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FDA -Approved Patient Labeling

Important Information for Women Who Could Become Pregnant About the Use of DEPAKOTE, DEPAKOTE ER, DEPAKOTE Sprinkle Capsules (divalproex sodium sprinkle capsules) , and DEPAKENE.

Please read this leaflet carefully before you take any of this medication. This leaflet provides a summary of important information about taking this medication to women who could become pregnant. If you have any questions or concerns, or want more information about this medication, contact your doctor or pharmacist.

Information For Women Who Could Become Pregnant

You can only obtain this medication by prescription from your doctor. The decision to use this medicine should be made by you and your doctor based on your health needs and medical condition.

Before starting this medicine, you should know that using this medicine during pregnancy causes an increased chance of birth defects in your baby. These birth defects may include spina bifida and other defects where the spinal canal does not close normally. These defects usually occur in 1 to 2 out of every 1000 babies born in the United States. Studies show that for babies born to epileptic women who took valproate in the first 12 weeks of pregnancy, these defects occur in 1 to 2 out of every 100 babies.

Use of valproate during pregnancy also increases the chance of other birth defects such as of the heart, bones, and other parts of the body. Studies suggest that other medicines used to treat your condition may be less likely to cause these defects.

Information For Women Who Are Planning to Get Pregnant

Women using valproate who plan to get pregnant should discuss their treatment options with their doctor.

Information For Women Who Become Pregnant

If you become pregnant while taking valproate, you should contact your doctor immediately.

Other Important Information

• You should take your medicine exactly as prescribed by your doctor to get the most benefit from your medicine and reduce the risk of side effects.
• If you have take more than the prescribed dose, contact your hospital emergency room or local poison center immediately.
• Your medicine was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

Facts About Birth Defects

It is important to know that birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. This summary provides important information about the use of DEPAKOTE, DEPAKOTE ER, DEPAKOTE Sprinkle Capsules (divalproex sodium sprinkle capsules) , and DEPAKENE. to women who could become pregnant. If you would like more information, ask your doctor or pharmacist to let you read the professional labeling and then discuss it with them. If you have any questions or concerns about taking this medication, you should discuss them with your doctor.

Administration Guide

DEPAKOTE®
Sprinkle Capsules
DIVALPROEX SODIUM
COATED PARTICLES IN CAPSULES

Depakote ® SprinkleCapsules sodium coated particles in capsules) may be swallowed whole or the capsule contents may be sprinkled onto soft food such as applesauce or pudding.

Serving Suggestions

Depakote ® Sprinkle Capsules (divalproex sodium coated particles in capsules) provide the medicine that your doctor has prescribed. The sprinkles are flavorless. Soft foods such as applesauce or pudding are best to use for mixing and taking Depakote Sprinkles.

TO ADMINISTER WITH FOOD:

1. 1. Hold the capsule so that the end marked "THIS END UP" is straight up and the arrow on the capsule is up. The capsule is extra large to help prevent spilling the Depakote Sprinkles, but it still must be handled carefully.
2. 2. To open the capsule, hold it carefully. As shown in the picture, gently twist the capsule apart to separate the top from the bottom. It may be helpful to hold the capsule over the food to which you will add the sprinkles. If you spill any of the capsule contents, start over with a new capsule and a new portion of food.
3. 3. Place all the sprinkles onto a small amount (about a teaspoonful) of soft food such as applesauce or pudding.
4. 4. Make sure that all of the sprinkle and food mixture is swallowed right away. Do not chew the sprinkle and food mixture. Drinking water right after taking the sprinkle and food mixture will help make sure all sprinkles are swallowed. Throw away any unused sprinkle and food mixture; do not store any sprinkle and food mixture for future use. Mix it each time, right before it is taken.

Make sure this medicine is taken exactly as your doctor prescribed it. If you have any questions, please contact your doctor or pharmacist. Keep all of your doctor's appointments as scheduled. Make sure that Depakote Sprinkle Capsules (divalproex sodium sprinkle capsules) and all other medicines are kept out of the reach of children.

Note

You may see the specially coated particles in Depakote Sprinkle Capsules (divalproex sodium sprinkle capsules) in stool. Ask your doctor or pharmacist about possible side effects with Depakote Sprinkle Capsules (divalproex sodium sprinkle capsules) .

Last reviewed on RxList: 4/17/2008
This monograph has been modified to include the generic and brand name in many instances.