Drug Safety Labeling Changes - January 2009
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January 2009
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 |
| Avelox (moxifloxacin hydrochloride) Tablets, 400 mg | - | - |  | - | | - | - | - |
| Avelox (moxifloxacin hydrochloride in NaCl injection) I.V., 160 mg/mL | - | - | | - | | - | - | - |
| Celexa (citalopram hydrobromide) tablets | - | - | | - | - | - | - | - |
| Celexa (citalopram hydrobromide) solution | - | - | | - | - | - | - | - |
| Lexapro (escitalopram oxalate) tablets | - | - | | - | - | - | - | - |
| Lexapro (escitalopram oxalate) oral solution | - | - | | - | - | - | - | - |
| Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg | - | - | | - | - | - | - | - |
| Effexor XR (venlafaxine HCl) Extended-Release Capsules and Effexor (venlafaxine HCl) Tablets | - | - | | - | - | - | - | - |
| Hycodan (hydrocodone and homatropine) Tablets | - | - | | | | - | - | - |
| Nicardipine Hydrochloride Injection 25 mg/Vial, 2.5 mg/ml | - | - | | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Paxil (paroxetine HCl) tablets | - | - | | - | - | - | - | - |
| Paxil (paroxetine HCl) CR tablets | - | - | | - | - | - | - | - |
| Paxil (paroxetine) oral suspension | - | - | | - | - | - | - | - |
| Pexeva (paroxetine mesylate) tablets | - | - | | - | - | - | - | - |
| Pristiq (desvenlafaxine succinate) Extended-Release tablets | - | - | | - | - | - | - | - |
| Prozac (fluoxetine HCl) pulvules | - | - | | - | - | - | - | - |
| Prozac (fluoxetine HCl) oral solution | - | - | | - | - | - | - | - |
| Prozac Weekly (fluoxetine HCl) delayed-release capsules | - | - | | - | - | - | - | - |
| Tygacil (tigecycline) | - | - | | | | - | - | - |
| Tyzeka (telbivudine) 600 mg tablets | - | - | | - | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Venlafaxine hydrochloride extended release tablets | - | - | | - | - | - | - | - |
| Zoloft (sertraline HCl) Tablets and Oral Concentrate | - | - | | - | - | - | - | - |
| ActoPlus Met (pioglitazone HCl plus metformin HCl tablets), 15 mg/500mg and 15 mg/850 mg | - | - | - | | - | - | - | - |
| Duetact (pioglitazone HCl plus glimepiride fixed-dose combination tablets), 30 mg/2 mg and 30 mg/4 mg | - | - | - | | - | - | - | - |
| Lotensin (benazepril hydrochloride) 2.5, 5, 10 and 20 mg | - | - | - | | - | - | - | - |
| Lotensin HCT (benazepril/hydrochlorothiazide) 5/6.25, 10/12.5, 20/12.5 and 20/25mg Tablets | - | - | - | | - | - | - | - |
| Nexium IV (esomeprazole sodium) for Injection | - | - | - | | - | - | - | - |
| Nexium (esomeprazole magnesium) for Delayed-Release Capsules and Delayed-Release Oral Suspensions | - | - | - | | - | - | - | - |
| Plasma-Lyte 148 and 5% Dextrose Injection in Plastic Container Plasma-Lyte 148 Injection in Plastic Container (includes Plasma-Lyte A Injection pH 7.4) | - | - | - | | - | - | - | - |
| Augmentin ES-600 (amoxicillin/clavulanate potassium) 600 mg/5 mL Powder for Oral Suspension | - | - | - | - | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Isentress (raltegravir potassium) 400 mg tablets | - | - | - | - | | - | - | - |
| Rapamune (sirolimus) Oral Solution | - | - | - | - | | - | - | - |
| Rapamune (sirolimus) Tablets | - | - | - | - | | - | - | - |
| Singulair (montelukast sodium) tablets, chewable tables and oral granules | - | - | - | - | | - | - | - |
| Crestor (rosuvastatin calcium) Tablets | - | - | - | - | - | - | - | - |
| Vytorin (ezetimibe/simvastatin) Tablets | - | - | - | - | - | - | - | - |
