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BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE
Overview
What is BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules is supplied in capsule form for oral administration.
Each capsule contains the following active ingredients: butalbital,
USP.......................................50 mgacetaminophen,
USP.........................325 mgcaffeine,
USP.........................................40 mg codeine phosphate,
USP.....................30 mg
Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to
intermediate-acting barbiturate. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide) is a non-opiate, non-salicylate analgesic
and antipyretic. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has
the following structural formula:
Codeine phosphate (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It
has the following structural formula:
Inactive Ingredients:
What does BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE look like?






What are the available doses of BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
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What should I talk to my health care provider before I take BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
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How should I use BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules is indicated for the relief of the symptom complex of tension (or
muscle contraction) headache.
Evidence supporting the efficacy and safety of Butalbital, Acetaminophen,
Caffeine, and Codeine Phosphate Capsules in the treatment of multiple recurrent
headaches is unavailable. Caution in this regard is required because codeine and
butalbital are habit-forming and potentially abusable.
One or 2 capsules every 4 hours. Total daily dosage should not
exceed 6 capsules.
Extended and repeated use of this product is not recommended because of the
potential for physical dependence.
What interacts with BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is contraindicated under the following conditions:− Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine.− Patients with porphyria.
What are the warnings of BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of and surgical evaluation should be instituted as clinically indicated.
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 the 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, Acetaminophen, Caffeine, and
Codeine Phosphate Capsules is not recommended.
What are the precautions of BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules should be prescribed with caution in certain special-risk patients such
as the elderly or debilitated, and those with severe impairment of renal or
hepatic function, head injuries, elevated intracranial pressure, acute abdominal
conditions, hypothyroidism, urethral stricture, Addison’s disease, or prostatic
hypertrophy.
Some individuals may be ultra-rapid metabolizers due to a
specific CYP2D6*2x2 genotype. These individuals convert codeine into its active
metabolite, morphine, more rapidly and completely than other people. This rapid
conversion results in higher than expected serum morphine levels. Even at
labeled dosage regimens, individuals who are ultra-rapid metabolizers may
experience overdose symptoms such as extreme sleepiness, confusion or shallow
breathing.
The prevalence of this CYP2D6 phenotype varies widely and has been estimated
at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in
Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians
and Arabs. Data is not available for other ethnic groups.
When physicians prescribe codeine-containing drugs, they should choose the
lowest effective dose for the shortest period of time and should inform their
patients about these risks and the signs of morphine overdose. (See PRECAUTIONS, Nursing
Mothers)
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules may impair mental and/or physical abilities required for the
performance of potentially hazardous tasks such as driving a car or operating
machinery. Such tasks should be avoided while taking Butalbital, Acetaminophen,
Caffeine, and Codeine Phosphate Capsules.
Alcohol and other CNS depressants may produce an additive CNS depression,
when taken with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules, and should be avoided.
Codeine and butalbital may be habit-forming. Patients should take the drug
only for as long as it is prescribed, in the amounts prescribed, and no more
frequently than prescribed.
For information on use in geriatric patients, see PRECAUTIONS, Geriatric Use.
Caution patients that some people have a variation in a liver enzyme and
change codeine into morphine more rapidly and completely than other people.
These people are ultra-rapid metabolizers and are more likely to have
higher-than-normal levels of morphine in their blood after taking codeine which
can result in overdose symptoms such as extreme sleepiness, confusion, or
shallow breathing. In most cases, it is unknown if someone is an ultra-rapid
codeine metabolizer.
Nursing mothers taking codeine can also have higher morphine levels in their
breast milk if they are ultra-rapid metabolizers. These higher levels of
morphine in breast milk may lead to life-threatening or fatal side effects in
nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity
in their infants including increased sleepiness (more than usual), difficulty
breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to
talk to the baby's doctor immediately if they notice these signs and, if they
cannot reach the doctor right away, to take the baby to an emergency room or
call 911 (or local emergency services).
In patients with severe hepatic or renal disease, effects of
therapy should be monitored with serial liver and/or renal function tests.
The CNS effects of butalbital may be enhanced by monoamine
oxidase (MAO) inhibitors.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules may
enhance the effects of:− Other narcotic analgesics, alcohol, general
anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or
other CNS depressants, causing increased CNS depression.
Codeine
Codeine may increase serum amylase levels.
Acetaminophen
Acetaminophen may produce false-positive test results for urinary
5-hydroxyindoleacetic acid.
No adequate studies have been conducted in animals to determine
whether acetaminophen, codeine and butalbital have a potential for
carcinogenesis or mutagenesis. No adequate studies have been conducted in
animals to determine whether acetaminophen and butalbital have a potential for
impairment of fertility.
