Brimonidine and brinzolamide Ophthalmic

In the U.S.

• Simbrinza

Available Dosage Forms:

• Suspension

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Brimonidine

Brimonidine and brinzolamide ophthalmic (eye) drops is used to treat increased pressure in the eye caused by open-angle glaucoma or a condition called ocular hypertension. Both eye conditions are caused by high pressure in your eye and can lead to pain from pressure in your eye and then can eventually harm your vision. brimonidine and brinzolamide can help you keep your sight by reducing the pressure in your eye and stopping eye pain.

brimonidine and brinzolamide is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• discoloration of the white part of the eye
• eye irritation or redness

• Decreased vision
• eye pain
• eyes sensitive to light
• red, sore eyes

• Burning, dry, or itching eyes
• discharge or excessive tearing
• hives or welts
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash

• Chest pain or discomfort
• constricted, pinpoint, or small pupils (black part of the eye)
• fast, pounding, or irregular heartbeat or pulse
• fever
• hoarseness
• irritation
• itching
• joint pain, stiffness, or swelling
• lightheadedness, dizziness, or fainting
• redness of the skin
• shortness of breath
• slow or irregular heartbeat
• swelling of the eyelids, face, lips, hands, or feet
• tearing
• throbbing pain
• tightness in the chest
• troubled breathing or swallowing
• unusual tiredness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• muscle cramps or pain
• numbness, tingling, pain, or weakness in the hands or feet
• seizures
• sweating
• trembling
• weakness and heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning and stinging sensation
• change in color vision
• change in taste
• difficulty seeing at night
• drowsiness
• feeling of having something in the eye
• headache
• increase in blood flow to the whites of the eyes
• increased sensitivity of the eyes to sunlight
• lack or loss of strength
• loss of taste
• paleness of the eye or inner lining of the eyelid
• redness and tiny bumps on the lining of the eyelid

• Dry eyes
• dry mouth
• muscle pain
• runny nose
• sneezing
• stuffy nose
• trouble sleeping

• Acid or sour stomach
• belching
• body aches or pain
• congestion
• cough
• crusting in the corner of the eye
• diarrhea
• double vision
• dryness or soreness of the throat
• excessive muscle tone
• hair loss or thinning of the hair
• heartburn
• hoarseness
• indigestion
• muscle stiffness
• muscle tension or tightness
• nausea
• stomach discomfort, upset, or pain
• tender, swollen glands in the neck
• tightness in the chest
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

An overdose of brimonidine and brinzolamide ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Applies to brimonidine / brinzolamide ophthalmic: ophthalmic suspension

Along with its needed effects, brimonidine / brinzolamide ophthalmic may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking brimonidine / brinzolamide ophthalmic:

• Blurred vision
• discoloration of the white part of the eye
• eye irritation or redness

• Decreased vision
• eye pain
• eyes sensitive to light
• red, sore eyes

• Burning, dry, or itching eyes
• discharge or excessive tearing
• hives or welts
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash

• Chest pain or discomfort
• constricted, pinpoint, or small pupils (black part of the eye)
• fast, pounding, or irregular heartbeat or pulse
• fever
• hoarseness
• irritation
• itching
• joint pain, stiffness, or swelling
• lightheadedness, dizziness, or fainting
• redness of the skin
• shortness of breath
• slow or irregular heartbeat
• swelling of the eyelids, face, lips, hands, or feet
• tearing
• throbbing pain
• tightness in the chest
• troubled breathing or swallowing
• unusual tiredness

Get emergency help immediately if any of the following symptoms of overdose occur while taking brimonidine / brinzolamide ophthalmic:

• Confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• muscle cramps or pain
• numbness, tingling, pain, or weakness in the hands or feet
• seizures
• sweating
• trembling
• weakness and heaviness of the legs

Some side effects of brimonidine / brinzolamide ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning and stinging sensation
• change in color vision
• change in taste
• difficulty seeing at night
• drowsiness
• feeling of having something in the eye
• headache
• increase in blood flow to the whites of the eyes
• increased sensitivity of the eyes to sunlight
• lack or loss of strength
• loss of taste
• paleness of the eye or inner lining of the eyelid
• redness and tiny bumps on the lining of the eyelid

• Dry eyes
• dry mouth
• muscle pain
• runny nose
• sneezing
• stuffy nose
• trouble sleeping

• Acid or sour stomach
• belching
• body aches or pain
• congestion
• cough
• crusting in the corner of the eye
• diarrhea
• double vision
• dryness or soreness of the throat
• excessive muscle tone
• hair loss or thinning of the hair
• heartburn
• hoarseness
• indigestion
• muscle stiffness
• muscle tension or tightness
• nausea
• stomach discomfort, upset, or pain
• tender, swollen glands in the neck
• tightness in the chest
• voice changes

2 years or older:
1 drop in the affected eye(s) 3 times per day

Comments:
-This drug may be used concomitantly with other topical ophthalmic drugs to lower intraocular pressure.
-If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.

Use: To lower elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Severe hepatic impairment: Use with caution

Data not available