Azopt

Name: Azopt

Other uses for this medicine

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Drug interactions

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: oral carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide), high doses of aspirin or related salicylates (e.g., high doses used for arthritis).Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Can brinzolamide eye drops cause problems?

Along with their useful effects, eye drops can cause unwanted side-effects although not everyone experiences them. The table below contains the most common ones associated with brinzolamide. You will find a full list in the manufacturer's information leaflet supplied with your drops. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Common brinzolamide side-effects (these affect less than 1 in 10 people)What can I do if I experience this?
Blurred vision, itching or irritation when the drops are first put inThis should quickly ease. If it continues, or if your eye becomes red, painful or inflamed, speak with your doctor as soon as possible
Altered tasteMake sure you press gently on the side of your nose (where the corner of your eye meets your nose) for a minute or so after you have used the drops

Bottles of eye drops contain preservatives which some people can develop an allergic reaction to. If your eye becomes red or inflamed after using the drops, contact your doctor for advice.

Patient information

Sulfonamide Reactions

Advise patients that if serious or unusual ocular or systemic reactions or signs of hypersensitivity occur, they should discontinue the use of the product and consult their physician.

Temporary Blurred Vision

Vision may be temporarily blurred following dosing with AZOPT (brinzolamide ophthalmic suspension) 1%. Advise patients to exercise care in operating machinery or driving a motor vehicle.

Avoiding Contamination Of The Product

Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures or other surfaces, since the product can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Intercurrent Ocular Conditions

Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.

Contact Lens Wear

The preservative in AZOPT (brinzolamide ophthalmic suspension) 1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of AZOPT (brinzolamide ophthalmic suspension) 1%, but may be reinserted 15 minutes after instillation.

Uses of Azopt

Azopt is a prescription eye drop used to treat open-angle glaucoma and ocular hypertension (higher than normal pressure inside the eye), a risk factor for glaucoma. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Manufacturer

  • Alcon Laboratories, Inc.

Azopt Drug Class

Azopt is part of the drug class:

  • Carbonic anhydrase inhibitors

Side Effects of Azopt

Common side effects include:

  • blurred vision
  • bitter, sour, or unusual taste after instilling the drops
  • dry eyes
  • feeling that something is in your eye
  • headache
  • runny nose

This is not a complete list of Azopt side effects. Ask your doctor or pharmacist for more information.

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

Cautions for Azopt

Contraindications

  • Known hypersensitivity to brinzolamide or any ingredient in the formulation.1

Warnings/Precautions

Sensitivity Reactions

Sulfonamide Sensitivity Reactions

Serious adverse events (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, other blood dyscrasias) associated with sulfonamide therapy possible.1

Usual precautions associated with systemic use of sulfonamides apply.1 Discontinue brinzolamide if serious reactions or signs or symptoms of hypersensitivity occur.1

General Precautions

Ocular Effects

Effect on corneal endothelium not fully evaluated.1

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk in rats following oral administration; not known whether distributed into human milk following topical application to eye.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established.1 9

Geriatric Use

No overall differences in safety and efficacy relative to younger adults.1

Hepatic Impairment

Not studied in patients with hepatic impairment; use with caution.1

Renal Impairment

Not studied in patients with severe renal impairment (Clcr< 30 mL/minute).1 Not recommended in such patients, since brinzolamide and its metabolite are excreted mainly by the kidneys.1

Common Adverse Effects

Blurred vision, taste disturbances (bitter, sour, or unusual taste).1

What do I need to tell my doctor BEFORE I take Azopt?

  • If you have an allergy to brinzolamide or any other part of Azopt (brinzolamide).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have kidney disease.
  • If you are taking any of these drugs: Acetazolamide, dichlorphenamide, methazolamide, or zonisamide.
  • If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Patient Counseling Information

Sulfonamide Reactions

Advise patients that if serious or unusual ocular or systemic reactions or signs of hypersensitivity occur, they should discontinue the use of the product and consult their physician.

Temporary Blurred Vision

Vision may be temporarily blurred following dosing with Azopt® (brinzolamide ophthalmic suspension) 1%. Advise patients to exercise care in operating machinery or driving a motor vehicle.

Avoiding Contamination of the Product

Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures or other surfaces, since the product can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Intercurrent Ocular Conditions

Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.

Contact Lens Wear

The preservative in Azopt® (brinzolamide ophthalmic suspension) 1%, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of Azopt® (brinzolamide ophthalmic suspension) 1%, but may be reinserted 15 minutes after instillation.

©2000-2009, 2011-2012, 2015 Novartis
                                                                                                               
U.S. Pat.: www.alconpatents.com
*TRUSOPT is a registered trademark of Merck & Co., Inc.
                          
Alcon®
a Novartis company

Distributed By:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
1-800-757-9195

9012603-1215

Brinzolamide ophthalmic Pregnancy Warnings

AU/US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. UK: Use is not recommended. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Animal studies have shown reproductive toxicity. There are no adequate and well-controlled studies in pregnant women. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Brinzolamide ophthalmic Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

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