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Betoptic Pilo (Betaxolol Hydrochloride / Pilocarpine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

Dosage and Administration

One or two drops of Betoptic®Pilo Ophthalmic Suspension should be instilled in the affected eye(s) three-times daily.

How Supplied

Betoptic®Pilo Ophthalmic Suspension is supplied as two parts requiring mixing before dispensing. Part I consists of a glass syringe containing pilocarpine hydrochloride sealed in a sterile blister pack also containing a sterile, one inch, blunt, 27 gauge cannula. Part II consists of a DROP-TAINER® containing betaxolol hydrochloride ophthalmic suspension. Once Part I is added into Part II and mixed, the resulting Betoptic®Pilo Ophthalmic Suspension is to be used for no longer than two (2) weeks. At this time, the reconstituted Betoptic®Pilo Ophthalmic Suspension should be replaced.

Storage: Store at 4 – 30°C (40 – 86°F). Shake well before using. Discard reconstituted suspension two (2) weeks after combining.

Caution: Federal (USA) Law Prohibits Dispensing Without a Prescription.

U.S. Patent No’s.: 4,252,984; 4,311,708; 4,342,783; and 4,911,920

March 26, 1997

Alcon®

Alcon Laboratories, Inc.

Fort Worth, Texas 76134

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