Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1170
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Ceftriaxone (Injection, Solution)
|
| dailymed-instance:dosage |
Ceftriaxone Injection, USP is administered intravenously. Ceftriaxone Injection, USP and
calcium-containing solutions, including continuous calcium-containing infusions such as parenteral nutrition, should
not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different
sites (see
CONTRAINDICATIONS and
WARNINGS).<br/>Neonates: Hyperbilirubinemic neonates, especially prematures, should
not be treated with Ceftriaxone Injection, USP .<br/>Pediatric Patients: For the treatment of skin and skin structure infections, the
recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day). The
total daily dose should not exceed 2 grams. For the treatment of serious miscellaneous infections other
than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The
total daily dose should not exceed 2 grams. In the treatment of meningitis, it is recommended that the
initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day
(not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided
doses every 12 hours). The usual duration of therapy is 7 to 14 days.<br/>Adults: The usual adult daily dose is 1 to 2 grams given once a day
(or in equally divided doses twice a day) depending on the type and severity of infection. The total daily dose
should not exceed 4 grams. If Chlamydia
trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because
ceftriaxone sodium has no activity against this organism. For preoperative use (surgical prophylaxis), a single dose of
1 gram administered intravenously 1/2 to 2 hours before surgery is recommended. Generally, Ceftriaxone Injection, USP therapy should be
continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of
therapy is 4 to 14 days; in complicated infections, longer therapy may be required. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days. No dosage adjustment is necessary for patients with
impairment of renal or hepatic function; however, blood levels should be monitored in patients with severe renal
impairment (e.g., dialysis patients) and in patients with both renal and hepatic dysfunctions. Ceftriaxone Injection, USP should be administered
intravenously by infusion over a period of 30 minutes.<br/>DIRECTIONS FOR USE: Ceftriaxone Injection, USP is for intravenous administration
using sterile equipment.<br/>Storage: Store in a freezer capable of maintaining a
temperature of -20��C/-4��F.<br/>Thawing of Plastic Container: Thaw frozen container at room temperature
(25��C/77��F) or under refrigeration (5��C/41��F). [DO NOT FORCE THAW BY
IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.] Check for minute leaks by squeezing container firmly.
If leaks are detected, discard solution as sterility may be impaired. Do not add supplementary medication. The container should be visually inspected.
Components of the solution may precipitate in the frozen state and will dissolve upon reaching room
temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room
temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is
noted or if any seals or outlet ports are not intact, the container should be discarded. The thawed solution is stable for 21 days under
refrigeration (5��C/41��F) or 48 hours at room temperature (25��C/77��F).
Do not refreeze thawed antibiotics. Caution: Do not
use plastic containers in series connections. Such use could result in air embolism due to residual air
being drawn from the primary container before administration of the fluid from the secondary container is
complete.<br/>Preparation for Intravenous Administration:: 1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of
container. 3. Attach administration set. Refer to complete
directions accompanying set.
|
| dailymed-instance:descripti... |
Ceftriaxone Injection, USP is a sterile, semisynthetic,
broad-spectrum cephalosporin antibiotic for intravenous administration. Ceftriaxone sodium is (6 R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,
7-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is CHNNaOS���7/2 HO. It has
a calculated molecular weight of 661.60 and the following structural formula: Ceftriaxone Sodium, USP is a white to yellowish-orange crystalline
powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. Ceftriaxone Injection, USP contains approximately 83 mg (3.6 mEq) of
sodium per gram of ceftriaxone activity. Ceftriaxone Injection, USP is supplied as a frozen, iso-osmotic,
sterile, nonpyrogenic solution premixed in a dextrose diluent. Dextrose has been added to adjust the osmolality. The pH
may be adjusted with sodium hydroxide and/or hydrochloric acid. Solutions of premixed Ceftriaxone Injection, USP may range
from light yellow to amber in color. After thawing, the solution is intended for intravenous use. The pH of thawed
solutions may range from 6.0 to 8.0. See HOW SUPPLIED for package description. The plastic container for the frozen solution is fabricated from a
specially designed multilayer plastic, PL 2040. Solutions are in contact with the polyethylene layer of this container and
can leach out certain chemical components of the plastic in very small amounts within the expiration period. The
suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic
containers as well as by tissue culture toxicity studies.
