WHAT IS Depakote/Divalproex SODIUM?

It is used in the UK and U.S. for the treatment of the manic episodes of bipolar disorder, and increasingly taken long-term for prevention of both manic and depressive phases of bipolar disorder, especially the rapid-cycling variant. It is also used in the US for the treatment of epilepsy.

Divalproex/Depakote sodium affects chemicals in the body that may be involved in causing seizures.

Divalproex/Depakote sodium is used to treat various types of seizure disorders. Divalproex/Depakote sodium is sometimes used together with other seizure medications.

Divalproex/Depakote sodium may also be used for purposes other than those listed in this medication guide.

WHAT HAPPENS IF I OVERDOSE?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a divalproex/Depakote sodium overdose may include sleepiness or drowsiness, shallow breathing, weak pulse, or loss of consciousness.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT Depakote/Divalproex SODIUM?

In rare cases, divalproex/Depakote sodium has caused life-threatening liver failure, especially in children younger than 2 years old. Children of this age may be at even greater risk for liver problems if they use more than one seizure medication, if they have a metabolic disorder, or if they have a brain disease causing mental impairment (such as Creutzfeldt-Jacob disease, Huntington disease, multiple sclerosis, or a brain injury or infection). Divalproex/Depakote sodium has also caused rare cases of life-threatening pancreatitis (inflammation of the pancreas). Pancreatitis can come on suddenly and symptoms may start even after you have been taking divalproex/Depakote sodium for several years. Seek emergency medical attention if the person taking this medicine has nausea, vomiting, stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis. Divalproex/Depakote sodium can cause birth defects. Do not use this medication without your doctor's consent if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not stop taking the medication even if you feel better. It is important to take divalproex/Depakote sodium regularly to prevent seizures from recurring. Call your doctor promptly if this medicine does not seem to be working as well in preventing your seizures. Do not crush, chew, break, or open a delayed-release or extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Carry an ID card or wear a medical alert bracelet stating that you are taking divalproex/Depakote sodium, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking divalproex/Depakote sodium.

Avoid using other drugs that make you sleepy (such as other seizure medicines, alcohol, cold medicine, pain medication, muscle relaxers, and medicine for depression or anxiety). They can add to sleepiness caused by divalproex/Depakote sodium.

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING Depakote/Divalproex SODIUM?

In rare cases, divalproex/Depakote sodium has caused life-threatening liver failure, especially in children younger than 2 years old. Children of this age may be at even greater risk for liver problems if they use more than one seizure medication, if they have a metabolic disorder, or if they have a brain disease causing mental impairment (such as Creutzfeldt-Jacob disease, Huntington disease, multiple sclerosis, or a brain injury or infection). Divalproex/Depakote sodium has also caused rare cases of life-threatening pancreatitis (inflammation of the pancreas). Pancreatitis can come on suddenly and symptoms may start even after you have been taking divalproex/Depakote sodium for several years. Do not take divalproex/Depakote sodium if you have liver disease or a urea cycle disorder.

Before taking divalproex/Depakote sodium, tell your doctor if you have:

• a family history of a urea cycle disorder;
• a bleeding or blood clotting disorder;
• a history of head injury, brain disorder, or coma;
• a family history of infant deaths with unknown cause; or
• HIV or CMV (cytomegalovirus) infection.

If you have any of these conditions, you may not be able to use divalproex/Depakote sodium, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use divalproex/Depakote sodium without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Divalproex/Depakote sodium can cause birth defects. Use an effective form of birth control while you are using this medication. Divalproex/Depakote sodium passes into breast milk and could harm a nursing infant. Do not take divalproex/Depakote sodium without telling your doctor if you are breast-feeding a baby. Divalproex/Depakote sodium should not be given to a child younger than 2 years of age without a doctor's consent. Older adults may be more sensitive to sleepiness caused by this medicine.

HOW SHOULD I TAKE Depakote/Divalproex SODIUM?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.

Take each dose with a full glass of water. Drink plenty of water while you are taking this medication. Your dose may need to be changed if you do not get enough fluids each day.

To be sure this medication is not causing harmful effects, your liver function will need to be tested. It is important that you not miss any scheduled visits to your doctor.

Do not stop taking the medication even if you feel better. It is important to take divalproex/Depakote sodium regularly to prevent seizures from recurring. Get your prescription refilled before you run out of medicine completely. Call your doctor promptly if this medicine does not seem to be working as well in preventing your seizures. Do not crush, chew, break, or open a delayed-release or extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

You may open the divalproex/Depakote sodium sprinkle capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Carry an ID card or wear a medical alert bracelet stating that you are taking divalproex/Depakote sodium, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking divalproex/Depakote sodium. Store divalproex/Depakote sodium at room temperature away from moisture and heat.

Depakote/Divalproex SODIUM SIDE EFFECTS

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• a red, blistering, peeling skin rash;
• hallucinations (seeing things that aren't there);
• unexplained weakness with vomiting and confusion or fainting;
• unusual bleeding or bruising; or
• easy bruising or bleeding, unusual weakness;
• urinating less than usual;
• weakness, lack of coordination;
• fever, skin rash, swollen glands;
• double vision or back-and-forth movements of the eyes.
• fever, chills, body aches, flu symptoms;
• blood in your urine;
• extreme drowsiness;

Continue using divalproex/Depakote sodium and talk with your doctor if you have any of these less serious side effects:

• unusual or unpleasant taste in your mouth.
• drowsiness or weakness;
• depression, anxiety, or other emotional changes;
• hair loss;
• a red, blistering, peeling skin rash;
• weight changes;
• enlarged breasts;
• tremor (shaking);
• changes in your menstrual periods;
• vision changes; or
• diarrhea, constipation, upset stomach;

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

WHAT OTHER DRUGS WILL AFFECT Depakote/Divalproex SODIUM?

Before taking divalproex/Depakote sodium, tell your doctor if you are using any of the following drugs:

• another seizure medicine such as phenytoin/Dilantin ( Dilantin ), carbamazepine ( Tegretol , Carbatrol ), phenobarbital (Luminal, Solfoton), felbamate (Felbatol), lamotrigine ( Lamictal ), or clonazepam (Klonopin).
• ethosuximide (Zarontin); or
• topiramate/Topamax ( Topamax );
• a blood thinner such as warfarin/Coumadin ( Coumadin );
• zidovudine/Retrovir ( Retrovir );
• clozapine/Clozaril ( Clozaril , Fazaclo);
• diazepam (Valium);
• rifampin (Rifadin, Rimactane, Rifater);
• tolbutamide (Orinase);
• aspirin or acetaminophen (Tylenol);
• meropenem (Merrem);

If you are using any of these drugs, you may not be able to use divalproex/Depakote sodium, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect divalproex/Depakote sodium. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

WHAT HAPPENS IF I MISS A DOSE?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

WHAT SHOULD I AVOID WHILE TAKING Depakote/Divalproex SODIUM?

Avoid drinking alcohol, which can increase some of the side effects of divalproex/Depakote sodium.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by divalproex/Depakote sodium.

Divalproex/Depakote sodium can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Divalproex/Depakote sodium can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.