Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/199
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Depakote ER (Tablet, Extended Release)
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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 ER is used in
this patient group, it 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 ER 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 ER (Tablet, Extended Release)
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Depakote ER
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