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DOXAZOSIN Mesylate Tablet (GREENSTONE LLC)

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DOXAZOSIN Mesylate Tablet (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Benign Prostatic Hyperplasia (BPH)

Doxazosin tablet is indicated for the treatment of the signs and symptoms of BPH.

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2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

Following the initial dose and with each dose increase of Doxazosin, monitor blood pressure for at least 6 hours...

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3 DOSAGE FORMS AND STRENGTHS

Tablets: 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) or 8 mg (green or white).

Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg or 8 mg doxazosin (...

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4 CONTRAINDICATIONS

The use of Doxazosin tablet 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...

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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...

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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...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The limited available...

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10 OVERDOSAGE

Experience with Doxazosin tablet overdosage is limited. Two adolescents, who each intentionally ingested 40 mg Doxazosin tablet with diclofenac or acetaminophen, were treated with gastric lavage with activated...

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11 DESCRIPTION

Doxazosin is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of Doxazosin is 1-(4-amino-6,7-dimethoxy-2-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Benign Prostatic Hyperplasia (BPH)...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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14 CLINICAL STUDIES

14.1 Benign Prostatic Hyperplasia (BPH)

The efficacy of Doxazosin tablet was evaluated extensively in over 900 patients with BPH in double-blind,...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Doxazosin is available as tablets for oral administration. Each tablet contains Doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow or white), 4 mg (orange or white) or 8 mg (...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

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