|
| dailymed-instance:clinicalP... |
Average plasma concentrations of ceftriaxone following a single
30-minute intravenous (IV) infusion of a 0.5, 1 or 2 gm dose in healthy subjects are presented in Table 1. Multiple IV doses ranging from 0.5 to 2 gm at 12- to 24-hour
intervals resulted in 15% to 36% accumulation of ceftriaxone above single dose values. Ceftriaxone concentrations in urine are high, as shown in Table 2. Thirty-three percent to 67% of a ceftriaxone dose was excreted in the
urine as unchanged drug and the remainder was secreted in the bile and ultimately found in the feces as microbiologically
inactive compounds. After a 1 gm IV dose, average concentrations of ceftriaxone, determined from 1 to 3 hours after
dosing, were 581 mcg/mL in the gallbladder bile, 788 mcg/mL in the common duct bile, 898 mcg/mL in the cystic duct bile,
78.2 mcg/gm in the gallbladder wall and 62.1 mcg/mL in the concurrent plasma. Over a 0.15 to 3 gm dose range in healthy adult subjects, the values
of elimination half-life ranged from 5.8 to 8.7 hours; apparent volume of distribution from 5.78 to 13.5 L; plasma
clearance from 0.58 to 1.45 L/hour; and renal clearance from 0.32 to 0.73 L/hour. Ceftriaxone is reversibly bound to human
plasma proteins, and the binding decreased from a value of 95% bound at plasma concentrations of<25 mcg/mL to a
value of 85% bound at 300 mcg/mL. Ceftriaxone crosses the blood placenta barrier. The average values of maximum plasma concentration, elimination
half-life, plasma clearance and volume of distribution after a 50 mg/kg IV dose and after a 75 mg/kg IV dose in pediatric
patients suffering from bacterial meningitis are shown in Table 3. Ceftriaxone penetrated the inflamed meninges of infants
and pediatric patients; CSF concentrations after a50 mg/kg IV dose and after a 75 mg/kg IV dose are also shown in Table
3. Compared to that in healthy adult subjects, the pharmacokinetics of
ceftriaxone were only minimally altered in elderly subjects and in patients with renal impairment or hepatic dysfunction
(Table 4); therefore, dosage adjustments are not necessary for these patients with ceftriaxone dosages up to 2 gm per day.
Ceftriaxone was not removed to any significant extent from the plasma by hemodialysis. In 6 of 26 dialysis patients, the
elimination rate of ceftriaxone was markedly reduced, suggesting that plasma concentrations of ceftriaxone should be
monitored in these patients to determine if dosage adjustments are necessary.<br/>Microbiology: The bactericidal activity of ceftriaxone results from
inhibition of cell wall synthesis. Ceftriaxone has a high degree of stability in the presence of beta-lactamases,
both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. Ceftriaxone has been shown to be active against most strains
of the following microorganisms, both in vitro and in clinical infections
described in the INDICATIONS AND USAGE section. Aerobic gram-negative microorganisms: Acinetobacter calcoaceticus Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus
influenzae (including ampicillin-resistant and beta-lactamase producing strains) Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae Moraxella
catarrhalis (including beta-lactamase producing strains) Morganella morganii Neisseria
gonorrhoeae (including penicillinase- and nonpenicillinase-producing strains) Neisseria meningitidis Proteus mirabilis Proteus vulgaris Serratia marcescens Ceftriaxone is also active against many strains of Pseudomonas aeruginosa. NOTE: Many strains of the above organisms that are multiply
resistant to other antibiotics, e.g., penicillins, cephalosporins, and aminoglycosides, are susceptible to
ceftriaxone. Aerobic gram-positive microorganisms: Staphylococcus
aureus (including penicillinase-producing strains) Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus pyogenes Viridans group streptococci NOTE: Methicillin-resistant staphylococci are resistant to
cephalosporins, including ceftriaxone. Most strains of Group D streptococci and enterococci, e.g., Enterococcus (Streptococcus) faecalis, are resistant. Anaerobic microorganisms: Bacteroides fragilis Clostridium species Peptostreptococcus species NOTE: Most strains of Clostridium difficile are resistant. The following in vitro
data are available,
but their clinical significance is unknown
. Ceftriaxone exhibits in vitro minimal inhibitory concentrations
(MICs) of���8 mcg/mL or less against most strains of the following microorganisms, however, the safety
and effectiveness of ceftriaxone in treating clinical infections due to these microorganisms have not been
established in adequate and well-controlled clinical trials. Aerobic gram-negative microorganisms: Citrobacter diversus Citrobacter freundii Providencia species
(including Providencia rettgeri) Salmonella species
(including Salmonella typhi) Shigella species Aerobic gram-positive microorganisms: Streptococcus agalactiae Anaerobic microorganisms: Prevotella (Bacteroides) bivius Porphyromonas (Bacteroides) melaninogenicus<br/>Susceptibility Tests:<br/>Dilution Techniques: Quantitative methods are used to determine
antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility
of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure.Standardized procedures are based on a dilution method (broth or agar) or equivalent with
standardized inoculum concentrations and standardized concentrations of ceftriaxone powder. The MIC values
should be interpreted according to the following criteriafor aerobic organisms other than
Haemophilus spp, Neisseria
gonorrhoeae, and Streptococcus spp, including Streptococcus pneumoniae: The following interpretive criteriashould be used when testing Haemophilus species using
Haemophilus Test Media (HTM). The absence of resistant strains precludes defining
any categories other than���Susceptible���. Strains yielding results suggestive of a���Nonsusceptible���category should be submitted to a reference laboratory for further
testing. The following interpretive criteriashould be used when testing Neisseria gonorrhoeae when
using GC agar base and 1% defined growth supplement. The absence of resistant strains precludes defining
any categories other than���Susceptible���. Strains yielding results suggestive of a���Nonsusceptible���category should be submitted to a reference laboratory for further
testing. The following interpretive criteriashould be used when testing Streptococcus spp including
Streptococcus pneumoniae using cation-adjusted Mueller-Hinton
broth with 2 to 5% lysed horse blood. A report of���Susceptible���indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches
the concentrations usually achievable. A report of���Intermediate���indicates that the
results 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 the drug can be used. This category also provides a buffer zone which prevents small
uncontrolled technical factors from causing major discrepancies in interpretation. A report of���Resistant���indicates that the pathogen is not likely to be inhibited if the
antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be
selected. Standardized susceptibility test procedures require
the use of laboratory control microorganisms to control the technical aspects of the laboratory
procedures. Standardized ceftriaxone powder should provide the following MIC values:<br/>Diffusion Techniques: Quantitative methods that require measurement of zone
diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One
such standardized procedurerequires the use of standardized inoculum concentrations. This procedure
uses paper discs impregnated with 30 mcg of ceftriaxone to test the susceptibility of microorganisms to
ceftriaxone. Reports from the laboratory providing results of the standard
single-disc susceptibility test with a 30 mcg ceftriaxone disc should be interpreted according to the following
criteria for aerobic organisms other than Haemophilus spp, Neisseria gonorrhoeae, and Streptococcus
spp: The following interpretive criteriashould be
used when testing Haemophilusspecies when using Haemophilus Test Media
(HTM). The absence of resistant strains precludes defining any
categories other than���Susceptible���. Strains yielding results suggestive of a���Nonsusceptible���category should be submitted to a reference laboratory for further testing. The following interpretive criteriashould be
used when testing Neisseria gonorrhoeae when using GC agar base and 1%
defined growth supplement. The absence of resistant strains precludes defining any
categories other than���Susceptible���. Strains yielding results suggestive of a���Nonsusceptible���category should be submitted to a reference laboratory for further testing. The following interpretive criteriashould be
used when testing Streptococcus spp other than Streptococcus pneumoniae when using Mueller-Hinton agar supplemented with 5% sheep blood incubated
in 5% CO. Interpretation should be as stated above for results using
dilution techniques. Interpretation involves correlation of the diameter obtained in the disc test with the MIC
for ceftriaxone. Disc diffusion interpretive criteria for ceftriaxone discs
against Streptococcus
pneumoniae are not available, however, isolates of pneumococci with
oxacillin zone diameters of>20 mm are susceptible (MIC���0.06 mcg/mL) to penicillin and can be
considered susceptible to ceftriaxone. Streptococcus pneumoniae isolates
should not be reported as penicillin (ceftriaxone) resistant or intermediate based solely on an oxacillin zone
diameter of���19 mm. The ceftriaxone MIC should be determined for those isolates with oxacillin zone
diameters���19 mm. As with standardized dilution techniques, diffusion methods
require the use of laboratory control microorganisms that are used to control the technical aspects of the
laboratory procedures. For the diffusion technique, the 30 mcg ceftriaxone disc should provide the following zone
diameters in these laboratory test quality control strains:<br/>Anaerobic Techniques: For anaerobic bacteria, the susceptibility to
ceftriaxone as MICs can be determined by standardized test methods.The MIC values obtained