Pregnancy Category C:
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 5 mg/kg, which was tapered without further seizure or other
withdrawal symptoms.
Use of codeine during labor may lead to respiratory depression in
the neonate.
Caffeine, barbiturates, acetaminophen 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, Acetaminophen, Caffeine, and Codeine Phosphate
Capsules, 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.
Codeine is secreted into human milk. In women with normal codeine metabolism
(normal CYP2D6 activity), the amount of codeine secreted into human milk is low
and dose-dependent. Despite the common use of codeine products to manage
postpartum pain, reports of adverse events in infants are rare. However, some
women are ultra-rapid metabolizers of codeine. These women achieve
higher-than-expected serum levels of codeine's active metabolite, morphine,
leading to higher-than-expected levels of morphine in breast milk and
potentially dangerously high serum morphine levels in their breastfed infants.
Therefore, maternal use of codeine can potentially lead to serious adverse
reactions, including death, in nursing infants.
The prevalence of this CYP2D6 phenotype varies widely and has been estimated
at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in
Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians
and Arabs. Data is not available for other ethnic groups.
The risk of infant exposure to codeine and morphine through breast milk
should be weighed against the benefits of breastfeeding for both the mother and
baby. Caution should be exercised when codeine is administered to a nursing
woman. If a codeine containing product is selected, the lowest dose should be
prescribed for the shortest period of time to achieve the desired clinical
effect. Mothers using codeine should be informed about when to seek immediate
medical care and how to identify the signs and symptoms of neonatal toxicity,
such as drowsiness or sedation, difficulty breastfeeding, breathing
difficulties, and decreased tone, in their baby. Nursing mothers who are
ultra-rapid metabolizers may also experience overdose symptoms such as extreme
sleepiness, confusion or shallow breathing. Prescribers should closely monitor
mother-infant pairs and notify treating pediatricians about the use of codeine
during breastfeeding. (See
PRECAUTIONS, General, Ultra-rapid Metabolizers of Codeine)
Safety and effectiveness in pediatric patients have not been
established.
Clinical studies of butalbital, acetaminophen, caffeine, and
codeine phosphate capsules did not include sufficient numbers of subjects aged
65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses
between the elderly and younger patients. In general, dose selection for an
elderly patient should be cautious, usually starting at the low end of the
dosing range, reflecting the greater frequency of decreased hepatic, renal, or
cardiac function, and of concomitant disease or other drug therapy.
Butalbital is known to be substantially excreted by the kidney, and the risk
of toxic reactions to this drug may be greater in patients with impaired renal
function. Because elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may be useful to
monitor renal function.
What are the side effects of BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
The most frequently reported adverse reactions are drowsiness,
lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting,
abdominal pain, and intoxicated feeling.
All adverse events tabulated below are classified as
infrequent.
Central Nervous:
Autonomic Nervous:
Gastrointestinal:
Cardiovascular:
Musculoskeletal:
Genitourinary:
Miscellaneous:
The following adverse reactions have been voluntarily
reported as temporally associated with Butalbital, Aspirin, Caffeine, and
Codeine Phosphate Capsules, USP, a related product containing aspirin,
butalbital, caffeine, and codeine.
Central Nervous:
Autonomic Nervous:
Gastrointestinal:
Cardiovascular:
Skin:
Urinary:
Miscellaneous:
The following adverse drug events may be borne in mind as
potential effects of the components of Butalbital, Acetaminophen, Caffeine, and
Codeine Phosphate Capsules. Potential effects of high dosage are listed in
the
section.
Acetaminophen:
Caffeine:
Codeine:
Several cases of dermatological reactions, including toxic epidermal
necrolysis and erythema multiforme, have been reported for Butalbital,
Acetaminophen, and Caffeine Tablets, USP.
What should I look out for while using BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is
contraindicated under the following conditions:− Hypersensitivity or
intolerance to acetaminophen, caffeine, butalbital, or codeine.− Patients
with porphyria.
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 the 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, Acetaminophen, Caffeine, and
Codeine Phosphate Capsules is not recommended.
What might happen if I take too much BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
Following an acute overdosage of Butalbital, Acetaminophen,
Caffeine, and Codeine Phosphate Capsules, toxicity may result from the
barbiturate, the codeine, or the acetaminophen. Toxicity due to the caffeine is
less likely, due to the relatively small amounts in this formulation.
Toxicity from poisoning include drowsiness, confusion, and coma; respiratory
depression; hypotension; and hypovolemic shock. Toxicity from poisoning includes the opioid triad of:
pinpoint pupils, depression of respiration, and loss of consciousness.
