Brimonidine Tartrate 1.5 mg/mL Solution, 5 mL — NDC 61314-144-05 (Billing 61314-0144-05)
This is a package of 5 mL of Brimonidine Tartrate 1.5 mg/mL Solution from Sandoz Inc, marketed since Oct 2010 and currently FDA-listed; retail pharmacies pay about $9.75 per mL (NADAC). It is the main listing for this product, which comes in 3 package sizes.
NDC database record
One package, one record: these facts belong to NDC 61314-144-05 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 61314 labeler · 144 product · 05 package
- Package marketed since
- Oct 2, 2010
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 5 mL per package
- Barcode (UPC)
- 0361314144058
- Medicaid fills, this package
- 1,440 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 048333
- GCN: 13752
- GPI-14 (Medi-Span): 86602020102007
- HICL (First Databank): 011786
- AHFS class code: 52:40.04.00
- RxCUI (RxNorm): 861208
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the alpha-Adrenergic Agonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Ophthalmic brimonidine is used to lower pressure in the eyes in patients who have glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision) or ocular hypertension (increased pressure in the eyes). Brimonidine is in a class of drugs called alpha adrenergic agonists. Brimonidine works by decreasing the amount of fluid in the eyes.
Read the full MedlinePlus article ↗- It lowers pressure inside your eye. Doctors prescribe it for open-angle glaucoma or ocular hypertension (high eye pressure). Lowering that pressure helps protect your optic nerve a...
- The 0.15% label describes one drop in the affected eye(s) three times a day, about 8 hours apart. If you use other eye drops, wait at least 5 minutes between them. Always follow wh...
- Eye redness, itching, burning or stinging, and dry mouth are common. Some people feel tired or notice blurred vision. Call your doctor if you have eye pain, discharge, swelling, a...
- The 0.2% product contains benzalkonium chloride, which soft lenses can absorb. Wait at least 15 minutes after the drop before putting soft lenses in. Ask me about your specific pro...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Brimonidine Tartrate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $9.747 | $48.74 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $14.51 | $72.57 / 5 ml |
| Medicare drug plans payPart D · Q2 2026 | $17.09 | $85.46 / 5 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 61314-0144-05 You're viewing this Main listing | 5 mL in 1 BOTTLE | $9.75 / mL | $48.74 | 2010-10-02 | — | Active |
| 61314-0144-10 61314-144-10 | 10 mL in 1 BOTTLE | $10.54 / mL | $105.42 | 2010-10-02 | — | Active |
| 61314-0144-15 61314-144-15 | 15 mL in 1 BOTTLE | $11.65 / mL | $174.78 | 2010-10-02 | — | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack has the lowest per-mL cost of the 3 priced pack sizes ($9.75 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 78% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 61314-0144-10?
What NDC number is used to bill for this package of Brimonidine Tartrate 1.5 mg/mL Solution?
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.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Brimonidine Tartrate 1.5 mg/mL 60505-0564-01 | Apotex | 1 bottle | $9.747 | AT | Availability likely | — |
| Brimonidine Tartrate 1.5 mg/mLthis 61314-0144-05 | Sandoz | 5 ml | $9.747 | AT | Availability likely | — |
| Brimonidine Tartrate ophthalmic solution, 0.15% 1.5 mg/mL 62332-0661-05 | Alembic | 1 bottle | $9.747 | AT | Availability likely | — |
| Brimonidine tartrate 1.5 mg/mL 82182-0773-05 | Pacific | 1 bottle | $9.747 | AT | Availability likely | — |
| Alphagan P 1.5 mg/mL 00023-9177-05 | Allergan, | 1 bottle | $39.749 | AT | Availability likely | +308% |
| Brimonidine Tartrate ophthalmic solution, 0.15% 1.5 mg/mL 46708-0661-05 | Alembic | 1 bottle | — | AT | FDA listed | — |
| Brimonidine Tartrate 1.5 mg/mL 00832-1420-05 | Upsher-Smith | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Brimonidine Ophthalmic inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII M4I0D6VV5M
Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII 91MBZ8H3QO
Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
