Medication Guide App

Drug Safety Labeling Changes - December 2008

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December 2008

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
Avandamet (rosiglitazone maleate and metformin hydrochloride) TabletsBoxed Warning-WarningsPrecautions----
Avandaryl (rosiglitazone maleate and glimepiride) TabletsBoxed Warning-WarningsPrecautions----
Myozyme (alglucosidase alfa) For Intravenous Infusion OnlyBoxed Warning-WarningsPrecautionsAdverse Reactions---
Avelox Tablets and Injection--Warnings-Adverse Reactions---
Celebrex (celecoxib) Capsules--WarningsPrecautions----
Children’s Advil Cold (ibuprofen 100 mg and pseudoephedrine HCL 15 mg/5 ml) suspension--Warnings-----
Delsym (dextromethorphan polistirex) Extended-Release Suspension, 30 mg/5 mL--Warnings-----
Dianeal Peritoneal Dialysis Solution in Plastic Container, PL-146, 1.5%, 2.5% and 4.25% Dextrose--Warnings-----
Ethyol Injection--WarningsPrecautionsAdverse Reactions---
Innohep (tinzaparin sodium injection)--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Lipofen (fenofibrate) Capsules--WarningsPrecautions----
OMNICEF (cefdinir) capsules, 300 mg and OMNICEF (cefdinir) oral suspension, 125 mg/5mL and 250 mg/5mL--Warnings-Adverse Reactions---
Rifater (rifampin, isoniazid and pyrazinamide) Tablets--Warnings-Adverse Reactions---
Sensipar (cinacalcet HCl) Tablets--WarningsPrecautionsAdverse Reactions---
Actos (pioglitazone hydrochloride) Tablets---Precautions----
Apokyn (apomorphine hydrochloride) 10mg/mL and Apokyn (apomorphine) Injection---Precautions----
Aredia (pamidronate disodium for injection) For Intravenous Infusion---PrecautionsAdverse Reactions---
Coreg (carvedilol) Tablets---Precautions----
Coreg CR (carvedilol phosphate) Extended-Release Capsules---Precautions----
E.E.S. 200 Liquid (erythromycin ethylsuccinate for oral suspension) Suspension---Precautions----
Drug Name BW C W P AR PPI MG PCI
E.E.S. 400 Liquid (erythromycin ethylsuccinate for oral suspension) Suspension---Precautions----
E.E.S. Granules (erythromycin ethylsuccinate for oral suspension) Granule, For Suspension---Precautions----
E.E.S. 400 Filmtab Tablets (erythromycin ethylsuccinate tablets) Tablet, Film Coated---Precautions----
Eryped 200 (erythromycin ethylsuccinate) Suspension---Precautions----
Eryped 400 (erythromycin ethylsuccinate) Suspension---Precautions----
Eryped Drops (erythromycin ethylsuccinate) Suspension---Precautions----
Eldepryl (selegiline hydrochloride) Capsules---Precautions----
Eldepryl (selegiline hydrochloride) Tablets---Precautions----
Elmiron (pentosan polysulfate sodium) Capsules---Precautions----
Famvir (famciclovir) Tablets 125, 250, 500 mg---Precautions----
Drug Name BW C W P AR PPI MG PCI
Mirapex (pramipexole dihydrochloride) Tablets ---Precautions----
PCE (erythromycin) Tablet---Precautions----
Prilosec (omeprazole magnesium) for Delayed-Release Oral Suspension---Precautions----
Requip (ropinirole) Tablets---Precautions----
Sinemet (carbidopa/levodopa) Tablets---Precautions----
Sinemet CR (carbidopa/levodopa) Tablets---Precautions----
Symmetrel (amantadine hydrochloride) Syrup---Precautions----
Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension and Chewable Tablets----Adverse Reactions---
Augmentin (amoxicillin/clavulanate potassium) Tablets----Adverse Reactions---
Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Enablex (darifenacin hydrobromide) Extended-Release Tablets----Adverse Reactions---
Malarone (atovaquone and proguanil hydrochloride) Tablets----Adverse Reactions---
Meridia (sibutramine hydrochloride monohydrate) Capsules----Adverse Reactions---
OsmoPrep, (sodium phosphate monobasic monohydrate, USP & sodium phosphate dibasic anhydrous, USP) Tablets----Adverse Reactions---
Aromasin (exemestane tablets)--------
CellCept (mycophenolate mofetil capsules and tablets)--------
CellCept Oral Suspension (mycophenolate mofetil for oral suspension)--------
CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)--------
Flomax (tamsulosin hydrochloride) Capsules--------
Myfortic (mycophenolic acid) Delayed-release Tablets--------
Drug Name BW C W P AR PPI MG PCI
Pegasys (interferon alfa 2a)--------
PegIntron (peginterferon alfa-2b) in combination with Rebetol (ribavirin)--------
Toradol Oral (ketorolac tromethamine) Tablets--------
Zerit (stavudine) Capsules--------
Zerit (stavudine) for Oral Solution--------
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