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 valproate 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. Fetal Risk Valproate can cause major congenital malformations, particularly neural tube defects e.
Women should use effective contraception while using valproate. 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. Because the study was observational in nature, conclusions regarding a causal association between in utero valproate exposure and an increased risk of autism spectrum disorder cannot be considered definitive.
In animal studies, offspring with prenatal exposure to valproate had structural malformations similar to those seen in humans and demonstrated neurobehavioral deficits. Clinical Considerations Neural tube defects are the congenital malformation most strongly associated with maternal valproate use.
Valproate can cause decreased IQ scores in children whose mothers were treated with valproate during pregnancy. Because of the risks of decreased IQ, neural tube defects, and other fetal adverse events, which may occur very early in pregnancy: Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition.
This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death e. Valproate is contraindicated during pregnancy in women being treated for prophylaxis of migraine headaches.
Valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other treatments have failed to provide adequate symptom control or are otherwise unacceptable. In such women, the benefits of treatment with valproate during pregnancy may still outweigh the risks. When treating a pregnant woman or a woman of childbearing potential, carefully consider both the potential risks and benefits of treatment and provide appropriate counseling.
To prevent major seizures, women with epilepsy should not discontinue valproate abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life. Even minor seizures may pose some hazard to the developing embryo or fetus. However, discontinuation of the drug may be considered prior to and during pregnancy in individual cases if the seizure disorder severity and frequency do not pose a serious threat to the patient.
Available prenatal diagnostic testing to detect neural tube and other defects should be offered to pregnant women using valproate.
Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases the risk for congenital neural tube defects in the general population. It is not known whether the risk of neural tube defects or decreased IQ in the offspring of women receiving valproate is reduced by folic acid supplementation. Dietary folic acid supplementation both prior to conception and during pregnancy should be routinely recommended for patients using valproate.
If valproate is used in pregnancy, the clotting parameters should be monitored carefully in the mother. If abnormal in the mother, then these parameters should also be monitored in the neonate. Fatal cases of hepatic failure in infants exposed to valproate in utero have also been reported following maternal use of valproate during pregnancy. Hypoglycemia has been reported in neonates whose mothers have taken valproate during pregnancy.
Data Human There is an extensive body of evidence demonstrating that exposure to valproate in utero increases the risk of neural tube defects and other structural abnormalities. These data show up to a five-fold increased risk for any major malformation following valproate exposure in utero compared to the risk following exposure in utero to other antiepileptic drugs taken in monotherapy.
The major congenital malformations included cases of neural tube defects, cardiovascular malformations, craniofacial defects e. Published epidemiological studies have indicated that children exposed to valproate in utero have lower IQ scores than children exposed to either another antiepileptic drug in utero or to no antiepileptic drugs in utero.
It is not known when during pregnancy cognitive effects in valproate-exposed children occur. Because the women in this study were exposed to antiepileptic drugs throughout pregnancy, whether the risk for decreased IQ was related to a particular time period during pregnancy could not be assessed.
Although all of the available studies have methodological limitations, the weight of the evidence supports a causal association between valproate exposure in utero and subsequent adverse effects on cognitive development. There are published case reports of fatal hepatic failure in offspring of women who used valproate during pregnancy. Animal In developmental toxicity studies conducted in mice, rats, rabbits, and monkeys, increased rates of fetal structural abnormalities, intrauterine growth retardation , and embryo-fetal death occurred following treatment of pregnant animals with valproate during organogenesis at clinically relevant doses calculated on a body surface area basis.
Valproate induced malformations of multiple organ systems, including skeletal, cardiac, and urogenital defects. The United States Pharmacopeia USP defines delayed-release tablets as enteric-coated to delay release of the medication until the tablet has passed through the stomach to prevent the drug from being destroyed or inactivated by gastric juices or where it may irritate the gastric mucosa.
USP defines extended-release tablets "formulated in such a manner to make the contained medicament available over an extended period of time following ingestion. Depakote ER is not enteric-coated. They are not interchangeable. Thus, an equivalent dose of either dosage form does not provide an equivalent pharmacokinetic profile.
Product confusion may therefore result in significant clinical effects in patients. Get medical help right away if you have any very serious side effects, including: A very serious allergic reaction to this drug is rare.
However, get medical help right away if you notice any symptoms of a serious allergic reaction , including: This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US - Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at Precautions 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: To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs , nonprescription drugs, and herbal products.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness , unsteadiness, or tremor.
Drowsiness, dizziness, unsteadiness can increase the risk of falling.
The absolute risks for autism spectrum disorders 500mg 4. Some of the cases have progressed rapidly from initial symptoms to death. There was a trend for the patients who experienced these events to have a lower baseline albumin concentration, lower valproate clearance, and pre higher BUN. Plasma clearance ranges from 0. Birth defects which have been reported include spina bifida where the bones of the spine are not properly developed ; facial and skull malformations; heart, kidney, urinary tract and sexual organ malformations; limb defects. If these drugs are administered concurrently, monitor patients for signs of valproic 500mg toxicity, such as diarrhea, depakote er 500mg pre o, bruising, tremor, changes depakote mood or behavior, yellowing pre skin or eyes, unusual tiredness or weakness, or severe stomach pain with nausea and vomiting, depakote er 500mg pre o. Depakote divalproex sodium is an example of such product-line extension. Do not start, stop, or change the dosage depakote any medicines without your doctor's approval, depakote er 500mg pre o. Women of childbearing potential have to use effective contraception during treatment. Moderate Until more data become available, it is advisable to depakote for effectiveness of clozapine as well as evidence of side effects during concurrent use of valproic acid. Does Depakote interact with other medications? Consult your 500mg or pharmacist if you are using aspirin for any reason. Product confusion may therefore result in significant clinical effects in patients. Adults The pre dosage should be established and controlled individually by the treating physician. Therefore clinical monitoring is recommended and dosage should be adjusted lamotrigine dosage decreased when appropriate.
If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. It is not clear whether these events indicate additional risk or whether they result from preexisting medical illness and concomitant medication use among these patients. In such cases, a patient may experience valproic acid toxicity even if the total drug concentration is within the therapeutic range. Any recent, significant change in dietary or exercise habits. Other adverse effects which depakote occurred during pregnancy include a woman with 500mg fibrinogen taking multiple anticonvulsants whose infant died from hemorrhage secondary to afibrinogenemia; valproate products are known to cause dose-related thrombocytopenia. Because citalopram causes dose-dependent QT prolongation, the maximum daily dose should not exceed 20 mg per day in patients receiving CYP2C19 inhibitors. Some anticonvulsants, such as phenobarbital or carbamazepine, pre potentially induce the metabolism of amoxapine as well. The sleep walking stopped after the valproic acid was discontinued and with a rechallenge the symptoms reappeared. Major Coadministration of tipranavir and valproic acid, divalproex sodium may result in decreased valproic acid concentrations.
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