Label: DORZOLAMIDE HYDROCHLORIDE solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 50383-232-05, 50383-232-10 - Packager: Akorn
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 1, 2022
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use Dorzolamide Hydrochloride Ophthalmic Solution safely and effectively. See full prescribing information for Dorzolamide Hydrochloride ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEDorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
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2 DOSAGE AND ADMINISTRATIONThe dose is one drop of dorzolamide hydrochloride ophthalmic solution in the affected eye(s) three times daily. Dorzolamide hydrochloride may be used concomitantly with other topical ophthalmic ...
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3 DOSAGE FORMS AND STRENGTHSOphthalmic solution containing dorzolamide 2% (20 mg/mL) equivalent to 22.3 mg/mL of dorzolamide hydrochloride.
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4 CONTRAINDICATIONSDorzolamide hydrochloride ophthalmic solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions (5.1)].
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5 WARNINGS AND PRECAUTIONS5.1 Sulfonamide Hypersensitivity - Dorzolamide hydrochloride ophthalmic solution contains dorzolamide, a sulfonamide; and although administered topically, it is absorbed systemically. Therefore ...
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6 ADVERSE REACTIONS6.1 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 ...
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7 DRUG INTERACTIONS7.1 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 ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies in pregnant women with dorzolamide hydrochloride ophthalmic solution. Dorzolamide caused fetal vertebral ...
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10 OVERDOSAGEElectrolyte 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 ...
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11 DESCRIPTIONDorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a two-year study of dorzolamide hydrochloride administered orally to male and female Sprague-Dawley rats, urinary bladder papillomas ...
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14 CLINICAL STUDIESThe efficacy of dorzolamide hydrochloride ophthalmic solution was demonstrated in clinical studies in the treatment of elevated intraocular pressure in patients with glaucoma or ocular ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGDorzolamide Hydrochloride Ophthalmic Solution 2% is supplied sterile in 10 mL white LDPE plastic dropper bottles with white LDPE dropper tips and orange P/P caps of the following - sizes: 5 mL ...
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17 PATIENT COUNSELING INFORMATIONAdvise the patient to read the FDA-approved patient labeling (Instructions for Use). Sulfonamide Reactions - Dorzolamide hydrochloride ophthalmic solution is a sulfonamide and although ...
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Package/Label Display Panel AKORN - NDC 50383-232-10 - Dorzolamide HCl Ophthalmic Solution 2% Dorzolamide Equivalent (Dorzolamide Hydrochloride 22.3 mg/mL) 10 mL - Rx only
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INGREDIENTS AND APPEARANCEProduct Information