Alfuzosin: uses, appearance and warnings

Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablet is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. ( 1.1 , 8.4 , 12.3 ) 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in the pediatric population. 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in the pediatric population.

Alfuzosin hydrochloride extended-release tablet, USP 10 mg is available as a yellow, round, flat-faced beveled-edge tablet. Engraved "APO" on one side, "ALF" over "10" on the other side. Extended-release tablet: 10 mg ( 3 )

Alfuzosin hydrochloride extended-release tablets, USP 10 mg are yellow, round, flat-faced beveled-edge tablets. Engraved “APO” on one side, “ALF” over “10” on the other side. They are supplied as follows: Bottles of 90 (NDC 60505-2850-9) Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from light and moisture. Keep alfuzosin hydrochloride extended-release tablets, USP out of reach of children.

Alfuzosin hydrochloride extended-release tablets are 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 alfuzosin hydrochloride extended-release tablets [ see Adverse Reactions ( 6.2 ) ] Moderate or severe hepatic impairment ( 4 , 8.7 , 12.3 ) Co-administration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) ( 4 , 5.4 , 7.1 , 12.3 ) Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients ( 4 , 6.2 )

Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates ( 5.1 ) Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min) ( 5.2 , 8.6 , 12.3 ) Use with caution in patients with mild hepatic impairment ( 5.3 , 8.7 , 12.3 ) Should not be used in combination with other alpha adrenergic antagonists ( 5.4 , 7.2 ) Prostate carcinoma should be ruled out prior to treatment ( 5.5 ) Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique ( 5.6) Discontinue alfuzosin hydrochloride extended-release tablets if symptoms of angina pectoris appear or worsen ( 5.8 ) Use with caution in patients with a history of QT prolongation or who are taking medications which prolong the QT interval ( 5.9 , 12.2 ) 5.1 Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of alfuzosin hydrochloride extended-release tablets. 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 may be an increased risk of hypotension/postural hypotension and syncope when taking alfuzosin hydrochloride extended-release tablets concomitantly with anti-hypertensive medication and nitrates. Care should be taken when alfuzosin hydrochloride extended-release tablets are administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications. 5.2 Patients with Renal Impairment Caution should be exercised when alfuzosin hydrochloride extended-release tablets are administered in patients with severe renal impairment (creatinine clearance < 30 mL/min) [ see Use in Specific Populations ( 8.6) and Clinical Pharmacology ( 12.3) ]. 5.3 Patients with Hepatic Impairment Alfuzosin hydrochloride extended-release tablets are contraindicated for use in patients with moderate or severe hepatic impairment [ see Contraindications ( 4 ), Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3) ]. Although the pharmacokinetics of alfuzosin hydrochloride extended-release tablets have not been studied in patients with mild hepatic impairment, caution should be exercised when alfuzosin hydrochloride extended-release tablets are administered to such patients [ see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3) ]. 5.4 Drug-Drug Interactions Potent CYP3A4 Inhibitors Alfuzosin hydrochloride extended-release tablets are 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) ]. Other alpha-adrenergic antagonists Alfuzosin hydrochloride extended-release tablets are an alpha-adrenergic antagonist and should not be used in combination with other alpha adrenergic antagonist [ see Drug Interactions ( 7.2 ) ]. Phosphodiesterase-5 (PDE5) Inhibitors PDE5-inhibitors are also vasodilators. Caution is advised for concomitant use of PDE5-inhibitors and alfuzosin hydrochloride extended-release tablets, as this combination can potentially cause symptomatic hypotension [ see Drug Interactions ( 7.4) ]. 5.5 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 to rule out the presence of carcinoma of the prostate prior to starting treatment with alfuzosin hydrochloride extended-release tablets. 5.6 Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been observed during cataract surgery in some patients on or previously treated with alpha adrenergic antagonists. 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 adrenergic antagonist therapy prior to cataract surgery. 5.7 Priapism Rarely (probably less than 1 in 50,000), alfuzosin, like other alpha-adrenergic antagonists, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition [ see Adverse Reactions ( 6.2) and Patient Counseling Information (17.3)] . 5.8 Coronary Insufficiency If symptoms of angina pectoris should appear or worsen, alfuzosin hydrochloride extended-release tablets 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 )].

Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800- 706-5575 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 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 alfuzosin hydrochloride 10 mg extended-release tablets. …

Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, can potentially cause symptomatic hypotension ( 5.4 , 7.4) 7.1 CYP3A4 Inhibitors Alfuzosin hydrochloride extended-release tablets are 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 ( 5.4) and Clinical Pharmacology ( 12.3) ]. 7.2 Alpha Adrenergic Antagonists The pharmacokinetic and pharmacodynamic interactions between alfuzosin hydrochloride extended-release tablets and other alpha-adrenergic antagonists have not been determined. …