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alfuzosin hcl er 10 mg tablet generic uroxatral

Out of Stock Manufacturer APOTEX CORP 60505285001
Out of Stock

Uses

Benign Prostatic Hyperplasia

Alfuzosin hydrochloride is used to reduce urinary obstruction and relieve associated manifestations in patients with symptomatic benign prostatic hyperplasia (BPH, benign prostatic hypertrophy). Alfuzosin relieves moderate to severe irritative (e.g., frequency, urgency, nocturia) and obstructive (e.g., hesitancy, interrupted or weak stream, sensation of incomplete bladder emptying or straining) manifestations and improves urinary flow rates in a substantial proportion of patients. Although drug therapy is not curative, α1-adrenergic blocking agents (e.g., alfuzosin) may be a useful alternative to surgery, particularly in those who are awaiting or are unwilling to undergo surgical correction of the hyperplasia (e.g., via transurethral resection of the prostate [TURP]) or who are not candidates for such surgery.

Results of several controlled studies indicate that alfuzosin hydrochloride is more effective than placebo in the management of BPH. In addition, results of several comparative studies in patients with BPH suggest that the drug (as conventional formulations) is at least as effective as other α1-adrenergic blocking agents (e.g., prazosin, tamsulosin). While symptomatic improvement has been maintained for up to 3 years of alfuzosin therapy in some patients, the long-term effects of α1-adrenergic blocking agents on the need for surgery and on the frequency of developing BPH-associated complications such as acute urinary obstruction remain to be established.

Combination therapy with an α1-adrenergic blocker and a 5α-reductase inhibitor (e.g., finasteride) has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression; combined therapy also can reduce the risks of long-term acute urinary retention and the need for invasive therapy compared with α-blocker monotherapy.

For additional information on the use of α1-blockers in the management of BPH, .

Other Uses

The manufacturer states that alfuzosin hydrochloride should not be used in the management of hypertension.

Dosage and Administration

General

Alfuzosin hydrochloride is administered orally. For the management of benign prostatic hyperplasia (BPH), the recommended adult dosage of alfuzosin hydrochloride is 10 mg once daily. Because the extent of absorption is decreased by 50% under fasting conditions, alfuzosin hydrochloride should be taken immediately after the same meal each day. The extended-release tablets should not be chewed or crushed.

Special Populations

The manufacturer states that use of alfuzosin hydrochloride is contraindicated in patients with moderate to severe hepatic impairment.(See Hepatic Impairment under Cautions: Special Populations.) Pharmacokinetics of alfuzosin hydrochloride have not been studied in patients with mild hepatic impairment, and the manufacturer does not provide guidelines for dosage adjustment in such patients.

No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 mL/minute) nor in geriatric patients. Caution is advised if alfuzosin hydrochloride is used in patients with severe renal impairment (creatinine clearance less than 30 mL/minute).(See Renal Impairment under Cautions: Special Populations.)

Cautions

Contraindications

Moderate or severe hepatic impairment (Child-Pugh class B or C).

Concomitant use with potent inhibitors of cytochrome P-450 (CYP) isoenzyme 3A4 (e.g., itraconazole, ketoconazole, ritonavir).(See Drug Interactions.)

Known hypersensitivity to alfuzosin hydrochloride or any ingredient in the formulation.

Warnings/Precautions

Warnings

Postural Hypotension

Like other α-adrenergic blocking agents, alfuzosin can cause postural hypotension with or without symptoms (e.g., dizziness), and the drug should be administered with caution to patients with symptomatic hypotension or patients who have had a hypotensive response to other drugs. During initiation of alfuzosin therapy, patients should be cautioned to avoid situations where injury could result if syncope occurs. If syncope occurs, the patient should be placed in a recumbent position and treated supportively as necessary.

General Precautions

Prostate Cancer

Because manifestations of prostate cancer may mimic those of benign prostatic hyperplasia (BPH), the possibility of prostate cancer should be excluded prior to initiation of therapy.

