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
Omnipen Warnings, Precautions, Pregnancy, Nursing, Abuse - Ampicillin
Omnipen Warnings, Precautions, Pregnancy, Nursing, Abuse - Ampicillin
WARNINGS
Serious and occasional fatal
hypersensitivity
(anaphylactoid) reactions have been reported in patients on penicillin
therapy. Although anaphylaxis is more frequent following parenteral
administration, it has occurred in patients on oral
penicillins. These reactions are more apt to occur in individuals with
a history at penicillin
hypersensitivity
and/or a history of sensitivity
to multiple allergens. There
have been well documented reports of individuals with a history
of penicillin hypersensitivity
who have experienced severe hypersensitivity
reactions when treated with cephalosporins. Before initiating therapy
with any penicillin, careful inquiry should be made concerning previous
hypersensitivity
reactions to penicillins, cephalosporins, and other allergens. If an allergic
reaction occurs, the drug
should be discontinued and appropriate
therapy instituted. Serious
anaphylactoid reactions require immediate
emergency treatment
with epinephrine. Oxygen, intravenous steroids, and airway
management, including intubation,
should also be administered as indicated.
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including ampicillin,
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 bean established, 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
Prolonged use of antibiotics may promote the overgrowth
of nonsusceptible organisms, including fungi. Should superinfection
occur, appropriate measures
should be taken. Patients with gonorrhea
who also have syphilis should
be given additional appropriate
parenteral penicillin
treatment. Treatment with ampicillin
does not preclude the need for
surgical procedures, particularly
in staphylococcal infections.
Laboratory Tests
In prolonged therapy, and
particularly with high dosage
regimens, periodic evaluation of the renal,
hepatic, and hematopoietic
systems is recommended.
In streptococcal infections,
therapy must be sufficient
to eliminate the organism
(10 days minimum); otherwise the sequelae of streptococcal disease may
occur. Cultures should be taken following completion of treatment to determine
whether streptococci
have been eradicated.
Cases of gonococcal infection
with a suspected lesion of
syphilis should have darkfield
examinations ruling out syphilis
before receiving ampicillin. Patients who do not have suspected lesions
of syphilis and are treated
with ampicillin should
have a follow- up serologic test
for syphilis each month for
four months to detect syphilis
that may have been masked from
treatment for gonorrhea.
Drug Interactions
See DRUG INTERACTIONS section.
Drug/Laboratory Test Interaction
After treatment with ampicillin,
a false-positive reaction
for glucose in the urine may
occur with copper sulfate
tests (Benedict's solution, Fehling's solution,
or Clinitest tablets) but not with enzyme
based tests such as Clinistix and Glucose Enzymatic Test Strip USP.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenesis,
mutagenesis, or impairment
of fertility in males or
females.
Pregnancy
Teratogenic Eftects: Category B: Reproduction studies in
animals have revealed no evidence
of impaired fertility or
harm to the fetus due to penicillin. There are, however, no
adequate and well-controlled studies in pregnant
women. Because animal reproduction
studies are not always predictive of human
response, penicillin should
be used during pregnancy only if clearly needed.
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 contractians, but moderately increased the height
and duration of contractions.
However, it is not known whether use of these drugs 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.
Nursing Mothers
Ampicillin-class antibiotics are excreted in milk. Ampicillin used by
nursing mothers may lead to sensitization
of infants; therefore, a decision should be made whether to discontinue
nursing or to discontinue
ampicillin, taking into account the importance of the drug
to the mother.
Pediatric Use
Penicillins are excreted primarily unchanged by the kidney,
therefore, the incompletely developed renal
functioning neonates and young infants will delay the excretion
of penicillin. Administration to neonates and young infants should be
limited to the lowest dosage
compatible with an effective
therapeutic regimen
(see DOSAGE AND ADMINISTRATION).
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