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Acupuncture treatment of chronic back pain. a double-blind placebo-controlled trial
s&urn IICATIOW I*
For lnlravenous or
k:
CEFOBID
IS conlralndlcaled
Intramuscularuse m oalients with
Abstracts
_ ____
PRECAUTIONS: Although transient elevations 01 Ihe BUN and serum creatinine have been observed, CEFOBID alone does not appear lo cause signllicanl nephroloxlcity However, concom!tant admlmstratlon of ammoglycosldes and other cephalosporlns has caused nephratoxlclly CErOBlLl IS exlensivelyexrreled m bile Thesefum hall-lileof CEFOBID IS increased 2-4 lold m pattents wtlh hepallc disease and/or blliary ab+KIIO~ In general. lolaI dally dosage above 4 g should not be necessary m such patients If higher dosages are used. serum concentrations should be monltared Because renal excretion IS not Ihe main route 01 elimination of CEFOBID (see CLINICAL PHARMACOLOGY), patients wllh renal lailure require no adlustment in dosage when usual dosesareadminislered When high doses of CEFOBID are used, concenlrations 01 drug m the serum should be monltoredperiodlcally IIev~denceofaccumulafionex~sls dosageshould bedecreased accord!ngly The half-Me of CEFOBID is reduced slightly during hemodlalysis Thus, dosmgshould bescheduledtolollowadiafys~sper~od Inpaf~entswlth both hepaticdysfunclionand signlficantrenal disease, CEFOBlDdosageshould not exceed l-2 g dally wlthout close monitorlog of serum concenfralions As with other antlblolics. Vitamin K deliciency has occurred rarely m pallenls treated with CEFOBID Those al risk mclude pallems with a poor nutr~t!onalstalus. malabsorplionslales(e g ,cysticfibrosis),alcohol!sm and pallenls on prolonged hyper-alimentat~on regimens (admimstered elther intravenoustyorv~aanaso-gastrictube), Prothromblnt~meshould bemonilored in thesepat~entsandexagenousVitaminKadministered asindicated Adisull~ram-I~kereact~oncharacteri~edbyflushing,sweating,headache. and tachycardla has been reported when alcohol (beer, wine) was ingested WIthlo 72 hours alter CEFOBID admlmstratlon Patients should be cauboned aboul the mgestlon ofalcohollc beverages following the adminislraIIon of CEFOBID A similar reaction has been reported with other cephalosparlns Prolonged use of CEFOBID may result in the overgrowth al nonsusceptible or amsms Careful observation 01 the patient IS essentml CEF8BID should beprescribedwith caubon m indlvlduals witha hlstory 01 gastrolntestlnal disease. patticularycol~t~s Drug LaboraIory Ten Intemctions A lalse-posltlve reaction for glucose in the urine may occur with BenedIct’s or Fehling’s solution Carclnogmesis. Mutagmmsis, lmgalrmanl of Fsrtllitv The maximum duratlon of CEFOEID anlmal toxicity studies IS SIX months In none 01 the in wo 01 in nlro genetic toxicology studies did CEFOBID show any muta enic potential aluther the chromOSomaf 01 subchromosomal level CEF 8 BID produced no lmpa~rment olferl~l~ty and had noeffects on general reproductive perlormance or fetal development when admimstered subcutaneously at dally doses up lo 500 to 1000 mgikg prior to and dung matlog and to pregnant lemale rats during gestation These doses are 10 to 20 times the estimated usual single climcal dose Usaga in Pregnancy: Pmgnan CalsgorTB, Aeproducllon studies have been perlormed m mice rats. an? monkeys at doses up IO IO times the hug man dose and have revealed no &ldence 01 lmpalred lert~llty or harm lo the fetus due to CEFOBID Thereare. however. no adeauale and well controlled studies m pregnant women Because animal reproduction studies are not always predictive 01 human response, this drug should be used durfng
of papers in this issue