10 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sandoz Inc labeler code 61314
- Proparacaine Hydrochloride 5 mg/mL Solution/ Drops NDC 61314-016-01
- DORZOLAMIDE HYDROCHLORIDE 20 mg/mL Solution/ Drops NDC 61314-019-10
- Dorzolamide Hydrochloride and Timolol Maleate 20 mg/mL; 5 mg/mL Solution NDC 61314-030-01
- Trifluridine 10 mg/mL Solution NDC 61314-044-75
- KETOROLAC TROMETHAMINE 5 mg/mL Solution NDC 61314-126-05
- Brimonidine Tartrate 2 mg/mL Solution NDC 61314-143-05
- Pilocarpine Hydrochloride 10 mg/mL Solution/ Drops NDC 61314-203-15
- Pilocarpine Hydrochloride 20 mg/mL Solution/ Drops NDC 61314-204-15
- Pilocarpine Hydrochloride 40 mg/mL Solution/ Drops NDC 61314-206-15
- Timolol GFS timolol maleate 2.5 mg/mL Solution, Gel Forming / Drops NDC 61314-224-05
- Timolol GFS timolol maleate 5 mg/mL Solution, Gel Forming / Drops NDC 61314-225-05
- Timolol Maleate 2.5 mg/mL Solution NDC 61314-226-05
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
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 ▾
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 ▾
8.5Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
🆘 Overdosage ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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
🍼 Nursing Mothers ▾
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.
🧬 Pharmacokinetics ▾
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.
🧬 Pharmacodynamics ▾
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.
🔬 Clinical Studies ▾
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.
14 CLINICAL STUDIES A clinical study was conducted to evaluate the safety and efficacy of brimonidine tartrate ophthalmic solution, 0.15% compared to Alphagan ® P** administered three times daily in patients with open-angle glaucoma or ocular hypertension. The results indicated that brimonidine tartrate ophthalmic solution, 0.15% is equivalent in IOP-lowering effect to Alphagan ® P (brimonidine tartrate ophthalmic solution), 0.15%, and effectively lowers IOP in patients with open-angle glaucoma or ocular hypertension by 2 - 6 mmHg.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and a 24-month study, respectively. In these studies, dietary administration of brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1.0 mg/kg/day in rats achieved 120 and 76 times the recommended human ophthalmic dose (RHOD) based on C max . Mutagenesis Brimonidine tartrate was not mutagenic or cytogenic in a series of in vitro and in vivo studies including the Ames test, chromosomal aberration assay in Chinese hamster ovary (CHO) cells, a host-mediated assay and cytogenic studies in mice, and dominant lethal assay.
Impairment of Fertility A reproduction and fertility study in rats with brimonidine tartrate demonstrated no adverse effect on male or female fertility at oral doses up to 1 mg/kg (approximately 180 times the recommended human ophthalmic dose (RHOD) based on estimated AUC).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and a 24-month study, respectively. In these studies, dietary administration of brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1.0 mg/kg/day in rats achieved 120 and 76 times the recommended human ophthalmic dose (RHOD) based on C max . Mutagenesis Brimonidine tartrate was not mutagenic or cytogenic in a series of in vitro and in vivo studies including the Ames test, chromosomal aberration assay in Chinese hamster ovary (CHO) cells, a host-mediated assay and cytogenic studies in mice, and dominant lethal assay.
Impairment of Fertility A reproduction and fertility study in rats with brimonidine tartrate demonstrated no adverse effect on male or female fertility at oral doses up to 1 mg/kg (approximately 180 times the recommended human ophthalmic dose (RHOD) based on estimated AUC).
📄 Recent Major Changes ▾
• Contraindications, Neonates and Infants (Pediatric Patients Younger than 2 Years Old) ( 4.1 ) 11/2025 • Warnings and Precautions, Severe Cardiovascular Disease ( 5.2 ) 11/2025 • Warnings and Precautions, Contamination of Topical Ophthalmic Products After Use ( 5.3 ) 11/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPLE DISPLAY PANEL NDC 61314-144-05 Brimonidine Tartrate Ophthalmic Solution 0.15% For Topical Eye Use Only Rx Only STERILE 5 mL SANDOZ 5mlswitz