Betaxolol 5 mg/mL Solution/ Drops
🆔 Identity & classification
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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.
Where does this data come from?
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?
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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Betaxolol 5 mg/mLthis 17478-0705-10 | Akorn | 1 vial | — | — | Discontinued | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 17478-0705-10 You're viewing this | 1 VIAL in 1 CARTON (17478-705-10) / 5 mL in 1 VIAL | 2003-04-01 | Inactivated by FDA |
| 17478-0705-11 | 1 VIAL in 1 CARTON (17478-705-11) / 10 mL in 1 VIAL | 2003-04-01 | Inactivated by FDA |
Pack size FAQ
What quantity is in NDC 17478-0705-10?
What NDC number is used to bill for this package of Betaxolol 5 mg/mL Solution/ Drops?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Betaxolol 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 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 Ophthalmic Solution in the affected eye(s) twice daily. In some patients, the intraocular pressure lowering responses to Betaxolol 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 is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure.
⚠️ Warnings ▾
WARNINGS 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 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 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 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 Ophthalmic Solution 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.
🔄 Drug Interactions ▾
Drug Interactions: Patients who are receiving a beta-adrenergic blocking agent orally and Betaxolol 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.
Ocular: In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle by constriction of the pupil with a miotic agent. Betaxolol has little or no effect on the pupil. When Betaxolol Ophthalmic Solution is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects: Pregnancy Category C: 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 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.
🆘 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 Ophthalmic Solution may be flushed from the eye(s) with warm tap water.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Betaxolol, 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 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 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.
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). 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*
42.8No 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. 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). Mean Heart Rates 1 Bruce Stress Exercise Test TREATMENT 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 Clinical Studies: Optic nerve head damage and visual field loss are the result of a sustained elevated intraocular pressure and poor ocular perfusion. Betaxolol 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 ophthalmic solution for up to three years shows that the intraocular pressure lowering effect is well maintained.
Clinical studies show that topical betaxolol ophthalmic solution reduces mean intraocular pressure 25% from baseline. In trials using 22 mmHg as a generally accepted index of intraocular pressure control, betaxolol ophthalmic solution was effective in more than 94% of the population studied, of which 73% were treated with the beta blocker alone. In controlled, double-masked studies, the magnitude and duration of the ocular hypotensive effect of ophthalmi…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Betaxolol Ophthalmic Solution 0.5% is a sterile, isotonic, aqueous solution of betaxolol hydrochloride, USP. Supplied as follows: 2.5 mL, 5 mL, 10 mL and 15 mL in plastic ophthalmic dropper tip bottles. NDC 17478-705-25 2.5 mL Bottle NDC 17478-705-10 5 mL Bottle NDC 17478-705-11 10 mL Bottle NDC 17478-705-12 15 mL Bottle Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Akorn Manufactued by: Akorn, Inc. Lake Forest, IL 60045 BX00N Rev. 06/16
📦 Storage and Handling ▾
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactued by: Akorn, Inc. Lake Forest, IL 60045 BX00N Rev. 06/16
📋 Description ▾
DESCRIPTION Betaxolol Ophthalmic Solution USP, 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 343.90. The structural formula is presented below: Molecular Formula: C 18 H 29 NO 3 •HCl Chemical Name: (±)-1[ p -[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride.
Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg; Inactives: Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH and Water for Injection; Preservative: Benzalkonium Chloride 0.01%. Structural Formula