Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4194
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ANCEF (Injection)
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dailymed-instance:dosage |
Usual Adult Dosage: In rare instances, doses
of up to 12 grams of ANCEF per day have been used.<br/>Perioperative Prophylactic Use: To prevent postoperative infection in contaminated or potentially
contaminated surgery, recommended doses are: a. 1 gram
IV or IM administered/hour to 1 hour prior
to the start of surgery. b. For lengthy operative procedures
(e.g., 2 hours or more), 500 mg to 1 gram IV or IM during surgery
(administration modified depending on the duration of the operative procedure). c.
500 mg to 1 gram IV or IM every 6 to 8 hours for 24 hours
postoperatively. It is important that (1) the preoperative
dose be given just (/to 1 hour) prior to the
start of surgery so that adequate antibiotic levels are present in the serum
and tissues at the time of initial surgical incision; and (2) ANCEF be administered,
if necessary, at appropriate intervals during surgery to provide sufficient
levels of the antibiotic at the anticipated moments of greatest exposure to
infective organisms. In surgery where the occurrence
of infection may be particularly devastating (e.g., open-heart surgery and
prosthetic arthroplasty), the prophylactic administration of ANCEF may be
continued for 3 to 5 days following the completion of surgery.<br/>Dosage Adjustment for Patients With Reduced Renal Function: ANCEF may be used in patients with reduced renal function
with the following dosage adjustments: Patients with a creatinine clearance
of 55 mL/min. or greater or a serum creatinine of 1.5 mg % or less
can be given full doses. Patients with creatinine clearance rates of 35 to
54 mL/min. or serum creatinine of 1.6 to 3.0 mg % can also be given
full doses but dosage should be restricted to at least 8 hour intervals.
Patients with creatinine clearance rates of 11 to 34 mL/min. or serum
creatinine of 3.1 to 4.5 mg % should be given/the
usual dose every 12 hours. Patients with creatinine clearance rates of
10 mL/min. or less or serum creatinine of 4.6 mg % or greater should
be given/the usual dose every 18 to 24 hours.
All reduced dosage recommendations apply after an initial loading dose appropriate
to the severity of the infection. Patients undergoing peritoneal dialysis:
See CLINICAL PHARMACOLOGY.<br/>Pediatric Dosage: In pediatric patients,
a total daily dosage of 25 to 50 mg per kg (approximately 10 to 20 mg
per pound) of body weight, divided into 3 or 4 equal doses, is effective for
most mild to moderately severe infections. Total daily dosage may be increased
to 100 mg per kg (45 mg per pound) of body weight for severe infections.
Since safety for use in premature infants and in neonates has not been established,
the use of ANCEF in these patients is not recommended. In pediatric patients with mild to moderate renal impairment
(creatinine clearance of 70 to 40 mL/min.), 60 percent of the normal
daily dose given in equally divided doses every 12 hours should be sufficient.
In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.),
25 percent of the normal daily dose given in equally divided doses every 12
hours should be adequate. Pediatric patients with severe renal impairment
(creatinine clearance of 20 to 5 mL/min.) may be given 10 percent of
the normal daily dose every 24 hours. All dosage recommendations apply after
an initial loading dose.
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dailymed-instance:descripti... |
ANCEF is a semi-synthetic cephalosporin for parenteral administration.
It is the sodium salt of 3-{[(5-methyl-1,3,4-thiadiazol-2-yl)thio]-methyl}-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic
acid. Structural Formula: Each vial
contains 48 mg of sodium/1 gram of cefazolin sodium. ANCEF
in lyophilized form is supplied in vials equivalent to 1 gram of cefazolin;
in���Piggyback���Vials for intravenous admixture equivalent to
1 gram of cefazolin; and in Pharmacy Bulk Vials equivalent to 10 grams
of cefazolin.
