Drug Safety Labeling Changes - September 2012

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September 2012

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Exjade (deferasirox) TabletsBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Accupril (quinapril hydrochloride) 5 mg, 10 mg, 20 mg and 40 mg Tablets-Contraindications-Precautions----
Accuretic (quinapril HCL/hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg and 20/25 mg Tablets-Contraindications-Precautions----
Arcapta Neohaler (indacaterol maleate) Inhalation Powder 75 mcg-ContraindicationsWarningsPrecautionsAdverse Reactions---
Avapro (irbesartan) 75 mg, 150 mg, and 300 mg tablets-Contraindications-Precautions----
Azor (amlodipine/olmesartan medoxomil) 5/20 mg, 5/40 mg, 10/20 mg and 10/40 mg Tablets-Contraindications-Precautions----
Benicar (olmesartan medoxomil) 5 mg 20 mg and 40 mg Tablets-Contraindications-Precautions----
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg and 40/25 mg Tablets-Contraindications-Precautions----
Cozaar (losartan potassium) 25 mg, 50 mg and 100 mg Tablets-Contraindications-Precautions----
Doxil (doxorubicin HCl liposome injection) for intravenous infusion, single dose vial: 20 mg/10 mL and 50 mg/25 mL-Contraindications------
Drug Name BW C W P AR PPI MG PCI
Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Hyzaar (losartan potassium/HCTZ) 50/12.5 mg, 100/25 mg, and 100/12.5 mg Tablets-Contraindications-Precautions----
Juvisync (sitagliptin/simvastatin) Tablets, 100mg/10mg, 100 mg/20 mg, 100mg/40mg, 50mg/10mg, 50 mg/20 mg, and 50mg/40mg-ContraindicationsWarningsPrecautionsAdverse Reactions---
Lotensin (benazepril HCl) 5 mg, 10 mg 20 mg and 40 mg Tablets-Contraindications-Precautions----
Lotensin HCT (benazepril HCl and hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg 20/12.5 mg and 20/25 mg Tablets-Contraindications-Precautions----
Mavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets-Contraindications-Precautions----
Multaq (dronedarone hydrochloride) 400 mg Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Ozurdex (dexamethasone intravitreal implant) 0.7 mg-Contraindications--Adverse Reactions---
Tarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg, and 4/240 mg Tablets-Contraindications-Precautions----
Teveten (Eprosartan Mesylate) 400 mg and 600 mg Tablets-Contraindications-Precautions----
Drug Name BW C W P AR PPI MG PCI
Teveten HCT (eprosartan mesylate hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets-Contraindications-Precautions----
Tribenzor (olmesartan medoxomil amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg 40/10/12.5 and 40/10/25 mg Tablets-Contraindications-Precautions----
Uniretic (moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets-Contraindications-Precautions----
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets-Contraindications-Precautions----
Vasotec (enalapril maleate) 2.5 mg, 5 mg, 10 mg, and 20 mg Tablets -Contraindications-Precautions----
Univasc (moexipril hydrochloride) 7.5 mg and 15 mg Tablets-Contraindications-Precautions----
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 milligram vial--WarningsPrecautionsAdverse Reactions---
Aggrenox (aspirin/extended release dipyridamole) 25 mg/200 mg Capsules--WarningsPrecautionsAdverse Reactions---
Cefepime for Injection USP and Dextrose Injection USP in the Duplex ContainerCefepime Injection in the GALAXY Container for intravenous use--WarningsPrecautionsAdverse Reactions---
Dexilant (dexlansoprazole) Delayed-release Capsules--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg--WarningsPrecautionsAdverse Reactions---
Lovaza (omega 3-acid ethyl esters) Capsules--WarningsPrecautions-Patient Package Insert--
Maxipime (cefepime hydrochloride) for Injection--WarningsPrecautionsAdverse Reactions---
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg; For Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg--WarningsPrecautions----
Nexium I.V. (esomeprazole sodium) For Injection--WarningsPrecautions----
Prevacid (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg and Delayed-Release Orally Disintegrating Tablets, 15 mg and 30 mg--WarningsPrecautions----
Prilosec (omeprazole) Delayed-Release Capsules, 10 mg, 20 mg and 40 mg; For Delayed-Release Oral Suspension, 2.5 mg and 10 mg--WarningsPrecautions----
Protonix (pantoprazole sodium) For Injection--WarningsPrecautions----
Rotarix (Rotavirus Vaccine, Live, Oral)--WarningsPrecautionsAdverse Reactions---
Trilipix (fenofibric acid) Delayed Release Capsules--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Vimovo (naproxen/esomeprazole magnesium) Delayed Release Tablets--WarningsPrecautions----
Xgeva (denosumab)--WarningsPrecautions----
Xyzal  (levocetirizine dihydrochloride) 5mg tablets and 2.5mg/5ml solution--WarningsPrecautionsAdverse Reactions---
Zomig (zolmitriptan) tabletsZomig-ZMT (zolmitriptan) orally disintegrating tablets--WarningsPrecautions----
Glyset (miglitol) Tablets, 25 mg, 50 mg and 100 mg---PrecautionsAdverse Reactions---
Voltaren Opthalmic (diclofenac sodium ophthalmic solution) 0.1%---PrecautionsAdverse Reactions---
Cayston (aztreonam for inhalation solution)----Adverse Reactions---
Singulair (Montelukast Sodium) 10 mg Tablets, 5 mg and 4 mg Chewable Tablets, and 4mg Oral Granules----Adverse Reactions---
Tradjenta (linagliptin) tablets, 5 mg----Adverse Reactions---
Ventolin HFA (albuterol sulfate) Inhalation Aerosol----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Xopenex (levalbuterol HCl) Inhalation Solution Concentrate, 1.25 mg/0.5 mL----Adverse Reactions---
AndroGel (testosterone gel) 1.62%--------
CellCept (mycophenolate mofetil) Capsules, Tablets, Oral Suspension and CellCept (mycophenolate mofetil hydrochloride) for Injection--------
Clobex (clobetasol propionate) Spray, 0.05%-----Patient Package Insert--
Micardis (telmisartan) 20, 40, and 80 mg Tablets-----Patient Package Insert--
Myfortic (mycophenolic acid) delayed-release tablets--------
Prolia (denosumab)--------

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