Talk to your doctor for details. This medication has rarely caused severe sometimes fatal disease of the pancreas pancreatitis.
This may occur at any time during treatment and can quickly worsen. Taking this medication during pregnancy can cause birth defects and may lower your child's IQ. Women of childbearing age should discuss the risks and benefits of this medication, other treatment options, and use of reliable forms of birth control with their doctor.
If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor. If you are taking divalproex sodium only to prevent migraine headaches , this medication must not be used during pregnancy. It works by restoring the balance of certain natural substances neurotransmitters in the brain. Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking divalproex sodium and each time you get a refill.
If you have any questions, ask your doctor or pharmacist. Take this medication by mouth once daily or as directed by your doctor. Variations within the CYP2C9 gene that result in decreased enzymatic activity have been associated with increased phenytoin concentrations, as well as reports of drug toxicities due to these increased concentrations. Phenytoin induces metabolizing enzymes in the liver. This leads to increased metabolism of vitamin D , thus decreased vitamin D levels.
Vitamin D deficiency , as well as low calcium and phosphate in the blood cause decreased bone mineral density. Antacids administered in a peptic ulcer regimen may decrease the AUC of a single dose of phenytoin. Patients should be cautioned against concomitant use of antacids and phenytoin. Consider using other options if possible. The list is not exhaustive nor could it be, since new interactions are continuously being reported. Valproate free fraction was increased 4-fold in the presence of aspirin compared to valproate alone.
Whether or not the interaction observed in this study applies to adults is unknown, but caution should be observed if valproate and aspirin are to be co-administered. Carbapenem Antibiotics A clinically significant reduction in serum valproic acid concentration has been reported in patients receiving carbapenem antibiotics for example, ertapenem, imipenem, meropenem; this is not a complete list and may result in loss of seizure control.
The mechanism of this interaction is not well understood. Serum valproic acid concentrations should be monitored frequently after initiating carbapenem therapy. Alternative antibacterial or anticonvulsant therapy should be considered if serum valproic acid concentrations drop significantly or seizure control deteriorates [see Warnings and Precautions 5.
Estrogen-Containing Hormonal Contraceptives Estrogen-containing hormonal contraceptives may increase the clearance of valproate, which may result in decreased concentration of valproate and potentially increased seizure frequency. Prescribers should monitor serum valproate concentrations and clinical response when adding or discontinuing estrogen containing products.
A decrease in valproate dosage may be necessary when felbamate therapy is initiated. Valproate dosage adjustment may be necessary when it is co-administered with rifampin. Drugs for which either no interaction or a likely clinically unimportant interaction has been observed Antacids A study involving the co-administration of valproate mg with commonly administered antacids Maalox, Trisogel, and Titralac - mEq doses did not reveal any effect on the extent of absorption of valproate.
Cimetidine and Ranitidine Cimetidine and ranitidine do not affect the clearance of valproate. Effects of Valproate on Other Drugs Valproate has been found to be a weak inhibitor of some P isozymes, epoxide hydrase, and glucuronosyltransferases.
The following list provides information about the potential for an influence of valproate co-administration on the pharmacokinetics or pharmacodynamics of several commonly prescribed medications. The list is not exhaustive, since new interactions are continuously being reported.
Rare postmarketing reports of concurrent use of valproate and amitriptyline resulting in an increased amitriptyline level have been received. Concurrent use of valproate and amitriptyline has rarely been associated with toxicity. Monitoring of amitriptyline levels should be considered for patients taking valproate concomitantly with amitriptyline.
Clonazepam The concomitant use of valproate and clonazepam may induce absence status in patients with a history of absence type seizures. Diazepam Valproate displaces diazepam from its plasma albumin binding sites and inhibits its metabolism.
The elimination half-life of diazepam remained unchanged upon addition of valproate. Ethosuximide Valproate inhibits the metabolism of ethosuximide.
Patients receiving valproate and ethosuximide, especially along with other anticonvulsants, should be monitored for alterations in serum concentrations of both drugs. The dose of lamotrigine should be reduced when co-administered with valproate. Serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with concomitant lamotrigine and valproate administration.
See lamotrigine package insert for details on lamotrigine dosing with concomitant valproate administration. Phenobarbital Valproate was found to inhibit the metabolism of phenobarbital.
There is evidence for severe CNS depression, with or without significant elevations of barbiturate or valproate serum concentrations. All patients receiving concomitant barbiturate therapy should be closely monitored for neurological toxicity. Serum barbiturate concentrations should be obtained, if possible, and the barbiturate dosage decreased, if appropriate.
Primidone, which is metabolized to a barbiturate, may be involved in a similar interaction with valproate. Phenytoin Valproate displaces phenytoin from its plasma albumin binding sites and inhibits its hepatic metabolism.
In patients with epilepsy, there have been reports of breakthrough seizures occurring with the combination of valproate and phenytoin. The dosage of phenytoin should be adjusted as required by the clinical situation. Propofol The concomitant use of valproate and propofol may lead to increased blood levels of propofol.
Reduce the dose of propofol when co-administering with valproate. Monitor patients closely for signs of increased sedation or cardiorespiratory depression. Rufinamide Based on a population pharmacokinetic analysis, rufinamide clearance was decreased by valproate.
Patients stabilized on rufinamide before being prescribed valproate should begin valproate therapy at a low dose, and titrate to a clinically effective dose [see Dosage and Administration 2. The clinical relevance of this displacement is unknown. Warfarin In an in vitro study, valproate increased the unbound fraction of warfarin by up to Advise women to use effective contraception while using valproate. When appropriate, counsel these patients about alternative therapeutic options. This is particularly important when valproate use is considered for a condition not usually associated with permanent injury or death.
Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number [see Use In Specific Populations ].
Suicidal Thinking And Behavior Counsel patients, their caregivers, and families that AEDs, including Depakote, may increase the risk of suicidal thoughts and behavior and to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
Multiorgan Hypersensitivity Reactions Instruct patients that a fever associated with other organ system involvement rash, lymphadenopathy, etc. The primary findings were an increase in the incidence of subcutaneous fibrosarcomas in high-dose male rats receiving valproate and a dose-related trend for benign pulmonary adenomas in male mice receiving valproate. The significance of these findings for humans is unknown.
Mutagenesis Valproate was not mutagenic in an in vitro bacterial assay Ames test , did not produce dominant lethal effects in mice, and did not increase chromosome aberration frequency in an in vivo cytogenetic study in rats. Increased frequencies of sister chromatid exchange SCE have been reported in a study of epileptic children taking valproate, but this association was not observed in another study conducted in adults.
There is some evidence that increased SCE frequencies may be associated with epilepsy. The biological significance of an increase in SCE frequency is not known.
The effect of valproate on testicular development and on sperm parameters and fertility in humans is unknown. This can be done by calling toll free , and must be done by the patients themselves.
Information on the registry can be found at the website, http: Maternal valproate use during pregnancy for any indication increases the risk of congenital malformations, particularly neural tube defects, but also malformations involving other body systems e.
The risk of major structural abnormalities is greatest during the first trimester; however, other serious developmental effects can occur with valproate use throughout pregnancy. An observational study has suggested that exposure to valproate products during pregnancy may increase the risk of autism spectrum disorders.
In this study, children born to mothers who had used valproate products during pregnancy had 2. The absolute risks for autism spectrum disorders were 4.
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.
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