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
Fioricet Warnings, Precautions, Pregnancy, Nursing, Abuse - Butalbital, Acetaminophen and Caffeine
Fioricet Warnings, Precautions, Pregnancy, Nursing, Abuse - Butalbital, Acetaminophen and Caffeine
WARNINGS
Butalbital is habit-forming and potentially abusable. Consequently,
the extended use of this product
is not recommended.
PRECAUTIONS
General
Butalbital, acetaminophen
and caffeine tablets
should be prescribed with caution in certain special- risk
patients, such as the elderly
or debilitated, and those with severe impairment
or renal or hepatic
function, or acute abdominal
conditions.
Information for Patients
See PATIENT INFORMATION section.
Laboratory Tests
In patients with severe hepatic
or renal disease,
effects of therapy should be monitored with serial
liver and/or renal
function tests.
Drug Interactions
See DRUG INTERACTIONS section.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No adequate studies have been conducted in animals to determine
whether acetaminophen or butalbital have a potential
for carcinogenesis,
mutagenesis or impairment
of fertility.
Pregnancy
Teratogenic Effects: Pregnancy Category C: Animal
reproduction studies have not been conducted with this combination
product. It is also not known whether butalbital, acetaminophen
and caffeine can cause
fetal harm when administered to a pregnant
woman or can affect
reproduction capacity.
This product should
be given to a pregnant
woman only when clearly
needed.
Nonteratogenic Effects: Withdrawal seizures were
reported in a two-day-old male
infant whose mother
had taken a butalbital-containing drug during the last two months
of pregnancy. Butalbital was found in the infant’s serum. The infant
was given phenobarbital
5 mg/kg, which was tapered without further seizure
or other withdrawal
symptoms.
Nursing Mothers
Caffeine, barbiturates
and acetaminophen
are excreted in breast
milk in small amounts, but the significance of their effects on
nursing infants is not
known. Because of potential
for serious adverse reactions in nursing infants from butalbital,
acetaminophen
and caffeine, a decision should be made whether to discontinue nursing
or to discontinue the drug,
taking into account the importance of the drug
to the mother.
Pediatric Use
Safety and effectiveness
in pediatric patients
have not been established.
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