Dorzolamide

Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (1)

• The dose is one drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three times daily
• Dorzolamide hydrochloride ophthalmic solution 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 five minutes apart
• The dose is one drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three times daily
• Dorzolamide hydrochloride ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure

Ophthalmic solution containing dorzolamide 2% (20 mg/mL) equivalent to 22.3 mg/mL of dorzolamide hydrochloride. Ophthalmic solution containing dorzolamide 2% (20 mg/mL). (3)

• Safety and effectiveness of dorzolamide hydrochloride ophthalmic solution have been demonstrated
• In pediatric patients in a 3-month, multicenter, double-masked, active-treatment-controlled trial

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

• Advise the patient to read the FDA-approved patient labeling (Instructions for Use)
• Sulfonamide Reactions Dorzolamide hydrochloride ophthalmic solution is a sulfonamide and although administered topically is absorbed systemically
• Therefore the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration
• Advise patients that if serious or unusual reactions including severe skin reactions or signs of hypersensitivity occur, they should discontinue the use of the product [see Warnings and Precautions ]. …

• Dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions ]
• Dorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product

· Potential additive effect of oral carbonic anhydrase inhibitor with dorzolamide hydrochloride ophthalmic solution . (7.1) Potential acid-base and electrolyte disturbances. (7.2) 7.1 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 dorzolamide hydrochloride ophthalmic solution. The concomitant administration of dorzolamide hydrochloride ophthalmic solution and oral carbonic anhydrase inhibitors is not recommended. …

• Sulfonamide Hypersensitivity (5.1) • Bacterial Keratitis (5.2) • Corneal Endothelium (5.3) • Allergic Reactions (5.4) • Acute Angle-Closure Glaucoma (5.5) 5.1 Sulfonamide Hypersensitivity Dorzolamide hydrochloride ophthalmic solution contains dorzolamide, a sulfonamide; and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of dorzolamide hydrochloride ophthalmic solution. …

The most frequently reported adverse reactions associated with dorzolamide hydrochloride ophthalmic solution were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. (6) To report SUSPECTED ADVERSE REACTIONS, contact Indoco Remedies Limited at +1-855-642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. Dorzolamide caused fetal vertebral malformations when administered orally to rabbits at 2.5 mg/kg/day (37 times the clinical exposure). Dorzolamide administered during the period of organogenesis was not teratogenic in rabbits dosed up to 1 mg/kg/day (15 times the clinical exposure). …

Electrolyte imbalance, development of an acidotic state, and possible central nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.

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