Download BETIMOL® (timolol ophthalmic solution) 0.25%, 0.5%

BETIMOL® (timolol ophthalmic solution) 0.25%, 0.5%
Prescription Only
Please read this information carefully before you use BETIMOL® and each time you get a refill
just in case any information has changed. However, keep in mind that what you read here is not
all the information on BETIMOL® that is available. It does not take the place of talking with your
healthcare provider. If you have any questions about BETIMOL®, be sure to discuss them with
your healthcare provider or pharmacist.
What is BETIMOL®?
BETIMOL® (pronounced bay-ta-mol) is a prescription eye drop medicine used to reduce pressure
inside the eye in patients with ocular hypertension or open-angle glaucoma.
Who should not use BETIMOL®?
BETIMOL® should not be used by anyone who has certain heart or breathing problems.
Specifically, BETIMOL® should not be used if you have heart failure, decreased heart function,
unusually slow heartbeat, irregular heartbeat, bronchial asthma, severe chronic bronchitis or
emphysema. Do not use BETIMOL® if you are allergic to any of the ingredients. For a list of
ingredients, refer to the “What are the ingredients of BETIMOL®” section.
What should I tell my healthcare provider before using BETIMOL®?
• If you have every been diagnosed with cardiac failure or have any other heart problems
as BETIMOL® may make it worse
• If you suffer from chronic bronchitis, emphysema or any other breathing problems as
BETIMOL® may make it worse
• If you are undergoing any major surgery (elective or non-elective) as BETIMOL® may
increase the chance of complications
• If you are diabetic as BETIMOL® may hide some of the symptoms of diabetes
• If you have ever been diagnosed with an overactive thyroid as BETIMOL® may hide
some of the symptoms
• If you have muscle weakness, as BETIMOL® may increase it
• If you are taking any other prescription and/or over-the-counter medications, including
vitamins and herbal supplements
• If you are pregnant or tying to become pregnant
• If you are breast-feeding
How should BETIMOL® be used?
It is important that BETIMOL® be used exactly as your healthcare provider tells you. Your
healthcare provider will determine how much BETIMOL® you should use and how many times
per day. Be sure to follow these instructions carefully. The usual starting dose is one drop of
BETIMOL® in the affected eye(s) twice a day. If your eye pressure decreases to a level
acceptable by your healthcare provider, he or she may change your dosing schedule to one drop
once daily in the affected eye(s). If you are taking other eye drop medications, you should put
these medicines in your eye(s) at least 5 minutes apart.
Other information I should know about using BETIMOL®
• Do not allow the tip of the bottle to touch the eyelid or surrounding areas of the eye as
this may contaminate the medication. Serious damage to the eye, including a potential
loss of vision, may result from using a contaminated medication
• Remove contact lenses before using BETIMOL® in the eyes. Wait 15 minutes after using
BETIMOL® before putting in your contact lenses because BETIMOL® contains a
preservative that may be absorbed by the lens
What are the possible side effects of BETIMOL®?
In studies of BETIMOL®, the most commonly reported side effects related to the eye were
stinging and burning. Other side effects related to the eye that occurred in more than 5% of
people were: dry eyes, itching, foreign body sensation, discomfort in the eye, redness in the eye,
and swollen eyelids. Other side effects relating to the body, in general, that occurred in more than
5% of people were headache. These are not all the possible side effects you may experience
when using BETIMOL®. For more information, ask your healthcare provider or pharmacist.
General information about BETIMOL®
Medicines are sometimes prescribed for conditions that are not mentioned in the patient
information. Do not use BETIMOL® for a condition for which it was not prescribed. Do not give
BETIMOL® to other people even if they have the same symptoms. It may harm them.
How should I store BETIMOL®?
BETIMOL® should be stored at room temperature, 59°-77° F. (15°-25°C). Do not freeze
BETIMOL® and protect it from light. Keep BETIMOL® and all medicines out of the reach of
children.
What are the ingredients of BETIMOL®?
The active ingredient of BETIMOL® is timolol hemihydrate and is available in concentrations of
0.25% and 0.5%. BETIMOL® also contains benzalkonium chloride 0.01%, as a preservative,
monosodium and disodium phosphate dihydrate and water.
How can I obtain additional information?
If you have questions related to BETIMOL®, call the toll-free number at 800-523-6225 (510-595-9855
direct), or log onto the website www.BETIMOL.com.
Marketed by:
VISTAKON® Pharmaceuticals, LLC
Jacksonville, FL 32256 USA
Manufactured by:
Santen Oy, P.O. Box 33, FIN-33721
Tampere, Finland
October 2007 Version
2707BE-015
IMPORTANT SAFETY INFORMATION
The most commonly reported ocular side effect was stinging and burning.
BETIMOL® is contraindicated in patients with overt heart failure, cardiogenic shock, sinus bradycardia, second- or third-degree
atrioventricular block, bronchial asthma or history of bronchial asthma, severe chronic obstructive pulmonary disease, or
hypersensitivity to any component of this product.
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1.
DuBiner, B, Harvey, MD, Hill, Richard, MD, Kaufman, Herbert, MD, et al. Timolol Hemihydrate vs Timolol Maleate to
2.
Stewart,W, Leland TM, Cate, EA, Stewart, JA. Efficacy and Safety of Timolol Solution Once Daily versus Timolol Gel in
3.
Stewart, C, William, MD, Day, G, Douglas, MD, Sharpe, D, Elizabeth, MD, Dubiner, B, Harvey, MD, Holmes, T, Keri,
Treat Ocular Hypertension and Open-Angle Glaucoma. American Journal of Ophthalmology, 1996.
Treating Elevated Intraocular Pressure. Journal of Glaucoma, 1998.
BS and Stewart, A, Jeanette, RN. Efficacy and Safety of Timolol Solution Once Daily vs. Timolol Gel Added to
Latanoprost. American Journal of Ophthalmology, 1999.
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BETIMOL® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
©2007 VISTAKON® Pharmaceuticals, LLC. All rights reserved.
This site is published by VISTAKON® Pharmaceuticals, LLC, which is solely responsible for its content.
It is intended for use by residents of the United States.
BETIMOL® is a registered trademark of Santen Pharmaceutical Co., LTD.
VISTAKON® is a registered trademark of VISTAKON® Pharmaceuticals, LLC.
, and marketed by VISTAKON® Pharmaceuticals, LLC.