FDA

Alfuzosin Hydrochloride

Approved 30 Aug 2012OralTablet, extended release

The FDA lists this product in 9 strengths and forms.

Indications

Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are 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 )

1.1Important 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.

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) 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)

Warnings and precautions

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)

Indications

(1.1) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1 , 8.4 , 12.3 )

1.1Important Limitations of Use

Contraindications

Warnings and precautions

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 Rising Health, LLC at 1-833-395-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 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 1 (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 3 (0.4%) of the placebo patients and in 4 (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.

6.2Post-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 pre-existing coronary artery disease, atrial fibrillation Gastrointestinal disorders: diarrhea, vomiting 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) ] .

Alfuzosin Hydrochloride

Indications

1.1Important Limitations of Use

Contraindications

Warnings and precautions

Two medicines in one question?

Alfuzosin Hydrochloride

Indications

1.1Important Limitations of Use

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Postural Hypotension

5.2Patients with Renal Impairment

5.3Patients with Hepatic Impairment

5.4Drug-Drug Interactions Potent CYP3A4 Inhibitors:

5.6Intraoperative Floppy Iris Syndrome (IFIS)

5.7Priapism Rarely

5.8Coronary Insufficiency

5.9Patients with Congenital or Acquired QT Prolongation Use

Interactions

7.1CYP3A4 Inhibitors

7.3Antihypertensive Medication and Nitrates

7.4PDE5 Inhibitors

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Post-Marketing Experience

Composition

Strengths and forms

Official product information

At a glance