Brinzolamide/Timolol Suspension - Ophthalmic

Uses

This product contains two medications used to treat high pressure inside the eye due to glaucoma (open angle-type) or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye helps to prevent blindness. These two medications work together to decrease the amount of fluid within the eye. Brinzolamide belongs to a class of drugs known as carbonic anhydrase inhibitors. Timolol belongs to a class of drugs known as beta-blockers.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using brinzolamide/timolol and each time you get a refill. If you have any questions regarding the information, ask your doctor or pharmacist.

This medication is for use in the eye(s), usually one drop in the affected eye(s) 2 times a day or as directed by your doctor. Shake the bottle well before each dose.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

The preservative in this product may be absorbed by contact lenses. If you wear contact lenses, remove them before using your eye drops. Wait at least 15 minutes after using this medication before putting your contact lenses back in.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. It is important to continue using this medication even if you feel well. Most people with glaucoma or high pressure in the eyes do not have symptoms.

Side Effects

Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, dry eyes, feeling as if something is in the eye, bitter/sour/unusual taste in your mouth, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur:

• dizziness
• new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)
• slow/irregular heartbeat
• eye or eyelid swelling/pain/discharge
• mental/mood changes (such as depression)
• coldness/numbness/pain in the hands or feet

Seek immediate medical attention if you have any of these rare but very serious side effects:

• wheezing/difficulty breathing
• chest/jaw/left arm pain
• fainting
• weakness on one side of the body
• slurred speech
• confusion
• sudden vision changes

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this product, tell your doctor or pharmacist if you are allergic to timolol or other beta-blockers; or to brinzolamide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• lung disease/breathing problems (such as current or past history of asthma, severe chronic obstructive pulmonary disease)
• slow/irregular heartbeat (such as sinus bradycardia, second- or third-degree AV block)
• heart disease (such as chest pain, heart failure)
• kidney disease (such as kidney stones, renal failure)
• liver disease
• diabetes
• low blood flow to the brain (cerebrovascular insufficiency)
• overactive thyroid disease
• certain muscle/nerve disease (myasthenia gravis)
• severe allergic reaction (such as anaphylaxis, atopy)

If you develop an eye infection or injury, or have eye surgery, check with your doctor about whether you should continue to use your current bottle of brinzolamide/timolol. You may be advised to start using a new bottle.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may cause temporary blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

If you have diabetes, this product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness and sweating, are unaffected by this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• high doses of aspirin or related salicylates (such as high doses used for arthritis)
• beta-blockers (such as propranolol)
• clonidine
• digoxin
• epinephrine
• fingolimod
• methyldopa

Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

Other medications can affect the removal of brinzolamide/timolol from your body, which may affect how this medication works. Examples include cimetidine, ketoconazole, itraconazole, clotrimazole, quinidine, ritonavir, troleandomycin, certain antidepressants (such as SSRIs like fluoxetine), among others.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: trouble breathing or slow/irregular heartbeat.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as eye exams, pulse/heart rate monitoring) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store between 36-86 degrees F (2-30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets. Discard 60 days after opening.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.