Betaxolol Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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.


There is currently no drug history available for this drug.

Other Information

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:

Structural Formula

Molecular Formula: C18H29NO3•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 Purified Water; Preservative: Benzalkonium Chloride 0.01%.

Betaxolol Manufacturers

  • Akorn, Inc.
    Betaxolol (Betaxolol Hydrochloride) Solution/ Drops [Akorn, Inc.]
  • Physicians Total Care, Inc.
    Betaxolol Tablet, Film Coated [Physicians Total Care, Inc.]
  • Golden State Medical Supply, Inc.
    Betaxolol Tablet, Film Coated [Golden State Medical Supply, Inc.]
  • Epic Pharma Llc
    Betaxolol Tablet, Film Coated [Epic Pharma Llc]

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