Depakote (valproate semisodium)

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How does it work?

Depakote tablets contain the active ingredient valproate semisodium, which is is a type of medicine called a mood stabiliser. It is used to treat the manic phase of a psychiatric illness known as bipolar affective disorder, or manic depression.

(NB. Valproate semisodium is another form of the antiepileptic medicine, sodium valproate. Sodium valproate is also used as a mood stabiliser, but is unlicensed for this purpose. Valproate semisodium is a form of sodium valproate that is licensed for use as a mood stabiliser. Both can be known simply as valproate.)

People with bipolar affective disorder suffer from abnormal mood swings, which range from episodes of abnormally high mood (mania or hypomania) to episodes of abnormally low mood (depression). Valproate semisodium works as a mood stabiliser by increasing the amount of a natural nerve calming chemical in the brain called GABA.

The brain and nerves are made up of thousands of nerve cells that communicate with each other through electrical signals. These signals must be carefully regulated for the brain and nerves to function properly. When abnormally rapid and repetitive electrical signals are released in the brain, it becomes over-stimulated and normal function is disturbed.

The nerve activity is normally kept in balance by a natural chemical in the brain called GABA. When GABA is released in the brain it acts as a natural calming agent. Once GABA is broken down in the brain, it can no longer act on the nerves. When only small amounts of GABA are present, the brain may become 'overexcited'.

Valproate semisodium prevents the breakdown of GABA in the brain. This enables more GABA to be available to calm nerve cells for a longer period of time. By calming the nerve cells, valproate semisodium prevents excessively rapid and repetitive firing of electrical signals. This stabilises the electrical nerve activity in the brain and is thought to explain how valproate semisodium calms periods of mania.

In addition to treating manic episodes, valproate semisodium is prescribed by specialists as a maintenance treatment to help stabilise mood and prevent episodes of ill health, though this is an unlicensed use of the medicine.

What is it used for?

- Treatment of manic episodes of bipolar affective disorder
- As a mood stabiliser in bipolar affective disorder to help prevent episodes of mania or depression (unlicensed use).

Warning!

- Depakote tablets should be swallowed whole with a drink of water and not broken, crushed or chewed.
- This medicine may cause drowsiness. If affected do not drive or operate machinery.
- This medicine can cause some people to put on weight.

Talk to your doctor about this before you start treatment so that you can discuss strategies, such as diet and exercise, for minimising any weight gain.
- This medicine may on rare occasions affect your liver, pancreas or blood cells. You should have blood tests to monitor your liver function, blood cells and blood clotting time before you start treatment. Your liver function should be monitored for the first six months of treatment, and your blood cell count should be checked before any surgery. Tell your doctor immediately if you experience any of the following symptoms during treatment, particularly if they come on suddenly or occur in the first six months of taking the medicine: lack of appetite and energy, weakness, feeling generally unwell, drowsiness, nausea, vomiting, severe abdominal pain, swelling of ankles, yellowing of the skin or whites of the eyes (jaundice), or unusual bruising or bleeding.
- People with diabetes should be aware that valproate semisodium can cause false positive results in urine tests for ketones.
- You should not suddenly stop taking this medicine unless your doctor tells you otherwise, as suddenly stopping treatment could make your symptoms return. When this medicine is stopped, it should normally be done gradually, under the supervision of your specialist.

Use with caution in

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- Decreased kidney function
- History of liver disease
- Disorders of urea production in the liver (urea cycle disorders)
- Long-term inflammation of skin and some internal organs (systemic lupus erythematosus).

Not to be used in

- Active liver disease
- Personal or family history of severe liver problems, particularly if due to a medicine
- Hereditary blood disorders called porphyrias.
- Depakote is not recommended for children and adolescents under 18 years of age, as it's safety and effectiveness for treating mania have not been studied in this age group.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

- Pregnant women taking valproate have a higher risk of carrying a baby with developmental problems and malformations. In view of this it is vital that women with bipolar disorder receive specialist psychiatric advice before starting treatment with valproate, so they are well informed of potential risks and benefits of treatment.

- Women who decide to try for a baby while taking valproate should start taking folic acid 5mg daily as soon as contraception is stopped, as this may reduce risk of neural tube defects such as spina bifida in the baby.
- Women who decide to continue taking valproate during a pregnancy should be prescribed valproate on its own, in the lowest effective dose, in doses that are split over the day, and if possible as a prolonged release brand. These measures can help minimise the risk to the baby. Specialist medical advice must be sought.
- Valproate passes into breast milk in small amounts, but there have been no reports of harmful effects from this on nursing infants. Seek further medical advice from your doctor.

Label warnings

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- This medication is to be swallowed whole, not chewed.

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