Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2256
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Rocephin (Injection, Powder, For Solution)
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Rocephin may be administered intravenously or intramuscularly. Do not use diluents containing
calcium, such as Ringer's solution or Hartmann's solution,
to reconstitute Rocephin. Particulate formation can result. Rocephin
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 .<br/>NEONATES: Hyperbilirubinemic neonates, especially prematures,
should not be treated with Rocephin .<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 acute
bacterial otitis media, a single intramuscular dose of 50 mg/kg (not
to exceed 1 gram) is recommended . 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 the
treatment of uncomplicated gonococcal infections, a single intramuscular
dose of 250 mg is recommended. For preoperative
use (surgical prophylaxis), a single dose of 1 gram administered intravenously
1/2 to 2 hours before surgery is recommended. Generally, Rocephin 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 (eg, dialysis patients) and
in patients with both renal and hepatic dysfunctions.<br/>DIRECTIONS FOR USE:<br/>Intramuscular Administration: Reconstitute Rocephin powder with the appropriate
diluent . Inject diluent into vial, shake
vial thoroughly to form solution. Withdraw entire contents of vial
into syringe to equal total labeled dose. After
reconstitution, each 1 mL of solution contains approximately 250 mg
or 350 mg equivalent of ceftriaxone according to the amount of diluent
indicated below. If required, more dilute solutions could be utilized. A 350 mg/mL concentration is not recommended for
the 250 mg vial since it may not be possible to withdrawthe entire
contents. As with all intramuscular
preparations, Rocephin should be injected well within the body of
a relatively large muscle; aspiration helps to avoid unintentional
injection into a blood vessel.<br/>Intravenous Administration: Rocephin should be administered intravenously by
infusion over a period of 30 minutes. Concentrations between 10 mg/mL
and 40 mg/mL are recommended; however, lower concentrations may be
used if desired. Reconstitute vials with an appropriate IV diluent
. After reconstitution, each 1 mL of solution contains
approximately 100 mg equivalent of ceftriaxone. Withdraw entire contents
and dilute to the desired concentration with the appropriate IV diluent.<br/>COMPATIBILITY AND STABILITY: Ceftriaxone has been shown to be compatible with
FlagylIV (metronidazole hydrochloride). The concentration
should not exceed 5 to 7.5 mg/mL metronidazole hydrochloride with
ceftriaxone 10 mg/mL as an admixture. The admixture is stable for
24 hours at room temperature only in 0.9% sodium chloride injection
or 5% dextrose in water (D5W). No compatibility studies have been
conducted with the Flagyl IV RTU (metronidazole) formulation or using other diluents. Metronidazole
at concentrations greater than 8 mg/mL will precipitate. Do not refrigerate
the admixture as precipitation will occur. Vancomycin,
amsacrine, aminoglycosides, and fluconazole are physically incompatible
with ceftriaxone in admixtures. When any of these drugs are to be
administered concomitantly with ceftriaxone by intermittent intravenous
infusion, it is recommended that they be given sequentially, with
thorough flushing of the intravenous lines (with one of the compatible
fluids) between the administrations. Do not use diluents containing calcium, such as Ringer's
solution or Hartmann's solution, to reconstitute Rocephin.
Particulate formation can result. Rocephin solutions should not be physically mixed with or piggybacked into solutions containing
other antimicrobial drugs or into diluent solutions other than those
listed above, due to possible incompatibility . Rocephin sterile powder should be stored
at room temperature���77��F (25��C)���or below and
protected from light. After reconstitution, protection from normal
light is not necessary. The color of solutions ranges from light yellow
to amber, depending on the length of storage, concentration and diluent
used. Rocephin intramuscular solutions remain stable (loss of potency
less than 10%) for the following time periods: Rocephin intravenous solutions, at concentrations of 10, 20 and 40 mg/mL, remain stable
(loss of potency less than 10%) for the following time periods stored
in glass or PVC containers: The following intravenous Rocephin solutions are stable at room temperature (25��C) for
24 hours, at concentrations between 10 mg/mL and 40 mg/mL: Sodium
Lactate (PVC container), 10% Invert Sugar (glass container), 5% Sodium
Bicarbonate (glass container), Freamine III (glass container), Normosol-M
in 5% Dextrose (glass and PVC containers), Ionosol-B in 5% Dextrose
(glass container), 5% Mannitol (glass container), 10% Mannitol (glass
container). After the indicated stability time
periods, unused portions of solutions should be discarded. NOTE: Parenteral drug products should be inspected visually
for particulate matter before administration. Rocephin reconstituted with 5% Dextrose or 0.9% Sodium Chloride solution
at concentrations between 10 mg/mL and 40 mg/mL, and then stored in
frozen state (-20��C) in PVC or polyolefin containers, remains
stable for 26 weeks. Frozen solutions of Rocephin
should be thawed at room temperature before use. After thawing, unused
portions should be discarded. DO NOT REFREEZE.
