Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3786
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TYLENOL with Codeine (Tablet)
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Dosage should be adjusted according to severity of
pain and response of the patient. The usual adult dosage
is: The usual dose of codeine phosphate in children is
0.5 mg/kg. Doses may be repeated up to every 4 hours. The
prescriber must determine the number of tablets per dose, and the maximum
number of tablets per 24 hours, based upon the above dosage guidance. This
information should be conveyed in the prescription. It
should be kept in mind, however, that tolerance to codeine can develop with
continued use and that the incidence of untoward effects is dose related.
Adult doses of codeine higher than 60 mg fail to give commensurate relief
of pain but merely prolong analgesia and are associated with an appreciably
increased incidence of undesirable side effects. Equivalently high doses
in children would have similar effects.
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TYLENOL with Codeine is supplied
in tablet form for oral administration. Acetaminophen,
4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder,
is a non-opiate, non-salicylate analgesic and antipyretic. It has the following
structural formula: Codeine phosphate, 7,8-didehydro-4, 5��-epoxy-3-methoxy-17-methylmorphinan-6��-ol
phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic
analgesic and antitussive. It has the following structural formula: Each tablet
contains: Acetaminophen 300 mgNo. 3 Codeine Phosphate 30
mg (Warning: May be habit forming) Acetaminophen 300
mgNo. 4 Codeine Phosphate 60
mg (Warning: May be habit forming) In addition, each tablet contains the following inactive ingredients: TYLENOLwith
Codeine No. 3 contains powdered cellulose, magnesium stearate, sodium metabisulfite���,
pregelatinized starch (corn), and modified starch (corn). TYLENOL with
Codeine No. 4 contains powdered cellulose, magnesium stearate, sodium metabisulfite���,
pregelatinized starch (corn), and corn starch. ���See WARNINGS
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This product combines the analgesic effects of a centrally
acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen.<br/>Pharmacokinetics: The behavior of the individual components is described below.<br/>Codeine: Codeine is rapidly 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 (about 70%), free and conjugated morphine (about 10%), normorphine
(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.<br/>Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal
tract and is distributed throughout most body tissues. The plasma half-life
is 1.25 to 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.
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This product should not be administered to patients
who have previously exhibited hypersensitivity to codeine or acetaminophen.
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TYLENOL with Codeine (acetaminophen
and codeine phosphate) tablets are white, round, flat-faced, beveled edged
tablet imprinted "McNEIL," on one side and "TYLENOL CODEINE" and either "3"
or "4" on the other side and are supplied as follows: No. 3 - NDC 0045-0513-60
bottles of 100, NDC 0045-0513-80 bottles of 1000, No. 4 - NDC 0045-0515-60
bottles of 100, NDC 0045-0515-70 bottles of 500. Store
TYLENOL with Codeine tablets at controlled room temperature
15�����30��C (59�����86��F). Dispense
in tight, light-resistant container as defined in the official compendium.
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General: TYLENOL with Codeine (acetaminophen
and codeine phosphate) tablets 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.<br/>Ultra-Rapid Metabolizers of Codeine: 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 to 10% in Caucasians, 3% in African Americans, and
16 to 28% in North Africans, Ethiopians, and Arabs. Data are 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 inform their patients about these risks and the signs of morphine
overdose (see PRECAUTIONS���Nursing Mothers).<br/>Information for Patients: Codeine may impair the 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 this
product. Alcohol and other CNS depressants
may produce an additive CNS depression, when taken with this combination product,
and should be avoided. Codeine 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. 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).<br/>Laboratory Tests: In patients with severe hepatic or renal disease, effects
of therapy should be monitored with serial liver and/or renal function tests.<br/>Drug Interactions: This drug 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.<br/>Drug and Laboratory Test Interactions: Codeine may increase serum amylase levels. Acetaminophen
may produce false-positive test results for urinary 5-hydroxyindoleacetic
acid.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: No adequate studies have been conducted in animals
to determine whether acetaminophen and codeine have a potential for carcinogenesis
or mutagenesis. No adequate studies have been conducted in animals to determine
whether acetaminophen has a potential for impairment of fertility. Acetaminophen
and codeine have been found to have no mutagenic potential using the Ames
Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells,
and the Micronucleus test on mouse bone marrow.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category C:<br/>Codeine: A study in rats and rabbits reported no teratogenic
effect of codeine administered during the period of organogenesis in doses
ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in
the toxic range for the adult animal, were associated with an increase in
embryo resorption at the time of implantation. In another study a single 100
mg/kg dose of codeine administered to pregnant mice reportedly resulted in
delayed ossification in the offspring. There
are no adequate and well-controlled studies in pregnant women.
TYLENOL with Codeine (acetaminophen and codeine phosphate)
tablets should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.<br/>Nonteratogenic Effects: Dependence has been reported in newborns whose
mothers took opiates regularly during pregnancy. Withdrawal signs include
irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and
diarrhea. These signs usually appear during the first few days of life.<br/>Labor and Delivery: Narcotic analgesics cross the placental barrier.
The closer to delivery and the larger the dose used, the greater the possibility
of respiratory depression in the newborn. Narcotic analgesics should be avoided
during labor if delivery of a premature infant is anticipated. If the mother
has received narcotic analgesics during labor, newborn infants should be observed
closely for signs of respiratory depression. Resuscitation may be required
. The effect of codeine,
if any, on the later growth, development, and functional maturation of the
child is unknown.<br/>Nursing Mothers: Acetaminophen is excreted in breast milk in small
amounts, but the significance of its effect on nursing infants is not known.
Because of the potential for serious adverse reactions in nursing infants
from acetaminophen, a decision should be made whether 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 to 10% in Caucasians, 3% in African Americans, and 16 to
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 metabolizersmay 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).<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not been
established.
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acetaminophen and codeine phosphate
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TYLENOL with Codeine (Tablet)
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The most frequently observed adverse reactions include
drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea
and vomiting. These effects seem to be more prominent in ambulatory than in
non-ambulatory patients, and some of these adverse reactions may be alleviated
if the patient lies down. Other adverse reactions include
allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus,
rash, thrombocytopenia, and agranulocytosis. At
higher doses, codeine has most of the disadvantages of morphine including
respiratory depression.
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TYLENOL with Codeine (acetaminophen
and codeine phosphate) tablets are indicated for the relief of mild to moderately
severe pain.
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TYLENOL with Codeine
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