Drugplain

Dorzolamide Hydrochloride 20 mg/mL

Dorzolamide Hydrochloride · SOLUTION · Gland Pharma Limited

2 Recalls on Record
Plain English

Dorzolamide Hydrochloride is a solution containing dorzolamide hydrochloride at 20 mg/mL, taken ophthalmic. Manufactured by Gland Pharma Limited.

Key Facts

Brand Name
Dorzolamide Hydrochloride
Generic Name
Dorzolamide Hydrochloride
NDC Code (Product)
68083-489
Manufacturer
Gland Pharma Limited
Strength
20 mg/mL
Dosage Form
SOLUTION
Route
OPHTHALMIC
Marketing Status
Application #
ANDA215660
Marketing Start
01/27/2022

Recall History

2 Recalls on Record
Class III12/20/2018

Akorn Inc

Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

treatment failure1,449 reports
drug ineffective875 reports
off label use536 reports
fatigue467 reports
headache381 reports
eye irritation364 reports
pain359 reports
eye pain346 reports
hypersensitivity327 reports
condition aggravated301 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 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 )

Contraindications

4 CONTRAINDICATIONS 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. ( 4 , 5.1 )

Drug Interactions

7 DRUG INTERACTIONS 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. 7.2 High-Dose Salicylate Therapy Although acid-base and electrolyte disturbances were not reported in the clinical trials with dorzolamide hydrochloride ophthalmic solution, these disturbances have been reported with oral carbonic anhydrase inhibitors and have, in some instances, resulted in drug interactions (e.g., toxicity associated with high-dose salicylate therapy). Therefore, the potential for such drug interactions should be considered in patients receiving Dorzolamide Hydrochloride Ophthalmic Solution.

Adverse Reactions

6 ADVERSE REACTIONS 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…

Frequently Asked Questions

What is Dorzolamide Hydrochloride used for?

Dorzolamide Hydrochloride contains Dorzolamide Hydrochloride. It is a solution taken ophthalmic. Consult your doctor for specific uses.

Is Dorzolamide Hydrochloride a controlled substance?

Dorzolamide Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Dorzolamide Hydrochloride?

The generic name for Dorzolamide Hydrochloride is Dorzolamide Hydrochloride. There are 10 other brand versions of Dorzolamide Hydrochloride.

What is the NDC code for Dorzolamide Hydrochloride 20 mg/mL?

The NDC (National Drug Code) for Dorzolamide Hydrochloride 20 mg/mL is 68083-489, listed by Gland Pharma Limited.

Product NDC

68083-489

Package NDC

68083-489-01

Other Dorzolamide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)