Data from FDA - Curated by EPG Health - Last updated 31 December 2017

Indication(s)

1 INDICATIONS AND USAGE Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride is an alpha adrenergic antagonist, indicated for treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride is not indicated for the treatment of hypertension. (1.1) Alfuzosin hydrochloride is not indicated for use in the pediatric population. (1.1, 8.4 , 12.3) 1.1 Important Limitations of Use Alfuzosin hydrochloride is not indicated for the treatment of hypertension. Alfuzosin hydrochloride is not indicated for use in the pediatric population.

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Advisory information

contraindications
4 CONTRAINDICATIONS Alfuzosin hydrochloride 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 alfuzosin hydrochloride 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)
Adverse reactions
6 ADVERSE REACTIONS 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 Exelan Pharmaceuticals Inc., at 1-855-295-7455 or www.exelanpharma.com 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. In these trials, 4% of patients taking alfuzosin hydrochloride 10 mg extended-release tablets withdrew from the trial due to adverse reactions, compared with 3% in the placebo group. Table 1 summarizes adverse reactions that occurred in ≥2% of patients receiving alfuzosin hydrochloride, and at a higher incidence than that of the placebo group. In general, the adverse reactions seen in long-term use were similar in type and frequency to the events described below for the 3-month trials. Table 1 —Adverse Reactions Occurring in ≥2% of Alfuzosin Hydrochloride Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Trials Adverse Event Placebo ( n = 678 ) Alfuzosin HCl ( n = 473 ) Dizziness Upper respiratory tract infection Headache Fatigue 19 (2.8%) 4 (0.6%) 12 (1.8%) 12 (1.8%) 27 (5.7%) 14 (3.0%) 14 (3.0%) 13 (2.7%) The following adverse reactions, reported by between 1% and 2% of patients receiving alfuzosin hydrochloride 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 Trials: The adverse reactions related to orthostasis that occurred in the double-blind phase 3 trials with alfuzosin 10 mg are summarized in Table 2. Approximately 20% to 30% of patients in these trials were taking antihypertensive medication. Table 2 — Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Trials Symptoms Placebo ( n = 678 ) Alfuzosin HCl ( n = 473 ) Dizziness Hypotension or postural hypotension Syncope 19 (2.8%) 0 0 27 (5.7%) 2 (0.4%) 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 alfuzosin hydrochloride 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 alfuzosin hydrochloride 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 alfuzosin hydrochloride patients. 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of alfuzosin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders: edema Cardiac disorders: tachycardia, chest pain, angina pectoris in patients with pre-existing coronary artery disease, atrial fibrillation 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 Blood and lymphatic system disorders: thrombocytopenia 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 adrenergic antagonists [see Warnings and Precautions (5.6)].

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride should be taken with food and with the same meal each day. The tablets should not be chewed or crushed. 10 mg once daily with food and with the same meal each day (2) Tablets should not be chewed or crushed (2, 12.3)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B. Alfuzosin hydrochloride is not indicated for use in women, and there are no studies of alfuzosin in pregnant women. Alfuzosin was not teratogenic, embryotoxic or fetotoxic in rats at plasma exposure levels (based on AUC of unbound drug) up to 1200 times (maternal oral dose of 250 mg/kg/day) the maximum recommended human dose (MRHD) of 10 mg. In rabbits administered up to 3 times the MRHD (based on body surface area) (maternal oral dose of 100 mg/kg/day) no embryofetal toxicity or teratogenicity was observed. Gestation was slightly prolonged in rats at exposure levels (based on AUC of unbound drug) approximately 12 times (greater than 5 mg/kg/day oral maternal dose) the MRHD, but difficulties with parturition were not observed. 8.4 Pediatric Use Alfuzosin hydrochloride extended release tablets are not indicated for use in the pediatric population. Additional information regarding a clinical study in which efficacy was not demonstrated in pediatric patients ages 2 to 16 years is approved for Sanofi-Aventis U.S. LLC’s alfuzosin hydrochloride extended-release tablets. However, due to Sanofi-Aventis U.S. LLC’s marketing exclusivity rights, this drug is not labeled with that pediatric information. 8.5 Geriatric Use Of the total number of subjects in clinical studies of alfuzosin hydrochloride, 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, but greater sensitivity of some older individuals cannot be ruled out [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 alfuzosin hydrochloride is administered in patients with severe renal impairment [see Warnings and Precautions(5.2)]. 8.7 Hepatic impairment The pharmacokinetics of alfuzosin hydrochloride have not been studied in patients with mild hepatic impairment. Alfuzosin hydrochloride 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 )].

Interactions

7 DRUG INTERACTIONS Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride, can potentially cause symptomatic hypotension (5.4, 7.4) 7.1 CYP3A4 inhibitors Alfuzosin hydrochloride 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 (5.4) and Clinical Pharmacology (12.3)]. 7.2 Alpha adrenergic antagonists The pharmacokinetic and pharmacodynamic interactions between alfuzosin hydrochloride and other alpha adrenergic antagonists have not been determined. However, interactions may be expected, and alfuzosin hydrochloride should not be used in combination with other alpha adrenergic antagonists [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 alfuzosin hydrochloride concomitantly with anti-hypertensive medication and nitrates [see Warnings and Precautions (5.1)]. 7.4 PDE5 Inhibitors Caution is advised when alpha adrenergic antagonists, including alfuzosin hydrochloride, are coadministered with PDE5 inhibitors. Alpha adrenergic antagonists 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 (5.4)].

More information

Category Value
Authorisation number ANDA090284
Agency product number 75046A1XTN
Orphan designation No
Product NDC 43353-945
Date Last Revised 19-12-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Aphena Pharma Solutions - Tennessee, LLC