should be interpreted according to the following criteria: As with other susceptibility techniques, the use of
laboratory control microorganisms is required to control the technical aspects of the laboratory
standardized procedures. Standardized ceftriaxone powder should provide the following MIC values for the
indicated standardized anaerobic dilutiontesting method: ATCCis a registered trademark of the American Type Culture
Collection.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Ceftriaxone Injection, USP is contraindicated in patients with known
allergy to the cephalosporin class of antibiotics. Solutions containing dextrose may be contraindicated in patients with
known allergy to corn or corn products.<br/>Neonates (���28 days): Hyperbilirubinemic neonates, especially prematures, should
not be treated with Ceftriaxone Injection, USP. In vitro studies have shown
that ceftriaxone can displace bilirubin from its binding to serum albumin and bilirubin encephalopathy can
possibly develop in these patients. Ceftriaxone Injection, USP must not
be co-administered with calcium-containing IV solutions, including continuous calcium-containing infusions
such as parenteral nutrition, in neonates because of the risk of precipitation of ceftriaxone-calcium
salt. Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in
neonates have been described. In some cases the infusion lines and the times of administration of
ceftriaxone and calcium-containing solutions differed. For information regarding all other patients, see WARNINGS.
|
| dailymed-instance:supply |
Ceftriaxone Injection, USP is supplied premixed as a frozen,
iso-osmotic, sterile, nonpyrogenic solution of ceftriaxone sodium in a carton of 24 x 50 mL single dose GALAXY containers
(PL 2040 plastic). The following strengths are available: 1 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.9 gm
Dextrose Hydrous, USP, added (NDC 0338-5002-41). 2 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.2 gm
Dextrose Hydrous, USP, added (NDC 0338-5003-41). NOTE: Store Ceftriaxone Injection, USP in the frozen state at or
below -20��C/-4��F. See DIRECTIONS FOR USE:
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: Prescribing Ceftriaxone Injection, USP 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. Although transient elevations of BUN and serum creatinine
have been observed, at the recommended dosages, the nephrotoxic potential of ceftriaxone is similar
to that of other cephalosporins. Ceftriaxone is excreted via both biliary and renal excretion
. Therefore, patients with renal failure normally require no adjustment in
dosage when usual doses of Ceftriaxone Injection, USP are administered, but concentrations of drug in the serum
should be monitored periodically. If evidence of accumulation exists, dosage should be decreased accordingly. Dosage adjustments should not be necessary in patients with
hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, Ceftriaxone
Injection, USP dosage should not exceed 2 gm daily without close monitoring of serum concentrations. Alterations in prothrombin times have occurred rarely in
patients treated with ceftriaxone. Patients with impaired vitamin K synthesis or low vitamin K stores (e.g.,
chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during Ceftriaxone Injection,
USP treatment. Vitamin K administration (10 mg weekly) may benecessary if the prothrombin time is prolonged
before or during therapy. Prolonged use of Ceftriaxone Injection, USP may result in
overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs
during therapy, appropriate measures should be taken. Ceftriaxone Injection, USP should be prescribed with caution
in individuals with a history of gastrointestinal disease, especially colitis. There have been reports of
sonographic abnormalities in the gallbladder of patients treated with ceftriaxone; some of these patients also
had symptoms of gallbladder disease.These abnormalities appear on sonography as an echo without
acoustical shadowing suggesting sludge or as an echo with acoustical shadowing which may be misinterpreted as
gallstones. The chemical nature ofthe sonographically detected material has been determined to be predominantly a
ceftriaxone-calcium salt. The condition appears to be transient and reversible upon
discontinuation of ceftriaxone and institution of conservative management.Therefore, Ceftriaxone
Injection, USP should be discontinued in patients who develop signs and symptoms suggestive of gallbladder disease
and/or the sonographic findings described above.<br/>Information for Patients: Patients should be counseled that antibacterial drugs
including Ceftriaxone Injection, USP should only be used to treat bacterial infections. They do not treat viral
infections (e.g., the common cold). When Ceftriaxone Injection, USP is prescribed to treat a bacterial infection,
patients should be told that although it is common to feel better early in the course of therapy, the medication
should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease
