Simbrinza

The recommended dose of Simbrinza is 1 drop instilled into the affected eye two times daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

To use the eye drops:

1. Wash your hands before using the eye drops.
2. Shake the eye drops well before using them.
3. Remove the cap and place it in a clean location. To avoid possible contamination, keep the tip of the container away from contact with any surface.
4. Tilt the head back and look towards the ceiling.
5. With your index finger, gently pull the lower eyelid down and away from the eye to form a pouch.
6. Apply one drop into the pouch by following the instructions on the eye drop container. Do not allow the tip of the container to touch the eye or areas around the eye.
7. Gently apply pressure to the inner corner of the eye (at the bridge of the nose) for about 60 seconds (this is called nasolacrimal occlusion). This prevents the medication from dripping down through the tear duct and entering the bloodstream, which could cause you to experience some side effects.
8. Repeat with the other eye, if prescribed by your physician.
9. Wash your hands again to remove any medication.

Do not allow the dropper tip of the bottle to touch the eye or other surrounding structures. This can contaminate the tip with common bacteria known to cause Eye Infections. Serious damage to the eye may result if you use eye drop solutions that have become contaminated.

If more than one type of eye drop is needed, wait at least 5 minutes before using the second type of eye drop.

It is important to take Simbrinza exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Simbrinza at room temperature, protect it from light and moisture, and keep it out of the reach of children. Discard any solution remaining in the dropper bottle 125 days after opening the 10 mL bottle or 32 days after opening the 5 mL bottle. If the suspension changes colour, do not use it.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause blurred vision and dryness of the mouth; it may alter your sense of taste; it may cause an allergic reaction (also known as hypersensitivity); it may cause drowsiness - use caution when driving; it may irritate your eyes. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

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.

This medication is for the eye. To use: Wash your hands as well as the skin surrounding the affected eye. Shake the container. Gently pull down the lower lid of the affected eye. Apply 1 drop of the medication. Unless your condition prevents you from doing so, close the eye for at least 1 minute, while gently pressing on the inner corner of the eye, near the nose. To avoid contaminating the medication, do not let the tip of the applicator touch your fingers or any part of your eye. Close the container tightly after each use. If you wear contact lenses, you should remove them before using this medication. Wait 15 minutes after administration before reinserting your lenses. This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time.