USAGE
1.1 Important Limitations of Use
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Postural Hypotension
5.2 Patients with Renal Impairment
5.3 Patients with Hepatic Impairment
5.4 Drug-Drug Interactions
5.5 Prostatic Carcinoma
5.6 Intraoperative Floppy Iris Syndrome (IFIS)
5.7 Priapism
5.8 Coronary Insufficiency
5.9 Patients with Congenital or Acquired QT Prolongation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 CYP3A4 Inhibitors
7.2 Alpha Adrenergic Antagonists
7.3 Antihypertensive Medication and Nitrates
7.4 PDE5 Inhibitors
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Hypotension/Syncope
17.2 Intraoperative Floppy Iris Syndrome
17.3 Priapism
17.4 Instructions of Use
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FULL PRESCRIBING INFORMATION
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1 INDICATIONS AND USAGE
UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
1.1 Important Limitations of Use
UROXATRAL is not indicated for the treatment of hypertension.
UROXATRAL is not indicated for use in the pediatric population.
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2 DOSAGE AND ADMINISTRATION
The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, Uroxatral should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.
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3 DOSAGE FORMS AND STRENGTHS
UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10.
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4 CONTRAINDICATIONS
UROXATRAL is contraindicated for use:
•in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
•with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
•in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of UROXATRAL tablets [see Adverse Reactions (6.2)]
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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 administration of UROXATRAL. As with other alpha adrenergic antagonists, there is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur. There |