mto breast milk of FOEID IS adminlstered to a nursmg woman Pediatric Use: Safety and ellect~veness m chlldren have not been established ADVERSE REACTIONS: In clinical studies the following adverse ellects wereobservedandwereconslderedto berelated,oCEFOBlDtherapyoruncertain ef~otnnv Hygsnsnsli~vl~: As with all cephalosporlns, hypersenslliv~ty manlfested by skin reactions (1 al~enl m 45). drug lever (1 in 260). or a change in Coombs:test if in 6 8 has been reported These reactloos are more likely to occur m patlents with a hlstory 01 allergies, particularly to penicll~n Hematology: Aswith other beta-lactam ant~blotics. reversble neutropenia may occur with prolonged admlmstratlon Shghl decreases I” neutrophll count (1 patlent m 50) have been reported Decreased hemoglobins (1 m 20) or hemalocrits (1 m 20) have been reported. which IS c~n~~~tent with published literature on other cephatosporlns Transient eoslnophiha has occurred I” 1 oatlent I” IO Hspilc: 01 l&5_pallenis treated with cefoperazone m cl~mcal trials one patient with a history 01 hver disease develo ed sigml~cantly elevated liver lunctione?zymesdur~ng CEFOBlDtherapy L!.t~n~calstgnsandsymptomsof nonspeclftc hepat~tisaccompaniedtheseincreases Alter CEFOBIDtherapy was discontinued, the palient’s enzymes relurned to pre-treatment levels and the symptomatology resolved As with other armblolics that achieve high btle levels mild IranSlent elevations of liver function enzymes have been observed m 5-10% 01 the patients receiving CEFOBID therapy The relev-?nce of lhese findlogs. which were not accompamed by overt signs or s mptoms of hepatic dysfunclion has not been estabhshed I.!arlmlntsstinal: Diarrhea of loose stools has been reported in 1 in 30 patients, Most 01 theseexperiences have been mild or moderate mseverilyand sell-hmltlng in nature In all cases, these symptoms responded to sympfomatic therapy or ceased when cefoperazone therapy was Slopped Nausea and vomltlng have been reported rarely Symptoms 01 pseudomembranous colitis can appear during or for several weeks subse uent to antibiotic therapy (see WARNINGS) Renal Function90111:Transient elevations 01 the BUN (1 in 16) and serum creatimne (1 m 48) have been noted Local Reactions: CEFOBID is well tolerated loflowlng mtramuscular admmstration OcCaSIonally, transient paln (1 m 140) may tollowadmimstratlon by thts route When CEFOBID is admlmstered by intravenous infuslon some patients may develop phlebitts (1 in 120) at the mfusion site
)
A diviston
New
York
Pfizer Pharmaceuticals New York 10017
of
A45
For lnlravenous or
k:
CEFOBID
IS conlralndlcaled
Intramuscularuse m oalients with
Abstracts
_ ____
PRECAUTIONS: Although transient elevations 01 Ihe BUN and serum creatinine have been observed, CEFOBID alone does not appear lo cause signllicanl nephroloxlcity However, concom!tant admlmstratlon of ammoglycosldes and other cephalosporlns has caused nephratoxlclly CErOBlLl IS exlensivelyexrreled m bile Thesefum hall-lileof CEFOBID IS increased 2-4 lold m pattents wtlh hepallc disease and/or blliary ab+KIIO~ In general. lolaI dally dosage above 4 g should not be necessary m such patients If higher dosages are used. serum concentrations should be monltared Because renal excretion IS not Ihe main route 01 elimination of CEFOBID (see CLINICAL PHARMACOLOGY), patients wllh renal lailure require no adlustment in dosage when usual dosesareadminislered When high doses of CEFOBID are used, concenlrations 01 drug m the serum should be monltoredperiodlcally IIev~denceofaccumulafionex~sls dosageshould bedecreased accord!ngly The half-Me of CEFOBID is reduced slightly during hemodlalysis Thus, dosmgshould bescheduledtolollowadiafys~sper~od Inpaf~entswlth both hepaticdysfunclionand signlficantrenal disease, CEFOBlDdosageshould not exceed l-2 g dally wlthout close monitorlog of serum concenfralions As with other antlblolics. Vitamin K deliciency has occurred rarely m pallenls treated with CEFOBID Those al risk mclude pallems with a poor nutr~t!onalstalus. malabsorplionslales(e g ,cysticfibrosis),alcohol!sm and pallenls on prolonged hyper-alimentat~on regimens (admimstered elther intravenoustyorv~aanaso-gastrictube), Prothromblnt~meshould bemonilored in thesepat~entsandexagenousVitaminKadministered asindicated Adisull~ram-I~kereact~oncharacteri~edbyflushing,sweating,headache. and tachycardla has been reported when alcohol (beer, wine) was ingested WIthlo 72 hours alter CEFOBID admlmstratlon Patients should be cauboned aboul the mgestlon ofalcohollc