Azopt

Name: Azopt

Warnings

Contraindications

Hypersensitivity

Severe renal impairment (CrCl <30 mL/min)

Cautions

Hepatic impairment

Corneal edema may occur in patients with low endothelial cell counts

What should I discuss with my healthcare provider before using Azopt (brinzolamide ophthalmic)?

You should not use this medication if you are allergic to brinzolamide.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have narrow-angle glaucoma.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether brinzolamide ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Azopt (brinzolamide ophthalmic)?

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the eye drops before putting your contact lenses in.

Use brinzolamide ophthalmic exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down on the lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.

  • If you use the drops in both eyes, repeat the steps above in your other eye. Also wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use this medicine if it has changed colors or has particles in it.

Tell your doctor right away if you have an eye infection, injury, or plan to have any type of eye surgery. You may need to stop using the medicine for a short time.

Store this medication at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What other drugs will affect Azopt (brinzolamide ophthalmic)?

Before using brinzolamide ophthalmic, tell your doctor if you are using any of the following drugs:

  • salicylates such as aspirin, Novasal, Doan's Extra Strength, Salflex, Tricosal, and others;

This list is not complete and there may be other drugs that can interact with brinzolamide ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What are some other side effects of Azopt?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Blurred eyesight.
  • Bad taste in your mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Azopt, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Azopt. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Azopt.

Review Date: October 4, 2017

Indications and Usage for Azopt

Azopt® (brinzolamide ophthalmic suspension) 1% is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Dosage Forms and Strengths

Solution containing 10 mg/mL brinzolamide.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Brinzolamide caused urinary bladder tumors in female mice at oral doses of 10 mg/kg/day and in male rats at oral doses of 8 mg/kg/day in 2 year studies. Brinzolamide was not carcinogenic in male mice or female rats dosed orally for up to 2 years. The carcinogenicity appears secondary to kidney and urinary bladder toxicity. These levels of exposure cannot be achieved with topical ophthalmic dosing in humans. The following tests for mutagenic potential were negative: (1) in vivo mouse micronucleus assay; (2) in vivo sister chromatid exchange assay; and (3) Ames E. coli test. The in vitro mouse lymphoma forward mutation assay was negative in the absence of activation, but positive in the presence of microsomal activation. In reproduction studies of brinzolamide in rats, there were no adverse effects on the fertility or reproductive capacity of males or females at doses up to 18 mg/kg/day (375 times the recommended human ophthalmic dose).

Principal display panel

NDC 0065-0275-10

Alcon®

Azopt®
(brinzolamide ophthalmic suspension) 1%

10 mL

Sterile

EACH mL Contains:

Active: Brinzolamide 10 mg

Preservative: Benzalkonium Chloride, 0.01%

Inactives: Mannitol; Carbomer 974P, Edetate Disodium, Tyloxapol, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide (to adjust pH), and Purified Water.

Rx Only

WARNING: Do not touch dropper tip to any surface, as this may contaminate the suspension.

USUAL DOSAGE: 1 drop in the affected eye(s) three times daily.

SHAKE WELL BEFORE USING.

FOR TOPICAL OPHTHALMIC USE ONLY.

Storage: Store at 39°F - 86°F (4°C - 30°C)

U.S. Patent Nos. 5,378,703; 5,461,081, 6,071,904.

Alcon®
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
©2000, 2010 Alcon, Inc.

243346-0410

LOT:

EXP.:

NDC 0065-0275-10

Alcon®

Azopt®
(brinzolamide ophthalmic suspension) 1%

Sterile

10mL

Rx Only

EACH mL CONTAINS: brinzolamide 10 mg.

STORAGE: Store at 4°- 30°C (39° - 86°F).

U.S. Patent Nos. 5,378,703; 5,461,081; 6,071,904.

SHAKE WELL BEFORE USING.

FOR TOPICAL OPHTHALMIC USE ONLY.

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA

©2000, 2004, 2006, 2011 Alcon, Inc.

LOT:

EXP.:

Azopt  
brinzolamide suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-0275
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BRINZOLAMIDE (BRINZOLAMIDE) BRINZOLAMIDE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL  
TYLOXAPOL  
EDETATE DISODIUM  
SODIUM CHLORIDE  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
WATER  
BENZALKONIUM CHLORIDE  
CARBOMER HOMOPOLYMER TYPE C  
Packaging
# Item Code Package Description
1 NDC:0065-0275-10 1 BOTTLE, PLASTIC in 1 CARTON
1 10 mL in 1 BOTTLE, PLASTIC
2 NDC:0065-0275-15 1 BOTTLE, PLASTIC in 1 CARTON
2 15 mL in 1 BOTTLE, PLASTIC
3 NDC:0065-0275-25 1 BOTTLE, PLASTIC in 1 CARTON
3 2.5 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020816 04/30/1998
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Research Ltd (007672236)
Establishment
Name Address ID/FEI Operations
Alcon Research Ltd 007672236 MANUFACTURE(0065-0275)
Revised: 03/2016   Alcon Laboratories, Inc.

Brinzolamide Identification

Substance Name

Brinzolamide

CAS Registry Number

138890-62-7

Drug Class

Antiglaucoma Agent

Carbonic Anhydrase Inhibitors

Administrative Information

LactMed Record Number

776

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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