Brimonidine and brinzolamide Ophthalmic

Name: Brimonidine and brinzolamide Ophthalmic

Before Using brimonidine and brinzolamide

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 brimonidine and brinzolamide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to brimonidine and brinzolamide 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.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with Medicines

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 brimonidine and brinzolamide, 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 brimonidine and brinzolamide 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.

  • Ceritinib
  • Idelalisib
  • Memantine

Interactions with Food/Tobacco/Alcohol

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 brimonidine and brinzolamide. 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.

What is the most important information I should know about brimonidine and brinzolamide ophthalmic?

Brimonidine and brinzolamide ophthalmic should not be given to a child younger than 2 years old.

What should I discuss with my healthcare provider before using brimonidine and brinzolamide ophthalmic?

You should not use this medicine if you are allergic to brimonidine or brinzolamide.

Brimonidine and brinzolamide ophthalmic should not be given to a child younger than 2 years old.

To make sure brimonidine and brinzolamide ophthalmic is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • congestive heart failure, coronary artery disease, history of stroke or blood clot;

  • high or low blood pressure;

  • circulation problems, such as Raynaud's syndrome (numbness or cold feeling in your fingers or toes);

  • depression;

  • an allergy to sulfa drugs; or

  • narrow-angle glaucoma.

FDA pregnancy category C. It is not known whether brimonidine and brinzolamide ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether brimonidine and brinzolamide ophthalmic passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Brimonidine and brinzolamide ophthalmic side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may have other signs of allergic reaction that develop more slowly while using this medicine. Call your doctor if you have:

  • sudden liver failure--nausea, vomiting, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), confusion, rapid weight gain, (especially in your midsection);

  • bone marrow suppression--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing, pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Stop using this medicine and call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

  • eye swelling, redness, severe discomfort, crusting or drainage (may be signs of infection).

Common side effects may include:

  • blurred vision;

  • mild itching, redness, or irritation of your eyes; or

  • dry mouth, unpleasant taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Brimonidine and brinzolamide ophthalmic dosing information

Usual Adult Dose for Intraocular Hypertension:

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.

Usual Adult Dose for Glaucoma (Open Angle):

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.

Usual Pediatric Dose for Intraocular Hypertension:

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.

Usual Pediatric Dose for Glaucoma (Open Angle):

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.

Precautions

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Other Comments

Administration advice:
-This drug is for topical use only and it is not for injection or oral ingestion.
-Shake well before use.

Patient advice:
-Pressure should be applied to the tear duct immediately following administration of the drug.
-To avoid contamination of the solution, the container should be kept tightly closed.

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