Uroxatral Recall
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                       Uses
                        
   
   
  
   
1 INDICATIONS AND USAGE 
  
UROXATRAL is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. UROXATRAL is not indicated for the treatment of hypertension.
 
  
  
  
   
2 DOSAGE AND ADMINISTRATION 
  The recommended dosage is one 10 mg UROXATRAL (alfuzosin HCl) extended-release tablet once daily. The extent of absorption of Uroxatral is 50% lower under fasting conditions. Therefore, Uroxatral should be taken immediately after the same meal each day. The tablets should not be chewed or crushed.
 
  
  
  
   
3 DOSAGE FORMS AND STRENGTHS 
  UROXATRAL (alfuzosin HCl) extended-release tablet 10 mg is available as a round, three-layer tablet: one white layer between two yellow layers, debossed with X10.
 
  
  
  
   
4 CONTRAINDICATIONS 
  UROXATRAL 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  Clinical Pharmacology (12.3)]. 
 
  UROXATRAL is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased. [see  Clinical Pharmacology (12.3)].
 
  UROXATRAL is contraindicated in patients known to be hypersensitive to alfuzosin hydrochloride or any component of UROXATRAL tablets.
 
  
 
                       
                        
     
    
                       
                       History
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                       Other Information
                        
   
   
  11 DESCRIPTION
  
Each UROXATRAL 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: colloidal silicon dioxide (NF), ethylcellulose (NF), hydrogenated castor oil (NF), hydroxypropyl methylcellulose (USP), magnesium stearate (NF), mannitol (USP), microcrystalline cellulose (NF), povidone (USP), and yellow ferric oxide (NF).
  
 
                       
                         
     
    
                       
                                                 
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