Azopt

DRUG DESCRIPTION

AZOPT® (brinzolamide ophthalmic suspension) 1% contains a carbonic anhydrase inhibitor formulated for multidose topical ophthalmic use. Brinzolamide is described chemically as: (R)-(+)-4-Ethylamino-2-(3-methoxypropyl)-3,4-dihydro2H-thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1-dioxide. Its empirical formula is C12H21N3O5S3, and its structural formula is:

AZOPT® (brinzolamide) Structural Formula Illustration

Brinzolamide has a molecular weight of 383.5 and a melting point of about 131°C. It is a white powder, which is insoluble in water, very soluble in methanol and soluble in ethanol.

AZOPT® (brinzolamide ophthalmic suspension) 1% is supplied as a sterile, aqueous suspension of brinzolamide which has been formulated to be readily suspended and slow settling, following shaking. It has a pH of approximately 7.5 and an osmolality of 300 mOsm/kg.

Each mL of AZOPT® (brinzolamide ophthalmic suspension) 1% contains: Active ingredient: brinzolamide 10 mg. Preservative: Benzalkonium chloride 0.01 mg. Inactives: mannitol, carbomer 974P, tyloxapol, edetate disodium, sodium chloride, purified water, with hydrochloric acid and/or sodium hydroxide to adjust pH.

What are the possible side effects of brinzolamide ophthalmic (Azopt)?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • swelling or redness of your eyelids;
  • eye redness, discomfort, or sensitivity to light;
  • drainage, crusting, or oozing of your eyes or eyelids;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin...

Read All Potential Side Effects and See Pictures of Azopt »

What are the precautions when taking brinzolamide ophthalmic suspension (Azopt)?

Before using brinzolamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye conditions, kidney problems, liver disease.

If you develop an eye infection or injury, or have eye surgery, check with your doctor about whether you should continue to use your current bottle of brinzolamide. You may be advised to start using a new bottle.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use...

Read All Potential Precautions of Azopt »


Azopt Consumer (continued)

SIDE EFFECTS: Temporary blurred vision, bitter/sour/unusual taste in your mouth, dry eyes, temporary discomfort/itching/redness of the eye, feeling as if something is in your eye, eye discharge, and headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if you have any of these rare but very serious side effects: eye or eyelid swelling/pain, stomach/side/back pain, persistent nausea or vomiting, yellowing eyes/skin, dark urine, easy bruising or bleeding, unusual tiredness, signs of infection (e.g., fever, chills, persistent sore throat), chest pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using brinzolamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye conditions, kidney problems, liver disease.

If you develop an eye infection or injury, or have eye surgery, check with your doctor about whether you should continue to use your current bottle of brinzolamide. You may be advised to start using a new bottle.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, consult your doctor before breast-feeding.


Azopt Patient Information Including Side Effects

Brand Names: Azopt

Generic Name: brinzolamide ophthalmic (Pronunciation: brin ZOE la mide off THAL mik)

  • What is brinzolamide ophthalmic (Azopt)?
  • What are the possible side effects of brinzolamide ophthalmic (Azopt)?
  • What is the most important information I should know about brinzolamide ophthalmic (Azopt)?
  • What should I discuss with my healthcare provider before using brinzolamide ophthalmic (Azopt)?
  • How should I use brinzolamide ophthalmic (Azopt)?
  • What happens if I miss a dose (Azopt)?
  • What happens if I overdose (Azopt)?
  • What should I avoid while using brinzolamide ophthalmic (Azopt)?
  • What other drugs will affect brinzolamide ophthalmic (Azopt)?
  • Where can I get more information?

What is brinzolamide ophthalmic (Azopt)?

Brinzolamide reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Brinzolamide ophthalmic (for the eyes) is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

Brinzolamide ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of brinzolamide ophthalmic (Azopt)?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • swelling or redness of your eyelids;
  • eye redness, discomfort, or sensitivity to light;
  • drainage, crusting, or oozing of your eyes or eyelids;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • pain in your upper stomach, jaundice (yellowing of your skin or eyes);
  • pale skin, easy bruising or bleeding; or
  • chest pain.

Less serious side effects may include:

  • blurred vision, double vision, drooping eyelid;
  • burning or stinging in your eye;
  • bitter or unusual taste in your mouth;
  • stomach or back pain;
  • dry eyes, feeling that something is in your eye;
  • headache; or
  • nausea, diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about brinzolamide ophthalmic (Azopt)?

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.

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

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 any other eye medication unless your doctor has prescribed it for you. If you use another eye medication, use it at least 10 minutes before or after using brinzolamide ophthalmic. Do not use the medications at the same time.

Brinzolamide ophthalmic can cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

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