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Rocephin is a sterile, semisynthetic, broad-spectrum
cephalosporin antibiotic for intravenous or intramuscular administration.
Ceftriaxone sodium is (6R,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���3.5HO. It has a calculated molecular weight of
661.59 and the following structural formula: Rocephin is a white to yellowish-orange crystalline powder
which is readily soluble in water, sparingly soluble in methanol and
very slightly soluble in ethanol. The pH of a 1% aqueous solution
is approximately 6.7. The color of Rocephin solutions ranges from
light yellow to amber, depending on the length of storage, concentration
and diluent used. Rocephin contains approximately
83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity.
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Average plasma concentrations of ceftriaxone following
a single 30-minute intravenous (IV) infusion of a 0.5, 1 or 2 gm dose
and intramuscular (IM) administration of a single 0.5 (250 mg/mL or
350 mg/mL concentrations) or 1 gm dose in healthy subjects are presented
in Table 1. Ceftriaxone was completely absorbed following IM
administration with mean maximum plasma concentrations occurring between
2 and 3 hours postdosing. Multiple IV or IM 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��g/mL
in the gallbladder bile, 788��g/mL in the common duct bile, 898��g/mL
in the cystic duct bile, 78.2��g/gm in the gallbladder wall and
62.1��g/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��g/mL
to a value of 85% bound at 300��g/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 a 50 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/>Pharmacokinetics in the Middle
Ear Fluid: In one study, total ceftriaxone concentrations (bound
and unbound) were measured in middle ear fluid obtained during the
insertion of tympanostomy tubes in 42 pediatric patients with otitis
media. Sampling times were from 1 to 50 hours after a single intramuscular
injection of 50 mg/kg of ceftriaxone. Mean (��SD) ceftriaxone
levels in the middle ear reached a peak of 35 (��12)��g/mL
at 24 hours, and remained at 19 (��7)��g/mL at 48 hours.
Based on middle ear fluid ceftriaxone concentrations in the 23 to
25 hour and the 46 to 50 hour sampling time intervals, a half-life
of 25 hours was calculated. Ceftriaxone is highly bound to plasma
proteins. The extent of binding to proteins in the middle ear fluid
is unknown.<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. In an in vitro study antagonistic effects have been observed with the combination
of chloramphenicol and ceftriaxone. 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 calcoaceticusEnterobacter
aerogenesEnterobacter cloacaeEscherichia coliHaemophilus
influenzae (including ampicillin-resistant and beta-lactamase
producing strains)Haemophilus parainfluenzaeKlebsiella oxytocaKlebsiella pneumoniaeMoraxella catarrhalis (including beta-lactamase producing strains)Morganella morganiiNeisseria gonorrhoeae (including penicillinase- and nonpenicillinase-producing strains)Neisseria meningitidisProteus
mirabilisProteus vulgarisSerratia 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, eg, penicillins, cephalosporins, and aminoglycosides,
are susceptible to ceftriaxone. Aerobic gram-positive
microorganisms:Staphylococcus aureus (including penicillinase-producing strains)Staphylococcus epidermidisStreptococcus pneumoniaeStreptococcus pyogenesViridans group streptococci NOTE: Methicillin-resistant staphylococci are resistant
to cephalosporins, including ceftriaxone. Most strains of Group D
streptococci and enterococci, eg, Enterococcus
(Streptococcus) faecalis, are resistant. Anaerobic microorganisms:Bacteroides
fragilisClostridium speciesPeptostreptococcus 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��g/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
diversusCitrobacter freundiiProvidencia species
(including Providencia rettgeri)Salmonella species (including Salmonella typhi)Shigella species Aerobic gram-positive microorganisms:Streptococcus agalactiae Anaerobic
microorganisms:Prevotella (Bacteroides)
biviusPorphyromonas (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��g 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��g 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 Haemophilus species 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��g/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��g 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:
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Rocephin is contraindicated in patients with known
allergy to the cephalosporin class of antibiotics.<br/>Neonates (���28 days): Hyperbilirubinemic neonates, especially prematures,
should not be treated with Rocephin. 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. Rocephin 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.