beverages following the adminislraIIon of CEFOBID A similar reaction has been reported with other cephalosparlns Prolonged use of CEFOBID may result in the overgrowth al nonsusceptible or amsms Careful observation 01 the patient IS essentml CEF8BID should beprescribedwith caubon m indlvlduals witha hlstory 01 gastrolntestlnal disease. patticularycol~t~s Drug LaboraIory Ten Intemctions A lalse-posltlve reaction for glucose in the urine may occur with BenedIct’s or Fehling’s solution Carclnogmesis. Mutagmmsis, lmgalrmanl of Fsrtllitv The maximum duratlon of CEFOEID anlmal toxicity studies IS SIX months In none 01 the in wo 01 in nlro genetic toxicology studies did CEFOBID show any muta enic potential aluther the chromOSomaf 01 subchromosomal level CEF 8 BID produced no lmpa~rment olferl~l~ty and had noeffects on general reproductive perlormance or fetal development when admimstered subcutaneously at dally doses up lo 500 to 1000 mgikg prior to and dung matlog and to pregnant lemale rats during gestation These doses are 10 to 20 times the estimated usual single climcal dose Usaga in Pregnancy: Pmgnan CalsgorTB, Aeproducllon studies have been perlormed m mice rats. an? monkeys at doses up IO IO times the hug man dose and have revealed no &ldence 01 lmpalred lert~llty or harm lo the fetus due to CEFOBID Thereare. however. no adeauale and well controlled studies m pregnant women Because animal reproduction studies are not always predictive 01 human response, this drug should be used durfng
of papers in this issue
mto breast milk of FOEID IS adminlstered to a nursmg woman Pediatric Use: Safety and ellect~veness m chlldren have not been established ADVERSE REACTIONS: In clinical studies the following adverse ellects wereobservedandwereconslderedto berelated,oCEFOBlDtherapyoruncertain ef~otnnv Hygsnsnsli~vl~: As with all cephalosporlns, hypersenslliv~ty manlfested by skin reactions (1 al~enl m 45). drug lever (1 in 260). or a change in Coombs:test if in 6 8 has been reported These reactloos are more likely to occur m patlents with a hlstory 01 allergies, particularly to penicll~n Hematology: Aswith other beta-lactam ant~blotics. reversble neutropenia may occur with prolonged admlmstratlon Shghl decreases I” neutrophll count (1 patlent m 50) have been reported Decreased hemoglobins (1 m 20) or hemalocrits (1 m 20) have been reported. which IS c~n~~~tent with published literature on other cephatosporlns Transient eoslnophiha has occurred I” 1 oatlent I” IO Hspilc: 01 l&5_pallenis treated with cefoperazone m cl~mcal trials one patient with a history 01 hver disease develo ed sigml~cantly elevated liver lunctione?zymesdur~ng CEFOBlDtherapy L!.t~n~calstgnsandsymptomsof nonspeclftc hepat~tisaccompaniedtheseincreases Alter CEFOBIDtherapy was discontinued, the palient’s enzymes relurned to pre-treatment levels and the symptomatology resolved As with other armblolics that achieve high btle levels mild IranSlent elevations of liver function enzymes have been observed m 5-10% 01 the patients receiving CEFOBID therapy The relev-?nce of lhese findlogs. which were not accompamed by overt signs or s mptoms of hepatic dysfunclion has not been estabhshed I.!arlmlntsstinal: Diarrhea of loose stools has been reported in 1 in 30 patients, Most 01 theseexperiences have been mild or moderate mseverilyand sell-hmltlng in nature In all cases, these symptoms responded to sympfomatic therapy or ceased when cefoperazone therapy was Slopped Nausea and vomltlng have been reported rarely Symptoms 01 pseudomembranous colitis can appear during or for several weeks subse uent to antibiotic therapy (see WARNINGS) Renal Function90111:Transient elevations 01 the BUN (1 in 16) and serum creatimne (1 m 48) have been noted Local Reactions: CEFOBID is well tolerated loflowlng mtramuscular admmstration OcCaSIonally, transient paln (1 m 140) may tollowadmimstratlon by thts route When CEFOBID is admlmstered by intravenous infuslon some patients may develop phlebitts (1 in 120) at the mfusion site
)
A diviston
New
York
Pfizer Pharmaceuticals New York 10017
of
A45