Label: DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION solution/ drops

  • NDC Code(s): 46708-553-10
  • Packager: Alembic Pharmaceuticals Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 6, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension ...
  • 2 DOSAGE AND ADMINISTRATION
    The dose is one drop of dorzolamide hydrochloride and timolol maleate ophthalmic solution in the affected eye(s) two times daily. If more than one topical ophthalmic drug is being used, the drugs ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Opthalmic solution containing dorzolamide 20 mg/mL (2%) equivalent to (22.26 mg/mL of dorzolamide hydrochloride) and timolol 5 mg/mL (0.5%)equivalent to (6.83 mg/mL timolol maleate).
  • 4 CONTRAINDICATIONS
    4.1 Asthma, COPD - Dorzolamide hydrochloride and timolol maleate ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Potentiation of Respiratory Reactions Including Asthma - Dorzolamide hydrochloride and timolol maleate ophthalmic solution contains timolol maleate, a beta-adrenergic blocking agent; and ...
  • 6 ADVERSE REACTIONS
    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 ...
  • 7 DRUG INTERACTIONS
    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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects. Developmental toxicity studies with dorzolamide hydrochloride in rabbits at oral doses of ≥2.5 mg/kg/day (37 times the recommended human ophthalmic dose ...
  • 10 OVERDOSAGE
    Symptoms consistent with systemic administration of beta-blockers or carbonic anhydrase inhibitors may occur, including electrolyte imbalance, development of an acidotic state, dizziness ...
  • 11 DESCRIPTION
    Dorzolamide hydrochloride and timolol maleate ophthalmic solution is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Dorzolamide hydrochloride and timolol maleate ophthalmic solution is comprised of two components: dorzolamide hydrochloride and timolol maleate. Each of these two ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis and Mutagenesis and Impairment of Fertility - In a two-year study of dorzolamide hydrochloride administered orally to male and female Sprague- Dawley rats, urinary bladder ...
  • 14 CLINICAL STUDIES
    Clinical studies of 3 to 15 months duration were conducted to compare the IOP-lowering effect over the course of the day of dorzolamide hydrochloride and timolol maleate ophthalmic solution twice ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Dorzolamide hydrochloride and timolol maleate ophthalmic solution 2% / 0.5% is supplied in opaque white low density polyethylene bottle which is closed with white low density polyethylene nozzle ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-Approved patient labeling (Patient Information and Instructions for Use ). Potential for Exacerbation of Asthma and COPD - Dorzolamide hydrochloride and ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP 2% & 0.5%- Bottle label - Alembic - Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, USP 2% ...
  • INGREDIENTS AND APPEARANCE
    Product Information