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