Betoptic Pilo
Loading...Betoptic Pilo Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
NOT FOR INJECTION OR ORAL ADMINISTRATION. FOR TOPICAL OPHTHALMIC USE ONLY. COMBINE PARTS I AND II PRIOR TO DISPENSING AND LABEL WITH A TWO (2) WEEK EXPIRATION DATE
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 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. Betoptic®Pilo Ophthalmic Suspension 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.
Uses
Betoptic®Pilo Ophthalmic Suspension is indicated for the reduction of elevated intraocular pressure in patients with primary open-angle glaucoma and ocular hypertension who are insufficiently responsive to Betoptic®-S (failed to achieve target IOP determined after multiple measurements over time).
It is not known whether Betoptic®Pilo is equivalent in IOP lowering efficacy to the administration of Betoptic®-S 0.25% and pilocarpine 1.75% dosed separately. It is not known whether Betoptic®Pilo is equivalent to other beta-blockers given in combination with pilocarpine.
History
There is currently no drug history available for this drug.
Other Information
Betoptic®Pilo Ophthalmic Suspension contains betaxolol hydrochloride, a cardiovascular (beta1) adrenoceptor antagonist and pilocarpine hydrochloride, a cholinergic parasympathomimetic agent.
Betaxolol hydrochloride is a white, crystalline powder. Its chemical name is (±)-1[p-(cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride with an empirical formula of C18H29NO3HCl and a molecular weight of 343.89. The chemical structure of betaxolol hydrochloride is as follows:
Pilocarpine hydrochloride is a white powder. Its chemical name is 2(3H)-furanone, 3-ethyldihydro-4-[(1-methyl-1H-imidazol-5-yl)-methyl]-, monohydrochloride, (3S-cis)- with an empirical formula of C11H16N2O2HCl and a molecular weight of 244.72. The chemical structure of pilocarpine hydrochloride is as follows:
Each mL of Betoptic®Pilo Ophthalmic Suspension contains the following:
Active: Betaxolol hydrochloride 2.8 mg equivalent to 2.5 mg betaxolol base and pilocarpine hydrochloride 17.5 mg;
Preservative: Benzalkonium chloride 0.01%.
Inactive: Mannitol, poly(styrene-divinyl benzene) sulfonic acid, carbomer 934P, boric acid, edetate disodium, sodium hydroxide and/or hydrochloric acid to adjust to a pH 6.0-8.0 and purified water.
Betoptic®Pilo Ophthalmic Suspension is provided as a two-part unit for combination by the Pharmacist. It consists of the following components: Part I – a glass syringe containing pilocarpine hydrochloride 8.75%, sodium hydroxide and/or hydrochloric acid (pH 5.0 ± 0.2) and purified water to 1.6 mL; and Part II – a DROP-TAINER® containing betaxolol 0.313%, poly(styrene-divinyl benzene) sulfonic acid, carbomer 934P, boric acid, mannitol, edetate disodium, benzalkonium chloride, sodium hydroxide (pH 8.0 ± 0.2) and purified water to 6.4 mL.
Betoptic®Pilo Ophthalmic Suspension is prepared by affixing a one-inch, blunt, 27 gauge cannula (supplied) to the syringe containing the pilocarpine hydrochloride solution and adding the entire contents of the syringe through the opening in the dropper tip to the DROP-TAINER® containing the betaxolol suspension and mixing well. The final pH of the combination suspension is 6.0 to 8.0
| Remove Cap from DropTainer |
Add Contents of Syringe through Orifice in DropTainer |
Cap and Mix Well. Label with a 2-Week Expiry Period |
ADD CONTENTS OF PART I TO PART II AND MIX WELL IMMEDIATELY PRIOR TO DISPENSING AND LABEL WITH A TWO (2) WEEK EXPIRATION DATE
Sources
Betoptic Pilo Manufacturers
-
Alcon Laboratories, Inc.
![Betoptic Pilo (Betaxolol Hydrochloride And Pilocarpine Hydrochloride) [Alcon Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Betoptic Pilo | Alcon Laboratories, Inc.
One or two drops of Betoptic®Pilo Ophthalmic Suspension should be instilled in the affected eye(s) three-times daily.
Login To Your Free Account