Medication Guide App

Drug Safety Labeling Changes - December 2014

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December 2014

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
Aciphex (rabeprazole sodium) Delayed-Release Tablets-ContraindicationsWarningsPrecautions----
Dexilant (dexlansoprazole) delayed-release capsules-ContraindicationsWarningsPrecautions----
Lastacaft (alcaftadine ophthalmic solution)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Nexium (esomeprazole magnesium) delayed-release capsules, for oral use-ContraindicationsWarningsPrecautions----
Nexium I.V. (esomeprazole sodium) for injection-ContraindicationsWarningsPrecautions----
Onfi (clobazam) tablets, for oral useOnfi (clobazam) oral suspension-Contraindications-PrecautionsAdverse Reactions---
Prevacid (lansoprazole) delayed release capsules-ContraindicationsWarningsPrecautions----
Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets-ContraindicationsWarningsPrecautions----
Protonix (pantoprazole sodium) delayed-release tablets-ContraindicationsWarningsPrecautions----
Protonix IV (pantoprazole sodium)-ContraindicationsWarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Somutaline depot (lanreotide) Injection-ContraindicationsWarningsPrecautionsAdverse Reactions---
Tecfidera (dimethyl fumarate) delayed-release capsules, for oral use-ContraindicationsWarningsPrecautions----
Vibativ (telavancin) for injection, for intravenous use-ContraindicationsWarningsPrecautions----
Wellbutrin XL (bupropion hydrochloride extended-release) tablets for oral use-ContraindicationsWarningsPrecautions----
Abilify (aripiprazole) Tablets Abilify DISCMELT (aripiprazole) Orally Disintegrating TabletsAbilify (aripiprazole) Oral Solution Abilify (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY--WarningsPrecautions----
Abilify MAINTENA (aripiprazole) for extended-release injectable suspension, for intramuscular use--WarningsPrecautions----
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)--WarningsPrecautions----
Brisdelle (paroxetine) capsules, for oral use--WarningsPrecautionsAdverse Reactions---
Cyramza (ramucirumab) injection, for intravenous use--WarningsPrecautions----
Dextrose in Plastic Container--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Extavia (interferon beta-1b) for injection, for subcutaneous use--WarningsPrecautionsAdverse Reactions---
Gazyva (obinutuzumab) Injection, for Intravenous Infusion--WarningsPrecautions----
Geodon (ziprasidone HCl) capsules--WarningsPrecautionsAdverse Reactions---
Idamycin (idarubicin hydrochloride for injection, USP) --Warnings-----
Idamycin PFS--Warnings-----
Jakafi (ruxolitinib) tablets, for oral use--WarningsPrecautionsAdverse Reactions---
Kalydeco (ivacaftor) Tablets--WarningsPrecautions----
Micardis (telmisartan) Tablets--WarningsPrecautions----
Omeclamox-Pak (omeprazole/clarithromycin/amoxicillin)--WarningsPrecautions----
Orencia (abatacept)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Potassium chloride in 5 Percent Dextrose Injection, USP in Plastic Container--WarningsPrecautionsAdverse Reactions---
Prilosec (omeprazole) delayed-release capsules Prilosec (omeprazole magnesium) for delayed-release oral suspension--WarningsPrecautions----
Qnasl (beclomethasone dipropionate) Nasal Aerosol--WarningsPrecautions----
Sarafem (fluoxetine hydrochloride tablets) for oral use--WarningsPrecautions----
Simponi (golimumab) injection, for Subcutaneous UseSimponi Aria (golimumab) Injection, for Intravenous Use--WarningsPrecautionsAdverse Reactions---
Sodium Chloride Injection, USP in VIAFLEX Plastic Container--WarningsPrecautionsAdverse Reactions---
Somatuline Depot (lanreotide) Injection--WarningsPrecautions----
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) fixed dose combination tablets--WarningsPrecautionsAdverse Reactions---
Subutex (buprenorphine) sublingual tablet--WarningsPrecautions----
Suboxone (buprenorphine and naloxone) sublingual tablets for sublingual administration--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Sutent (sunitinib malate) capsules--WarningsPrecautions----
Symbyax (fluoxetine hydrochloride; olanzapine)--WarningsPrecautionsAdverse Reactions---
Twynsta (telmisartan/amlodipine) Tablets--WarningsPrecautions----
Vimovo (naproxen and esomeprazole magnesium) delayed release tablets--WarningsPrecautions----
Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension--WarningsPrecautions----
Zubsolv (buprenorphine and naloxone sublingual tablets) for sublingual administration--WarningsPrecautions----
Zyprexa (olanzapine) Tablets    Zyprexa Orally Disintegrating TabletsZyprexa ZydisZyprexa Relprevv--WarningsPrecautionsAdverse Reactions---
Camptosar (irinotecan hydrochloride) Intravenous Injection---Precautions----
Capoten (Captopril Tablets, USP)---Precautions----
Cordarone (amiodarone HCl) Tablets---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Exparel (bupivacaine liposome injectable suspension)---Precautions----
Lamictal (lamotrigine) TabletsLamictal (lamotrigine) Chewable Dispersible TabletsLamictal ODT (lamotrigine) Orally Disintegrating TabletsLamictal XR Extended-Release Tablets---Precautions----
Lotensin (benazepril hydrochloride) Tablets ---Precautions----
Lotensin HCT (20033) (benazepril hydrochloride/hydrochlorothiazide USP Combination Tablets) ---Precautions----
Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules ---Precautions----
Mavik (trandolapril tablets)---Precautions----
Merrem I.V. (meropenem for Injection)---PrecautionsAdverse Reactions---
Micardis HCT (telmisartan and hydrochlorothiazide) Tablets---Precautions----
Plasma-Lyte 56 and Dextrose 5 percent in Plastic Container---Precautions----
Taclonex (calcipotriene and betamethasone dipropionate) Ointment---Precautions----
Drug Name BW C W P AR PPI MG PCI
Tarka (trandolapril/verapamil hydrochloride ER tablets) ---Precautions----
Vaseretic (enalapril Maleate-hydrochlorothiazide)---Precautions----
Vasotec (enalapril) Tablets ---Precautions----
Zestoretic (lisinopril and hydrochlorothiazide)---Precautions----
Zestril (lisinopril) tablets, for oral use---Precautions----
Acuvail (ketorolac tromethamine ophthalmic solution)----Adverse Reactions---
Mozobil (plerixafor injection), Solution for Subcutaneous Use----Adverse Reactions---
Primaxin I.V. (Imipenum and cilastatin for injection)----Adverse Reactions---
Tivicay (dolutegravir) Tablets for Oral Use----Adverse Reactions---
Topamax (topiramate) TabletsTopamax (topiramate) Sprinkle Capsules----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Vizamyl (flutemetamol F 18 injection) for intravenous use----Adverse Reactions---
Xarelto (rivaroxaban) Tablets----Adverse Reactions---
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