CARDURA- doxazosin mesylate tablet CARDURA- doxazosin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)

Available from:

ROERIG

INN (International Name):

DOXAZOSIN MESYLATE

Composition:

DOXAZOSIN 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CARDURA is indicated for the treatment of the signs and symptoms of BPH. CARDURA is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive dru

Product summary:

CARDURA (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 (green or white) of doxazosin as the free base. NDC 0049-2750-66 (Bottle of 100) NDC 0049-2750-41 (Unit dose of 100) 1 mg White, capsule shaped tablet engraved "Cardura" on one side, scored and engraved "1 mg" on the other side. NDC 0049-2410-10 (Bottle of 100) 1 mg White, round tablet engraved "CN1" on one side and "Pfizer" on the other side. NDC 0049-2760-66 (Bottle of 100) NDC 0049-2760-41 (Unit dose of 100) 2 mg Yellow, capsule shaped tablet engraved "Cardura" on one side, scored and engraved "2 mg" on the other side. NDC 0049-2512-10 (Bottle of 100) 2 mg White capsule shaped tablet with break score and engraved "CN2" on one side and "Pfizer" on the other side. NDC 0049-2770-66 (Bottle of 100) NDC 0049-2770-41 (Unit Dose of 100) 4 mg Orange, capsule shaped tablet engraved "Cardura" on one side, scored and engraved "4 mg" on the other side. NDC 0049-2614-10 (Bottle of 100) 4 mg White, diamond shaped tablet with break score and engraved "CN4" on one side and "Pfizer" on the other side. NDC 0049-2780-66 (Bottle of 100) NDC 0049-2780-41 (Unit dose of 100) 8 mg Green, capsule shaped tablet engraved "Cardura" on one side, scored and engraved "8 mg" on the other side. NDC 0049-2716-10 (Bottle of 100) 8 mg White, capsule shaped tablet with break score and engraved "CN8" on one side and "Pfizer" on the other side. Recommended Storage: Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

CARDURA- DOXAZOSIN MESYLATE TABLET
ROERIG
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE 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 U.S. APPROVAL: 1990
INDICATIONS AND USAGE
CARDURA is an alpha adrenergic antagonist indicated for: (1)
Signs and symptoms of Benign Prostatic Hyperplasia (BPH)
Treatment of Hypertension
DOSAGE AND ADMINISTRATION
For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose
may be titrated at 1 to 2-week
intervals, up to 8 mg once daily. (2.2)
For the treatment hypertension: Initiate therapy at 1 mg once daily.
Dose may be titrated as needed,
up to 16 mg once daily. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, 4 mg, 8 mg.
CONTRAINDICATIONS
Hypersensitivity to doxazosin, other quinazolines, or any other
ingredient in CARDURA. (4)
WARNINGS AND PRECAUTIONS
Postural hypotension with or without syncope may occur. (5.1)
Risk of Intraoperative Floppy Iris Syndrome during cataract surgery.
(5.2)
Screen for the presence of prostate cancer prior to treatment for BPH
and at regular intervals
afterwards. (5.3)
ADVERSE REACTIONS
The most commonly reported adverse reactions from clinical trials are
Fatigue, malaise, hypotension, and
dizziness. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER, INC. AT
1-800-438-1985 OR FDA AT
1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
Strong cytochrome P450 (CYP) 3A inhibitors may increase exposure to
doxazosin and increased risk of
hypotension. (7.1)
Concomitant administration of CARDURA with a phosphodiesterase-5
(PDE-5) inhibitor can result in
additive blood pressure lowering effects and symptomatic hypotension.
(7.2)
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: Monitor for hypotension. (8.6, 12.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
®
1
1.1 Benign