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Home : DrugWatch : Zyban : FDA Information : March 2007 Monthly Safety Labeling Changes

March 2007 Monthly Safety Labeling Changes

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

DRUG NAME	SECTIONS MODIFIED
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Cyclessa (desogestrel/ethinyl estradiol) Tablets		X	X	X	X	PPI
Genotropin (somatropin [rDNA origin] for injection)		X		X
Saizen (somatropin [rDNA origin] for injection) for Subcutaneous or Intramuscular Injection		X	X	X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Ambien (zolpidem tartrate) Tablets			X	X
Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL			X	X
Aristospan (triamcinolone hexacetonide injectable suspension, USP) 20 mg/mL			X	X
Cordarone (amiodarone HCl) Tablets			X		X
Keppra (levetiracetam) Tablets and Oral Solution			X	X		PPI
Noroxin (norfloxacin) Tablets			X	X
Prilosec OTC (omeprazole magnesium delayed-release tablet)			X
Primaxin I.M. (imipenem and cilastatin injectable suspension)			X		X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Aldara (imiquimod) Cream, 5% for Topical Use Only				X		PPI
Carnitor (levocarnitine) Tablets and Oral Solution Carnitor SF (levocarnitine) Sugar-Free Oral Solution				X	X
Delatestryl (testosterone enanthate injection, USP)				X
Detrol LA (tolterodine tartrate extended release capsules)				X	X
Flumadine (rimantadine hydrochloride tablets and syrup)				X
Focalin (dexmethylphenidate hydrochloride) Tablets				X
Fortaz (ceftazidime for injection) Fortaz (ceftazidime injection)				X
Nexavar (sorafenib) Tablets				X	X
Orencia (abatacept)				X		PPI
Prozac (fluoxetine capsules and oral solution, USP) Prozac Weekly (fluoxetine delayed-relase capsules, USP)				X
Reyataz (atazanavir sulfate) Capsules				X	X	PPI
Risperdal Consta (risperidone) Long-Acting Injection				X	X
Symmetrel (amantadine hydrochloride, USP) Tablets and Syrup				X	X
Timentin (ticarcillin disodium and clavulanate potassium) Injection				X
Timentin (sterile ticarcillin disodium and clavulanate potassium) for Intravenous Administration				X
Toprol-XL (metoprolol succinate) Extended-Release Tablets				X	X
Uroxatral (alfuzosin HCl extended-release tablets)				X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Aggrenox (aspirin/extended-release dipyridamole) Capsules					X
Detrol (tolterodine tartrate tablets)					X
Lipitor (atorvastatin calcium) Tablets					X
Zelnorm (tegaserold maleate) Tablets					X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Avandaryl (rosiglitazone maleate and glimepiride) Tablets						PPI
Baraclude (entecavir) Tablets and Oral Solution						PPI
Dolobid (diflunisal) Tablets						MG
Fentora (fentanyl buccal tablet)						MG
Geodon (ziprasidone HCl) Capsules						PPI
Kaletra (lopinavir/ritonavir) Tablets and Oral Solution						PPI
Soliris (eculizumab)						MG
Zyban (bupropion hydrochloride) Sustained-Release Tablets						MG

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