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October 2011

Fri, 11/25/2011 - 1:31pm
U.S. Food & Drug Administration

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

           
DRUG NAME
SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

   W

P

AR

PPI/MG
Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension X   X X X  
Evamist (estradiol transdermal spray)
X
  X X   PCI/PPI
Selzentry (maraviroc) Tablets
X
  X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Demerol (meperidine hydrochloride)   X   X    
Hycamtin (topotecan) Capsules   X X X X  
Premarin (conjugated estrogens tablets, USP)   X X     PPI
Suprenza (phentermine hydrochloride) ODT   X        
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Amturnide (amlodipine/aliskiren/hydrochlorothiazide) Tablets     X X X  
Avelox (moxifloxacin hydrochloride) Tablets and IV     X X    
Byetta (exenatide) injection     X X X PCI/MG
Clozaril (clozapine) Tablets     X X    
Ciprofloxacin Tablets

Ciprofloxacin IV for Inusion Vial

Ciprofloxacin 0.2 % Solution in 5% Dextrose

Ciprofloxacin Oral Suspension

Cipro XR Tablets

    X      
Factive (gemifloxacin mesylate) Tablets     X      
Gallium Citrate Ga 67 Injection     X      

Lactated Ringer’s injection in aviva plastic container

Lactated Ringer’s,

Lactated Ringer’s and 5% Dextrose

Sodium Lactate (M/6 sodium lactate) injections in viaflex plastic container

    X X X  
Levaquin (levofloxacin) Tablets     X X    
Lithium Carbonate 150 mg, 300 mg, and 600 mg capsules     X   X PCI
Lithobid (lithium carbonate) Extended-Release tablets     X   X PCI
Nexavar (sorafenib)     X X X PCI
Noroxin (norfloxacin) Tablets     X      
OxyContin (oxycodone hydrochloride) Controlled-Release Tablets     X X    
Tasigna (nilotinib) Capsules     X X    
Veramyst, (fluticasone furoate) Nasal Spray     X X X PCI
Votrient (pazopanib hydrochloride) Tablets     X X X MG
Vumon (teniposide) Injection     X   X  
Vytorin (ezetimibe/simvastatin) Tablets     X X X PCI
Zocor (simvastatin) Tablets     X X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Accupril (quinapril hydrochloride) Tablets       X    
Accuretic (quinapril HCl/hydrochlorothiazide)       X    
Azor (amlodipine and olmesartan medoxomil) Tablets       X    
Dexilant (dexlansoprazole) delayed-release capsules       X    
Exforge (amlodipine/valsartan) Tablets       X    
Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) Tablets

      X    
Intelence (etravirine) Tablets       X   PPI
Ixempra kit (ixabepilone) for injection       X    
Leukeran (chlorambucil) Tablet       X    
Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules       X    
Macugen (pegaptanib sodium injection)       X    
Norvasc (amlodipine besylate) Tablets       X    
Prevacid (lansoprazole) Delayed-Release Capsules and

Prevacid Solutab (lansoprazole) Delayed-Release Orally Disintegrating Tablets

      X    
Protonix (pantoprazole sodium) For Delayed Release Oral Suspension and Delayed Release Tablets       X    
Tekturna (aliskiren) Tablets       X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Prezista (darunavir) Tablets        
X
PPI
Reyataz (atazanavir sulfate)        
X
 
Saphris (asenapine) sublingual Tablets        
X
 
Sprycel (dasatinib) Tablets        
X
 
Symbyax (olanzapine and fluoxetine HCl)        
X
 
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG

Humalog (insulin lispro injection)

Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro injection [rDNA origin])

Humalog Mix 50/50 (50% insulin lispro protamine suspension/50 insulin lispro injection [rDNA origin])

          PPI
 
       

 

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