Betaxolol Hydrochloride 5.6 mg/mL Solution/ Drops
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the beta-Adrenergic Blocker class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ophthalmic betaxolol is used to treat glaucoma, a condition in which increased pressure in the eye can lead to gradual loss of vision. Betaxolol is in a class of medications called beta blockers. It works by decreasing the pressure in the eye.
Read the full MedlinePlus article ↗- That's a really common concern, and it's a good one to ask. The eye drops are absorbed into the bloodstream to some extent, but betaxolol is specifically designed to target the eye...
- I'm getting the eye drops for glaucoma — will they affect my heart or lungs like a regular beta-blocker pill would?
- Please don't stop them on your own, especially not abruptly. With betaxolol tablets, stopping suddenly — particularly if you have any coronary artery disease — can cause a rebound...
- Can I just stop taking my betaxolol tablets if I feel fine and my blood pressure seems okay?
Patient education
Supplement & herbal interactions
Betaxolol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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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 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.
6 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 | $8.987 | $89.87 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | $10.32 | $103.19 / 10 ml |
| Medicare drug plans payPart D · Q2 2026 | $8.99 | $89.89 / 10 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Betaxolol Hydrochloride 5.6 mg/mLthis 61314-0245-03 | Sandoz | 1 bottle | $8.987 | AT | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 61314-0245-01 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC | $8.94 / mL | $44.71 | 2000-05-15 | Active |
| 61314-0245-02 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC | — | — | 2000-05-15 | Active |
| 61314-0245-03 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC | $8.99 / mL | $89.87 | 2000-05-15 | Active |
This pack effectively ties for the lowest per-mL cost of the 2 priced pack sizes ($8.99 NADAC).
This pack accounts for about 1.5% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 61314-0245-03?
What NDC number is used to bill for this package of Betaxolol Hydrochloride 5.6 mg/mL Solution/ Drops?
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
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Betaxolol Hydrochloride Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, Betaxolol Hydrochloride Ophthalmic Solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months.
However, caution should be used in treating patients with severe reactive airway disease or a history of asthma.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended dose is one to two drops of Betaxolol Hydrochloride Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betaxolol Hydrochloride Ophthalmic Solution may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.
If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine and/or carbonic anhydrase inhibitors can be instituted.
⛔ Contraindications ▾
CONTRAINDICATIONS Hypersensitivity to any component of this product. Betaxolol Hydrochloride Ophthalmic Solution is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure.
⚠️ Warnings ▾
WARNING Topically applied beta-adrenergic blocking agents may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents.
Betaxolol Hydrochloride Ophthalmic Solution has been shown to have a minor effect on heart rate and blood pressure in clinical studies. Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with Betaxolol Hydrochloride Ophthalmic Solution should be discontinued at the first signs of cardiac failure.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been reported in clinical trials with Betaxolol Hydrochloride Ophthalmic Solution. Ocular Discomfort of short duration was experienced by one in four patients, but none discontinued therapy; occasional tearing has been reported. Rare instances of decreased corneal sensitivity, erythema, itching sensation, corneal punctate staining, keratitis, anisocoria, edema, and photophobia have been reported.
Additional medical events reported with other formulations of betaxolol include blurred vision, foreign body sensation, dryness of the eyes, inflammation, discharge, ocular pain, decreased visual acuity, and crusty lashes. Systemic Systemic reactions following administration of Betaxolol Hydrochloride Ophthalmic Solution 0.5% or Betaxolol Hydrochloride Ophthalmic Suspension 0.25% have been rarely reported. These include: Cardiovascular Bradycardia, heart block and congestive failure.
Pulmonary Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma and respiratory failure. Central Nervous System Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis. Other Hives, toxic epidermal necrolysis, hair loss and glossitis.
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.
🔄 Drug Interactions ▾
Drug Interactions Patients who are receiving a beta-adrenergic blocking agent orally and Betaxolol Hydrochloride Ophthalmic Solution should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade. Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia. Betaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.
🤰 Pregnancy ▾
Pregnancy Reproduction, teratology, and peri- and postnatal studies have been conducted with orally administered betaxolol HCl in rats and rabbits. There was evidence of drug related postimplantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg, respectively. Betaxolol HCl was not shown to be teratogenic, however, and there were no other adverse effects on reproduction at subtoxic dose levels.
There are no adequate and well-controlled studies in pregnant women. Betaxolol Hydrochloride Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE No information is available on overdosage of humans. The oral LD 50 of the drug ranged from 350-920 mg/kg in mice and 860-1050 mg/kg in rats. The symptoms which might be expected with an overdose of a systemically administered beta-1-adrenergic receptor blocker agent are bradycardia, hypotension and acute cardiac failure. A topical overdose of Betaxolol Hydrochloride Ophthalmic Solution may be flushed from the eye(s) with warm tap water.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Betaxolol Hydrochloride, a cardioselective (beta-1-adrenergic) receptor blocking agent, does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action. Orally administered beta-adrenergic blocking agents reduce cardiac output in healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac function.