the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistanceand will not be treatable by Ceftriaxone Injection, USP or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which
usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients
can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months
after having taken the last dose of the antibiotic. If thisoccurs, patients should contact their physician as
soon as possible.<br/>Carcinogenesis and Mutagenesis and Impairment of Fertility:<br/>Carcinogenesis: Considering the maximum duration of treatment and the
class of the compound, carcinogenicity studies with ceftriaxone in animals have not been performed. The
maximum duration of animal toxicity studies was 6 months.<br/>Mutagenesis: Genetic toxicology tests included the Ames test, a
micronucleus test and a test for chromosomal aberrations in human lymphocytes cultured in vitro with
ceftriaxone. Ceftriaxone showed no potential for mutagenic activity in these studies.<br/>Impairment of Fertility: Ceftriaxone produced no impairment of fertility when
given intravenously to rats at daily doses up to 586 mg/kg/day, approximately 20 times the recommended
clinical dose of 2 gm/day.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Nonteratogenic Effects: In rats, in the Segment I (fertility and general
reproduction) and Segment III (perinatal and postnatal) studies with intravenously administered
ceftriaxone, no adverse effects were noted on various reproductive parameters during gestation and
lactation, including postnatal growth, functional behavior and reproductive ability of the offspring, at
doses of 586 mg/kg/day or less<br/>Nursing Mothers: Low concentrations of ceftriaxone are excreted in human milk.
Caution should be exercised when Ceftriaxone Injection, USP is administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness of Ceftriaxone Injection, USP in
neonates, infants and pediatric patients have been established for the dosages described in the DOSAGE AND
ADMINISTRATION section. In vitro studies have shown that ceftriaxone, like some other
cephalosporins, can displace bilirubin from serum albumin. Ceftriaxone Injection, USP should not be administered
to hyperbilirubinemic neonates, especially prematures .
|
| dailymed-instance:overdosag... |
In the case of overdosage, drug concentration would not be reduced by
hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be
symptomatic.
|
| dailymed-instance:genericMe... |
Ceftriaxone Sodium
|
| dailymed-instance:fullName |
Ceftriaxone (Injection, Solution)
|
| dailymed-instance:adverseRe... |
Ceftriaxone is generally well tolerated. In clinical trials, the
following adverse reactions, which were considered to be related to ceftriaxone therapy or of uncertain etiology, were
observed: LOCAL REACTIONS���pain, induration and tenderness was 1% overall. Phlebitis was reported in<1% after IV administration. HYPERSENSITIVITY���rash (1.7%). Less frequently reported (<1%) were pruritus, fever or chills. HEMATOLOGIC���eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported (<1%) were anemia,
hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time. GASTROINTESTINAL���diarrhea (2.7%). Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. The onset of
pseudomembranous colitis symptoms may occur during or after antibacterial treatment . HEPATIC���elevations
of SGOT (3.1%) or SGPT (3.3%). Less frequently reported (<1%) were elevations of alkaline phosphatase and
bilirubin. RENAL���elevations of
the BUN (1.2%). Less frequently reported (<1%) were elevations of creatinine and the presence of casts in the
urine. CENTRAL NERVOUS
SYSTEM���headache or dizziness were reported occasionally (<1%). GENITOURINARY���moniliasis or vaginitis were reported occasionally (<1%). MISCELLANEOUS���diaphoresis and flushing were reported occasionally (<1%). Other rarely observed adverse reactions (<0.1%) include
abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis,
dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis,
monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum
sickness. Cases of fatal reactions with ceftriaxone-calcium precipitates in
lung and kidneys in neonates have been described. In some cases the infusion lines and times of administration of
ceftriaxone and calcium-containing solutions differed .
|
| dailymed-instance:warning |
Hypersensitivity: BEFORE THERAPY WITH CEFTRIAXONE INJECTION, USP IS INSTITUTED,
CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO
CEPHALOSPORINS, PENICILLINS OR OTHER DRUGS. THIS PRODUCT SHOULD BE GIVEN CAUTIOUSLY TO PENICILLIN-SENSITIVE
PATIENTS. ANTIBIOTICS SHOULD BE ADMINISTERED WITH CAUTION TO ANY PATIENT WHO HAS DEMONSTRATED SOME FORM OF
ALLERGY, PARTICULARLY TO DRUGS. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE THE USE OF SUBCUTANEOUS
EPINEPHRINE AND OTHER EMERGENCY MEASURES.<br/>Interaction with Calcium-Containing Products: There are no reports to date of intravascular or pulmonary
precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing IV solutions.
