AZOPT is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.

The recommended dose is one drop of AZOPT in the affected eye(s) 3 times daily. Shake well before use. AZOPT may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 10 minutes apart.

Ophthalmic suspension containing brinzolamide 1% (10 mg/mL).

AZOPT is contraindicated in patients who are hypersensitive to any component of this product.

Although no human data are available, electrolyte imbalance, development of an acidotic state, and possible nervous system effects may occur following oral administration of an overdose. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

AZOPT contains a carbonic anhydrase inhibitor formulated for multidose topical ophthalmic use. Brinzolamide is described chemically as: (R)-(+)-4-Ethylamino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1- dioxide. Its empirical formula is C

Brinzolamide has a molecular weight of 383.5 g/mol 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 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 contains:

In two, 3-month clinical studies, AZOPT dosed 3 times per day in patients with elevated IOP, produced significant reductions in IOPs (4 mmHg to 5 mmHg). These IOP reductions are equivalent to the reductions observed with TRUSOPT* (dorzolamide hydrochloride ophthalmic solution) 2% dosed 3 times per day in the same studies.

In 2 clinical studies in patients with elevated IOP, AZOPT was associated with less stinging and burning upon instillation than TRUSOPT* 2%.

AZOPT (brinzolamide ophthalmic suspension) 1% is supplied in plastic dispensers with a controlled dispensing-tip as follows:

10 mL NDC 66758-085-70

15 mL NDC 66758-085-85

Store AZOPT at 4°C to 30°C (39°F to 86°F). Shake well before use. After opening, AZOPT can be used until the expiration date on the bottle.

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 immediately

Vision may be temporarily blurred following dosing with AZOPT. Advise patients to exercise care in operating machinery or driving a motor vehicle.

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.

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 multi-dose container.

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

The preservative in AZOPT, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of AZOPT, but may be reinserted 15 minutes after instillation.

*TRUSOPT is a registered trademark of Merck & Co., Inc.

Manufactured by

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 for

Sandoz Inc., Princeton, NJ 08540

300064739-1123

NDC 66758-085-70

Azopt®

(brinzolamide

ophthalmic

suspension) 1%

10 mL Sterile

Sandoz

NDC 66758-085-70

Azopt

(brinzolamide

10 mL Sterile

Sandoz