Safety-Related Drug Labeling Changes Approved by FDA

FDA Medical Bulletin * Summer 1997 * Volume 27 Number 2

SAFETY-RELATED DRUG LABELING
CHANGES APPROVED BY FDA

Summaries of the labeling changes can be found on the medWatch home page (www.fda.gov/medwatch). The summaries include only those sections that have been modified and therefore do not contain all the information needed for safe and effective prescribing. Contact the manufacturer for the complete labeling/package insert.

MAY 1997

BECONASE AQ (beclomethasone dipropionate)
CEDAX (ceftibuten)
CEFZIL (cefprozil)
CITANEST PLAIN (prilocaine HCl)
CITANEST FORTE (prilocaine and epinephrine)
COREG (carvedilol)
ETHMOZINE (moricizine HCl)
FEMSTAT (butoconazole nitrate)
GLUCAGONINTAL (cromolyn Na)
LUPRON DEPOT (leuprolide acetate)
MAXIPIME (cefepime HCl)
MEPRON (atovaquone)
METHERGINE (methylergonovine maleate)
METHOTREXATE SODIUMMETROGEL (metronidazole)
MIRALUMA (technetium Tc 99m sestamibi)
NEBCIN (tobramycin sulfate)
NIZORAL (ketoconazole)
PAXIL (paroxetine HCl)
PRONESTYL (procainamide HCl)
SERZONE (nefazodone HCl)
TIMOPTIC (timolol maleate)
VANCOCIN HCl (vancomycin HCl)
VIVELLE (estradiol)
YUTOPAR (ritodrine HCl)
ZOCOR (simvastatin)
ZOVIRAX (acyclovir)

APRIL 1997

ACCOLATE (zafirlukast)
AMICAR (aminocaproic acid)
ANAFRANIL (clomipramine HCl)
CEFZIL (cefprozil)
CLIMARA (estradiol)
CLOZARIL (clozapine)
CUTIVATE (fluticasone propionate)
DESFERAL (deferoxamine mesylate)
E.E.S. (erythromycin ethylsuccinate)
ERY-PED (erythromycin ethylsuccinate)
FOSAMAX (alendronate sodium)
GLUCAGONGLYNASE (glyburide)
ILOSONE (erythromycin estolate)
INSULINKLONOPIN (clonazepam)
LOTENSIN HCT (benazepril HCl/hydrochlorothiazide)
LUDIOMIL (maprotiline HCl)
MAGNESIUM SULFATEMEFOXIN (cefoxitin)
MICRONASE (glyburide)
PCE (erythromycin)
PENETREX (enoxacin)
PONDIMIN (fenfluramine HCl)
PRAVACHOL (pravastatin sodium)
PRELAY (troglitazone)
PRILOSEC (omeprazole)
PROCARDIA (nifedipine)
PROCARDIA XL (nifedipine)
PROGRAF (tacrolimus)
PROVENTIL-HFA (albuterol sulfate HFA)
REZULIN (troglitazone)
TRENTAL (pentoxifylline)
VALTREX (valacyclovir HCl)
ZOFRAN (ondansetron HCl)

MARCH 1997

AUGMENTIN (amoxicillin/clavulanate potassium)
CAMPTOSAR (irinotecan HCl)
CLARITIN-D (loratadine/pseudoephedrine sulfate)
CLEOCIN (clindamycin)
CRIXIVAN (indinavir sulfate)
FURADANTIN (nitrofurantoin)
LAMICTAL (lamotrigine)
LOTREL (amlodipine/benazepril HCl)
MACROBID (nitrofurantoin)
MACRODANTIN (nitrofurantoin)
NORVIR (ritonavir)
PROZAC (fluoxetine HCl)
RYTHMOL (propafenone HCl)
SALAGEN (pilocarpine HCl)
SEPTRA (trimethoprim/sulfamethoxazole)
THALLOUS CHLORIDE T1201
TRECATOR-SC (ethionamide)

FEBRUARY 1997

CLARITIN-D (loratadine/pseudoephedrine sulfate)
DIFLUCAN (fluconazole)
INVIRASE (saquinavir mesylate)
MAXAQUIN (lomefloxacin HCl)
MEVACOR (lovastatin)
ORTHO-CEPT (desogestrel/ethinyl estradiol)
PENTAM 300 (pentamidine isethionate)
PREVACID (lansoprazole)
SULAR (nisoldipine)
THALLOUS CHLORIDE T1 201
UNASYN (ampicillin Na/sulbactam Na)
XYLOCAINE (lidocaine HCl)
ZOLADEX (goserelin acetate)

JANUARY 1997

ACEON (perindopril erbumine)
DEPO-PROVERA (medroxypro-gesterone acetate)
FAMVIR (famciclovir)
KYTRIL (granisetron HCl)
LOVENOX (enoxaparin sodium)
LUPRON DEPOT-PED (leuprolide acetate)
MAXZIDE (triamterene/hydrochlorothiazide)
NOROXIN (norfloxacin)
NORVASC (amlodipine besylate)
NORVIR (ritonavir)
OXYCONTIN (oxycodone HCl)
PERIDEX (chlorhexidine gluconate)
PROCARDIA XL (nifedipine)
ZOVIRAX (acyclovir)

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