Approved Drug Label (PDF)
5
Warnings and Precautions
PRECAUTIONS
Additions and/or
revisions underlined:
Pregnancy
Teratogenic
effects: Reproduction
studies performed in the mouse, rat, and rabbit have revealed no evidence of
impaired fertility or harm to the fetus due to penicillin G. Human experience
with the penicillins during pregnancy has not shown any positive evidence of
adverse effects on the fetus. There are, however, no adequate and
well-controlled studies in pregnant women showing conclusively that harmful
effects of these drugs on the fetus can be excluded. Because animal
reproduction studies are not always predictive of human response, this drug
should be used during pregnancy only if clearly needed.
Nursing
Mothers
Soluble
penicillin G (the hydrolysate of penicillin G benzathine) is excreted in
breast milk. Caution should be exercised when penicillin G benzathine and penicillin
G procaine are administered to a nursing woman.
Approved Drug Label (PDF)
5
Warnings and Precautions
WARNINGS
Additions and/or
revisions underlined:
Severe
cutaneous adverse reactions
Severe
cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS),
toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic
symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have
been reported in patients taking penicillin G (the active moiety in Bicillin
C-R 900/300). When SCAR is suspected, Bicillin C-R 900/300 should be
discontinued immediately and an alternative treatment should be considered.
…
Inadvertent
intravascular administration, including inadvertent direct intra-arterial
injection or injection immediately adjacent to arteries, of Bicillin C-R and
other penicillin preparations has resulted in severe neurovascular damage,
including transverse myelitis with permanent paralysis, gangrene requiring
amputation of digits and more proximal portions of extremities, and necrosis
and sloughing at and surrounding the injection site consistent with the
diagnosis of Nicolau syndrome.
…
Because
of these adverse effects and the vascularity of this region, administration in
the anterolateral thigh is not recommended.
PRECAUTIONS
Additions
and/or revisions underlined:
Pregnancy
Teratogenic
effects: Reproduction
studies performed in the mouse, rat, and rabbit have revealed no evidence of
impaired fertility or harm to the fetus due to penicillin G. Human experience
with the penicillins during pregnancy has not shown any positive evidence of
adverse effects on the fetus. There are, however, no adequate and
well-controlled studies in pregnant women showing conclusively that harmful
effects of these drugs on the fetus can be excluded. Because animal
reproduction studies are not always predictive of human response, this drug
should be used during pregnancy only if clearly needed.
Nursing
Mothers
Soluble
penicillin G (the hydrolysate of penicillin G benzathine) is excreted in
breast milk. Caution should be exercised when penicillin G benzathine and
penicillin G procaine are administered to a nursing woman.
6
Adverse Reactions
Additions and/or
revisions underlined:
The following adverse reactions have been reported
with Bicillin C-R 900/300 during post-marketing experience:
Skin
and Appendages: Stevens-Johnson syndrome
(SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS) (See
WARNINGS.)
The following have been reported with parenteral
penicillin G (the active moiety in Bicillin C-R 900/300):
General:
Hypersensitivity reactions including the following:
skin eruptions (maculopapular to efoliative dermatitis), urticaria, laryngeal
edema, fever, eosinophilia; other serum sickness-like reactions (including
chills, fever, edema, arthralgia, and prostration); and anaphylaxis including
shock and death: severe cutaneous adverse reactions (SCAR), such as toxic
epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP)
(See WARNINGS.)
…
The following adverse events have been temporally
associated with parenteral administrations of penicillin
G benzathine (a component of Bicillin C-R 900/300), although a causal
relationship has not necessarily been established:
Body
as a Whole: Hypersensitivity reactions including allergic
vasculitis, pruritus, fatigue, asthenia, and pain; aggravation of existing
disorder; headache, Nicolau syndrome.
