Label: DOXAZOSIN tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 15, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension - Doxazosin tablets are indicated for the ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosing Information - Following the initial dose and with each dose increase of doxazosin tablets, monitor blood pressure for at least 6 hours following administration. If doxazosin tablets ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Doxazosin Tablets, USP are available as 1 mg (white to off-white, round, scored tablets, imprinted "APO" on one side and "093" with a partial bisect on the other side), 2 mg (white to off-white ...
  • 4 CONTRAINDICATIONS
    The use of doxazosin tablets is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of its components.
  • 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 doxazosin tablets. However, infrequently ...
  • 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 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - The limited available data with doxazosin tablets in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage ...
  • 10 OVERDOSAGE
    Experience with doxazosin overdosage is limited. Two adolescents, who each intentionally ingested 40 mg doxazosin tablets with diclofenac or acetaminophen, were treated with gastric lavage with ...
  • 11 DESCRIPTION
    Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7 ...
  • 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, and ...
  • 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 doses of ...
  • 14 CLINICAL STUDIES
    14.1 Benign Prostatic Hyperplasia (BPH) The efficacy of doxazosin was evaluated extensively in over 900 patients with BPH in double-blind, placebo-controlled trials. Doxazosin tablets treatment ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Doxazosin tablets, USP are available as white to off-white tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg, 4 mg or 8 mg of the active ...
  • 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 ...
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION - Doxazosin Tablets - (dox az' oh sin) What are doxazosin tablets? Doxazosin tablets are a prescription medicine that contains doxazosin mesylate and is called an ...
  • Package/Label Display Panel
    MAJOR® NDC 0904-5522-61 - Unit Dose - Doxazosin - Tablets, USP - 1 mg* Pharmacist: Dispense with - Patient Information - 100 TABLETS (10 x 10) Rx only
  • Package/Label Display Panel
    MAJOR® NDC 0904-5523-61 - Unit Dose - Doxazosin - Tablets, USP - 2 mg* Pharmacist: Dispense with - Patient Information - 100 TABLETS (10 x 10) Rx only
  • Package/Label Display Panel
    MAJOR® NDC 0904-5524-61 - Unit Dose - Doxazosin - Tablets, USP - 4 mg* Pharmacist: Dispense with - Patient Information - 100 TABLETS (10 x 10) Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information