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CARDURA® XL (doxazosin mesylate extended release tablets)

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CARDURA® XL Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

CARDURA® XL (doxazosin mesylate extended release tablets) is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

CARDURA XL is...

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2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

The initial dose of CARDURA XL, 4 mg given once daily, should be administered with breakfast. Depending...

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3 DOSAGE FORMS AND STRENGTHS

White, round, film-coated tablets containing 4 mg and 8 mg doxazosin mesylate.

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4 CONTRAINDICATIONS

CARDURA XL is contraindicated in patients with a known hypersensitivity to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of the inert ingredients. Allergic reactions to doxazosin and...

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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 3A4 Inhibitors

No in vivo drug interaction studies were conducted with CARDURA XL.

...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

CARDURA XL is not...

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10 OVERDOSAGE

There is no experience with CARDURA XL overdosage. Overdosage experience with the doxazosin IR is limited. Two adolescents who each intentionally ingested 40 mg doxazosin IR with diclofenac or paracetamol were...

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11 DESCRIPTION

CARDURA XL contains doxazosin mesylate which is a quinazoline compound with the chemical name 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The symptoms associated with benign prostatic hyperplasia (BPH), such as urinary frequency, nocturia, weak stream,...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis...

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14 CLINICAL STUDIES

14.1 Studies in Patients with BPH

Two controlled clinical studies were conducted with CARDURA XL in BPH patients, followed by an open-label...

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16 HOW SUPPLIED/STORAGE AND HANDLING

CARDURA XL (doxazosin mesylate extended release tablets) is available as 4 mg (white, imprinted with CXL 4) and 8 mg (white, imprinted with CXL 8) tablets.

Bottle of 30: 4 mg (NDC...

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17 PATIENT COUNSELING INFORMATION

See

17.1 Postural Hypotension

Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness or syncope,...

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PATIENT INFORMATION
CARDURA® XL (kar-DUR-a eks el)
(doxazosin mesylate)
Tablets

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