Amoxicillin precautions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
List of precautions
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Labor and Delivery
Nursing Mothers
Pediatric Use
Drug/Laboratory Test Interactions
High urine concentrations of ampicillin may result in
false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as
CLINISTIX®) be used.
Following administration of ampicillin to pregnant women, a transient decrease in plasma
concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol
has been noted. This effect may also occur with amoxicillin. Return to top
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene
conversion assay. Return to top
Pregnancy
Teratogenic Effects: Pregnancy Category B. Reproduction studies have been
performed in mice and rats at doses up to 10 times the human dose and have revealed no
evidence of impaired fertility or harm to the fetus due to amoxicillin. 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. Return to top
Labor and Delivery
Oral ampicillin-class antibiotics are poorly absorbed during labor.
Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased
the uterine tone and frequency of contractions but moderately increased the height and duration
of contractions. However, it is not known whether use of amoxicillin in humans during labor or
delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or
increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of
the newborn will be necessary. Return to top
Nursing Mothers
Penicillins have been shown to be excreted in human milk. Amoxicillin use
by nursing mothers may lead to sensitization of infants. Caution should be exercised when
amoxicillin is administered to a nursing woman. Return to top
Pediatric Use
Because of incompletely 313 developed renal function in neonates and young
314 infants, the elimination of amoxicillin may be delayed. Dosing of AMOXIL should be modified
315 in pediatric patients 12 weeks or younger (≤3 months). Return to top
Adapted from the FDA Package Insert.