Drug Safety Labeling Changes - January 2013
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January 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 |
| Brilinta (ticagrelor) 90 mg Tablets | - |  | - | - | | - | - | - |
| Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) 200 mg/25 mg /300 mg fixed dose combination (FDC) tablets | - | | | | | - | - | - |
| Prozac (fluoxetine HCl) 10 mg, 20 mg, and 40 mg capsules Prozac (fluoxetine HCl) delayed-release 90 mg capsules | - | | | | - | - | - | - |
| Symbyax (olanzapine and fluoxetine HCl) Capsules 3 mg/25 mg, 6 mg/25 mg, 12 mg/25 mg, 6 mg/50 mg, 12 mg/50 mg | - | | | | | - | - | - |
| Ampyra (dalfampridine) | - | - | | | - | - | - | - |
| Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets 10 mg, 20 mgBentyl (dicyclomine hydrochloride, USP) Injection 10 mg/mL | - | - | | | | - | - | - |
| Cancidas (caspofungin acetate) | - | - | | | | - | - | - |
| Ciprofloxin | - | - | | | | - | - | - |
| Fanapt (iloperidone) 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg tablets | - | - | | | | - | - | - |
| Gelnique (oxybutynin chloride), 3 percent gel | - | - | | | - | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Heparin Sodium in 5 percent Dextrose Injection in Excel | - | - | | - | - | - | - | - |
| Heparin Sodium in 0.9 percent Sodium Chloride Injection in Excel | - | - | | - | - | - | - | - |
| Lipofen (fenofibrate) Capsules, 50 mg and 150 mg | - | - | | | | - | - | - |
| Peridex (chlorhexidine gluconate) Oral Rinse, 0.12 percent | - | - | | - | - | - | - | - |
| Pre-Scrub (chlorhexidine gluconate) 4 percent Surgical Hand Scrub | - | - | | - | - | - | - | - |
| Reyataz (atazanavir sulfate), 100 mg, 150 mg, 200 mg and 300 mg capsules | - | - | | | | | - | - |
| Stelara (ustekinumab) | - | - | | | - | - | - | - |
| Triglide (fenofibrate) Tablets, 50 mg and 160 mg | - | - | | | | - | - | - |
| Augmentin (amoxicillin/clavulanate potassium) Tablets, 250 mg/125mg and 500 mg/125 mgAugmentin (amoxicillin/clavulanate potassium) Powder for Oral SuspensionAugmentin (amoxicillin/clavulanate potassium) Chewable TabletsAugmentin (amoxicillin/clavulanate potassium) Tablets, 875mg/125 mgAugmentin (amoxicillin/clavulanate potassium) Oral SuspensionAugmentin (amoxicillin/clavulanate potassium) Chewable Tablets | - | - | - | | - | - | - | - |
| Clolar (clofarabine) Injection | - | - | - | | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Kaletra (lopinavir/ritonavir) 133.3mg/mL/33.3 mg/mL soft gelatin capsules | - | - | - | | - | - | - | - |
| Kaletra (lopinavir/ritonavir) 80/20 mg/mL oral solution and 100/25mg and 200/50mg tablets | - | - | - | | - | - | - | - |
| Norvasc (amlodipine besylate) 2.5 mg, 5.0 mg and 10 mg Tablets | - | - | - | | - | - | - | - |
| TriLuma (fluocinolone acetonide, 0.01 percent, hydroquinone, 4 percent, tretinoin, 0.05 percent) Cream | - | - | - | | - | - | - | - |
| Proscar (finasteride) 5mg Tablets | - | - | - | - | | - | - | - |
| Tyzeka (telbivudine) 600 mg Tablets and 100 mg/5 mL Oral | - | - | - | - | | - | - | - |
| Dulera (mometasone furoate/formoterol fumarate) Inhalation Aerosol | - | - | - | - | - | - | - | - |
| Opana ER (oxymorphone hydrochloride extended-release) Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg | - | - | - | - | - | - | - | - |
