Drug Safety Labeling Changes - March 2009
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March 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 |
| Epzicom (abacavir sulfate and lamivudine) tablets |  | | | | - | - | - | - |
| OsmoPrep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets | | - | - | - | | - | - | - |
| Raptiva (efalizumab) | | | | | | - | - | - |
| Sporanox (itraconazole) Oral Solution, 10 mg/mL | | | | | | - | - | - |
| Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets | | | | | - | - | - | - |
| Visicol (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) | | - | - | - | | - | - | - |
| Diabeta (glyburide) Tablets | - | | - | | - | - | - | - |
| Macrobid (nitrofurantoin monohydrate/macrocrystals) capsules, 100 mg | - | | - | - | - | - | - | - |
| Macrodantin (nitrofurantoin macrocrystals) capsules, 25, 50 and 100 mg | - | | | - | - | - | - | - |
| Rocephin (ceftriaxone sodium) for injection, 250 mg, 500 mg, 1 g and 2 g | - | | | - | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Sporanox (itraconazole) Capsules, 100 mg | - | | | | | | - | - |
| Sporanox (itraconazole) Injection, 10 mg/mL | - | | | | | | - | - |
| Theophylline in 5% Dextrose injection, USP, Flexible Plastic Container | - | | | | | - | - | - |
| Tracleer (bosentan) 62.5 and 125 mg Tablets | - | | - | | - | - | - | - |
| Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder) | - | - | | | - | - | - | - |
| Altace (ramipril) 1.25, 2.5, 5, and 10 mg Capsules | - | - | | | - | - | - | - |
| Altace (ramipril) 1.25, 2.5, 5 and 10 mg Tablets | - | - | | | - | - | - | - |
| Axert (almotriptan malate) Tablets 6.25 and 12.5 mg | - | - | | | | | - | - |
| Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules 20, 30 and 60 mg | - | - | | | | - | - | - |
| Frova (frovatriptan succinate) Tablets 2.5 mg | - | - | | | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Lexiscan (regadenoson) Injection | - | - | | | | - | - | - |
| Spiriva HandiHaler inhalation powder | - | - | | - | | - | - | - |
| NegGram (nalidixic acid) Caplets | - | - | - | | - | - | - | - |
| Novothyrox (levothyroxine sodium) Tablets | - | - | - | | - | - | - | - |
| Tarka (trandolopril/verapamil hydrochloride) 2/180, 1/240, 2/240, 4/240 mg ER Tablets | - | - | - | | - | - | - | - |
| Zithromax (azithromcyin) for Oral Suspension, 200 mg, 500 mg, Single Dose Packet, 600 mg, IV | - | - | - | | - | - | - | - |
| Clinoril (sulindac) Tablets | - | - | - | - | | - | - | - |
| Cosmegen (dactinomycin) for Injection | - | - | - | - | | - | - | - |
| Crestor (rosuvastatin calcium) Tablets | - | - | - | - | | - | - | - |
| Demerol (meperidine hydrochloride) Tablets and Oral Solution | - | - | - | - | | - | - | - |
| Drug Name |
BW |
C |
W |
P |
AR |
PPI |
MG |
PCI |
| Eloxatin (oxaliplatin) powder for solution for intravenous use | - | - | - | - | | - | - | - |
| Eloxatin (oxaliplatin) concentrate for solution for intravenous use | - | - | - | - | | - | - | - |
| Vancocin Hcl (vancomycin for injection, USP) 500 mg/100mL and 1g/200mL | - | - | - | - | | - | - | - |
| Dalmane (flurazepam hydrochloride), 15 mg and 30 mg oral Capsules | - | - | - | - | - | - | - | - |
| Prozac (fluoxetine hydrochloride) capsules | - | - | - | - | - | - | - | - |
| Symbyax (olanzapine/fluoxetine) capsules | - | - | - | - | - | - | - | - |
| Synagis (palivizumab) | - | - | - | - | - | | - | - |
| Zyprexa (olanzapine) Tablet | - | - | - | - | - | - | - | - |
| Zyprexa Zydis (olanzapine) Tablet, Orally Disintegrating | - | - | - | - | - | - | - | - |
