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
Cefzil Warnings, Precautions, Pregnancy, Nursing, Abuse - Cefprozil
Cefzil Warnings, Precautions, Pregnancy, Nursing, Abuse - Cefprozil
WARNINGS
BEFORE THERAPY WITH CEFPROZIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE
MADE TO DETERMINE WHETHER THE PATIENT
HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO
CEFPROZIL, CEPHALOSPORINS, PENICILLINS, OR
OTHER DRUGS. IF THIS PRODUCT IS TO
BE GIVEN TO PENICILLIN-SENSITIVE
PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY 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
CEFPROZIL OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY
REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES,
INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS,
PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS
CLINICALLY INDICATED.
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including cefprozil,
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
Clostridium difficile
colitis.
PRECAUTIONS
General
In patients with known or suspected renal
impairment (see DOSAGE
AND ADMINISTRATION), careful clinical
observation and appropriate laboratory studies should be done prior to
and during therapy. The total daily dose
of cefprozil should be reduced in these patients because high and/or prolonged
plasma antibiotic
concentrations can occur in such individuals from usual doses. Cephalosporins,
including cephprozil, should be given with caution to patients receiving
concurrent treatment with
potent diuretics since these
agents are suspected of adversely affecting renal
function.
Prolonged use of cephprozil may result in the overgrowth
of nonsusceptible organisms. Careful observation of the patient
is essential. If superinfection occurs during therapy, appropriate
measures should be taken.
Cefprozil should be prescribed with caution in individuals with a history
of gastrointestinal
disease particularly colitis.
Positive direct Coombs' tests have been reported during treatment
with cephalosporin antibiotics.
Information for the Patient
Phenylketonurics: Cephprozil for oral
suspension contains phenylalanine
28 mg per
5 ml (1 teaspoon) constituted suspension
for both the 125 mg/5 ml and 250
mg/5 ml dosage
forms.
Drug/Laboratory Test Interactions
Cephalosporin antibiotics may produce a false positive
reaction for glucose in the
urine with copper
reduction tests (Benedict's
or Fehling's solution or with Clinitest tablets), but not with enzyme-based
tests for glycosuria (e.g., Tes-Tape). A false negative
reaction may occur in the
ferricyanide test for blood
glucose. The presence of cefprozil in the blood
does not interfere with the assay of plasma
or urine creatinine by the alkaline
picrate method.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long term in vivo studies
have not been performed to evaluate the carcinogenic
potential of cefprozil.
Cefprozil was not found to be mutagenic in either the Ames Salmonella
or E. coli WP2 urvA reversion
assays or the Chinese hamster
ovary cell HGPRT forward gene
mutation assay and it did
not induce chromosomal abnormalities in Chinese hamster
ovary cells or unscheduled DNA
synthesis in rat
hepatocytes in vitro. Chromosomal aberrations were not observed
in bone marrow cells from rats
dosed orally with over 30 times the highest recommended human dose
based upon mg/m2.
Impairment of fertility was not observed in male
or female rats given oral doses
of cefprozil up to 18.5 times the highest recommended human dose based
upon mg/m2.
Pregnancy, Teratogenic Effects, Pregnancy Category B
Reproduction studies have been performed in rabbits, mice and rats using
oral doses of cefprozil of 0.8, 8.5 and 18.5 times the maximum
daily human dose (1000 mg) based upon mg/m2 and have revealed
no harm to the fetus. 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.
Labor and Delivery
Cefprozil has not been studied for use during labor
and delivery. Treatment should only be given if clearly needed.
Nursing Mothers
Small amounts of cefprozil (<0.3% of dose) have been detected in human
milk following administration
of a single 1 gram dose
to lactating women. The average
levels over 24 hours ranged from 0.25 to 3.3 mcg/ml. Caution should be
exercised when cefprozil is administered to a nursing woman, since the
effect of cefprozil on nursing
infants is unknown.
Pediatric Use (See INDICATIONS
AND USAGE and DOSAGE AND ADMINISTRATION)
The safety and effectiveness
of cefprozil in the treatment
of otitis media have been established in the age
groups 6 months to 12 years. Use of cefprozil for the treatment
of otitis media
is supported by evidence from adequate and well-controlled studies of
cefprozil in pediatric patients.
(See CLINICAL STUDIES).
The safety and effectiveness
of cefprozil in the treatment
of pharyngitis/tonsillitis or uncomplicated skin
and skin structure
infections have been established in the age
groups 2 to 12 years. Use of cefprozil for the treatment
of these infections is supported by evidence
from adequate and well-controlled studies in pediatric
patients.
The safety and effectiveness
of cefprozil in the treatment
of acute sinusitis have been established in the age
groups 6 months to 12 years. Use of cefprozil in these age
groups is supported by evidence
from adequate and well controlled studies of cefprozil in adults.
Safety and effectiveness
in pediatric patients below
the age of 6 months have not been
established for the treatment
of otitis media
or acute sinusitis, or below
the age of 2 years for the treatment
of pharyngitis/tonsillitis or uncomplicated skin
and skin structure
infections. However, accumulation of other cephalosporin
antibiotics in newborn infants
(resulting from prolonged drug half-life
in this age group) has been reported.
Geriatric Use
Healthy geriatric volunteers (³65 years
old) who received a single 1 g dose
of cefprozil had 35%-60% higher AUC and 40% lower renal
clearance values when compared
to healthy adult volunteers
20-40 years of age. In clinical
studies, when geriatric patients received the usual recommended adult
doses, clinical efficacy
and safety were acceptable and comparable to results in non-geriatric
adult patients.
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