brimonidine tartrate
Pharmaranks rates Brimonidine Tartrate 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Brimonidine Tartrate is an alpha-adrenergic agonist used to treat Open-Angle Glaucoma.
Alpha-Adrenergic Agonist · by Sandoz
Generic of Alphagan P
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Brimonidine Tartrate
- Drug class
- Alpha-Adrenergic Agonist
- Form
- Solution, Drops
- Strength
- Brimonidine Tartrate 0.2%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- open-angle glaucoma
- Manufacturer
- Sandoz
- What the pharmacy pays
- ~$10.38 per ml — not your price
- FDA application
- ANDA076254
What is Brimonidine Tartrate?
From the FDA label: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
How to use
Brimonidine Tartrate is sold in more than one form (Solution and Drops), and each is dosed differently. The instructions below come from the FDA label for application ANDA076254 — follow the label that came with the product you were actually prescribed.
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 )
Side effects
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. 6.1 Clinical 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…
Warnings
Important safety information
Potentiation of vascular insufficiency. ( 5.1 ) 5.1 Potentiation 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. 5.2 Severe 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. 5.3 Contamination 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 )]. 5.4 Use 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.
Who should not take Brimonidine Tartrate
Neonates and infants (under the age of 2 years). ( 4.1 ) 4.1 Neonates 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 )]. 4.2 Hypersensitivity 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 )].
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 ) 7.1 Antihypertensives/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. 7.2 CNS 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. 7.3 Tricyclic 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. 7.4 Monoamine 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.
Drug class
How this class works, per Alpha-1 Receptor Agonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Brimonidine Tartrate ranks — best-rated alpha-adrenergic agonist for:
Dosage forms
Solution and Drops
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Brimonidine Tartrate treat?
- Brimonidine Tartrate (Brimonidine Tartrate) may be used to treat open-angle glaucoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Brimonidine Tartrate work?
- Brimonidine Tartrate is a alpha-adrenergic agonist. Alpha-adrenergic agonists switch on alpha receptors on blood-vessel walls, much like the body's own adrenaline. This tightens the smooth muscle around the vessels, narrowing them to raise blood pressure or reduce swelling and congestion.
- How is Brimonidine Tartrate rated?
- pharmaranks gives Brimonidine Tartrate a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Brimonidine Tartrate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $10.38 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Iopidine — about $9.81 on the same basis.
- Is there a coupon or discount for Brimonidine Tartrate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Brimonidine Tartrate. To pay less, Brimonidine Tartrate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Brimonidine Tartrate?
- Brimonidine Tartrate is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
- Is Brimonidine Tartrate a brand-name or generic drug?
- Brimonidine Tartrate is a generic medication; its active ingredient is Brimonidine Tartrate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Brimonidine Tartrate available over the counter?
- No. Brimonidine Tartrate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Brimonidine Tartrate come in?
- Brimonidine Tartrate is currently marketed as solution and drops, per the FDA's National Drug Code Directory.
- What class of drug is Brimonidine Tartrate?
- Brimonidine Tartrate is classified as alpha-adrenergic agonist, per the FDA's Established Pharmacologic Class.
- Is Brimonidine Tartrate FDA-registered?
- Brimonidine Tartrate is on record with the U.S. FDA under application number ANDA076254. You can verify this on its official FDA label.
- Has Brimonidine Tartrate been recalled by the FDA?
- Brimonidine Tartrate has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Brimonidine Tartrate safe?
- There's no single safe-or-not verdict. pharmaranks gives Brimonidine Tartrate a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Brimonidine Tartrate?
- Brimonidine Tartrate's side effects are taken directly from its FDA label. From the label: 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 Warnin… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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