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dailymed-instance:clinicalP... |
After intramuscular administration of ANCEF to normal volunteers,
the mean serum concentrations were 37 mcg/mL at 1 hour and 3 mcg/mL
at 8 hours following a 500-mg dose, and 64 mcg/mL at 1 hour and
7 mcg/mL at 8 hours following a 1-gram dose. Studies
have shown that following intravenous administration of ANCEF to normal volunteers,
mean serum concentrations peaked at approximately 185 mcg/mL and were
approximately 4 mcg/mL at 8 hours for a 1-gram dose. The
serum half-life for ANCEF is approximately 1.8 hours following IV administration
and approximately 2.0 hours following IM administration. In
a study (using normal volunteers) of constant intravenous infusion with dosages
of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg
the next 2 hours (approximately 100 mg), ANCEF produced a steady
serum level at the third hour of approximately 28 mcg/mL. Studies
in patients hospitalized with infections indicate that ANCEF produces mean
peak serum levels approximately equivalent to those seen in normal volunteers. Bile
levels in patients without obstructive biliary disease can reach or exceed
serum levels by up to 5 times; however, in patients with obstructive biliary
disease, bile levels of ANCEF are considerably lower than serum levels (<1.0 mcg/mL). In
synovial fluid, the level of ANCEF becomes comparable to that reached in serum
at about 4 hours after drug administration. Studies
of cord blood show prompt transfer of ANCEF across the placenta. ANCEF is
present in very low concentrations in the milk of nursing mothers. ANCEF
is excreted unchanged in the urine. In the first 6 hours approximately
60% of the drug is excreted in the urine and this increases to 70% to 80%
within 24 hours. ANCEF achieves peak urine concentrations of approximately
2,400 mcg/mL and 4,000 mcg/mL respectively following 500-mg and
1-gram intramuscular doses. In patients undergoing
peritoneal dialysis (2 L/hr.), ANCEF produced mean serum levels of approximately
10 and 30 mcg/mL after 24 hours' instillation of a dialyzing
solution containing 50 mg/L and 150 mg/L, respectively. Mean peak
levels were 29 mcg/mL (range 13 to 44 mcg/mL) with 50 mg/L
(3 patients), and 72 mcg/mL (range 26 to 142 mcg/mL) with 150 mg/L
(6 patients). Intraperitoneal administration of ANCEF is usually well tolerated. Controlled
studies on adult normal volunteers, receiving 1 gram 4 times a day
for 10 days, monitoring CBC, SGOT, SGPT, bilirubin, alkaline phosphatase,
BUN, creatinine, and urinalysis, indicated no clinically significant changes
attributed to ANCEF.<br/>Microbiology: In vitro tests demonstrate that the bactericidal action
of cephalosporins results from inhibition of cell wall synthesis. Cefazolin
has been shown to be active against most strains of the following microorganisms,
both in vitro and in clinical infections as described in INDICATIONS AND USAGE.<br/>Gram-Positive Aerobes: Staphylococcus
aureus (including��-lactamase���producing strains) Staphylococcus epidermidis Streptococcus pyogenes,Streptococcus
agalactiae, and other strains of streptococci Streptococcus pneumoniae Methicillin-resistant
staphylococci are uniformly resistant to cefazolin, and many strains of enterococci
are resistant.<br/>Gram-Negative Aerobes: Escherichia
coli Proteus
mirabilis Most strains of indole positive
Proteus (Proteus vulgaris), Enterobacter spp., Morganella
morganii, Providencia rettgeri,Serratia spp., and Pseudomonas spp. are resistant to cefazolin.<br/>Susceptibility Tests:<br/>Diffusion Techniques: Quantitative methods that require measurement of zone diameters
provide reproducible estimates of the susceptibility of bacteria to antimicrobial
compounds. One such standardized procedurethat has been recommended
for use with disks to test the susceptibility of microorganisms to cefazolin
uses the 30-mcg cefazolin disk. Results of the standardized single-disk susceptibility
testwith a 30-mcg cefazolin disk should be interpreted according
to the following criteria: RECOMMENDED RANGES FOR CEFAZOLIN
SUSCEPTIBILITY TESTING Standardized single-disk susceptibility test should be
performed ONLY with a 30-mcg cefazolin disk. A report
of "Susceptible" indicates that the pathogen is likely to be inhibited by
usually achievable concentrations of the antimicrobial compound in the blood.
A report of "Intermediate" indicates that the result should be considered
equivocal, and, if the microorganism is not fully susceptible to alternative,
clinically feasible drugs, the test should be repeated. This category implies
possible clinical applicability in body sites where the drug is physiologically
concentrated or in situations where high dosage of drug can be used. This
category also provides a buffer zone that prevents small uncontrolled technical
factors from causing major discrepancies in interpretation. A report of "Resistant"
indicates that usually achievable concentrations of the antimicrobial compound
in the blood are unlikely to be inhibitory and that other therapy should be
selected. Standardized susceptibility test procedures
require the use of laboratory control microorganisms. The 30-mcg cefazolin
disk should provide the following zone diameters in these laboratory test
quality control strains: The cefazolin disk should not be used for testing susceptibility
to other cephalosporins.<br/>Dilution Techniques: Quantitative methods
that are used to determine minimum inhibitory concentrations provide reproducible
estimates of the susceptibility of bacteria to antimicrobial compounds. One
such standardized procedure uses a standardized dilution method(broth,
agar, or microdilution) or equivalent with cefazolin powder. The MIC values
obtained should be interpreted according to the following criteria: Interpretation should be as stated above for results using
diffusion techniques. As with standard diffusion techniques,
dilution methods require the use of laboratory control microorganisms. Standard
cefazolin powder should provide the following MIC values:
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dailymed-instance:contraind... |
ANCEF IS CONTRAINDICATED IN PATIENTS WITH KNOWN ALLERGY
TO THE CEPHALOSPORIN GROUP OF ANTIBIOTICS.
