Alfuzosin Hydrochloride extended release 10 mg/1

Alfuzosin Hydrochloride · TABLET · Cipla USA Inc.

1 Recall on Record

Plain English

Alfuzosin Hydrochloride extended release is a tablet containing alfuzosin hydrochloride at 10 mg/1, taken oral. Manufactured by Cipla USA Inc..

Key Facts

Brand Name: Alfuzosin Hydrochloride extended release
Generic Name: Alfuzosin Hydrochloride
NDC Code (Product): 69097-844
Manufacturer: Cipla USA Inc.
Strength: 10 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA090284
Marketing Start: 06/30/2016

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 tablet USP, 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 ) Alfuzosin hydrochloride tablets USP, are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 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.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 10 mg once daily with food and with the same meal each day ( 2 ) Tablets should not be chewed or crushed ( 2 , 12.3 ) 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.

Contraindications

4 CONTRAINDICATIONS 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 ) 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 ) ].

Drug 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 alfu…

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 Cipla Ltd. at 1-866-604-3268 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 hig…

Frequently Asked Questions

What is Alfuzosin Hydrochloride extended release used for?

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

Is Alfuzosin Hydrochloride extended release a controlled substance?

Alfuzosin Hydrochloride extended release is not classified as a controlled substance by the DEA.

What is the generic name for Alfuzosin Hydrochloride extended release?

The generic name for Alfuzosin Hydrochloride extended release is Alfuzosin Hydrochloride. There are 11 other brand versions of Alfuzosin Hydrochloride.

What is the NDC code for Alfuzosin Hydrochloride extended release 10 mg/1?

The NDC (National Drug Code) for Alfuzosin Hydrochloride extended release 10 mg/1 is 69097-844, listed by Cipla USA Inc..

Product NDC

69097-844

Package NDC

69097-844-02

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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