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-Contraindications--Adverse Reactions---
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) 200 mg/25 mg /300 mg fixed dose combination (FDC) tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Prozac (fluoxetine HCl) 10 mg, 20 mg, and 40 mg capsules Prozac (fluoxetine HCl) delayed-release 90 mg capsules-ContraindicationsWarningsPrecautions----
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-ContraindicationsWarningsPrecautionsAdverse Reactions---
Ampyra (dalfampridine)--WarningsPrecautions----
Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets 10 mg, 20 mgBentyl (dicyclomine hydrochloride, USP) Injection 10 mg/mL--WarningsPrecautionsAdverse Reactions---
Cancidas (caspofungin acetate)--WarningsPrecautionsAdverse Reactions---
Ciprofloxin--WarningsPrecautionsAdverse Reactions---
Fanapt (iloperidone) 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg tablets--WarningsPrecautionsAdverse Reactions---
Gelnique (oxybutynin chloride), 3 percent gel--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Heparin Sodium in 5 percent Dextrose Injection in Excel--Warnings-----
Heparin Sodium in 0.9 percent Sodium Chloride Injection in Excel--Warnings-----
Lipofen (fenofibrate) Capsules, 50 mg and 150 mg--WarningsPrecautionsAdverse Reactions---
Peridex (chlorhexidine gluconate) Oral Rinse, 0.12 percent--Warnings-----
Pre-Scrub (chlorhexidine gluconate) 4 percent Surgical Hand Scrub--Warnings-----
Reyataz (atazanavir sulfate), 100 mg, 150 mg, 200 mg and 300 mg capsules--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Triglide (fenofibrate) Tablets, 50 mg and 160 mg--WarningsPrecautionsAdverse Reactions---
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---Precautions----
Clolar (clofarabine) Injection---PrecautionsAdverse Reactions---
Kaletra (lopinavir/ritonavir) 133.3mg/mL/33.3 mg/mL soft gelatin capsules---Precautions----
Drug Name BW C W P AR PPI MG PCI
Kaletra (lopinavir/ritonavir) 80/20 mg/mL oral solution and 100/25mg and 200/50mg tablets---Precautions----
Norvasc (amlodipine besylate) 2.5 mg, 5.0 mg and 10 mg Tablets---Precautions----
TriLuma (fluocinolone acetonide, 0.01 percent, hydroquinone, 4 percent, tretinoin, 0.05 percent) Cream---Precautions----
Proscar (finasteride) 5mg Tablets----Adverse Reactions---
Tyzeka (telbivudine) 600 mg Tablets and 100 mg/5 mL Oral----Adverse Reactions---
Opana ER (oxymorphone hydrochloride extended-release) Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg--------
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