Description
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 (eye) 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. This medicine can help you keep your sight by reducing the pressure in your eye and stopping eye pain.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Suspension
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Use of Simbrinza™ is not recommended in children younger than 2 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Simbrinza™ in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Isocarboxazid
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amphetamine
- Aspirin
- Ceritinib
- Dextroamphetamine
- Insulin Aspart, Recombinant
- Iobenguane I 131
- Landiolol
- Lisdexamfetamine
- Memantine
- Metformin
- Topiramate
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to sulfa drugs—Use with caution. May increase risk for more serious side effects.
- Bacterial eye infection (eg, keratitis) or
- Cerebral or coronary insufficiency or
- Cornea (part of the eye) problems, history of or
- Depression or
- Eye infection or
- Eye surgery, recent or
- Heart or blood vessel disease (eg, thromboangiitis obliterans) or
- Liver disease or
- Orthostatic hypotension or
- Raynaud's phenomenon—Use with caution. May make these conditions worse.
- Kidney disease, severe—Should not be used in patients with this condition.
Proper Use
Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
If you are wearing contact lenses, remove them before you use this medicine. Wait at least 15 minutes before putting the contact lenses back in.
To use the eye drops:
- Wash your hands with soap and water.
- Shake the eye drops well just before each use.
- Lie down or tilt your head back. With your index finger, pull down the lower lid of your eye to form a pocket.
- Hold the dropper close to your eye with the other hand. Drop the correct number of drops into the pocket made between your lower lid and eyeball.
- Gently close your eyes. Place your index finger over the inner corner of your eye for 1 minute.
- If you think you did not get the drop of medicine into your eye properly, repeat the process with another drop.
- Do not rinse or wipe the dropper or allow it to touch anything, including your eye.
- Put the cap on the bottle right away.
- Wash your hands after using the eye drops to remove any medicine.
- Do not use this medicine if the solution changes color or becomes cloudy.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.
This medicine can be used with other eye drops. Wait at least 5 minutes before using other eye drops. This will help prevent the second medicine from “washing out” the first one.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For ophthalmic dosage form (eye drops):
- For glaucoma or hypertension of the eye:
- Adults—Instill one drop in the affected eye(s) 3 times a day.
- Children 2 years of age and older—Use and dose must be determined by your doctor.
- Children younger than 2 years of age—Use is not recommended.
- For glaucoma or hypertension of the eye:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
You may also keep the medicine in the refrigerator. Do not freeze.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor. These signs may mean that you are allergic to brimonidine or brinzolamide.
Serious allergic and skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) may occur while using this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chills, dark urine, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, unusual bleeding or bruising, unusual tiredness or weakness, or yellow eyes or skin.
If you hurt your eye, develop an eye infection, or need to have an eye surgery, talk with your doctor right away. Your doctor may want you or your child to use a new bottle of eye drops to help prevent an eye infection or keep an infection from getting worse.
You should not use this medicine together with acetazolamide (Ak-Zol®, Diamox®), dorzolamide (Cosopt®, Trusopt®), or methazolamide (Neptazane®). Using these medicines together may increase risk for unwanted effects.
This medicine may cause blurred vision or other vision problems. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. If these reactions are especially bothersome, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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:
More common
- Blurred vision
- discoloration of the white part of the eye
- eye irritation or redness
Less common
- Decreased vision
- eye pain
- eyes sensitive to light
- red, sore eyes
Rare
- 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
Incidence not known
- Chest pain, discomfort, or tightness
- 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
- slow or irregular heartbeat
- swelling of the eyelids, face, lips, hands, or feet
- tearing
- throbbing pain
- trouble breathing or swallowing
- unusual tiredness
Incidence not known
- Blistering, peeling, or loosening of the skin
- chills
- cough
- diarrhea
- muscle pain
- red irritated eyes
- red skin lesions, often with a purple center
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- 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:
More common
- 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
Less common
- Dry eyes
- dry mouth
- muscle pain
- sneezing
- stuffy or runny nose
- trouble sleeping
Rare
- Acid or sour stomach
- belching
- body aches or pain
- cough
- crusting in the corner of the eye
- double vision
- dryness or soreness of the throat
- excessive muscle tone
- hair loss or thinning of the hair
- heartburn
- hoarseness
- indigestion
- muscle stiffness, tension, or tightness
- nausea
- stomach discomfort, upset, or pain
- tender, swollen glands in the neck
- 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.
DRG-20060918
