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Drug Safety Labeling Changes - January 2012

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January 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
Accupril (quinapril hydrochloride) 5 mg, 10 mg 20 mg, 40 mg TabletsBoxed Warning-WarningsPrecautions----
Accuretic (quinapril HCl/ hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, 20/25 mg TabletsBoxed Warning-WarningsPrecautions----
Altace (ramipril) 1.25, 2.5, 5, and 10 mg TabletsBoxed Warning-WarningsPrecautions----
Avalide (irbesartan/hydrochlorothiazide) Tablets, 150/12.5 mg and 300/12.5 mgBoxed Warning-WarningsPrecautions----
Azor (amlodipine/olmesartan) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg TabletsBoxed Warning-WarningsPrecautions----
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg, and 40/25 mg TabletsBoxed Warning-WarningsPrecautions----
Diovan HCT (valsartan/hydrochlorothiazide) 80/12.5 mg, 160/12.5 mg,160/25 mg, 320/12.5 mg, and 320/25 mg TabletsBoxed Warning-WarningsPrecautions----
Lotensin (benazepril) 5 mg, 10 mg, 20 mg, and 40 mg TabletsBoxed Warning-WarningsPrecautions----
Lotensin HCT (benazepril/hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg, 20/12.5 mg, and 25/25/mg TabletsBoxed Warning-WarningsPrecautions----
Lotrel (amlodipine besylate and benazepril hydrochloride) 2.5/10 mg, 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg TabletsBoxed Warning-WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, 80/12.5 mg, and 80/25 mg TabletsBoxed Warning-WarningsPrecautions----
Tarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg 2/240 mg and 4/240 mg TabletsBoxed Warning-WarningsPrecautions----
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) 600/12.5 mg and 600/25 mg TabletsBoxed Warning-WarningsPrecautions----
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 Boxed Warning-WarningsPrecautions----
Uniretic (moexipril hydrochloride/hydrochlorothiazide) 7.5/12.5 mg, 15/12.5 mg and 15/25 mg Tablets Boxed Warning-WarningsPrecautions----
Ceftriaxone for Injection and Dextrose Injection in Duplex Container-ContraindicationsWarnings-Adverse Reactions---
Evoclin (clindamycin phosphate) Foam-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Mavik (trandolapril) 1 mg, 2 mg, and 4 mg Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Micardis (telmisartan) 20 mg, 40 mg, and 80 mg Tablets-Contraindications--Adverse Reactions---
Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, and 80/12.5 mg, and 80/25 mg Tablets-ContraindicationsWarnings-Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets-ContraindicationsWarnings-Adverse Reactions---
Chantix (varenicline) Tablets 0.5 mg and 1 mg--WarningsPrecautionsAdverse Reactions---
Fanapt (iloperidone) Tablets--WarningsPrecautions----
Fazaclo (clozapine) Orally Disintegrating Tablets--WarningsPrecautionsAdverse Reactions---
Gralise (gabapentin) Tablets, 300 mg and 600 mg--WarningsPrecautions----
Morphine Sulfate Oral Solution, 10 mg/5 mL, 20 mg/5 mL, and 100 mg/5 mL--WarningsPrecautionsAdverse Reactions---
Morphine Sulfate Tablets, 15 mg and 30 mg--WarningsPrecautionsAdverse Reactions---
Nexium (esomeprazole sodium) For Injection--WarningsPrecautionsAdverse Reactions---
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg; Delayed-Release Oral Suspension, 10 mg, 20 mg, and 40 mg--WarningsPrecautionsAdverse Reactions---
Perforomist (formoterol fumarate) Inhalation Solution--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Amturnide (amlodipine/aliskiren/hydrochlorothiazide) 150/5/12.5 mg, 300/5/12.5 mg, 300/5/25 mg, 300/10/12.5 mg and 300/10/25 mg Tablets ---PrecautionsAdverse Reactions---
Droxia (hydroxyurea capsules, USP) 200 mg, 300 mg, 400 mg and Hydrea (hydroxyurea capsules, USP) 500 mg---Precautions----
Marcaine and Marcaine with Epinephrine InjectionMarcaine Spinal InjectionBupivacaine hydrochloride and epinephrine bitartrate injection---Precautions----
Parlodel SnapTabs (bromocriptine mesylate) Tablets and Capsules---Precautions----
Tekamlo (aliskiren/amlodipine) 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg and 300 mg/10 mg Tablets ---PrecautionsAdverse Reactions---
Tekturna (aliskiren) 150 mg, 300 mg Tablets--------
Tekturna HCT (aliskiren/hydrochlorothiazide) 150/12.5 mg, 150/25 mg, 300/12.5 mg, and 300/25 mg Tablets---PrecautionsAdverse Reactions---
Valturna (aliskiren and valsartan) 150/160 mg and 300/320 mg Tablets---PrecautionsAdverse Reactions---
Zetia (ezetimibe) Tablets---Precautions----
Zyban (bupropion hydrochloride) Sustained-Release Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Astelin (azelastine) Nasal Spray----Adverse Reactions---
Enablex  (darifenacin) extended-release tablets----Adverse Reactions---
Lupron Depot (leuprolide acetate for depot suspension), 11.25 mg----Adverse Reactions---
Lupron Depot (leuprolide acetate for depot suspension), 3.75 mg----Adverse Reactions---
Synarel (nafarelin acetate) nasal solution, 2 mg/mL----Adverse Reactions---
Welchol (colesevelam HCL) Tablets and Welchol (colesevelam HCl) for Oral Suspension----Adverse Reactions---
Zonegran (zonisamide) Capsules----Adverse Reactions---
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