Dorzolamide Hydrochloride Ophthalmic Solution 20 mg/mL

Dorzolamide Hydrochloride · SOLUTION/ DROPS · Micro Labs Limited

No Recall History

Plain English

Dorzolamide Hydrochloride Ophthalmic Solution is a solution/ drops containing dorzolamide hydrochloride at 20 mg/mL, taken ophthalmic. Manufactured by Micro Labs Limited.

Key Facts

Brand Name: Dorzolamide Hydrochloride Ophthalmic Solution
Generic Name: Dorzolamide Hydrochloride
NDC Code (Product): 42571-141
Manufacturer: Micro Labs Limited
Strength: 20 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: ANDA204778
Marketing Start: 11/11/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective205 reports

treatment failure152 reports

off label use149 reports

fatigue135 reports

eye pain133 reports

eye irritation128 reports

headache118 reports

pain114 reports

condition aggravated109 reports

product dose omission issue101 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 Micro Labs USA, Inc. at 1-855-839-8195 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 …

Frequently Asked Questions

What is Dorzolamide Hydrochloride Ophthalmic Solution used for?

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

Is Dorzolamide Hydrochloride Ophthalmic Solution a controlled substance?

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

What is the generic name for Dorzolamide Hydrochloride Ophthalmic Solution?

The generic name for Dorzolamide Hydrochloride Ophthalmic Solution is Dorzolamide Hydrochloride. There are 12 other brand versions of Dorzolamide Hydrochloride.

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

The NDC (National Drug Code) for Dorzolamide Hydrochloride Ophthalmic Solution 20 mg/mL is 42571-141, listed by Micro Labs Limited.

Product NDC

42571-141

Package NDC

42571-141-26

Other Dorzolamide Brands

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

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