Dorzolamide HCl 20 mg/mL
Dorzolamide HCl · SOLUTION/ DROPS · Bausch & Lomb Incorporated
Dorzolamide HCl is a solution/ drops containing dorzolamide hcl at 20 mg/mL, taken ophthalmic. Manufactured by Bausch & Lomb Incorporated.
Key Facts
- Brand Name
- Dorzolamide HCl
- Generic Name
- Dorzolamide HCl
- NDC Code (Product)
24208-485- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- 20 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA090143
- Marketing Start
- 06/25/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 Bausch & Lomb Incorporated at 1-800-553-5340 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-quar…
Frequently Asked Questions
What is Dorzolamide HCl used for?
Dorzolamide HCl contains Dorzolamide HCl. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Dorzolamide HCl a controlled substance?
Dorzolamide HCl is not classified as a controlled substance by the DEA.
What is the generic name for Dorzolamide HCl?
The generic name for Dorzolamide HCl is Dorzolamide HCl. There are no other listed brand versions of Dorzolamide HCl.
What is the NDC code for Dorzolamide HCl 20 mg/mL?
The NDC (National Drug Code) for Dorzolamide HCl 20 mg/mL is 24208-485, listed by Bausch & Lomb Incorporated.
Other Dorzolamide HCl Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)