Drug Safety Labeling Changes - September 2013

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September 2013

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
Arzerra (ofatumumab) InjectionBoxed Warning-WarningsPrecautions----
CombiPatch (estradiol/norethindrone acetate transdermal system)Boxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Potiga (ezogabine) tablets 50 mg, 200 mg, 300 mg, 400 mgBoxed Warning-WarningsPrecautions----
Rituxan (rituximab)Boxed Warning-WarningsPrecautions----
Tasigna (nilotinib) capsules, 150 mg and 200 mgBoxed Warning-WarningsPrecautions----
Tygacil (tigecycline) for InjectionBoxed Warning-WarningsPrecautionsAdverse Reactions---
Accupril (quinapril hydrochloride) 5 mg, 10 mg, 20 mg, and 40 mg Tablets-ContraindicationsWarningsPrecautions----
Accuretic (quinapril hydrochloride/HCTZ) 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets-ContraindicationsWarningsPrecautions----
Altace (ramipril) 1.25 mg, 2.5 mg, 5 mg, and 10 mg-ContraindicationsWarningsPrecautions----
Arixtra (fondaparinux sodium) injection-Contraindications--Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Janumet (sitagliptin and metformin HCl) tablets, 50 mg/ 500 mg and 50 mg/ 1000 mg-ContraindicationsWarningsPrecautionsAdverse Reactions---
Plasma-Lyte 148 and Plasma-Lyte A pH 7.4 (Multiple Electrolytes, Type 1, USP) Injection-ContraindicationsWarningsPrecautionsAdverse Reactions---
Septra and Septra DS (Trimethoprim and Sulfamethoxazole) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Suprane (desflurane, USP)-ContraindicationsWarningsPrecautions----
CellCept (mycophenolate mofetil)--Warnings-----
Biaxin Filmtabs (clarithromycin tablets, USP) Biaxin Filmtabs (clarithromycin tablets, USP) Biaxin Granules (clarithromycin for oral suspension, USP) Biaxin XL Filmtabs (clarithromycin extended release tablets) --WarningsPrecautions----
Gemcitabine Injection 38 mg/mL--WarningsPrecautions----
Golytely (PEG 3350 and electrolytes) for Oral Solution, 1 Gallon and 4 Liter--WarningsPrecautions----
Jentadueto (linagliptin and metformin hydrochloride) tablets, 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1000 mg--WarningsPrecautions----
Myfortic (mycophenolic acid) Delayed-Release Tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Nulytely (PEG 3350 and electrolytes) for Oral Solution--WarningsPrecautions----
Plavix (clopidogrel bisulfate) 75 mg Tablets--WarningsPrecautionsAdverse Reactions---
Prograf (tacrolimus) Capsules, 0.5 mg, 1 mg, and 5 mgPrograf (tacrolimus) Injection, 5 mg/ml--WarningsPrecautionsAdverse Reactions---
Remodulin (treprostinil) 20 mg, 50 mg, 100 mg, and 200 mg for Injection--WarningsPrecautionsAdverse Reactions---
Terazol 7 (terconazole) Vaginal Cream, 0.4%Terazol 3 (terconazole) Vaginal Suppositories, 80 mgTerazol 3 (terconazole) Vaginal Cream, 0.8%--Warnings-Adverse Reactions---
Unisom SleepTabs (doxylamine succinate) Tablets, 25mg--Warnings-----
Vimpat (lacosamide) tablets Vimpat (lacosamide) Injection Vimpat (lacosamide) oral solution--WarningsPrecautionsAdverse Reactions---
Zometa (zoledronic acid) Injection, 4 mg/100 mL single-use ready-to-use bottle and 4 mg/5 mL single-use vial of concentrate--WarningsPrecautions----
Zosyn (piperacillin and tazobactam for injection, USP)Zosyn (piperacillin and tazobactam injection) in Galaxy Containers (PL 2040 Plastic)--WarningsPrecautionsAdverse Reactions---
Anzemet (dolasetron mesylate)---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Bosulif (bosutinib) Tablets, 100 mg and 500 mg---Precautions----
Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride InjectionsPotassium Chloride in Dextrose 5% and Sodium Chloride Injections---PrecautionsAdverse Reactions---
5% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container2.5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container5% Dextrose and 0.2% Sodium Chloride Injection, USP in Plastic Container10% Dextrose and 0.9% Sodium Chloride Injection, USP in Plastic Container5% Dextrose and 0.45% Sodium Chloride Injection, USP in Plastic Container5% Dextrose and 0.33% Sodium Chloride Injection, USP in Plastic Container---PrecautionsAdverse Reactions---
Diflucan (fluconazole) TabletsDiflucan (fluconazole) IVDiflucan (fluconazole) Powder for Oral Suspension ---Precautions----
Makena (hydroxyprogesterone caproate injection) 250ml/mg---PrecautionsAdverse Reactions---
Neupogen (filgrastim)---PrecautionsAdverse Reactions---
Sodium Chloride Injections:---PrecautionsAdverse Reactions---
0.9% Sodium Chloride Injection, USP in VIAFLEX Plastic Container; 0.9% Sodium Chloride Injection, USP in AVIVA Plastic Container0.45% Sodium Chloride Injection, USP in VIAFLEX Plastic Container; 0.45% Sodium Chloride Injection, USP in AVIVA Plastic ContainerRinger’s Injection, USP ---PrecautionsAdverse Reactions---
Tobi (tobramycin inhalation solution, USP) 300mg/5mL---PrecautionsAdverse Reactions---
Vibramycin Monohydrate (doxycycline monohydrate) for Oral SuspensionVibramycin Hyclate (doxycycline hyclate capsules, USP) CapsulesVibramycin Calcium (doxycycline calcium oral suspension) SyrupVibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Alimta (pemetrexed for injection) for intravenous use, 100 mg and 500 mg vials----Adverse Reactions---
Inlyta (axitinib) tablets----Adverse Reactions---
Macrobid (nitrofurantoin monohydrate 75 mg/nitrofurantoin macrocrystals 25 mg) Capsules----Adverse Reactions---
Macrodantin (nitrofurantoin macrocrystals) Capsules----Adverse Reactions---
Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol----Adverse Reactions---
Fortesta (testosterone gel)--------
Skyla (levonorgestrel-releasing intrauterine system)--------
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