A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rocephin Warnings, Precautions, Pregnancy, Nursing, Abuse - Ceftriaxone
Rocephin Warnings, Precautions, Pregnancy, Nursing, Abuse - Ceftriaxone
WARNINGS
BEFORE THERAPY WITH ROCEPHIN 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.
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including
ceftriaxone 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 one primary
cause of ''antibiotic-associated"
colitis. After the diagnosis
of pseudomembranous colitis
has been established, appropriate 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 antibacterial
drug clinically effective
against C. difficile colitis.
PRECAUTIONS
General
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
(see CLINICAL PHARMACOLOGY).
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 (e.g., 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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.
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.
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.
Pregnancy
Teratogenic Effects: Pregnancy Category B.
Reproductive studies have been performed in mice and rats at doses
up to 20 times the usual human
dose and have no
evidence of embryotoxicity,
fetotoxicity or teratogenicity. In
primates, no embryotoxicity
or teratogenicity was demonstrated at a dose
approximately 3 times the human
dose. There are, however, no adequate and well- controlled studies
in pregnant women.
Because animal reproductive studies are not always predictive of
human response, this drug
should be used during pregnancy
only if clearly needed.
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.
Nursing Mothers
Low concentrations of ceftriaxone
are excreted in human
milk. Caution should be exercised when Rocephin is administered
to a nursing woman.
Pediatric Use
Safety and effectiveness
of Rocephin in neonates, infants and children 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.
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