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Depakote ER (Divalproex Sodium Extended-Release) Information

Depakote ER (divalproex sodium extended-release) is a prescription antiepileptic drug (AED), also known as an anticonvulsant and a mood stabilizer. It is an extended-release formulation of the active compound valproic acid, designed for once-daily dosing. The extended-release formulation provides a smoother and more consistent plasma concentration compared to the immediate-release tablet, which may help reduce specific dose-related side effects, particularly gastrointestinal distress. Depakote ER is a cornerstone treatment for several neurological and psychiatric conditions, including particular seizure disorders (such as Complex Partial Seizures and Simple and Complex Absence Seizures), acute manic episodes of Bipolar Disorder, and the prophylaxis of migraine headaches.

The therapeutic action of divalproex sodium is primarily achieved by increasing the concentration of the inhibitory neurotransmitter, gamma-aminobutyric acid (GABA), in the brain. Divalproex achieves this by inhibiting the enzyme GABA transaminase, which is responsible for the catabolism (breakdown) of GABA, thereby prolonging its presence and activity in the synaptic clefts. This enhanced inhibitory neurotransmission helps to stabilize electrical activity in the brain. Additionally, divalproex sodium has been shown to suppress high-frequency neuronal firing by blocking voltage-gated sodium channels and modulating T-type calcium channels. This combination of effects contributes to its broad-spectrum ability to prevent seizures and stabilize mood.

Depakote ER Side Effects

While Depakote ER is widely used, it is associated with a range of common side effects, which are generally more frequent when starting the medication or following a dosage increase. The most common effects reported include gastrointestinal symptoms like nausea, vomiting, abdominal pain, and diarrhea. Other common side effects include alopecia (hair loss), tremor, sedation (somnolence), dizziness, asthenia (weakness), weight gain, nervousness, and amnesia (memory loss).

However, more serious side effects can occur. Depakote ER carries four distinct Black Box Warnings (the most severe type of warning required by the FDA). The patient should immediately contact their healthcare provider or seek emergency care if any of the following symptoms are experienced:

• Fetal Risk (Boxed Warning): Use during pregnancy is associated with a significant risk of major congenital malformations, including neural tube defects (e.g., spina bifida), as well as decreased cognitive function (lower IQ) in the child. It is contraindicated for migraine prophylaxis in pregnant women and women of childbearing potential not using effective contraception.

• Hepatotoxicity (Liver Damage) (Boxed Warning): Can lead to life-threatening or fatal liver failure, particularly in children under two and in patients with certain congenital metabolic or mitochondrial disorders. This risk is highest during the first six months of therapy, requiring regular monitoring of liver function tests.

• Hyperammonemia and Encephalopathy: High levels of ammonia in the blood, which can lead to changes in mental status, lethargy, confusion, or coma. This risk is significantly increased in patients with a Urea Cycle Disorder (UCD).

• Hypothermia: A significant and severe drop in body temperature (less than 35°C or 95°F) has been reported, sometimes associated with hyperammonemia.

• Pancreatitis (Boxed Warning): Can cause life-threatening or fatal inflammation and hemorrhage of the pancreas. Symptoms include severe abdominal pain that may radiate to the back, and persistent nausea and vomiting.

• Suicidal Thoughts and Behaviour (AED Boxed Warning): Like other AEDs, divalproex sodium can increase the risk of suicidal ideation and behaviour, particularly during the initial phase of treatment or following a dose change.

• Thrombocytopenia/Bleeding: Divalproex can cause a low platelet count, which may lead to severe bleeding or bruising. Platelet counts and coagulation tests should be monitored.

Depakote ER Precautions

A comprehensive medical evaluation and discussion with a healthcare provider is necessary before starting Depakote ER. Due to the Black Box Warnings, individuals with pre-existing liver disease, known or suspected mitochondrial disorders (e.g., POLG-related disorders), or a known or suspected Urea Cycle Disorder (UCD) are generally contraindicated or at significantly increased risk. Routine monitoring of liver function tests and serum ammonia levels is essential. All women of childbearing age must be informed of the high teratogenicity risk and the increased risk of developing Polycystic Ovary Syndrome (PCOS); they should use highly effective contraception. Caution is required in patients concurrently taking other medications that affect the central nervous system (CNS), such as alcohol, other antiepileptic drugs, or sedatives, due to the potential for increased sedation or cognitive effects. Since Depakote ER can cause thrombocytopenia, it should be used cautiously in patients with a history of bleeding disorders or those taking anticoagulants, with regular monitoring of platelet counts and coagulation tests.

Do I need a prescription to order Depakote ER?

Yes, a prescription is required from your physician to order Depakote ER.