1996 Index - Drug Labeling Changes

MedWatch

INDEX OF SAFETY-RELATED DRUG LABELING CHANGE SUMMARIES APPROVED BY FDA
July - December 1996

(Posted: 2/7/97)

Note: The summaries include only those safety-related 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.

INDEX OF SAFETY-RELATED DRUG LABELING CHANGE SUMMARIES APPROVED BY FDA July - December 1996

|A |B |C |D |E |F |G |H |I |J |K |L |M |N |O |P |Q |R |S |T |U |V |W |X |Y |Z|

ADENOCARD (adenosine) ALTACE (ramipril) ANDRODERM (testosterone) AREDIA (pamidronate disodium) ASACOL (mesalamine) ATROVENT (ipratropium bromide) AVENTYL (nortriptyline HCl) AZACTAM (aztreonam) AZULFIDINE EN-TABS (sulfasalazine)

BECONASE AQ (beclomethasone dipropionate, monohydrate) BENTYL (dicyclomine) BIAXIN (clarithromycin) BSS PLUS

DDAVP (desmopressin acetate) DESOGEN (desogestrel/ethinyl estradiol) DIDRONEL (etidronate disodium) DIFLUCAN (fluconazole) - jul DIFLUCAN (fluconazole) - aug DOVONEX (calcipotriene)

ENKAID (encainide HCl) ERYTHROCIN (erythromycin lactobionate for injection, USP)

FAMVIR (famciclovir) FLAREX (fluorometholone acetate) FLONASE (fluticasone propionate) FLOXIN (ofloxacin) FORTAZ (ceftazidime)

HUMATROPE [somatropin (rDNA origin)] HYDREA (hydroxyurea) HYTRIN (terazosin HCl) HYZAAR (losartan/hydrochlorothiazide)

INVIRASE (saquinavir mesylate) IMITREX (sumatriptan succinate) IOPIDINE (apraclonidine HCl) ISONIAZID

LIDOCAINE HCl LOZOL (indapamide) LUPRON DEPOT (leuprolide acetate) LUVOX (fluvoxamine maleate)

MAXAQUIN (lomefloxacin HCl) MAXIDEX (dexamethasone) MEFOXIN (cefoxitin) MEGACE(megestrol acetate) MIACALCIN(calcitonin-salmon) MONOPRIL (fosinopril) MONOPRIL-HCT (fosinopril/hydrochlorothiazide)

NIMOTOP (nimodipine) NIZORAL (ketoconazole) NOLVADEX (tamoxifen citrate) NOROXIN (norfloxacin) NOR-QD (norethindrone) NORVIR (ritonavir) NORMODYNE (labetalol HCl) NOVANTRONE (mitoxantrone)

REDUX (dexfenfluramine HCl) RESERPINE RHINOCORT (budesonide) RETROVIR (zidovudine) ROCALTROL (calcitriol)

SALAGEN (pilocarpine HCl) SEREVENT (salmeterol xinafoate) SPORANOX (itraconazole) SULAR (nisoldipine)

TAMBOCOR (flecainide acetate) TOBRADEX (tobramycin/dexamethasone)

VALTREX (valacyclovir HCl) VASERETIC (enalapril maleate/hydrochlorothiazide) VASOTEC (enalapril maleate) VASOTEC I.V. (enalaprilat) VISTIDE (cidofovir)

XANAX (alprazolam)

ZINACEF (cefuroxime sodium) ZOLOFT (sertraline HCl)

INDEX OF SAFETY-RELATED DRUG LABELING CHANGE SUMMARIES APPROVED BY FDA
July - December 1996

ADENOCARD (adenosine)
ALTACE (ramipril)
ANDRODERM (testosterone)
AREDIA (pamidronate disodium)
ASACOL (mesalamine)
ATROVENT (ipratropium bromide)
AVENTYL (nortriptyline HCl)
AZACTAM (aztreonam)
AZULFIDINE EN-TABS (sulfasalazine)

BECONASE AQ (beclomethasone dipropionate, monohydrate)
BENTYL (dicyclomine)
BIAXIN (clarithromycin)
BSS PLUS

DDAVP (desmopressin acetate)
DESOGEN (desogestrel/ethinyl estradiol)
DIDRONEL (etidronate disodium)
DIFLUCAN (fluconazole) - jul
DIFLUCAN (fluconazole) - aug
DOVONEX (calcipotriene)

ENKAID (encainide HCl)
ERYTHROCIN (erythromycin lactobionate for injection, USP)

FAMVIR (famciclovir)
FLAREX (fluorometholone acetate)
FLONASE (fluticasone propionate)
FLOXIN (ofloxacin)
FORTAZ (ceftazidime)

HUMATROPE [somatropin (rDNA origin)]
HYDREA (hydroxyurea)
HYTRIN (terazosin HCl)
HYZAAR (losartan/hydrochlorothiazide)

INVIRASE (saquinavir mesylate)
IMITREX (sumatriptan succinate)
IOPIDINE (apraclonidine HCl)
ISONIAZID

LIDOCAINE HCl
LOZOL (indapamide)
LUPRON DEPOT (leuprolide acetate)
LUVOX (fluvoxamine maleate)

MAXAQUIN (lomefloxacin HCl)
MAXIDEX (dexamethasone)
MEFOXIN (cefoxitin)
MEGACE(megestrol acetate)
MIACALCIN(calcitonin-salmon)
MONOPRIL (fosinopril)
MONOPRIL-HCT (fosinopril/hydrochlorothiazide)

NIMOTOP (nimodipine)
NIZORAL (ketoconazole)
NOLVADEX (tamoxifen citrate)
NOROXIN (norfloxacin)
NOR-QD (norethindrone)
NORVIR (ritonavir)
NORMODYNE (labetalol HCl)
NOVANTRONE (mitoxantrone)

REDUX (dexfenfluramine HCl)
RESERPINE
RHINOCORT (budesonide)
RETROVIR (zidovudine)
ROCALTROL (calcitriol)

SALAGEN (pilocarpine HCl)
SEREVENT (salmeterol xinafoate)
SPORANOX (itraconazole)
SULAR (nisoldipine)

TAMBOCOR (flecainide acetate)
TOBRADEX (tobramycin/dexamethasone)

VALTREX (valacyclovir HCl)
VASERETIC (enalapril maleate/hydrochlorothiazide)
VASOTEC (enalapril maleate)
VASOTEC I.V. (enalaprilat)
VISTIDE (cidofovir)

ZINACEF (cefuroxime sodium)
ZOLOFT (sertraline HCl)