Alfuzosin Hydrochloride Extended Release Recall
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
Alfuzosin hydrochloride is not indicated for the treatment of hypertension.
Alfuzosin hydrochloride is not indicated for use in the pediatric population.
There is currently no drug history available for this drug.
Each alfuzosin hydrochloride extended-release tablet contains 10 mg alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane.
Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The empirical formula of alfuzosin hydrochloride is C19H27N5O4•HCl. The molecular weight of alfuzosin hydrochloride is 425.9.
Its structural formula is:
The tablet also contains the following inactive ingredients: microcrystalline cellulose (NF), guar gum NF, hydroxypropyl methyl cellulose (USP), colloidal silicon dioxide (NF) and magnesium stearate (NF).