However, the theoretical possibility exists for an interaction between ceftriaxone and IV calcium-containing
solutions in patients other than neonates. Therefore, Ceftriaxone Injection, USP and calcium-containing solutions,
including continuous calcium-containing infusions such as parenteral nutrition, should not be mixedor
co-administered to any patient irrespective of age, even via different infusion lines at different sites. As a
further theoretical consideration and based on 5 half-lives of ceftriaxone, Ceftriaxone Injection, USP and IV
calcium-containing solutions should not be administered within 48 hours of each other in any patient (see
CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).<br/>Clostridium difficile: Clostridium difficile associated diarrhea (CDAD)
has been reported with use of nearly all antibacterial agents, including Ceftriaxone Injection, USP, and may
range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal
flora of the colon leading to overgrowth of C. difficile. C. difficile produces
toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be
refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present
with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur
over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not
directed against C. difficile may need to be discontinued. Appropriate
fluid and electrolyte management, protein supplementation, antibiotic treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated.
|
| dailymed-instance:indicatio... |
Before instituting treatment with Ceftriaxone Injection, USP,
appropriate specimens should be obtained for isolation of the causative organism and for determination of its
susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ceftriaxone Injection, USP and other antibacterial drugs, Ceftriaxone Injection, USP 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 modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to theempiric selection of
therapy. Ceftriaxone Injection, USP is indicated for the treatment of the
following infections when caused by susceptible organisms: LOWER RESPIRATORY TRACT
INFECTIONS caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus
influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus
mirabilis or Serratia marcescens. ACUTE BACTERIAL OTITIS
MEDIA caused by Streptococcus pneumoniae, Haemophilus influenzae
(including beta-lactamase producing strains) or Moraxella catarrhalis (including
beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a
single dose of ceftriaxone compared to 10 days of oral therapy. In a second study comparable cure rates were observed
between single dose ceftriaxone and the comparator. The potentially lower clinical cure rate of ceftriaxone
should be balanced against the potential advantages of parenteral therapy. SKIN AND SKIN STRUCTURE
INFECTIONS caused by Staphylococcus aureus, Staphylococcus epidermidis,
Streptococcus pyogenes, Viridans group streptococci, Escherichia coli,
Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii,*
Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides
fragilis* or Peptostreptococcus species. URINARY TRACT
INFECTIONS (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella
pneumoniae. UNCOMPLICATED GONORRHEA
(cervical/urethral and rectal) caused by Neisseria gonorrhoeae,
including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by
nonpenicillinase-producing strains of Neisseria gonorrhoeae. PELVIC INFLAMMATORY
DISEASE caused by Neisseria gonorrhoeae. Ceftriaxone, like other
cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when
cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be
added. BACTERIAL SEPTICEMIA caused by
Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus
influenzae or Klebsiella pneumoniae. BONE AND JOINT
INFECTIONS caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia
coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter
species. INTRA-ABDOMINAL
INFECTIONS caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis,
Clostridium species (Note: most strains of Clostridium difficile are
resistant) or Peptostreptococcus species. MENINGITIS caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus
pneumoniae.Ceftriaxone has also been used successfully in a limited number of cases of meningitis and shunt
infection caused by Staphylococcus epidermidis* and Escherichia coli.* *Efficacy for this organism in this organ system was studied in fewer
than ten infections. SURGICAL PROPHYLAXIS: The
preoperative administration of a single 1 gm dose of ceftriaxone may reduce the incidence of postoperative infections in
patients undergoing surgical procedures classified as contaminated or potentially contaminated (e.g., vaginal or abdominal
hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of
age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones)
and in surgical patients for whom infection at the operative site would present serious risk (e.g., during coronary artery
bypass surgery). Although ceftriaxone has been shown to have been as effective as cefazolin in the prevention of infection
following coronary artery bypass surgery, no placebo controlled trials have been conducted to evaluate any cephalosporin
antibiotic in the prevention of infection following coronary artery bypass surgery. When administered prior to surgical procedures for which it is
indicated, a single 1 gm dose of ceftriaxone provides protection from most infections due to susceptible organisms
throughout the course of the procedure.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Ceftriaxone
|