Drug Safety Labeling Changes - April 2008

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April 2008

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
Aldurazyme (laronidase) Solution for Intravenous Infusion OnlyBoxed Warning-Warnings-Adverse Reactions---
Emtriva (emtricitabine) Capsules and Oral SolutionBoxed Warning-Warnings--Patient Package Insert--
Lotronex (alosetron hydrochloride) TabletsBoxed Warning-WarningsPrecautionsAdverse Reactions---
Advair Diskus (fluticasone propionate and salmeterol inhalation powder)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Amitiza (lubiprostone) Capsules-ContraindicationsWarningsPrecautionsAdverse Reactions---
Crixivan (indinavir sulfate) Capsules-ContraindicationsWarningsPrecautions-Patient Package Insert--
Tigan (trimethobenzamide hydrochloride) Injectable for Intramuscular Use Only-Contraindications-Precautions----
Actonel (risedronate sodium) Tablets--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Augmentin (amoxicillin/clavulanate potassium)Tablets--WarningsPrecautions----
Augmentin ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Augmentin XR (amoxicillin/clavulanate potassium) Extended Release Tablets--WarningsPrecautions----
Declomycin (demeclocycline hydrochloride) Tablets--WarningsPrecautions----
Levaquin (levofloxacin) Tablets and Oral Solution--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Levaquin (levofloxacin) Injection, for Intravenous Use--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Luvox (fluvoxamine maleate) Tablets--WarningsPrecautions----
Nafcillin Injection, USP in PL 2040 Plastic Container For Intravenous Use Only - Galaxy Container (PL 2040 Plastic)--WarningsPrecautions----
Neulasta (pegfilgrastim)--Warnings-Adverse ReactionsPatient Package Insert--
Orencia (abatacept) Lyophilized Powder for Intravenous Infusion--WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Oxacillin (oxacillin) Injection, Solution in Plastic Container For Intravenous Use Only - Galaxy Container (PL 2040)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Pipracil (piperacillin for injection) for Intravenous and Intramuscular Use--WarningsPrecautions----
Prevacid (lansoprazole) Delayed-Release Capsules--WarningsPrecautionsAdverse Reactions---
Prevacid (lansoprazole) Delayed-Release Oral Suspension--WarningsPrecautionsAdverse Reactions---
Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets--WarningsPrecautionsAdverse Reactions---
Timentin (ticarcillin disodium and clavulanate potassium) for Intravenous Administration--WarningsPrecautions----
Timentin (ticarcillin disodium and clavulanate potassium) Injection - Galaxy (PL 2040) Plastic Container--WarningsPrecautions----
Unasyn (ampicillin sodium/sulbactam sodium)--WarningsPrecautions----
Zosyn (piperacillin and tazobactam injection) in Galaxy Containers (PL 2040 Plastic)--WarningsPrecautions----
Zosyn (piperacillin and tazobactam for injection) Individual Vials--WarningsPrecautions----
Zosyn (piperacillin and tazobactam for injection) Pharmacy Bulk Package--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Cardiolite Kit for the Preparation of Technetium Tc99m Sestamibi for Injection---Precautions----
Cetrotide (cetrorelix acetate for injection)---Precautions----
Dibenzyline (phenoxybenzamine hydrochloride capsules, USP)---Precautions----
Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) Capsules---Precautions----
Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension---Precautions----
Pilopine HS (pilocarpine hydrochloride ophthalmic gel) 4%---Precautions----
Propranolol Hydrochloride Injection, USP---Precautions----
Pulmicort Flexhaler (budesonide inhalation powder) For Oral Inhalation Only---PrecautionsAdverse ReactionsPatient Package Insert--
Synthroid (levothyroxine sodium tablets, USP)---Precautions----
Tenormin (atenolol) Tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Copegus (ribavirin, USP) Tablets----Adverse Reactions---
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension----Adverse ReactionsPatient Package Insert--
Navane (thiothixene) Capsules----Adverse Reactions---
Navane (thiothixene hydrochloride) Concentrate----Adverse Reactions---
Singulair (montelukast sodium) Granule----Adverse ReactionsPatient Package Insert--
Singulair (montelukast sodium) Tablet, Chewable----Adverse ReactionsPatient Package Insert--
Singulair (montelukast sodium) Tablet, Film Coated----Adverse ReactionsPatient Package Insert--
Theophylline in 5% Dextrose Injections, USP----Adverse Reactions---
Zerit (stavudine) Capsules----Adverse ReactionsPatient Package Insert--
Zerit (stavudine) for Oral Solution----Adverse ReactionsPatient Package Insert--
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