Drug Safety Labeling Changes - June 2009
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June 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 |
| Prometrium (progesterone, USP) 100 and 200 mg Capsules |  | - | | | | | - | - |
| Reglan (metoclopramide) tablets, ODT (Orally Disintegrating Tablets), and injection | | - | | - | - | - | - | - |
| Coreg (carvedilol) 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg tablets | - | | - | - | | | - | - |
| Videx (didanosine) pediatric powder and Videx EC capsules | - | | - | | - | - | - | - |
| Amaryl (glimepiride) tablets | - | - | | | | - | - | - |
| Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL and 20 mg/mL Parenteral | - | - | | - | - | - | - | - |
| Cancidas (caspofungin acetate) 50mg/vial and 70 mg/vial for Injection | - | - | | | | - | - | - |
| CellCept (mycophenolate mofetil) Capsules, Tablets, Injection and Suspension | - | - | | | | - | - | - |
| Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol | - | - | | - | - | - | - | - |
| Coreg CR (carvedilol phosphate) 10 mg, 20 mg, 40 mg, and 80 mg Extended Release Capsules | - | - | | | - | | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Rocephin (ceftriaxone sodium) for injection, 250 mg, 500 mg, 1g and 2g | - | - | | - | - | - | - | - |
| Strattera (atomoxetine hydrochloride) 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg capsules | - | - | | | | - | - | - |
| Aptivus (tipranavir) 250 mg capsules and 100 mg/mL oral solution | - | - | - | - | - | - | - | - |
| Aralen (chloroquine phosphate, USP) 500 mg tablets | - | - | - | | | - | - | - |
| BenzaClin Topical Gel (clindamycin 1%- benzoyl peroxide gel 5%) | - | - | - | | | - | - | - |
| Coly-Mycin S Otic (colistin sulfate-neomycin sulfate-thonzonium bromide-hydrocortisone acetate) otic suspension | - | - | - | | - | - | - | - |
| Covera-HS (verapamil hydrochloride) Extended Release tablets | - | - | - | | - | - | - | - |
| Entocort EC (budesonide) Capsules | - | - | - | | | - | - | - |
| Natrecor (nesiritide) for Injection | - | - | - | | | - | - | - |
| Nexium (esomeprazole magnesium) for Delayed Release Oral Suspension | - | - | - | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Prezista (darunavir) tablets | - | - | - | - | - | | - | - |
| Hyzaar (losartan potassium hydrochlorothiazide) 50-12.5 mg, 100-12.5 mg, and 100-25 mg Tablets | - | - | - | - | | - | - | - |
| Lupron Depot (leuprolide acetate for depot suspension) 3.75 mg and 11.25 mg Injection | - | - | - | - | | - | - | - |
| Stromectol (ivermectin) 3 mg Tablets | - | - | - | - | | - | - | - |
| Salonpas Pain Relief Patch (10% methyl salicylate & 3% 1-menthol) | - | - | - | - | - | - | - | - |
| Tylenol 8-Hour (650 mg acetaminophen) extended-release tablets | - | - | - | - | - | - | - | - |
