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Fiorinal-Cod Warnings, Precautions, Pregnancy, Nursing, Abuse - Butalbital Compound With Codeine
Fiorinal-Cod Warnings, Precautions, Pregnancy, Nursing, Abuse - Butalbital Compound With Codeine
WARNINGS
Therapeutic doses of aspirin
can cause anaphylactic
shock and other severe
allergic reactions.
It should be ascertained if the patient
is allergic to aspirin, although a specific
history of allergy
may be lacking.
Significant bleeding
can result from aspirin
therapy in patients
with peptic ulcer or other
gastrointestinal
lesions, and in patients with bleeding disorders.
Aspirin administered pre-operatively may prolong the bleeding
time.
In the presence of head
injury or other intracranial
lesions, the respiratory depressant effects of codeine
and other narcotics may be markedly enhanced, as well as their capacity
for elevating cerebrospinal
fluid pressure. Narcotics
also produce other CNS depressant
effects, such as drowsiness,
that may further obscure
the clinical course
of patients with head injuries.
Codeine or other narcotics may obscure
signs on which to judge the diagnosis or clinical
course of patients with acute
abdominal conditions.
Butalbital and codeine
are both habit-forming and potentially abusable. Consequently, the
extended use of Butalbital compound
with Codeine is not recommended.
Results from epidemiologic studies indicate an association
between aspirin and Reye Syndrome. Caution should be used in administering
this product to children including teenagers, with chicken pox
or flu.
PRECAUTIONS
General
Butalbital compound
with Codeine should be prescribed with caution for certain special-
risk patients such
as the elderly or debilitated, and those with severe impairment
of renal or hepatic
function, coagulation disorders, or head
injuries.
Aspirin should be used with caution in patients on anticoagulant
therapy and in patients with underlying hemostatic
defects.
Precautions should be taken when administering salicylates to persons
with known allergies. Hypersensitivity to aspirin
is particularly likely in patients with nasal
polyps, and relatively common in those with asthma.
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
The CNS effects of butalbital
may be enhanced by monoamine
oxidase (MAO) inhibitors.
In patients receiving concomitant
corticosteroids and chronic
use of aspirin, withdrawal
of corticosteroids may result in salicylism
because corticosteroids enhance renal
clearance of salicylates
and their withdrawal is followed by return to normal
rates of renal clearance.
Butalbital compound
with Codeine may enhance the effects of:
1. Oral anticoagulants, causing bleeding
by inhibiting prothrombin
formation in the liver
and displacing anticoagulants from plasma
protein binding sites.
2. Oral antidiabetic
agents and insulin,
causing hypoglycemia
by contributing an additive
effect, if dosage of
Butalbital compound
with Codeine exceeds maximum recommended daily dosage.
3. 6-mercaptopurine and methotrexate, causing bone
marrow toxicity
and blood dyscrasias by displacing these drugs from secondary
binding sites, and, in the case
of methotrexate, also reducing its excretion.
4. Non-steroidal anti-inflammatory
agents, increasing the risk
of peptic ulceration and bleeding
by contributing additive
effects.
5. Other narcotic
analgesics, alcohol,
general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics,
or other CNS depressants,
causing increased CNS depression.
Butalbital compound
with Codeine may diminish the effects of:
Uricosuric agents such
as probenecid and
sulfinpyrazone, reducing their effectiveness in the treatment
of gout. Aspirin competes with these agents for protein
binding sites.
Drug/Laboratory Test Interactions
Aspirin: Aspirin may interfere with the following
laboratory determinations
in blood: serum amylase,
fasting blood
glucose, cholesterol,
protein, serum glutamic-oxalacetic
transaminase (SGOT),
uric acid,
prothrombin time
and bleeding time. Aspirin may interfere with the following laboratory
determinations in urine: glucose,
5-hydroxyindoleacetic acid,
Gerhardt ketone, vanillylmandelic acid (VMA), uric
acid, diacetic acid,
and spectrophotometric detection of barbiturates.
Codeine: Codeine may increase serum
amylase levels.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Adequate long-term studies have been conducted in mice and rats
with aspirin, alone or in combination with other drugs, in which
no evidence of carcinogenesis
was seen. No adequate studies
have been conducted in animals to determine whether aspirin
has a potential for
mutagenesis or impairment
of fertility. No adequate
studies have been conducted in animals to determine whether butalbital
has a potential for
carcinogenesis,
mutagenesis, or impairment
of fertility.
Pregnancy
Teratogenic Effects: Pregnancy Category C. Animal
reproduction studies
have not been conducted with Butalbital compound
with Codeine. It is also not known whether Butalbital compound with
Codeine can cause fetal
harm when administered to a pregnant woman or can affect
reproduction capacity.
Butalbital compound
with Codeine should be given to a pregnant
woman only when clearly
needed.
Nonteratogenic Effects: Although Butalbital compound
with Codeine was not implicated in the birth defect, a female
infant was born with
lissencephaly, pachygyria
and heterotopic gray matter.
The infant was born 8
weeks prematurely to a woman who had taken an average
of 90 Butalbital compound
with Codeine capsules each month from the first few days of pregnancy.
The child's development was mildly delayed and from one year of
age she had partial simple
motor seizures.
Withdrawal seizures were reported in a two-day-old male
infant whose mother had
taken a butalbital-containing drug
during the last 2 months of pregnancy. Butalbital was found in the
infant's serum. The infant
was given phenobarbital
5mg/kg, which was tapered without further seizure
or other withdrawal
symptoms.
Studies of aspirin
use in pregnant women
have not shown that aspirin increases the risk
of abnormalities when administered during the first trimester of
pregnancy. In controlled
studies involving 41,337 pregnant women and their offspring, there
was no evidence
that aspirin taken during
pregnancy caused stillbirth, neonatal
death or reduced birth
weight. In controlled studies of 50 282 pregnant
women and their offspring, aspirin administration in moderate and
heavy doses during the first four lunar months of pregnancy
showed no teratogenic
effect.
Reproduction studies have been performed in rabbits and rats at
doses up to 150 times the human
dose and have revealed
no evidence
of impaired fertility or harm to the fetus
due to codeine.
Therapeutic doses of aspirin
in pregnant women close
to term may cause bleeding
in mother, fetus, or neonate.
During the last 6 months of pregnancy, regular use of aspirin
in high doses may prolong pregnancy
and delivery.
Labor and Delivery
Ingestion of aspirin
prior to delivery may
prolong delivery or
lead to bleeding in
the mother or neonate.
Use of codeine during
labor may lead to respiratory
depression in the
neonate.
Nursing Mothers
Aspirin, caffeine, barbiturates
and codeine 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
compound with Codeine,
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 children below the age
of 12 have not been established.
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