Intraoperative Floppy Iris Syndrome

Intraoperative floppy iris syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients currently receiving or previously treated with α1-adrenergic blocking agents. IFIS is a variant of small pupil syndrome and is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with mydriatics, and potential prolapse of the iris toward the phacoemulsification incisions. Male patients being considered for cataract surgery should be advised to inform their ophthalmologist of current or prior therapy with α1-adrenergic blockers, including alfuzosin. If a patient has received such agents, the ophthalmologist should be prepared to modify the surgical technique (e.g., through use of iris hooks, iris dilator rings, or viscoelastic substances) to minimize complications of IFIS. There does not appear to be a benefit from discontinuing α1-blocker therapy prior to cataract surgery.

Prolongation of QT Interval

Prolongation of the QT interval has been observed with higher than recommended dosages of alfuzosin; however, development of atypical ventricular tachycardia (torsades de pointes) has not been reported to date in patients receiving the drug. The manufacturer states that the QT-interval prolongation observed with higher than recommended dosages of the drug should be considered in clinical decisions regarding use of alfuzosin in patients with known prolongation of the QT interval and in those receiving drugs known to prolong the QT interval.

Angina Pectoris

If symptoms of angina pectoris develop or worsen in patients with coronary artery disease, alfuzosin should be discontinued.

Specific Populations

Pregnancy

Category B. Alfuzosin is not intended for use in women.

Lactation

Alfuzosin is not intended for use in women.

Pediatric Use

Alfuzosin is not intended for use in children.

Geriatric Use

When the total number of patients studied in clinical trials of alfuzosin is considered, 48% were 65 years of age or older, while 11% were 75 years of age or older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients, and other clinical experience revealed no evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.

Hepatic Impairment

Apparent plasma clearance of alfuzosin is decreased in patients with moderate or severe hepatic impairment (Child-Pugh class B or C), resulting in 3- to 4-fold higher plasma concentrations of alfuzosin in these patients compared with healthy individuals. Alfuzosin is contraindicated in patients with moderate or severe hepatic impairment.

Renal Impairment

Systemic exposure to alfuzosin is increased by approximately 50% in patients with renal impairment (creatinine clearance less than 80 mL/minute) relative to those with normal renal function. In phase III studies, the safety profile of alfuzosin hydrochloride in patients with mild (creatinine clearance of 60-80 mL/minute) or moderate (creatinine clearance of 30-59 mL/minute) renal impairment was similar to that in patients with normal renal function (creatinine clearance exceeding 80 mL/minute). Safety data are available for only a limited number of patients with severe renal impairment (creatinine clearance less than 30 mL/minute). Therefore, the manufacturer recommends that alfuzosin be used with caution in patients with severe renal impairment.

Common Adverse Effects

Adverse effects reported in 2% or more of patients receiving alfuzosin and at an incidence higher than that reported with placebo include dizziness, upper respiratory tract infection, headache, and fatigue.

Drug Interactions

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interaction (increased plasma alfuzosin concentrations) with inhibitors of the cytochrome P-450 (CYP) 3A4 isoenzyme. Concomitant use of potent inhibitors of the CYP 3A4 isoenzyme (e.g., itraconazole, ketoconazole, ritonavir) with alfuzosin is contraindicated.

Drugs that Prolong the QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation).(See Prolongation of QT Interval under Cautions: Warnings.)

α1-Adrenergic Blocking Agents

Potential pharmacologic interaction (additive cardiovascular effects) with other α1-adrenergic blocking agents. Concomitant use is not recommended by the manufacturer.

Atenolol

Potential pharmacologic (additive cardiovascular effects) and pharmacokinetic (increased plasma concentrations of alfuzosin and atenolol) interactions.

Diltiazem

Potential pharmacologic (additive cardiovascular effects) and pharmacokinetic (increased plasma concentrations of alfuzosin and diltiazem) interactions.

Hydrochlorothiazide

No pharmacologic or pharmacokinetic interaction observed between hydrochlorothiazide and alfuzosin.

Cimetidine

Potential pharmacokinetic interaction (increased plasma alfuzosin concentrations).

Digoxin

Pharmacokinetic interaction unlikely.

Warfarin

Pharmacologic interaction unlikely.

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