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
Pce 333 Warnings, Precautions, Pregnancy, Nursing, Abuse - Erythromycin PCE
Pce 333 Warnings, Precautions, Pregnancy, Nursing, Abuse - Erythromycin PCE
WARNINGS
There have been reports of hepatic
dysfunction, including increased liver enzymes, and hepatocellular
and/or cholestatic hepatitis,
with or without jaundice,
occurring in patients receiving oral
erythromycin products.
There have been reports suggesting that erythromycin
does not reach the fetus
in adequate concentration
to prevent congenital
syphilis. Infants born to women treated during pregnancy
with oral erythromycin
for early syphilis should be treated with an appropriate
penicillin regimen.
Rhabdomyolysis with or without renal
impairment has been
reported in seriously ill
patients receiving erythromycin
concomitantly with lovastatin. Therefore, patients receiving concomitant
lovastatin and erythromycin
should be carefully monitored for creatine
kinase (CK) and serum
transaminase levels. (See package insert for lovastatin.)
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including
erythromycin, 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 over-growth 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 discontinuation
of the drug 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
Since erythromycin
is principally excreted by the liver,
caution should be exercised when erythromycin
is administered to patients with impaired hepatic function. (See
CLINICAL PHARMACOLOGY and
WARNINGS
.)
There have been reports that erythromycin
may aggravate the weakness of patients with myasthenia
gravis.
Prolonged or repeated use of erythromycin
may result in an overgrowth of nonsusceptible bacteria
or fungi. If superinfection
occurs, erythromycin should be discontinued and appropriate
therapy instituted.
When indicated, incision
and drainage or other
surgical procedures
should be performed in conjunction with antibiotic
therapy.
Drug Interactions
Erythromycin use in patients who are receiving high doses of theophylline
may be associated with an increase in serum
theophylline levels
and potential theophylline toxicity. In
case of theophylline
toxicity and/or elevated
serum theophylline
levels, the dose of theophylline
should be reduced while the patient
is receiving concomitant
erythromycin therapy.
Concomitant administration
of erythromycin
and digoxin has been
reported to result in elevated digoxin
serum levels.
There have been reports of increased anticoagulant
effects when erythromycin and oral
anticoagulants were used concomitantly. Increased anticoagulation
effects due to interactions of erythromycin
with oral anticoagulants
may be more pronounced in the elderly.
Concurrent use of erythromycin
and ergotamine or
dihydroergotamine has been associated in some patients with acute
ergot toxicity
characterized by severe peripheral
vasospasm and dysesthesia.
Erythromycin has been reported to decrease the clearance
of triazolam and midazolam and
thus, may increase the pharmacologic effect
of these benzodiazepines.
The use of erythromycin
in patients concurrently taking drugs metabolized by the cytochrome
P450 system may be associated
with elevations in serum levels of these other drugs. There have
been reports of interactions of erythromycin with carbamazepine,
cyclosporine, tacrolimus, hexobarbital, phenytoin, alfentanil, cisapride,
disopyramide, lovastatin, bromocriptine, valproate, terfenadine,
and astemizole. Serum concentrations of drugs metabolized by the
cytochrome P450 system
should be monitored closely in patients concurrently receiving erythromycin.
Erythromycin has been reported to significantly alter the metabolism
of the nonsedating antihistamines terfenadine and astemizole when
taken concomitantly. Rare cases of serious cardiovascular
adverse events, including electro-cardiographic QT/QTc interval
prolongation, cardiac
arrest, torsades de pointes, and other ventricular
arrhythmias, have been observed. (See CONTRAINDICATIONS.)
In addition, deaths have
been reported rarely with concomitant
administration
of terfenadine and erythromycin.
There have been post-marketing reports of drug
interactions when erythromycin was coadministered with cisapride,
resulting in QT prolongation, cardiac arrhythmias, ventricular
tachycardia, ventricular
fibrillation, and
torsades de pointes, most likely due to the inhibition
of hepatic metabolism
of cisapride by erythromycin. Fatalities have been reported. (See
CONTRAINDICATIONS).
Drug/Laboratory Test interactions
Erythromycin interferes with the fluorometric determination
of urinary catecholamines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term (2-year) oral
studies conducted in rats with erythromycin base did not provide
evidence of tumorigenicity.
Mutagenicity studies have not been conducted. There was no
apparent effect
on male or female
fertility in rats fed erythromycin
(base) at levels up to 0.25 percent
of diet.
Pregnancy
Teratogenic effects: Pregnancy Category B: There
is no evidence of teratogenicity or any other adverse effect
on reproduction in female
rats fed erythromycin
base (up to 0.25 percent
of diet) prior to and during mating, during gestation,
and through weaning of two successive litters. 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
The effect of erythromycin
on labor and delivery
is unknown.
Nursing Mothers
Erythromycin is excreted in human
milk. Caution should be exercised when erythromycin
is administered to a nursing
woman.
Pediatric Use
See INDICATIONS and DOSAGE
AND ADMINISTRATION.
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