Azopt (brinzolamide) ophthalmic suspension

Azopt is a prescription medicine used to treat the symptoms of ocular hypertension of open-angle glaucoma. Azopt may be used alone or with other medications.

It is not known if Azopt is safe and effective in children.

Azopt may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling in your face or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• eye pain or redness,
• swelling of the eyes,
• sensitivity to light,
• feeling like something is in your eye,
• stomach pain (upper right side),
• yellowing of your skin or eyes (jaundice),
• crusting or drainage from the eye, and
• severe discomfort of the eye

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Azopt include:

• blurred vision, and
• bitter or unusual taste in your mouth

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Azopt. For more information, ask your doctor or pharmacist.

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

• The recommended dose is one drop of Azopt (brinzolamide ophthalmic suspension) 1% in the affected eye(s) three times daily.
• Azopt (brinzolamide ophthalmic suspension) 1% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure.
• If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten (10) minutes apart.

Oral Carbonic Anhydrase Inhibitors

• There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and Azopt (brinzolamide ophthalmic suspension) 1%.
• The concomitant administration of Azopt (brinzolamide ophthalmic suspension) 1% and oral carbonic anhydrase inhibitors is not recommended.

High-Dose Salicylate Therapy

• Carbonic anhydrase inhibitors may produce acid-base and electrolyte alterations. These alterations were not reported in the clinical trials with brinzolamide.
• However, in patients treated with oral carbonic anhydrase inhibitors, rare instances of acidbase alterations have occurred with high-dose salicylate therapy.
• Therefore, the potential for such drug interactions should be considered in patients receiving Azopt (brinzolamide ophthalmic suspension) 1%.

• There are no adequate and well-controlled studies in pregnant women. Azopt (brinzolamide ophthalmic suspension) 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Azopt (brinzolamide ophthalmic suspension) 1%, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.