosides Alpha-2 agonists, as a class, may reduce blood pressure. Caution in using drugs such as beta-blockers (ophthalmic and systemic), anti-hypertensives and/or cardiac glycosides is advised.

7.2CNS Depressants Although specific drug interaction studies have not been conducted with brimonidine tartrate ophthalmic solution, 0.15%, 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, 0.15% in humans can lead to resulting interference with its IOP-lowering effect. Caution, however, 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, 0.15% 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, 0.15% 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 tartrate 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 experiences 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 50-times the recommended human ophthalmic dose (RHOD) based on AUC). The no observed adverse effect level (NOAEL) for developmental toxicity in rabbits was 1 mg/kg/day (approximately 6-fold the RHOD based on AUC).

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 750-fold the RHOD based on AUC). 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 (180-fold the RHOD based on AUC). 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 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, 0.15% in nursing infants, brimonidine tartrate ophthalmic solution, 0.15% 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, 0.15% 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 events with brimonidine…

🤰 Pregnancy ~2 min read

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with brimonidine tartrate ophthalmic solution, 0.15% 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, 0.15% 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 tartrate 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 experiences 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 50-times the recommended human ophthalmic dose (RHOD) based on AUC). The no observed adverse effect level (NOAEL) for developmental toxicity in rabbits was 1 mg/kg/day (approximately 6-fold the RHOD based on AUC).

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 750-fold the RHOD based on AUC). 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 (180-fold the RHOD based on AUC). 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 127 words

8.4Pediatric Use Brimonidine tartrate ophthalmic solution, 0.15% 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 events 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 (>20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of pediatric patients on brimonidine tartrate ophthalmic solution 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 74 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 as part of medical treatment of congenital glaucoma or 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 ~1 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Brimonidine tartrate ophthalmic solution, 0.15% is an alpha-2 adrenergic receptor agonist. 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.

12.2Pharmacodynamics Brimonidine tartrate ophthalmic solution, 0.15% has a peak ocular hypotensive effect occurring at two hours post-dosing. Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Brimonidine tartrate has the action of lowering intraocular pressure with minimal effect on cardiovascular and pulmonary parameters.

12.3Pharmacokinetics Absorption In a pharmacokinetic study, 14 healthy subjects (4 males and 10 females) received a single topical ocular administration of brimonidine tartrate ophthalmic solution, 0.15%, one drop per eye. The peak plasma concentrations (C max ) and AUC 0-inf were 73 ± 19 pg/mL and 375 ± 89 pg•hr/mL, respectively. T max was 1.7 ± 0.7 hours after dosing.

The systemic half-life was approximately 2.1 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% of the radioactivity recovered in the urine.

🧬 Mechanism of Action 40 words

12.1Mechanism of Action Brimonidine tartrate ophthalmic solution, 0.15% is an alpha-2 adrenergic receptor agonist. 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 79 words

16 HOW SUPPLIED/STORAGE AND HANDLING Brimonidine tartrate ophthalmic solution, 0.15% is supplied sterile in opaque white LDPE plastic bottles and natural tips with purple polypropylene caps as follows: 5 mL in 8 mL bottle NDC 61314-144-05 10 mL in 10 mL bottle NDC 61314-144-10 15 mL in 15 mL bottle NDC 61314-144-15 Storage: Store at 15°C to 25° C (59°F to 77°F). After opening, Brimonidine tartrate ophthalmic solution, 0.15% can be used until the expiration date on the bottle.

📋 Description 177 words

11 DESCRIPTION Brimonidine tartrate ophthalmic solution, 0.15% (1.5 mg brimonidine tartrate per mL equivalent to 1.0 mg brimonidine free base per mL) is a relatively selective alpha-2-adrenergic agonist for topical ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It is a white to off-white, pale yellow to yellow powder.

It has a molecular weight of 442.24 as the tartrate salt, and is both soluble in water (1.5 mg/mL) and in the product vehicle (3.0 mg/mL) at pH 7.2. The structural formula is: Formula: C 11 H 10 BrN 5 • C 4 H 6 O 6 CAS Number: 59803-98-4 In solution, brimonidine tartrate ophthalmic solution, 0.15% has a clear, pale yellow to greenish yellow color. It has an osmolality of 250 - 350 mOsmol/kg and a pH of 6.6 to 7.4.

Contains: Active ingredient: brimonidine tartrate 1.5 mg/mL (1.5 mg/mL), Preservative: Polyquad (polyquaternium-1) 0.001% (0.01 mg/mL), Inactives: boric acid, calcium chloride, magnesium chloride, mannitol, potassium chloride, povidone, purified water, sodium borate, sodium chloride, with hydrochloric acid and/or sodium hydroxide 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 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 drugs in this class, brimonidine tartrate ophthalmic solution, 0.15% may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness.

Rx Only **ALPHAGAN P is a registered trademark of Allergan, Inc. Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc.

Princeton, NJ 08540 300069925-1125

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.