Generic equivalent of Alfuzosin Hydrochloride
3 SKUs available · Available to order · NABP accredited · DSCSA compliant
Alfuzosin hydrochloride is the generic equivalent of the brand-name drug Alfuzosin Hydrochloride. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Alfuzosin hydrochloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Alfuzosin hydrochloride extended-release tablets, USP, 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, USP are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in pediatric population. ( 1.1 , 8.4 , 12.3 ) Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP a…
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 Unichem Pharmaceuticals (USA), Inc. at 1-866-562-4616 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…
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 Clin…
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 extended-release tablets should be taken with food and with the same meal each day. The tablets should not be chewed or crushed.
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling. Additional patient information leaflets can be obtained by calling Unichem at 1-866-562-4616. 17.1 Hyoptension/Syncope Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning alfuzosin hydrochloride extended-release tablets, and they should be cautioned about driving, operating machinery, or performing hazardous tasks during this period. This is important for those with low blood pressure or who are taking antihypertensive medications or nitrates [se…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| AFLUZOSIN ER 10MG TAB 90 | 2-Day |
| ALFUZOSIN ER 10 MG 100 TAB | 2-Day |
| ALFUZOSIN ER TABS 10 MG 100 TAB | 2-Day |
Premier Pharma stocks 3 Alfuzosin hydrochloride SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Alfuzosin hydrochloride is the generic equivalent of Alfuzosin Hydrochloride. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Alfuzosin hydrochloride in 10 mg/1 and TABLET, EXTENDED RELEASE, TABLET, FILM COATED, EXTENDED RELEASE.
Alfuzosin hydrochloride carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
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