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Patient Info
Information for Patients
Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/ or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly. Patients should be informed of the signs and symptoms associated with hyperammonemic encephalopathy (see PRECAUTIONS – Hyperammonemia) and be told to inform the prescriber if any of these symptoms occur. Since DEPAKOTE products may produce CNS depression, especially when combined with another CNS depressant (eg, alcohol), patients should be advised not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug. Since DEPAKOTE has been associated with certain types of birth defects, female patients of child-bearing age considering the use of DEPAKOTE ER for the prevention of migraine should be advised to read t Text Continues Below
he Patient Information Leaflet, which appears as the last section of the labeling.Patient Information Important Information for Women Who Could Become Pregnant
About the Use of DEPAKOTE ER (divalproex sodium) Tablets for Migraine Please read this leaflet carefully before you take DEPAKOTE ER (divalproex sodium) tablets. This leaflet provides a summary of important information about taking DEPAKOTE ER for migraine to women who could become pregnant. DEPAKOTE ER may also be prescribed for uses other than those discussed in this leaflet. If you have any questions or concerns, or want more information about DEPAKOTE ER, contact your doctor or pharmacist. Information For Women Who Could Become Pregnant DEPAKOTE ER is used to prevent or reduce the number of migraines you experience.
DEPAKOTE ER can be obtained only by prescription from your doctor. The decision to use DEPAKOTE ER for the prevention of migraine is one that you and your doctor should make together, taking into account your individual needs and medical condition. Before using DEPAKOTE ER, women who can become pregnant should consider the fact that DEPAKOTE has been associated with birth defects, in particular, with spina bifida and other defects related to failure of the spinal canal to close normally. Although the incidence is unknown in migraine patients treated with DEPAKOTE, approximately 1 to 2% of children born to women with epilepsy taking DEPAKOTE in the first 12 weeks of pregnancy had these defects (based on data from the Centers for Disease Control, a U. S. agency based in Atlanta). The incidence in the general population is 0.1 to
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