Depakote By Mail

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. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months of valproate therapy. However, healthcare providers should not rely totally on serum biochemistry since these tests may not be abnormal in all instances, but should also consider the results of careful interim medical history and physical examination.

Caution should be observed when administering valproate products to patients with a prior history of hepatic disease. Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk. When Depakote 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. In progressively older patient groups experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably. Patients with Known or Suspected Mitochondrial Disease Depakote is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder [see Contraindications 4 ].

Most of the reported cases of liver failure in patients with these syndromes have been identified in children and adolescents. POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura. POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders.

In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakote should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakote for the development of acute liver injury with regular clinical assessments and serum liver test monitoring. The drug should be discontinued immediately in the presence of significant hepatic dysfunction, suspected or apparent. In some cases, hepatic dysfunction has progressed in spite of discontinuation of drug [see Boxed Warning and Contraindications 4 ]. Pregnancy registry data show that maternal valproate use can cause neural tube defects and other structural abnormalities e.

The rate of congenital malformations among babies born to mothers using valproate is about four times higher than the rate among babies born to epileptic mothers using other anti-seizure monotherapies. 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 [see Use in Specific Populations 8. Published epidemiological studies have indicated that children exposed to valproate in utero have lower cognitive test scores than children exposed in utero to either another antiepileptic drug or to no antiepileptic drugs.

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 the conclusion that valproate exposure in utero can cause decreased IQ in children. In animal studies, offspring with prenatal exposure to valproate had malformations similar to those seen in humans and demonstrated neurobehavioral deficits [see Use in Specific Populations 8.

This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headaches [see Contraindications 4 ]. Women should use effective contraception while using valproate. Women of childbearing potential should be counseled regularly regarding the relative risks and benefits of valproate use during pregnancy. Like other antiepileptic drugs, Depakote may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Do not take Depakote if you: Ask your healthcare provider about the best way to feed your baby. Taking Depakote with certain other medicines, even for a short period of time, can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Depakote can cause other serious side effects, including: Bleeding problems: High ammonia levels in your blood: Low body temperature hypothermia: Allergic hypersensitivity reactions: Drowsiness or sleepiness in the elderly.

This extreme drowsiness may cause you to eat or drink less than you normally would. Tell your doctor if you are not able to eat or drink as you normally do.

When you use this card, you are confirming that you have not submitted and will not submit a claim for this prescription for reimbursement under any federal, state, or government-funded healthcare program, such as Medicare including Part D , Medicare Advantage, Medicaid, Medigap, Veterans Affairs, the Department of Defense, or TRICARE. Do not stop taking Depakote without first talking to your healthcare provider. Stopping Depakote suddenly can cause serious problems. Depakote can cause serious side effects, including: Serious liver damage that can cause death, especially in children younger than 2 years old.

The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. In some cases, liver damage may continue despite stopping the drug. Call your healthcare provider right away if you get any of the following symptoms: Depakote may harm your unborn baby. If you take Depakote during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy.

These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out urethra on the bottom of the penis can also happen. Patients with Known or Suspected Mitochondrial Disease Depakote is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder [see Contraindications 4 ]. Most of the reported cases of liver failure in patients with these syndromes have been identified in children and adolescents.

POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy focal, myoclonic , status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura. POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders.

In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakote should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakote for the development of acute liver injury with regular clinical assessments and serum liver test monitoring. The drug should be discontinued immediately in the presence of significant hepatic dysfunction, suspected or apparent. In some cases, hepatic dysfunction has progressed in spite of discontinuation of drug [see Boxed Warning and Contraindications 4 ].

Pregnancy registry data show that maternal valproate use can cause neural tube defects and other structural abnormalities e. The rate of congenital malformations among babies born to mothers using valproate is about four times higher than the rate among babies born to epileptic mothers using other anti-seizure monotherapies. 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 [see Use in Specific Populations 8.

Published epidemiological studies have indicated that children exposed to valproate in utero have lower cognitive test scores than children exposed in utero to either another antiepileptic drug or to no antiepileptic drugs. It is not known when during pregnancy cognitive effects in valproate-exposed children occur. I weaned myself off and had no problems. My boyfriend is on lithium and a handful of other medications for his schizoaffective. His hair is falling out he now has bald spots. His doctor told him to take a multi vitamin that is high in zinc and selenium to help this side affect. Hes also on Geodon. Which can be used for bipolar as well as schizophrenia.

Check complete blood counts and coagulation times before starting therapy or surgery, at periodic intervals, and during pregnancy. Hyperammonemia has been associated with valproate; it may be present despite normal liver function tests and should be considered if hypothermia occurs. Asymptomatic elevations of ammonia are more common and require close monitoring. Hypothermia has been associated with valproate therapy both in conjunction with, and in the absence of, hyperammonemia. It can occur after starting topiramate treatment or after increasing the daily dose of topiramate.

Patients typically present with fever, rash, and lymphadenopathy associated with other organ system involvement, e. Early symptoms may not include rash. In a clinical trial, somnolence was associated with valproate in some elderly dementia patients along with reduced nutritional intake; weight loss; and a trend to have a lower baseline albumin concentration, higher BUN, and lower valproate clearance. Rare reports of medication residue in the stool have occurred, some in patients with anatomic ileostomy or colostomy or functional gastrointestinal disorders with shortened GI transit times or in the context of diarrhea.

Keep Depakote and all other medications where children cannot reach them. North Chicago, IL: AbbVie Inc. Depakote ER [package insert]. Depakote Sprinkle Capsules [package insert]. If you have any questions about AbbVie's Depakote. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only, and is not intended to replace a discussion with a healthcare provider.

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