Metipranolol Ophthalmic Solution

OptiPranolol (metipranolol ophthalmic solution) Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open angle glaucoma.

OptiPranolol® (metipranolol ophthalmic solution) 0.3% is supplied in a plastic bottle with a controlled drop tip and a yellow plastic screw-top cap as follows:

5  mL: NDC 24208-275-07 - AB40207
10 mL: NDC 24208-275-09 - AB40209

Storage

Store between 15° - 30° C (59° - 86° F). Replace cap immediately after use.

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

FOR OPHTHALMIC USE ONLY.

Bausch & Lomb Incorporated, Tampa, FL 33637. REV. 11/03-91. FDA rev date: 11/21/2006

As with other topically applied ophthalmic drugs, this drug may be absorbed systemically. Thus, 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 following topical application of beta-adrenergic blocking agents (see CONTRAINDICATIONS).

Since OptiPranolol (metipranolol ophthalmic solution) Ophthalmic Solution had a minor effect on heart rate and blood pressure in clinical studies, caution should be observed in treating patients with a history of cardiac failure. Treatment with OptiPranolol (metipranolol ophthalmic solution) Ophthalmic Solution should be discontinued at the first evidence of cardiac failure.

OptiPranolol (metipranolol ophthalmic solution) Ophthalmic Solution, or other beta-blockers, should not, in general, be administered to patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity (see CONTRAINDICATIONS). However, if the drug is necessary in such patients, then it should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta2 receptors.

Do not use this medication if you are allergic to metipranolol, or if you have:

• asthma, or severe chronic obstructive pulmonary disease (COPD);
• slow heartbeats; or
• a heart condition called "AV block."

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• breathing problems such as bronchitis or emphysema;
• a history of heart disease or congestive heart failure;
• diabetes;
• history of stroke, blood clot, or circulation problems;
• a thyroid disorder; or
• a muscle disorder such as myasthenia gravis.

FDA pregnancy category C. It is not known whether metipranolol ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether metipranolol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

• Lumigan
• Mitosol

• Simbrinza

© Optipranolol Patient Information is supplied by Cerner Multum, Inc. and Optipranolol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Side effects that you should report to your doctor or health care professional as soon as possible:

• breathing problems
• changes in blood sugar
• changes in vision
• chest pain or palpitations
• inflamed or infected eyes or eyelids
• slow, irregular heart rate

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• burning, stinging, or discomfort immediately after using the solution
• sensitivity of the eyes to light
• tearing