Label: CARDURA- doxazosin tablet
- NDC Code(s): 58151-074-01, 58151-075-01, 58151-076-01, 58151-077-01
- Packager: Viatris Specialty LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated October 15, 2023
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use CARDURA safely and effectively. See full prescribing information for CARDURA. CARDURA® (doxazosin) tablets, for oral use - Initial ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE 1.1 Benign Prostatic Hyperplasia (BPH) CARDURA is indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension - CARDURA is indicated for the treatment of hypertension, to ...
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2 DOSAGE AND ADMINISTRATION 2.1 Dosing Information - Following the initial dose and with each dose increase of CARDURA, monitor blood pressure for at least 6 hours following administration. If CARDURA administration is ...
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3 DOSAGE FORMS AND STRENGTHS Tablets: 1 mg (white), 2 mg (white), 4 mg (white) or 8 mg (white). Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg or 8 mg doxazosin (free base).
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4 CONTRAINDICATIONS The use of CARDURA is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components.
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5 WARNINGS AND PRECAUTIONS 5.1 Postural Hypotension - Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of CARDURA. However, infrequently, symptomatic ...
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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 ...
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7 DRUG INTERACTIONS 7.1 CYP 3A Inhibitors - In vitro studies suggest that doxazosin is a substrate of CYP 3A4. Strong CYP3A inhibitors may increase exposure to doxazosin. Monitor blood pressure and for symptoms of ...
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8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy - Risk Summary - The limited available data with CARDURA in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. However ...
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10 OVERDOSAGE Experience with CARDURA overdosage is limited. Two adolescents, who each intentionally ingested 40 mg CARDURA with diclofenac or acetaminophen, were treated with gastric lavage with activated ...
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11 DESCRIPTION CARDURA® (doxazosin) is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is ...
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12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action - Benign Prostatic Hyperplasia (BPH) The symptoms associated with benign prostatic hyperplasia (BPH), such as urinary frequency, nocturia, weak stream, hesitancy ...
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13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis and Mutagenesis - Chronic dietary administration (up to 24 months) of doxazosin mesylate at maximally tolerated ...
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14 CLINICAL STUDIES 14.1 Benign Prostatic Hyperplasia (BPH) The efficacy of CARDURA was evaluated extensively in over 900 patients with BPH in double-blind, placebo-controlled trials. CARDURA treatment was ...
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16 HOW SUPPLIED/STORAGE AND HANDLING CARDURA (doxazosin) is available as tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (white), 4 mg (white) or 8 mg (white) of doxazosin as ...
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17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Postural Hypotension - Advise patients of the possibility of syncopal and orthostatic symptoms, especially at ...
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PATIENT INFORMATION CARDURA® (kar-DUR-a) (doxazosin tablets) What is CARDURA? CARDURA is a prescription medicine that contains doxazosin mesylate and is called an “alpha-blocker”. CARDURA is used to ...
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PRINCIPAL DISPLAY PANEL – 1 mg NDC 58151-074-01 - Cardura® (doxazosin) tablets - 1 mg* 100 Tablets - Rx only - Store at 25°C (77°F); excursions permitted - from 15°C to 30°C - (59°F to 86°F) [see USP Controlled ...
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PRINCIPAL DISPLAY PANEL – 2 mg NDC 58151-075-01 - Cardura® (doxazosin) tablets - 2 mg* 100 Tablets - Rx only - Store at 25°C (77°F); excursions permitted - from 15°C to 30°C - (59°F to 86°F) [see USP Controlled ...
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PRINCIPAL DISPLAY PANEL – 4 mg NDC 58151-076-01 - Cardura® (doxazosin) tablets - 4 mg* 100 Tablets - Rx only - Store at 25°C (77°F); excursions permitted - from 15°C to 30°C - (59°F to 86°F) [see USP Controlled ...
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PRINCIPAL DISPLAY PANEL – 8 mg NDC 58151-077-01 - Cardura® (doxazosin) tablets - 8 mg* 100 Tablets - Rx only - Store at 25°C (77°F); excursions permitted - from 15°C to 30°C - (59°F to 86°F) [see USP Controlled ...
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INGREDIENTS AND APPEARANCEProduct Information