Convulsions may occur. In overdosage: dose-dependent, potentially fatal hepatic necrosis is the
most serious adverse effect. Renal tubular necroses, hypoglycemic coma, and
thrombocytopenia may also occur. Early symptoms following a potentially
hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general
malaise. Clinical and laboratory evidence of hepatic toxicity may not be
apparent until 48-72 hours post-ingestion. In adults hepatic toxicity has rarely
been reported with acute overdoses of less than 10 grams, or fatalities with
less than 15 grams. Acute poisoning
may cause insomnia, restlessness, tremor, and delirium, tachycardia, and
extrasystoles.
A single or multiple overdose with Butalbital, Acetaminophen,
Caffeine, and Codeine Phosphate Capsules is a potentially lethal polydrug
overdose, and consultation with a regional poison control center is recommended.
Immediate treatment includes support of cardiorespiratory function and measures
to reduce drug absorption. Vomiting should be induced mechanically, or with
syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal
reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The
first dose should be accompanied by an appropriate cathartic. If repeated doses
are used, the cathartic might be included with alternate doses as required.
Hypotension is usually hypovolemic and should respond to fluids. The value of
vasopressor agents such as Norepinephrine or Phenylephrine Hydrochloride in
treating hypotension is questionable since they increase vasoconstriction and
decrease blood flow. However, if prolonged support of blood pressure is
required, Norepinephrine Bitartrate (Levophed®) may be given I.V. with the usual
precautions and serial blood pressure monitoring. A cuffed endotracheal tube
should be inserted before gastric lavage of the unconscious patient and, when
necessary, to provide assisted respiration. If renal function is normal, forced
diuresis may aid in the elimination of the barbiturate. Alkalinization of the
urine increases renal excretion of some barbiturates, especially
phenobarbital.
Meticulous attention should be given to maintaining adequate pulmonary
ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably
hemodialysis may be considered. If hypoprothrombinemia occurs due to
acetaminophen overdose, vitamin K should be administered intravenously.
Naloxone, a narcotic antagonist, can reverse respiratory depression and coma
associated with opioid overdose. Naloxone 0.4-2 mg is given parenterally. Since
the duration of action of codeine may exceed that of the naloxone, the patient
should be kept under continuous surveillance and repeated doses of the
antagonist should be administered as needed to maintain adequate respiration. A
narcotic antagonist should not be administered in the absence of clinically
significant respiratory or cardiovascular depression.
If the dose of acetaminophen may have exceeded 140 mg/kg, N-acetyl-cysteine
should be administered as early as possible. Serum acetaminophen levels should
be obtained, since levels 4 or more hours following ingestion help predict
acetaminophen toxicity. Do not await acetaminophen assay results before
initiating treatment. Hepatic enzymes should be obtained initially, and repeated
at 24-hour intervals.
Methemoglobinemia over 30% should be treated with methylene blue by slow
intravenous administration.
Butalbital:
Acetaminophen:
Caffeine:
Codeine:
How should I store and handle BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CapsulesBottles of 10 NDC 54868-5162-1,Bottles of 90 NDC 54868-5162-2,Bottles of 100 NDC 54868-5162-0,Bottles of 30 NDC 54868-5162-3.Below 30°C (86°F); tight container.Rx onlyButalbital, Acetaminophen, Caffeine, and Codeine Phosphate CapsulesBottles of 10 NDC 54868-5162-1,Bottles of 90 NDC 54868-5162-2,Bottles of 100 NDC 54868-5162-0,Bottles of 30 NDC 54868-5162-3.Below 30°C (86°F); tight container.Rx onlyButalbital, Acetaminophen, Caffeine, and Codeine Phosphate CapsulesBottles of 10 NDC 54868-5162-1,Bottles of 90 NDC 54868-5162-2,Bottles of 100 NDC 54868-5162-0,Bottles of 30 NDC 54868-5162-3.Below 30°C (86°F); tight container.Rx onlyButalbital, Acetaminophen, Caffeine, and Codeine Phosphate CapsulesBottles of 10 NDC 54868-5162-1,Bottles of 90 NDC 54868-5162-2,Bottles of 100 NDC 54868-5162-0,Bottles of 30 NDC 54868-5162-3.Below 30°C (86°F); tight container.Rx only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Capsules is a combination drug product intended as a treatment for tension
headache.
Butalbital, Acetaminophen, and Caffeine Tablets, USP consists of a fixed
combination of butalbital 50 mg, acetaminophen 325 mg, and caffeine 40 mg. The
role each component plays in the relief of the complex of symptoms known as
tension headache is incompletely understood.
The behavior of the individual components is described below.
Codeine
Codeine is readily absorbed from the gastrointestinal tract. It is rapidly
distributed from the intravascular spaces to the various body tissues, with
preferential uptake by parenchymatous organs such as the liver, spleen and
kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue
and breast milk. The plasma concentration does not correlate with brain
concentration or relief of pain; however, codeine is not bound to plasma
proteins and does not accumulate in body tissues.