…
Immune
System Disorders: Acute myocardial ischemia
with or without myocardial infarction occurring as part of an allergic reaction
…
Approved Drug Label (PDF)
5
Warnings and Precautions
WARNINGS
Newly added information (following Anaphylaxis):
Severe cutaneous adverse
reactions
Severe cutaneous adverse
reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic
epidermal necrolysis (TEN), drug
reaction with eosinophilia and systemic symptoms (DRESS),
and acute generalized
exanthematous pustulosis (AGEP) have been reported in patients taking
beta-lactam antibiotics. When
SCAR is suspected, Bicillin C-R should be discontinued
immediately and an alternative
treatment should be considered.
Approved Drug Label (PDF)
5
Warnings and Precautions
WARNINGS
Method of Administration
Injection into or near a nerve
may result in permanent neurological damage.
Additions and/or revisions
underlined:
Inadvertent intravascular administration, including inadvertent direct
intra-arterial injection or injection
immediately adjacent to arteries, of Bicillin C-R and other penicillin
preparations has resulted in severe
neurovascular damage, including transverse myelitis with permanent
paralysis, gangrene requiring
amputation of digits and more proximal portions of extremities, and
necrosis and sloughing at and
surrounding the injection site consistent with the diagnosis of
Nicolau syndrome. Such severe effects …
6
Adverse Reactions
Additions and/or revisions underlined:
Body as a Whole: Hypersensitivity
reactions including allergic vasculitis, pruritus, fatigue,
asthenia, and pain; aggravation
of existing disorder; headache, Nicolau syndrome.
Approved Drug Label (PDF)
5
Warnings and Precautions
PRECAUTIONS
(revisions are underlined)Examples of Drugs Associated with Methemoglobinemia:
Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase
Approved Drug Label (PDF)
5
Warnings and Precautions
WARNINGS
(additions
underlined)
…
Method
of Administration
…
FOR DEEP
INTRAMUSCULAR INJECTION ONLY. There have
been reports of inadvertent intravenous administration of penicillin G
benzathine which has been associated with cardiorespiratory arrest and death. Therefore,
do not inject intravenously or admix with other intravenous solutions.
Administer
by DEEP INTRAMUSCULAR INJECTION ONLY in the upper, outer quadrant of the
buttock (dorsogluteal) or the ventrogluteal site. Quadriceps
femoris fibrosis and atrophy have been reported following repeated
intramuscular injections of penicillin preparations into the anterolateral
thigh. Therefore, administration in the anterolateral thigh is not
recommended.
Approved Drug Label (PDF)
5
Warnings and Precautions
PRECAUTIONS
Information
for Patients
Newly
added information:
Inform patients that use of local
anesthetics may cause methemoglobinemia, a serious condition that must be
treated promptly. Advise patients or caregivers to seek immediate medical
attention if they or someone in their care experience the following signs or
symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart
rate; shortness of breath; lightheadedness; or fatigue …
Drug
Interactions
Newly
added information:
Patients who are administered local
anesthetics are at increased risk of developing methemoglobinemia when
concurrently exposed to the following drugs, which could include other local
anesthetics:
Examples of Drugs Associated with
Methemoglobinemia: Newly added
table; please see label for complete information.
WARNINGS
Newly
added information following Anaphylaxis:
Methemoglobinemia
Cases of methemoglobinemia have been reported
in association with local anesthetic use. Although all patients are at risk for
methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency,
congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise,
infants under 6 months of age, and concurrent exposure to oxidizing agents or
their metabolites are more susceptible to developing clinical manifestations of
the condition. If local anesthetics must be used in these patients, close
monitoring for symptoms and signs of methemoglobinemia is recommended.
Signs of methemoglobinemia may occur
immediately or may be delayed some hours after exposure, and are characterized
by a cyanotic skin discoloration and/or abnormal coloration of the blood.
Methemoglobin levels may continue to rise; therefore, immediate treatment is
required to avert more serious central nervous system (CNS) and cardiovascular
adverse effects, including seizures, coma, arrhythmias, and death. Discontinue
Bicillin C-R and any other oxidizing agents. Depending on the severity of the
signs and symptoms, patients may respond to supportive care, i.e., oxygen
therapy, hydration. A more severe clinical presentation may require treatment
with methylene blue, exchange transfusion, or hyperbaric oxygen …
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