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CARDURA XL Extended-release tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

Συγγραφείς

Roerig

Λέξεις κλειδιά

0049-2710 0049-2720

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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 not indicated for the treatment of ...

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 on the patients symptomatic response and tolerability, the dose may ...

3. Dosage Forms and Strengths

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

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 ...

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 XL. However, infrequently, symptomatic postural ...

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 compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse events have been identified during post-approval use of doxazosin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 CYP 3A4 Inhibitors No <em>in vivo</em> drug interaction studies were conducted with CARDURA XL. <em>In vitro</em> studies suggest that doxazosin is a substrate of CYP 3A4. Caution should be exercised ...

8.1. Pregnancy

Risk Summary CARDURA XL is not indicated for use in females and is not indicated for the treatment of hypertension. The limited available data with CARDURA XL in pregnant women are not sufficient to inform ...

8.2. Lactation

Risk Summary CARDURA XL is not indicated for use in females and is not indicated for the treatment of hypertension. Doxazosin is present in human milk. There is no information on the effects of CARDURA ...

8.4. Pediatric Use

The safety and effectiveness of CARDURA XL in pediatric patients have not been established.

8.5. Geriatric Use

The incidence of hypotension with CARDURA XL use appears to be age related and more prevalent in patients 70 years or older. At steady state, increases of 27% in maximum plasma concentrations (C<sub>max ...

8.6. Hepatic Impairment

Since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended. CARDURA XL should be administered with caution to patients with mild or moderate ...

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 ...

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 empirical ...

12.1. Mechanism of Action

The symptoms associated with benign prostatic hyperplasia (BPH), such as urinary frequency, nocturia, weak stream, hesitancy, and incomplete emptying are related to two components, anatomical (static) ...

12.2. Pharmacodynamics

Administration of CARDURA XL to patients with symptomatic BPH resulted in a statistically significant improvement in maximum urinary flow rate <em>[see Clinical Studies (14.1)]</em>.

12.3. Pharmacokinetics

The pharmacokinetics of CARDURA XL is different from that of doxazosin IR. CARDURA XL provides a controlled release of doxazosin over a 24-hour period. Absorption Pharmacokinetic parameters describing ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis and Mutagenesis Doxazosin mesylate was not carcinogenic to rats or mice when administered daily for 2 years at doses up to 40 mg/kg/day or 120 mg/kg/day, respectively. Systemic drug exposures, ...

13.2. Animal Toxicology and/or Pharmacology

Studies in Sprague-Dawley rats after 6, 12, and 18 months, and in CD-1 mice after 18 months of dietary administration, showed an increased incidence of myocardial necrosis or fibrosis at doxazosin base ...

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 extension study. Study 1 was a randomized, double-blind, parallel-group, ...

16.1. How Supplied

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 0049-2710-30) Bottle ...

16.2. Storage and Handling

Recommended Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

See FDA-approved patient labeling (Patient Information). 17.1 Postural Hypotension Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness or ...