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dailymed-instance:supply |
ANCEF<br/>Single-Dose Vials: Each vial contains cefazolin
sodium equivalent to 1 gram of cefazolin. NDC 0007-3130-16
(package of 25 vials)<br/>���Piggyback���Vials: Each vial contains cefazolin sodium equivalent to 1 gram
of cefazolin. NDC 0007-3137-05 (package of 10 "piggyback"
vials)<br/>Pharmacy Bulk Vials: Each vial contains cefazolin sodium equivalent to 10 grams
of cefazolin. NDC 0007-3135-05 (package of 10 pharmacy
bulk vials) As with other cephalosporins, ANCEF tends
to darken depending on storage conditions; within the stated recommendations,
however, product potency is not adversely affected. Before
reconstitution protect from light and store at Controlled Room Temperature
20��to 25��C (68��to 77��F).
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dailymed-instance:precautio... |
General: Prolonged use of ANCEF
may result in the overgrowth of nonsusceptible organisms. Careful clinical
observation of the patient is essential. When ANCEF
is administered to patients with low urinary output because of impaired renal
function, lower daily dosage is required (see DOSAGE AND ADMINISTRATION). As
with other��-lactam antibiotics, seizures may occur if inappropriately
high doses are administered to patients with impaired renal function (see
DOSAGE AND ADMINISTRATION). ANCEF, as with all cephalosporins,
should be prescribed with caution in individuals with a history of gastrointestinal
disease, particularly colitis. Cephalosporins may be
associated with a fall in prothrombin activity. Those at risk include patients
with renal or hepatic impairment or poor nutritional state, as well as patients
receiving a protracted course of antimicrobial therapy, and patients previously
stabilized on anticoagulant therapy. Prothrombin time should be monitored
in patients at risk and exogenous vitamin K administered as indicated. Prescribing
ANCEF in the absence of a proven or strongly suspected bacterial infection
or a prophylactic indication is unlikely to provide benefit to the patient
and increases the risk of the development of drug-resistant bacteria.<br/>Drug Interactions: Probenecid may decrease
renal tubular secretion of cephalosporins when used concurrently, resulting
in increased and more prolonged cephalosporin blood levels.<br/>Drug/Laboratory Test Interactions: A false positive reaction
for glucose in the urine may occur with Benedict's solution, Fehling's
solution or with CLINITEST tablets, but not with enzyme-based
tests such as CLINISTIX. Positive
direct and indirect antiglobulin (Coombs) tests have occurred; these may also
occur in neonates whose mothers received cephalosporins before delivery.<br/>Information for Patients:<br/>Carcinogenesis/Mutagenesis: Mutagenicity studies
and long-term studies in animals to determine the carcinogenic potential of
ANCEF have not been performed.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed
in rats, mice, and rabbits at doses up to 25 times the human dose and have
revealed no evidence of impaired fertility or harm to the fetus due to ANCEF.
There are, however, no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response,
this drug should be used during pregnancy only if clearly needed.<br/>Labor and Delivery: When cefazolin has been administered prior to caesarean section,
drug levels in cord blood have been approximately one quarter to one third
of maternal drug levels. The drug appears to have no adverse effect on the
fetus.<br/>Nursing Mothers: ANCEF is present in very
low concentrations in the milk of nursing mothers. Caution should be exercised
when ANCEF is administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness for use in premature infants and
neonates have not been established. See DOSAGE AND ADMINISTRATION for recommended
dosage in pediatric patients older than 1 month.<br/>Geriatric Use: Of the 920 subjects who received ANCEF in clinical studies,
313 (34%) were 65 years and over, while 138 (15%) were 75 years
and over. No overall differences in safety or effectiveness were observed
between these subjects and younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger
patients, but greater sensitivity of some older individuals cannot be ruled
out. This drug is known to be substantially excreted
by the kidney, and the risk of toxic reactions to this drug may be greater
in patients with impaired renal function. Because elderly patients are more
likely to have decreased renal function, care should be taken in dose selection,
and it may be useful to monitor renal function (see PRECAUTIONS, General and
DOSAGE AND ADMINISTRATION).
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dailymed-instance:genericMe... |
cefazolin sodium
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dailymed-instance:fullName |
ANCEF (Injection)
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dailymed-instance:adverseRe... |
The following reactions have been reported:<br/>Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), vomiting, nausea,
stomach cramps, anorexia, and pseudomembranous colitis. Onset of pseudomembranous
colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).