When instilled in the eye, Betaxolol Hydrochloride Ophthalmic Solution has the action of reducing elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma. Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters. Ophthalmic betaxolol (one drop in each eye) was compared to timolol and placebo in a three-way crossover study challenging nine patients with reactive airway disease who were selected on the basis of having at least a 15% reduction in the forced expiratory volume in one second (FEV 1 ) after administration of ophthalmic timolol.
Betaxolol HCl had no significant effect on pulmonary function as measured by FEV 1 , Forced Vital Capacity (FVC) and FEV 1 /VC. Additionally, the action of isoproterenol, a beta stimulant, administered at the end of the study was not inhibited by ophthalmic betaxolol. In contrast, ophthalmic timolol significantly decreased these pulmonary functions.
FEV 1 - Percent Change from Baseline 1 Means Betaxolol 1.0% a Timolol 0.5% Placebo Baseline 1.6 1.4 1.4 60 Minutes 2.3 -25.7* 5.8 120 Minutes 1.6 -27.4* 7.5 240 Minutes -6.4 -26.9*
6.9Isoproterenol b 36.1 -12.4* 42.8 1 Schoene, R. B. et al. , Am. J.
Ophthal. 97:86, 1984. a Twice the clinical concentration. b Inhaled at 240 minutes; measurement at 270 minutes. *Timolol statistically different from betaxolol and placebo (p < 0.05). No evidence of cardiovascular beta-adrenergic blockade during exercise was observed with betaxolol in a double-masked, three-way crossover study in 24 normal subjects comparing ophthalmic betaxolol, timolol and placebo for effect on blood pressure and heart rate.
Mean arterial blood pressure was not affected by any treatment; however, ophthalmic timolol produced a significant decrease in the mean heart rate. Mean Heart Rates 1 TREATMENT Bruce Stress Exercise Test Minutes Betaxolol 1% a Timolol 0.5% Placebo 0 79.2 79.3 81.2 2 130.2 126.0 130.4 4 133.4 128.0* 134.3 6 136.4 129.2* 137.9 8 139.8 131.8* 139.4 10 140.8 131.8* 141.3 1 Atkins, J. M. et al. , Am.
J. Oph. 99:173-175, Feb., 1985. a Twice the clinical concentration. *Mean pulse rate significantly lower for timolol than betaxolol or placebo (p < 0.05).
Clinical Studies Optic nerve head damage and visual field loss are the result of a sustained elevated intraocular pressure and poor ocular perfusion. Betaxolol Hydrochloride Ophthalmic Solution has the action of reducing elevated as well as normal intraocular pressure, and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry. The onset of action with Betaxolol Hydrochloride Ophthalmic Solution can generally be noted within 30 minutes and the maximal effect can usually be detected 2 hours after topical administration.
A single dose provides a 12-hour reduction in intraocular pressure. Clinical observation of glaucoma patients treated with Betaxolol Hydrochloride Ophthalmic Solution for up to three years shows that the intraocular pressure lowering effect is well maintained. Clinical studies show that topical Betaxolol Hydrochloride Ophthalmic Solution reduces mean intraocular pressure 25% from baseline.
In trials using 22 mmHg as a generally accepted index of intraocular pressure control, Betaxolol Hydrochloride Ophthalmic Solution was effective in more than 94% of the population studied, of which 73% were treated with the b…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Betaxolol Hydrochloride Ophthalmic Solution is a sterile, isotonic, aqueous solution of betaxolol hydrochloride. Supplied as follows: 5, 10 and 15 mL in plastic ophthalmic dispensers. 5 mL: NDC 61314-245-01 15 mL: NDC 61314-245-02 10 mL: NDC 61314-245-03 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Rev. May 2023 300059509-0523 Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc.
Princeton, NJ 08540
📋 Description ▾
DESCRIPTION Betaxolol Hydrochloride Ophthalmic Solution contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution. Betaxolol hydrochloride is a white, crystalline powder, soluble in water, with a molecular weight of 343.89. The chemical structure is presented below: Empirical Formula: C 18 H 29 NO 3 •HCl Chemical Name: (±)-1-[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride.
Each mL contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, purified water, sodium chloride, with hydrochloric acid and/or sodium hydroxide (to adjust pH). chemical
💬 Information for Patients ▾
Information for Patients Do not touch dropper tip to any surface as this may contaminate the solution.