The plasma half-life is about 2.9 hours. The elimination of codeine is
primarily via the kidneys, and about 90% of an oral dose is excreted by the
kidneys within 24 hours of dosing. The urinary secretion products consist of
free and glucuronide conjugated codeine (about 70%), free and conjugated
norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine
(about 4%), and hydrocodone (1%). The remainder of the dose is excreted in the
feces.
At therapeutic doses, the analgesic effect reaches a peak within 2 hours and
persists between 4 and 6 hours.
See OVERDOSAGE for
toxicity information.
Butalbital
Butalbital is well absorbed from the gastrointestinal tract and is expected
to distribute to most tissues in the body. Barbiturates in general may appear in
breast milk and readily cross the placental barrier. They are bound to plasma
and tissue proteins to a varying degree and binding increases directly as a
function of lipid solubility.
Elimination of butalbital is primarily via the kidney (59%-88% of the dose)
as unchanged drug or metabolites. The plasma half-life is about 35 hours.
Urinary excretion products include parent drug (about 3.6% of the dose),
5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose),
5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose),
products with the barbituric acid ring hydrolyzed with excretion of urea (about
14% of the dose), as well as unidentified materials. Of the material excreted in
the urine, 32% is conjugated.
The plasma protein binding of butalbital
is 45% over the concentration range of 0.5-20 mcg/mL. This falls within the
range of plasma protein binding (20%-45%) reported with other barbiturates such
as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood
concentration ratio was almost unity indicating that there is no preferential
distribution of butalbital into either plasma or blood cells.
See OVERDOSAGE for
toxicity information.
Caffeine
Like most xanthines, caffeine is rapidly absorbed and distributed in all body
tissues and fluids, including the CNS, fetal tissues, and breast milk.
Caffeine is cleared through metabolism and excretion in the urine. The plasma
half-life is about 3 hours. Hepatic biotransformation prior to excretion results
in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of
the dose that is recovered in the urine, only 3% is unchanged drug.
See OVERDOSAGE for
toxicity information.
Acetaminophen
Acetaminophen is rapidly absorbed from the gastrointestinal tract and is
distributed throughout most body tissues. The plasma half-life is 1.25-3 hours,
but may be increased by liver damage and following overdosage. Elimination of
acetaminophen is principally by liver metabolism (conjugation) and subsequent
renal excretion of metabolites. Approximately 85% of an oral dose appears in the
urine within 24 hours of administration, most as the glucuronide conjugate, with
small amounts of other conjugates and unchanged drug.
See OVERDOSAGE for
toxicity information.
Non-Clinical Toxicology
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is contraindicated under the following conditions:− Hypersensitivity or intolerance to acetaminophen, caffeine, butalbital, or codeine.− Patients with porphyria.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 the 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, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is not recommended.
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules should be prescribed with caution in certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison’s disease, or prostatic hypertrophy.
Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.
The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.
When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose. (See PRECAUTIONS, Nursing Mothers)
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules.
Alcohol and other CNS depressants may produce an additive CNS depression, when taken with Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, and should be avoided.
Codeine and butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
For information on use in geriatric patients, see PRECAUTIONS, Geriatric Use.
Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.
Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules may enhance the effects of:− Other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
Codeine
Codeine may increase serum amylase levels.
Acetaminophen
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
No adequate studies have been conducted in animals to determine whether acetaminophen, codeine and butalbital have a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in animals to determine whether acetaminophen and butalbital have a potential for impairment of fertility.
Pregnancy Category C:
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 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
Use of codeine during labor may lead to respiratory depression in the neonate.
Caffeine, barbiturates, acetaminophen 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, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 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.
Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.
The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.
The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. (See PRECAUTIONS, General, Ultra-rapid Metabolizers of Codeine)
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of butalbital, acetaminophen, caffeine, and codeine phosphate capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
All adverse events tabulated below are classified as infrequent.
Central Nervous:
Autonomic Nervous:
Gastrointestinal:
Cardiovascular:
Musculoskeletal:
Genitourinary:
Miscellaneous:
The following adverse reactions have been voluntarily reported as temporally associated with Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP, a related product containing aspirin, butalbital, caffeine, and codeine.
Central Nervous:
Autonomic Nervous:
Gastrointestinal:
Cardiovascular:
Skin:
Urinary:
Miscellaneous:
The following adverse drug events may be borne in mind as potential effects of the components of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Potential effects of high dosage are listed in the
section.
Acetaminophen:
Caffeine:
Codeine:
Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported for Butalbital, Acetaminophen, and Caffeine Tablets, USP.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).