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warnings and cautions
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-blockers, 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 may be an increased risk of hypotension/postural hypotension and syncope when taking UROXATRAL concomitantly with anti-hypertensive medication and nitrates. Care should be taken when UROXATRAL is administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications. 5.2 Renal Impairment Caution should be exercised when UROXATRAL is administered in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . 5.3 Hepatic Impairment UROXATRAL is contraindicated for use in patients with moderate or severe hepatic impairment [see Use in Specific Populations (8.7) and Contraindications (4) ] . The pharmacokinetics of UROXATRAL have not been studied in patients with mild hepatic impairment [see Clinical Pharmacology (12.3) ] . 5.4 Pharmacodynamic Drug-Drug Interactions UROXATRAL is a selective alpha-blocker and should not be used in combination with other alpha-blockers [see Drug Interactions (7.2) ] . Because of the vasodilatory effects of alpha-blockers and inhibitors of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5-inhibitors), patients treated with alpha-blocker therapy should be hemodynamically stable before treatment with PDE5-inhibitors is initiated. [see Drug Interactions (7.4) ] . 5.5 Pharmacokinetic Drug-Drug Interactions UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) since alfuzosin blood levels are increased [see Contraindications (4) , Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] . 5.6 Prostatic Carcinoma Carcinoma of the prostate and benign prostatic hyperplasia (BPH) cause many of the same symptoms. These two diseases frequently coexist. Therefore, patients thought to have BPH should be examined prior to starting treatment with UROXATRAL to rule out the presence of carcinoma of the prostate. 5.7 Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been observed during cataract surgery in some patients on or previously treated with alpha-1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient's ophthalmologist should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha-1 blocker therapy prior to cataract surgery. 5.8 Coronary Insufficiency If symptoms of angina pectoris should appear or worsen, UROXATRAL should be discontinued. 5.9 Patients with Congenital or Acquired QT Prolongation Use with caution in patients with acquired or congenital QT prolongation or who are taking medications that prolong the QT interval [see Clinical Pharmacology (12.2) ] . 5.10 Laboratory Test Interactions No laboratory test interactions with UROXATRAL tablets are known.
6 ADVERSE REACTIONS 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The incidence of treatment-emergent adverse events has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received UROXATRAL (alfuzosin HCl) 10 mg extended-release tablets. In these studies, 4% of patients taking UROXATRAL (alfuzosin HCl) 10 mg extended-release tablets withdrew from the study due to adverse events, compared with 3% in the placebo group. Table 1 summarizes the treatment-emergent adverse events that occurred in ≥2% of patients receiving UROXATRAL, and at an incidence numerically higher than that of the placebo group. In general, the adverse events seen in long-term use were similar in type and frequency to the events described below for the 3-month trials. Table 1 — Treatment-Emergent Adverse Events Occurring in ≥2% of UROXATRAL-Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Studies Adverse Event Placebo (n=678) UROXATRAL (n=473) Dizziness 19 (2.8%) 27 (5.7%) Upper respiratory tract infection 4 (0.6%) 14 (3.0%) Headache 12 (1.8%) 14 (3.0%) Fatigue 12 (1.8%) 13 (2.7%) The following adverse events, reported by between 1% and 2% of patients receiving UROXATRAL and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system: Body as a whole: pain Gastrointestinal system: abdominal pain, dyspepsia, constipation, nausea Reproductive system: impotence Respiratory system: bronchitis, sinusitis, pharyngitis Signs and Symptoms of Orthostasis in Clinical Studies: The adverse reactions related to orthostasis that occurred in the double-blind phase 3 studies with alfuzosin 10 mg are summarized in Table 2. Approximately 20% to 30% of patients in these studies were taking antihypertensive medication. Table 2— Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Studies Symptoms Placebo (n=678) UROXATRAL (n=473) Dizziness 19 (2.8%) 27 (5.7%) Hypotension or postural hypotension 0 2 (0.4%) Syncope 0 1 (0.2%) Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies. Decreased systolic blood pressure (≤90 mm Hg, with a decrease ≥20 mm Hg from baseline) was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 UROXATRAL patients. Decreased diastolic blood pressure (≤50 mm Hg, with a decrease ≥15 mm Hg from baseline) was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the UROXATRAL patients. A positive orthostatic test (decrease in systolic blood pressure of ≥20 mm Hg upon standing from the supine position) was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the UROXATRAL patients. 6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of UROXATRAL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. General disorders: edema Cardiac disorders: tachycardia, chest pain, angina pectoris in patients with pre-existing coronary artery disease Gastrointestinal disorders: diarrhea Hepatobiliary disorders: hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation) Respiratory system disorders: rhinitis Reproductive system disorders: priapism Skin and subcutaneous tissue disorders: rash, pruritis, urticaria, angioedema Vascular disorders: flushing During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in some patients on or previously treated with alpha-1 blockers [see Warnings and Precautions (5.7) ] . 7 DRUG INTERACTIONS 7.1 CYP3A4 Inhibitors UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased. [see Contraindications (4) , Warnings and Precautions (5.5) and Clinical Pharmacology (12.3) ] . 7.2 Alpha-blockers The pharmacokinetic and pharmacodynamic interactions between UROXATRAL and other alpha-blockers have not been determined. However, interactions may be expected, and UROXATRAL should NOT be used in combination with other alpha-blockers [see Warnings and Precautions (5.4) ] . 7.3 Antihypertensive Medication and Nitrates There may be an increased risk of hypotension/postural hypotension and syncope when taking UROXATRAL concomitantly with anti-hypertensive medication and nitrates [see Warnings and Precautions (5.1) ] . 7.4 PDE5 Inhibitors Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Patients treated with alpha-blockers should be hemodynamically stable before treatment with PDE5 inhibitors initiation [see Warnings and Precautions (5.4) ] . 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B . UROXATRAL is not indicated for use in women. There was no evidence of teratogenicity or embryotoxicity in rats at maternal (oral gavage) doses up to 250 mg/kg/day, corresponding to systemic exposure levels 1,200-fold higher than in humans. In rabbits, up to the dose of 100 mg/kg/day (approximately 3 times the clinical dose by body surface area) given orally (via gavage), no evidence of fetal toxicity or teratogenicity was seen. Gestation was slightly prolonged in rats with a maternal dose >5 mg/kg/day (oral gavage), which corresponds to systemic exposure levels (based on AUC of unbound drug) 12 times higher than human exposure levels, but there were no difficulties with parturition. 8.4 Pediatric Use UROXATRAL is not indicated for use in children. 8.5 Geriatric Use Of the total number of subjects in clinical studies of UROXATRAL, 48% were 65 years of age and over, whereas 11% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects [see Clinical Pharmacology (12.3) ] 8.6 Renal Impairment Systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12.3) ] . In phase 3 studies, the safety profile of patients with mild (n=172) or moderate (n=56) renal impairment was similar to the patients with normal renal function in those studies. Safety data are available in only a limited number of patients (n=6) with creatinine clearance below 30 mL/min; therefore, caution should be exercised when UROXATRAL is administered in patients with severe renal impairment [see Warnings and Precautions (5.2) ] . 8.7 Hepatic Impairment The pharmacokinetics of UROXATRAL have not been studied in patients with mild hepatic impairment. UROXATRAL is contraindicated for use in patients with moderate or severe hepatic impairment [see Contraindications (4) , Warnings and Precautions (5.3) and Clinical Pharmacology (12.3) ] .