Betaxolol Hydrochloride Ophthalmic Suspension

Dosage Forms And Strengths

Bottle filled with 2.5, 5, 10, and 15 mL of 0.25% sterile ophthalmic suspension

BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% is supplied as follows: 2.5, 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER® dispensers. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER package.

2.5 mL: NDC 0065-0246-20

5 mL: NDC 0065-0246-05

10 mL: NDC 0065-0246-10

15 mL: NDC 0065-0246-15

Storage and Handling

Store upright at 2°- 25°C (36°- 77°F). Shake well before using.

Alcon Laboratories, Inc. Fort Worth, Texas 76134. FDA Rev date: 5/8/2008

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, the most frequent adverse reaction associated with the use of BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% has been transient ocular discomfort. The following other adverse reactions have been reported in small numbers of patients:

Ocular: blurred vision, corneal punctate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity and crusty lashes.

Systemic adverse reactions 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. Perversions of taste and smell have been reported.

In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% was comparable to that seen in adult patients.

Additional Potential Adverse Reactions Associated with Betaxolol

Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctate staining which may appear in dendritic formations, edema and anisocoria.

How to Use The DROP-TAINER®*Bottle

The DROP-TAINER® bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER® bottle, read the complete instructions carefully.

1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) .
2. Wash hands before each use.
3. Before using the medication for the first time, be sure the Safety Seal on the bottle is unbroken.
4. Tear off the Safety Seal to break the seal.
5. Before each use, shake well and remove the screw cap.
6. Invert the bottle and hold the bottle between your thumb and middle finger, with the tips of the fingers pointing towards you.
7. Tilt your head back and position the bottle above the affected eye. DO NOT TOUCH THE EYE WITH THE TIP OF THE DROPPER.
8. With the opposite hand, place a finger under the eye. Gently pull down until a "V" pocket is made between your eye and lower lid.
9. With the hand holding the bottle, place your index finger on the bottom of the bottle. Push the bottom of the bottle to dispense one drop of medication. DO NOT SQUEEZE THE SIDES OF THE BOTTLE.
10. Repeat 6, 7, 8, and 9 with other eye if instructed to do so. 11. Replace screw cap by turning until firmly touching the bottle.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye(s) or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, could become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye(s) and subsequent loss of vision may result from using contaminated solutions. physician's present multidose container.

Patients requiring concomitant topical ophthalmic medications should be instructed to administer these at least 10 minutes before instilling BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) Suspension.

Betaxolol is a beta-blocker that reduces pressure inside the eye.

Betaxolol ophthalmic (for the eyes) is used to treat open-angle glaucoma and other causes of high pressure inside the eye.

Betaxolol ophthalmic may also be used for other purposes not listed in this medication guide.

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.