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Rocephin is supplied as a sterile crystalline powder
in glass vials. The following packages are available: Vials containing 250 mg equivalent of ceftriaxone. Box of 1 (NDC
0004-1962-02) and box of 10 (NDC 0004-1962-01). Vials containing 500 mg equivalent of ceftriaxone. Box of 1 (NDC
0004-1963-02) and box of 10 (NDC 0004-1963-01). Vials containing 1 gm equivalent of ceftriaxone. Box of 1 (NDC 0004-1964-04)
and box of 10 (NDC 0004-1964-01). Vials containing
2 gm equivalent of ceftriaxone. Box of 10 (NDC 0004-1965-01). Bulk pharmacy containers, containing 10 gm equivalent
of ceftriaxone. Box of 1 (NDC 0004-1971-01). NOT FOR DIRECT ADMINISTRATION. NOTE: Rocephin sterile powder should be stored at room
temperature, 77��F (25��C) or below, and protected from light.
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General: Prescribing Rocephin 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
Rocephin 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 Rocephin 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, Rocephin dosage should not exceed 2
gm daily without close monitoring of serum concentrations. Alterations in prothrombin times have occurred rarely
in patients treated with Rocephin. Patients with impaired vitamin
K synthesis or low vitamin K stores (eg, chronic hepatic disease and
malnutrition) may require monitoring of prothrombin time during Rocephin
treatment. Vitamin K administration (10 mg weekly) may be necessary
if the prothrombin time is prolonged before or during therapy. Prolonged use of Rocephin may result in overgrowth of
nonsusceptible organisms. Careful observation of the patient is essential.
If superinfection occurs during therapy, appropriate measures should
be taken. Rocephin 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 Rocephin; 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 of the sonographically detected
material has been determined to be predominantly a ceftriaxone-calcium
salt. The condition appears to be transient
and reversible upon discontinuation of Rocephin and institution of
conservative management. Therefore, Rocephin should be discontinued
in patients who develop signs and symptoms suggestive of gallbladder
disease and/or the sonographic findings described above. Cases of pancreatitis, possibly secondary to biliary obstruction,
have been reported rarely in patients treated with Rocephin. Most
patients presented with risk factors for biliary stasis and biliary
sludge (preceding major therapy, severe illness, total parenteral
nutrition). A cofactor role of Rocephin-related biliary precipitation
cannot be ruled out. The elimination of Rocephin
is not altered by probenecid. As with other
cephalosporins, anaphylactic shock cannot be ruled out even if a thorough
patient history is taken.<br/>Information for Patients: Patients should be counseled that antibacterial drugs
including Rocephin should only be used to treat bacterial infections.
They do not treat viral infections (eg, common cold). When Rocephin
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 resistance and will not be treatable by
Rocephin 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 this occurs, patients should contact their physician as soon as
possible.<br/>Carcinogenesis, Mutagenesis,
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 Rocephin is administered
to a nursing woman.<br/>Pediatric Use: Safety and effectiveness of Rocephin 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. Rocephin should not be administered to hyperbilirubinemic
neonates, especially prematures .<br/>Geriatric Use: Of the total number of subjects in clinical studies
of Rocephin, 32% were 60 and over. No overall differences in safety
or effectiveness were observed between these subjects and younger
subjects, and 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. The pharmacokinetics of ceftriaxone were
only minimally altered in geriatric patients compared to healthy adult
subjects and dosage adjustments are not necessary for geriatric patients
with ceftriaxone dosages up to 2 grams per day (see CLINICAL
PHARMACOLOGY). 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.<br/>ADVERSE REACTIONS: Rocephin is generally well tolerated. In clinical
trials, the following adverse reactions, which were considered to
be related to Rocephin therapy or of uncertain etiology, were observed: LOCAL REACTIONS���pain, induration and tenderness was 1% overall. Phlebitis
was reported in<1% after IV administration. The incidence of warmth,
tightness or induration was 17% (3/17) after IM administration of
350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL. 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 the times of administration of
ceftriaxone and calcium-containing solutions differed .<br/>Postmarketing Experience: In addition to the adverse reactions reported during
clinical trials, the following adverse experiences have been reported
during clinical practice in patients treated with Rocephin. Data are
generally insufficient to allow an estimate of incidence or to establish
causation. GASTROINTESTINAL���stomatitis and glossitis. GENITOURINARY���oliguria. DERMATOLOGIC���exanthema,
allergic dermatitis, urticaria, edema. As with many medications, isolated
cases of severe cutaneous adverse reactions (erythema multiforme,
Stevens-Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis)
have been reported.<br/>Cephalosporin Class Adverse Reactions: In addition to the adverse reactions listed above
which have been observed in patients treated with ceftriaxone, the
following adverse reactions and altered laboratory test results have
been reported for cephalosporin class antibiotics: Adverse Reactions: Allergic
reactions, drug fever, serum sickness-like reaction, renal dysfunction,
toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction
including cholestasis, aplastic anemia, hemorrhage, and superinfection. Altered Laboratory Tests: Positive direct Coombs' test, false-positive test for urinary glucose,
and elevated LDH. Several cephalosporins have
been implicated in triggering seizures, particularly in patients with
renal impairment when the dosage was not reduced (see DOSAGE AND
ADMINISTRATION). If seizures associated with
drug therapy occur, the drug should be discontinued. Anticonvulsant
therapy can be given if clinically indicated.
