Drugplain

Alfuzosin hydrochloride 10 mg/1

Alfuzosin hydrochloride · TABLET, EXTENDED RELEASE · Bryant Ranch Prepack

1 Recall on Record
Plain English

Alfuzosin hydrochloride is a tablet, extended release containing alfuzosin hydrochloride at 10 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Alfuzosin hydrochloride
Generic Name
Alfuzosin hydrochloride
NDC Code (Product)
63629-9155
Manufacturer
Bryant Ranch Prepack
Strength
10 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA203192
Marketing Start
03/15/2016

Recall History

1 Recall on Record
Class II01/05/2017

Sun Pharmaceutical Industries, Inc.

Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet identified as a broken piece of wire rope from the manufacturing equipment.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective115 reports
off label use102 reports
dyspnoea92 reports
fatigue89 reports
drug interaction88 reports
acute kidney injury83 reports
dizziness74 reports
hypotension74 reports
diarrhoea73 reports
asthenia70 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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.

Dosage & 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 )

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 ) 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 )

Drug 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 anti-hypertensive medication and nitrates [see Warni…

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 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. 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 extended-rel…

Frequently Asked Questions

What is Alfuzosin hydrochloride used for?

Alfuzosin hydrochloride contains Alfuzosin hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Alfuzosin hydrochloride a controlled substance?

Alfuzosin hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Alfuzosin hydrochloride?

The generic name for Alfuzosin hydrochloride is Alfuzosin hydrochloride. There are 8 other brand versions of Alfuzosin hydrochloride.

What is the NDC code for Alfuzosin hydrochloride 10 mg/1?

The NDC (National Drug Code) for Alfuzosin hydrochloride 10 mg/1 is 63629-9155, listed by Bryant Ranch Prepack.

Product NDC

63629-9155

Package NDC

63629-9155-1

Other Alfuzosin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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