Simbrinza

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Simbrinza. If you are concerned about side effects, discuss the risks and benefits of Simbrinza with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bad taste in mouth
• blurred vision
• drowsiness
• dry eyes
• Dry Mouth
• dry nose or throat
• eye pain
• eye redness
• headache
• increased tear production
• stomach ache
• tired eyes
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• decreased heart rate
• unusual eye symptoms (e.g., severe eye pain, sensitivity to light, sudden decrease or loss of vision)
• signs of Low Blood Pressure (e.g., fainting, dizziness, weakness, changes in breathing)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Simbrinza.

Each 1 mL of white-to-off-white uniform suspension, supplied in a round, white, low density polyethylene (LDPE) bottle with a natural LDPE dispensing plug and white polypropylene screw cap (DROP-TAINER®), contains 10 mg brinzolamide and 2 mg brimonidine tartrate. Nonmedicinal ingredients: boric acid, carbomer 974P, mannitol, propylene glycol, purified water, sodium chloride, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH), and benzalkonium chloride (0.003%) as a preservative.

Do not take this medication if you:

• are allergic to brinzolamide, brimonidine or any ingredients of the medication
• are allergic to sulfonamides
• have severely reduced kidney function
• have a condition known as hyperchloroaemic acidosis
• have taken an MAO inhibitor (e.g., Tranylcypromine, Phenelzine, Linezolid) within the last 14 days

Do not give Simbrinza to infants and children under 2 years of age.

There may be an interaction between brinzolamide - brimonidine and any of the following:

• alcohol
• Aldesleukin
• Aliskiren
• alpha/beta agonists (e.g., Epinephrine, norepinephrine)
• alpha agonists (e.g., Clonidine, methyldopa)
• alpha blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., candasartan, Irbesartan, Losartan)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• azelastine
• “azole” antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Baclofen
• barbiturates (e.g., butalbital, pentobarbital Phenobarbital)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• boceprevir
• Buprenorphine
• Buspirone
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• carbonic anhydrase inhibitors (e.g., acetazolamide, Dorzolamide, Topiramate)
• chloral hydrate
• clarithromycin
• conivaptan
• delavirdine
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• dronabinol
• droperidol
• efavirenz
• general anesthetics (medications used to put people to sleep before surgery)
• Guanfacine
• HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, saquinavir, tipranavir)
• levodopa
• magnesium sulfate 
• Methotrimeprazine
• metyrosine
• Minoxidil
• Mirtazapine
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, phenelzine, Rasagiline, Selegiline, tranylcypromine)
• muscle relaxants (e.g., Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nefazodone
• nelfinavir
• nitrates (e.g., Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• Olopatadine
• orphenadrine
• paraldehyde
• Perampanel
• Pramipexole
• Ropinirole
• Rotigotine
• Rufinamide
• saquinavir
• scopolamine
• seizure medications (e.g., Carbamazepine, Ethosuximide, felbamate, Levetiracetam, phenobarbital, Phenytoin, primidone, topiramate, Valproic acid, zonisamide)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, duloxetine, Venlafaxine)
• sodium oxybate
• Tapentadol
• thalidomide
• Tramadol
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Zolpidem 
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Simbrinza. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Simbrinza.

Allergy: Brinzolamide belongs to the family of medications known as sulfonamides or "sulfas." The same type of allergic reaction can occur with this medication as with other sulfonamides. Contact your doctor if you experience a skin rash while using Simbrinza. Stop using Simbrinza and get medical attention if you experience Hives; shortness of breath; peeling or blistering skin; or swelling of the mouth, lips, tongue, or throat.

Blurred vision: This medication may temporarily cause blurred vision. If you experience blurred vision, do not drive or operate machinery until your vision returns to normal.

Contact lenses: This medication contains the preservative benzalkonium chloride which may be absorbed by soft contact lenses. Contact lenses should be removed when applying these eye drops but can be reinserted 15 minutes after application.

Eye surgery, infections, and trauma: If you have had eye surgery, trauma to the eye, or  symptoms of an eye infection (e.g., eye redness, itchiness, discharge, crusts on the eyelids, or the feeling of something in the eye), talk your doctor about whether you should continue taking Simbrinza.

General: As with other topically applied eye drops, Simbrinza may be absorbed into the bloodstream. The same side effects reported with oral medications from the families known as carbonic anhydrase inhibitors (e.g., Acetazolamide, Methazolamide) or sulfonamides (e.g., sulfamethoxazole) may occur with these eye drops. The side effects may include rash and nausea.

Depression: If you have clinical depression or a history of depression, discuss with your doctor how Simbrinza may affect your medical condition and whether any special monitoring is needed. You may need to visit your doctor more often to ensure that Simbrinza is not making your condition worse.

Drowsiness/reduced alertness: Brimonidine may cause temporary fatigue and drowsiness. Do not drive, operate machinery, or engage in any potentially hazardous activities until you determine how Simbrinza affects you.

Kidney function: The use of Simbrinza by people with Kidney Disease has not been studied. If you have reduced kidney function or kidney disease, discuss with your doctor how Simbrinza may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simbrinza, and whether any special monitoring is needed.

Liver function: The use of brinzolamide-brimonidine eye drops by people with liver disease has not been studied. If you have reduced liver function or liver disease, discuss with your doctor how Simbrinza may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simbrinza, and whether any special monitoring is needed.

Orthostatic hypotension: Orthostatic hypotension, also known as postural hypotension, is a drop in blood pressure when getting up from a lying position. This may happen to people using brimonidine eye drops. If you experience this, rise slowly from a lying or sitting position when using brimonidine.

Raynaud's disease: Raynaud's disease is a disorder of the small blood vessels that feed the skin. If you have Raynaud's disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simbrinza, and whether any special monitoring is needed.

Severe cardiovascular (heart) disease: Although brimonidine typically has little effect on blood pressure and heart rate, it may lower blood pressure and heart rate (pulse) if you have severe heart disease. If you have severe heart disease, discuss with your doctor how Simbrinza may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simbrinza, and whether any special monitoring is needed.

Thromboangiitis obliterans: Thromboangiitis obliterans is a condition causing inflammation of small- and medium-sized arteries and veins. If you have thromboangiitis obliterans, discuss with your doctor how Simbrinza may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Simbrinza, and whether any special monitoring is needed.

Pregnancy: Simbrinza should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Simbrinza, contact your doctor immediately.

Breast-feeding: It is not known if brinzolamide - brimonidine passes into breast milk. If you are a breast-feeding mother and are taking Simbrinza, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children:The safety and effectiveness of using Simbrinza have not been established for children.