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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.
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| dailymed-instance:genericMe... |
ceftriaxone sodium
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Rocephin (Injection, Powder, For Solution)
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Rocephin is generally well tolerated. In clinical
trials, the following adverse reactions, which were considered to
be related to Rocephin therapy or of uncertain etiology, were observed: LOCAL REACTIONS���pain, induration and tenderness was 1% overall. Phlebitis
was reported in<1% after IV administration. The incidence of warmth,
tightness or induration was 17% (3/17) after IM administration of
350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL. 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 the times of administration of
ceftriaxone and calcium-containing solutions differed .<br/>Postmarketing Experience: In addition to the adverse reactions reported during
clinical trials, the following adverse experiences have been reported
during clinical practice in patients treated with Rocephin. Data are
generally insufficient to allow an estimate of incidence or to establish
causation. GASTROINTESTINAL���stomatitis and glossitis. GENITOURINARY���oliguria. DERMATOLOGIC���exanthema,
allergic dermatitis, urticaria, edema. As with many medications, isolated
cases of severe cutaneous adverse reactions (erythema multiforme,
Stevens-Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis)
have been reported.<br/>Cephalosporin Class Adverse Reactions: In addition to the adverse reactions listed above
which have been observed in patients treated with ceftriaxone, the
following adverse reactions and altered laboratory test results have
been reported for cephalosporin class antibiotics: Adverse Reactions: Allergic
reactions, drug fever, serum sickness-like reaction, renal dysfunction,
toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction
including cholestasis, aplastic anemia, hemorrhage, and superinfection. Altered Laboratory Tests: Positive direct Coombs' test, false-positive test for urinary glucose,
and elevated LDH. Several cephalosporins have
been implicated in triggering seizures, particularly in patients with
renal impairment when the dosage was not reduced (see DOSAGE AND
ADMINISTRATION). If seizures associated with
drug therapy occur, the drug should be discontinued. Anticonvulsant
therapy can be given if clinically indicated.
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| dailymed-instance:indicatio... |
Before instituting treatment with Rocephin, 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 Rocephin and other antibacterial drugs,
Rocephin 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 the empiric selection of therapy. Rocephin 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 Rocephin compared to 10 days of oral therapy. In a
second study comparable cure rates were observed between single dose
Rocephin and the comparator. The potentially lower clinical cure rate
of Rocephin should be balanced against the potential advantages of
parenteral therapy (see CLINICAL
STUDIES). 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 fragilisor 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. Rocephin, 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. Rocephin has also been used successfully in
a limited number of cases of meningitis and shunt infection caused
by Staphylococcus epidermidisand Escherichia
coli. SURGICAL PROPHYLAXIS: The
preoperative administration of a single 1 gm dose of Rocephin may
reduce the incidence of postoperative infections in patients undergoing
surgical procedures classified as contaminated or potentially contaminated
(eg, 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 (eg, during coronary artery bypass surgery).
Although Rocephin 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 Rocephin
provides protection from most infections due to susceptible organisms
throughout the course of the procedure.
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| dailymed-instance:name |
Rocephin
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