Cardura XL 8 mg/1
doxazosin mesylate · TABLET, FILM COATED, EXTENDED RELEASE · Viatris Specialty LLC
Cardura XL is a tablet, film coated, extended release containing doxazosin mesylate at 8 mg/1, taken oral. Manufactured by Viatris Specialty LLC.
Key Facts
- Brand Name
- Cardura XL
- Generic Name
- doxazosin mesylate
- NDC Code (Product)
58151-079- Manufacturer
- Viatris Specialty LLC
- Strength
- 8 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA021269
- Marketing Start
- 01/04/2024
Recall History
Viatris Inc
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Inc
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Inc
Failed Impurities/Degradation Specifications
Pfizer Inc.
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Viatris Inc
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE CARDURA ® XL is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CARDURA XL is not indicated for the treatment of hypertension. CARDURA XL is an alpha 1 adrenergic antagonist indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. ( 1 ) CARDURA XL is not indicated for the treatment of hypertension. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended starting dose (initial therapy or switching from immediate-release): 4 mg once daily with breakfast ( 2.1 , 2.2 ) Dose range: 4 to 8 mg once daily ( 2.1 ) 2.1 General Dosing Information The initial dose of CARDURA XL, 4 mg given once daily, should be administered with breakfast. Depending on the patient’s symptomatic response and tolerability, the dose may be increased to 8 mg, the maximum recommended dose. The recommended titration interval is 3-4 weeks. If CARDURA XL administration is discontinued for several days, therapy should be restarted using the 4 mg once daily dose. Tablets should be swallowed whole, and must not be chewed, divided, cut, or crushed. 2.2 Patients Switching from CARDURA to CARDURA XL If switching from CARDURA immediate-release (IR) to CARDURA XL, therapy should be initiated with the lowest dose (4 mg once daily). Prior to starting therapy with CARDURA XL, the final evening dose of CARDURA should not be taken. 2.3 Concomitant Administration with PDE-5 Inhibitors Concomitant administration of CARDURA XL with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension; therefore, …
Contraindications
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 other quinazolines have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see Adverse Reactions (6.2) ] . Patients with known sensitivity to doxazosin, other quinazolines, or any of the inert ingredients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Caution should be exercised when concomitantly administering CARDURA XL with a strong cytochrome P450 (CYP) 3A4 inhibitor. ( 7.1 ) Concomitant administration of CARDURA XL with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. ( 7.3 ) 7.1 CYP 3A4 Inhibitors No in vivo drug interaction studies were conducted with CARDURA XL. In vitro studies suggest that doxazosin is a substrate of CYP 3A4. Caution should be exercised when concomitantly administering CARDURA XL with a strong CYP 3A4 inhibitor, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole [see Clinical Pharmacology (12.3) ] . 7.2 Antihypertensive Medications Pharmacodynamic interactions between CARDURA XL and antihypertensive medications or other vasodilating agents have not been determined. 7.3 PDE-5 Inhibitors Concomitant administration of CARDURA XL with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension [see Dosage and Administration (2.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions from clinical trials are asthenia, headache, hypotension, and dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in clinical practice. The incidence of adverse reactions was derived from two controlled efficacy and safety trials involving 1473 BPH patients. In Study 1, CARDURA XL (n = 317) was compared to doxazosin IR tablets (n = 322) and to placebo (n = 156). In Study 2, CARDURA XL (n = 350) was compared just to doxazosin IR tablets (n = 330). In both of these studies, CARDURA XL was initiated at a dose of 4 mg, which could be increased by the investigator to 8 mg after seven weeks if an adequate response was not seen [see Clinical Studies (14.1) ] . Similarly, doxazosin IR was begun at a dose of 1 mg, which was increased in all pat…
Frequently Asked Questions
What is Cardura XL used for?
Cardura XL contains doxazosin mesylate. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Cardura XL a controlled substance?
Cardura XL is not classified as a controlled substance by the DEA.
What is the generic name for Cardura XL?
The generic name for Cardura XL is doxazosin mesylate. There are 11 other brand versions of doxazosin mesylate.
What is the NDC code for Cardura XL 8 mg/1?
The NDC (National Drug Code) for Cardura XL 8 mg/1 is 58151-079, listed by Viatris Specialty LLC.