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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 (alfuzosin hcl) , 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 (alfuzosin hcl) -Treated Patients and More Frequently than with Placebo
in 3-Month Placebo-Controlled Clinical Studies
|Adverse Event|| Placebo
|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 (alfuzosin hcl) 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
Reproductive system: impotence
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
|Dizziness||19 (2.8%)||27 (5.7%)|
|Hypotension or postural hypotension||0||2 (0.4%)|
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 (alfuzosin hcl) 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 (alfuzosin hcl) 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 (alfuzosin hcl) patients.
The following adverse reactions have been identified during post approval use of UROXATRAL (alfuzosin hcl) . 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
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
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].
Read the Uroxatral (alfuzosin hcl) Side Effects Center for a complete guide to possible side effects »
UROXATRAL (alfuzosin hcl) is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
The pharmacokinetic and pharmacodynamic interactions between UROXATRAL (alfuzosin hcl) and other alpha-blockers have not been determined. However, interactions may be expected, and UROXATRAL (alfuzosin hcl) should NOT be used in combination with other alpha-blockers [see WARNINGS AND PRECAUTIONS].
Antihypertensive Medication and Nitrates
There may be an increased risk of hypotension/postural hypotension and syncope when taking UROXATRAL (alfuzosin hcl) concomitantly with anti-hypertensive medication and nitrates [see WARNINGS AND PRECAUTIONS].
Caution is advised when alpha adrenergic blocking agents, including UROXATRAL (alfuzosin hcl) , are co-administered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 5/3/2010
This monograph has been modified to include the generic and brand name in many instances.
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