Data from FDA - Curated by Marshall Pearce - Last updated 10 October 2017

Indication(s)

1 INDICATIONS AND USAGE Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets, an alpha adrenergic antagonist, are 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 are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.

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Advisory information

contraindications
4 CONTRAINDICATIONS 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) •Coadministration 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 Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) 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 three placebo-controlled clinical trials involving 1,608 men where daily doses of 10 mg and 15 mg alfuzosin were evaluated. In these three trials, 473 men received alfuzosin hydrochloride extended-release tablets 10 mg. In these trials, 4% of patients taking alfuzosin hydrochloride extended-release tablets 10 mg 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 extended-release tablets, 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 Extended-Release Tablets-Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Trials Adverse Reaction Placebo (n = 678) Alfuzosin Hydrochloride Extended-Release Tablets (n = 473) Dizziness 19 (2.8%) 27 (5.7%) Upper respiratory tract infection 4 (0.6%) 14 (3%) Headache 12 (1.8%) 14 (3%) Fatigue 12 (1.8%) 13 (2.7%) The following adverse reactions, reported by between 1% and 2% of patients receiving alfuzosin hydrochloride extended-release tablets 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 Hydrochloride Extended-Release Tablets (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 one (0.2%) of the 469 alfuzosin hydrochloride extended-release tablets patients. Decreased diastolic blood pressure (≤ 50 mm Hg, with a decrease ≥ 15 mm Hg from baseline) was observed in three (0.4%) of the placebo patients and in four (0.9%) of the alfuzosin hydrochloride extended-release tablets 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 extended-release tablets patients. 6.2 Post-Marketing Experience The following adverse reactions have been identified during post approval use of alfuzosin hydrochloride extended-release tablets. 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 preexisting 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, toxic epidermal necrolysis 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 extended-release tablets 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 Teratogenic Effects. Pregnancy Category B Alfuzosin hydrochloride extended-release tablets are 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. Efficacy of alfuzosin hydrochloride was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years with elevated detrusor leak point pressure (LPP ≥ 40 cm H2O) of neurologic origin treated with alfuzosin hydrochloride using pediatric formulations. The trial included a 12-week efficacy phase followed by a 40-week safety extension period. No statistically significant difference in the proportion of patients achieving a detrusor leak point pressure of < 40 cm H20 was observed between the alfuzosin and placebo groups. During the placebo-controlled trial, the adverse reactions reported in ≥ 2% of patients treated with alfuzosin and at a higher incidence than in the placebo group were: pyrexia, headache, respiratory tract infection, cough, epistaxis and diarrhea. The adverse reactions reported for the whole 12-month trial period, which included the open-label extension, were similar in type and frequency to the reactions observed during the 12-week period. Alfuzosin hydrochloride was not studied in patients below the age of 2. 8.5 Geriatric Use Of the total number of subjects in clinical studies of alfuzosin hydrochloride extended-release tablets, 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 extended-release tablets are administered in patients with severe renal impairment [see Warnings and Precautions (5.2)]. 8.7 Hepatic Impairment The pharmacokinetics of alfuzosin hydrochloride extended-release tablets have not been studied in patients with mild hepatic impairment. Alfuzosin hydrochloride extended-release tablets are 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 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. However, interactions may be expected, and alfuzosin hydrochloride extended-release tablets 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 extended-release tablets concomitantly with antihypertensive medication and nitrates [see Warnings and Precautions (5.1)]. 7.4 PDE5 Inhibitors Caution is advised when alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, 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 ANDA079014
Agency product number 75046A1XTN
Orphan designation No
Product NDC 43353-746
Date Last Revised 01-08-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Aphena Pharma Solutions - Tennessee, LLC