Depakote Sprinkle Capsules
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Depakote Sprinkle Capsules
Depakote Sprinkle Capsules
WARNING: LIFE THREATENING ADVERSE REACTIONS
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 (divalproex sodium 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].
Valproate can produce teratogenic effects such as neural tube defects (e.g., spina bifida). Accordingly, the use of Depakote Sprinkle Capsules (divalproex sodium 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]
An information sheet describing the teratogenic potential of valproate is available for patients [See Patient Counseling Information].
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].
Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:
Divalproex sodium occurs as a white powder with a characteristic odor. Depakote Sprinkle Capsules (divalproex sodium sprinkle capsules) are for oral administration. Depakote Sprinkle Capsules contain specially coated particles of divalproex sodium equivalent to 125 mg of valproic acid in a hard gelatin capsule.
125 mg Depakote Sprinkle Capsules (divalproex sodium sprinkle capsules) : cellulosic polymers, D&C Red No. 28, FD&C Blue No. 1, gelatin, iron oxide, magnesium stearate, silica gel, titanium dioxide, and triethyl citrate.
What are the possible side effects of divalproex sodium (Depakote, Depakote ER, Depakote Sprinkles)?
Seek emergency medical attention if the person taking this medicine has nausea, vomiting, upper stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage or pancreatitis.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
What are the precautions when taking divalproex sodium sprinkle capsules (Depakote Sprinkle Capsules)?
See also Warning section.
Before taking divalproex sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or valproate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, pancreatitis, certain metabolic disorders (such as urea cycle disorders, Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems, brain disease (dementia), kidney disease, low body water (dehydration), poor nutrition.
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Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Depakote Sprinkle Capsules Information
- Depakote Sprinkle Capsules Drug Interactions Center: divalproex oral
- Depakote Sprinkle Capsules Side Effects Center
- Depakote Sprinkle Capsules in detail including Side Effects and Drug Images
- Depakote Sprinkle Capsules Overview including Precautions
- Depakote Sprinkle Capsules FDA Approved Prescribing Information including Dosage
Depakote Sprinkle Capsules - User Reviews
Depakote Sprinkle Capsules User Reviews
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