Nausea and vomiting have been reported rarely.<br/>Allergic: Anaphylaxis, eosinophilia, itching, drug fever, skin rash,
Stevens-Johnson syndrome.<br/>Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia.<br/>Hepatic: Transient rise in SGOT,
SGPT, and alkaline phosphatase levels has been observed. As with other cephalosporins,
reports of hepatitis have been received.<br/>Renal: As with other cephalosporins, reports of increased BUN and
creatinine levels, as well as renal failure, have been received.<br/>Local Reactions: Rare instances of phlebitis have been reported at site of
injection. Pain at the site of injection after intramuscular administration
has occurred infrequently. Some induration has occurred.<br/>Other Reactions: Genital and anal pruritus (including vulvar pruritus, genital
moniliasis, and vaginitis).
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dailymed-instance:warning |
BEFORE THERAPY WITH ANCEF IS INSTITUTED, CAREFUL INQUIRY
SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY
REACTIONS TO CEFAZOLIN, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS
PRODUCT IS GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED
BECAUSE CROSS-HYPERSENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY
DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN
ALLERGY. IF AN ALLERGIC REACTION TO ANCEF OCCURS, DISCONTINUE TREATMENT WITH
THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH
EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV
ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS
CLINICALLY INDICATED. Pseudomembranous
colitis has been reported with nearly all antibacterial agents, including
cefazolin, and may range in severity from mild to life-threatening. Therefore,
it is important to consider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the
normal flora of the colon and may permit overgrowth of clostridia. Studies
indicate that a toxin produced by Clostridium
difficile is a primary cause of���antibiotic-associated colitis���. After the diagnosis of pseudomembranous colitis
has been established, therapeutic measures should be initiated. Mild cases
of pseudomembranous colitis usually respond to drug discontinuation alone.
In moderate to severe cases, consideration should be given to management with
fluids and electrolytes, protein supplementation, and treatment with an oral
antibacterial drug clinically effective against C.
difficile colitis.
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dailymed-instance:indicatio... |
ANCEF is indicated in the treatment of the following infections
due to susceptible organisms:<br/>Respiratory Tract Infections: Due to S. pneumoniae, S aureus (including��-lactamase���producing
strains) and S. pyogenes. Injectable benzathine penicillin is considered
to be the drug of choice in treatment and prevention of streptococcal infections,
including the prophylaxis of rheumatic fever. ANCEF
is effective in the eradication of streptococci from the nasopharynx; however,
data establishing the efficacy of ANCEF in the subsequent prevention of rheumatic
fever are not available.<br/>Urinary Tract Infections: Due to E. coli, P mirabilis.<br/>Skin and Skin Structure Infections: Due to S. aureus (including��-lactamase���producing
strains), S. pyogenes, and other strains of streptococci.<br/>Biliary Tract Infections: Due to E. coli, various strains of streptococci, P. mirabilis, and S. aureus.<br/>Bone and Joint Infections: Due to S. aureus.<br/>Genital Infections: (i.e., prostatitis, epididymitis) due to E. coli, P. mirabilis.<br/>Septicemia: Due to S. pneumoniae, S. aureus (including��-lactamase���producing
strains), P. mirabilis, E. coli.<br/>Endocarditis: Due to S. aureus (including��-lactamase���producing
strains) and S. pyogenes. Appropriate culture and susceptibility
studies should be performed to determine susceptibility of the causative organism
to ANCEF.<br/>Perioperative Prophylaxis: The prophylactic administration of ANCEF preoperatively,
intraoperatively, and postoperatively may reduce the incidence of certain
postoperative infections in patients undergoing surgical procedures which
are classified as contaminated or potentially contaminated (e.g., vaginal
hysterectomy, and cholecystectomy in high-risk patients such as those older
than 70 years, with acute cholecystitis, obstructive jaundice, or common
duct bile stones). The perioperative use of ANCEF may
also be effective in surgical patients in whom infection at the operative
site would present a serious risk (e.g., during open-heart surgery and prosthetic
arthroplasty). The prophylactic administration of ANCEF
should usually be discontinued within a 24-hour period after the surgical
procedure. In surgery where the occurrence of infection may be particularly
devastating (e.g., open-heart surgery and prosthetic arthroplasty), the prophylactic
administration of ANCEF may be continued for 3 to 5 days following the
completion of surgery. If there are signs of infection,
specimens for cultures should be obtained for the identification of the causative
organism so that appropriate therapy may be instituted. (See
DOSAGE AND ADMINISTRATION.) To reduce the development
of drug-resistant bacteria and maintain the effectiveness of ANCEF and other
antibacterial drugs, ANCEF should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be
considered in selecting or modifyingantibacterial therapy. In the absence
of such data, local epidemiology and susceptibility patterns may contribute
to the empiric selection of therapy.
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ANCEF
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