Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1060
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Depakote (Capsule)
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| dailymed-instance:activeIng... | |
| dailymed-instance:genericDr... | |
| dailymed-instance:boxedWarn... |
BOXED WARNING: WARNING: LIFE THREATENING
ADVERSE REACTIONS HEPATOTOXICITY Hepatic
failure resulting in fatalities has occurred in patients receiving
valproic acid and its derivatives. Children under the age of two years
are at a considerably increased risk of developing fatal hepatotoxicity,
especially those on multiple anticonvulsants, those with congenital
metabolic disorders, those with severe seizure disorders accompanied
by mental retardation, and those with organic brain disease. When
Depakote Sprinkle Capsules are used in this patient group, they should
be used with extreme caution and as a sole agent. The benefits of
therapy should be weighed against the risks. The incidence of fatal
hepatotoxicity decreases considerably in progressively older patient
groups. These incidents usually have occurred
during the first six months of treatment. Serious or fatal hepatotoxicity
may be preceded by non-specific symptoms such as malaise, weakness,
lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy,
a loss of seizure control may also occur. Patients should be monitored
closely for appearance of these symptoms. Liver function tests should
be performed prior to therapy and at frequent intervals thereafter,
especially during the first six months [See Warnings and Precautions (5.1)]. TERATOGENICITY Valproate can produce teratogenic effects
such as neural tube defects (e.g., spina bifida). Accordingly, the
use of Depakote Sprinkle Capsules in women of childbearing potential
requires that the benefits of its use be weighed against the risk
of injury to the fetus. This is especially important when the treatment
of a spontaneously reversible condition not ordinarily associated
with permanent injury or risk of death (e.g., migraine) is contemplated. [See Warnings and Precautions (5.2)] An information sheet describing the
teratogenic potential of valproate is available for patients[See Patient Counseling Information (17.7)]. PANCREATITIS Cases of life-threatening pancreatitis have been reported in both
children and adults receiving valproate. Some of the cases have been
described as hemorrhagic with a rapid progression from initial symptoms
to death. Cases have been reported shortly after initial use as well
as after several years of use. Patients and guardians should be warned
that abdominal pain, nausea, vomiting and/or anorexia can be symptoms
of pancreatitis that require prompt medical evaluation. If pancreatitis
is diagnosed, valproate should ordinarily be discontinued. Alternative
treatment for the underlying medical condition should be initiated
as clinically indicated [see Warnings
and Precautions (5.3)].
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| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:possibleD... | |
| dailymed-instance:genericMe... |
divalproex sodium
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| dailymed-instance:fullName |
Depakote (Capsule)
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Depakote
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