Dorzolamide

Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid.

• 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.ICD-10: H40.059, H40.9

• Dorzolamide Hydrochloride Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions ( 5.1 )]. Dorzolamide Hydrochloride Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product.contraindicated

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. ( 2 )

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. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation [see Contraindications ( 4 )]. 5.2 Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. 5.3 Corneal Endothelium Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. There is an increased potential for developing corneal edema in patients with low endothelial cell counts.

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 Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Controlled clinical trials : The most frequent 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%. Reactions occurring in approximately 1 to 5% of patients were conjunctivitis and lid reactions [see Warnings and Precautions ( 5.4 )] , blurred vision, eye redness, tearing, dryness, and photophobia.

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). Dorzolamide hydrochloride administered orally to rats during late gestation and lactation caused growth delays in offspring at 7.5 mg/kg/day (52 times the clinical exposure). Growth was not delayed at 1 mg/kg/day (8.0 times the clinical exposure). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Developmental toxicity studies were conducted in pregnant rabbits administered dorzolamide hydrochloride orally during the period of organogenesis from gestation days 6 through 18 at doses of 0.2, 1, 2.5, 5, and 10 mg/kg/day. The developmental lowest observed adverse effect level (LOAEL) was 2.5 mg/kg/day, based on vertebral malformations and decreased fetal body weight.

Metabolism

When topically applied, dorzolamide reaches the systemic circulation. To assess the potential for systemic carbonic anhydrase inhibition following topical administration, drug and metabolite concentrations in RBCs and plasma and carbonic anhydrase inhibition in RBCs were measured.

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.

• Apr 7, 1998NDANDA020869Thea Pharma
• Oct 28, 2008ANDAANDA078395Rubicon Research
• Apr 13, 2009ANDAANDA078981Sandoz
• Jun 25, 2009ANDAANDA090143Bausch And Lomb
• Jul 14, 2009ANDAANDA090037Bausch And Lomb
• Nov 18, 2009ANDAANDA090604Sandoz
• Feb 1, 2012NDANDA202667Thea Pharma
• Sep 3, 2014ANDAANDA202054Regcon Holdings

1. 1Treatment Failure2,14913%
2. 2Drug Ineffective1,3848.2%
3. 3Eye Irritation1,1416.8%
4. 4Ocular Hyperaemia8475.0%
5. 5Eye Pain8224.9%
6. 6Fatigue7614.5%
7. 7Off Label Use7364.4%
8. 8Intraocular Pressure Increased6173.7%
9. 9Headache6083.6%
10. 10Death5843.5%
11. 11Vision Blurred5813.5%
12. 12Hypersensitivity5623.3%
13. 13Pain5173.1%
14. 14Dyspnoea5163.1%
15. 15Eye Pruritus5113.0%

The 10 most recently updated of 89 ClinicalTrials.gov registrations naming Dorzolamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Safety of DNN.31.19.026 for Ocular Hypertension or Primary Open-Angle Glaucoma
  Not yet recruiting · Phase 3 · Interventional · 336 enrolled · Ache Laboratorios Farmaceuticos S.A.
  NCT07617532updated 2026-06-01
• Comparative Study of the Efficacy of Either Krytantek Ofteno PF® or Eliptic Ofteno PF® Plus Gaap Ofteno PF® for POAG or Ocular Hypertension.
  Terminated · Phase 4 · Interventional · 28 enrolled · Laboratorios Sophia S.A de C.V.
  NCT04702789updated 2026-05-07
• Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues
  Not yet recruiting · Observational · 1,500 enrolled · Association for Innovation and Biomedical Research on Light and Image
  NCT07074782updated 2026-05-06
• Efficacy and Safety of HUC3-637 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
  Recruiting · Phase 3 · Interventional · 206 enrolled · Huons Co., Ltd.
  NCT07335211updated 2026-01-13
• Stop Retinal Ganglion Cell Dysfunction Study
  Terminated · Phase 3 · Interventional · 28 enrolled · University of Miami
  NCT02390284updated 2025-08-26
• Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost
  Recruiting · Phase 4 · Interventional · 70 enrolled · Prairie Eye Center
  NCT06883123updated 2025-05-15
• PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)
  Terminated · Phase 3 · Interventional · 51 enrolled · Laboratorios Sophia S.A de C.V.
  NCT03193333updated 2025-03-06
• Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety
  Completed · Phase 4 · Interventional · 84 enrolled · Laboratorios Poen
  NCT05857267updated 2024-11-06
• How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure?
  Terminated · Phase 4 · Interventional · 36 enrolled · CT Glaucoma Associates
  NCT06369077updated 2024-08-23
• Impact of Timolol/Dorzolamide Therapy on Autoregulation in Glaucoma Patients
  Completed · Phase 4 · Interventional · 30 enrolled · Universitaire Ziekenhuizen KU Leuven
  NCT02053298updated 2024-07-16

Frequently asked questions

How does Dorzolamide work?

Carbonic anhydrase (CA) is an enzyme found in many tissues of the body including the eye. It catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid.

What is Dorzolamide used for?

According to FDA labeling, Dorzolamide carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Dorzolamide?

Dorzolamide is classified as Carbonic anhydrase inhibitors, Carbonic Anhydrase Inhibitor, Carbonic Anhydrase Inhibitors, Decreased Intraocular Fluid Pressure.

What are the brand names for Dorzolamide?

Dorzolamide is marketed under brand names including Cosopt.

What are the contraindications for Dorzolamide?

Dorzolamide labeling lists contraindications including: Dorzolamide Hydrochloride Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions ( 5.1 )]. Dorzolamide Hydrochloride Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product.. Always consult the full prescribing information and a clinician.