DESCRIPTION
id: 55cd405b-1221-4986-aca3-e69bd28005b9
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:
Divalproex sodium occurs as a white powder with a characteristic odor.
DIVALPROEX SODIUM DELAYED RELEASE TABLETS are for oral administration. DIVALPROEX SODIUM DELAYED RELEASE TABLETS are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid.
CONTRAINDICATIONS
id: 29a45147-7aa6-4cd1-be70-8c833705987b
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
DIVALPROEX SODIUM SHOULD NOT BE ADMINISTERED TO PATIENTS WITH HEPATIC DISEASE OR SIGNIFICANT HEPATIC DYSFUNCTION.
Divalproex sodium is contraindicated in patients with known hypersensitivity to the drug.
Divalproex sodium is contraindicated in patients with known urea cycle disorders (See
WARNINGS)
OVERDOSAGE
id: c3a04d2c-6f6b-468c-88ef-3d9ab6a55f72
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Overdosage with valproate may result in somnolence, heart block, and deep coma. Fatalities have been reported; however patients have recovered from valproate levels as high as 2120 µg/mL.
In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug. The benefit of gastric lavage or emesis will vary with the time since ingestion. General supportive measures should be applied with particular attention to the maintenance of adequate urinary output.
Naloxone has been reported to reverse the CNS depressant effects of valproate overdosage. Because naloxone could theoretically also reverse the antiepileptic effects of valproate, it should be used with caution in patients with epilepsy.
HOW SUPPLIED
id: 74b3d60d-65b3-446f-ae1e-f85a351fc2a4
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
DIVALPROEX SODIUM DELAYED RELEASE TABLETS USP are available as:
125 mg:
Orange colored, modified capsule shaped, biconvex enteric coated tablets imprinted with “UL 125” on one side and plain on other side
250 mg:
Pink colored, oval shaped, biconvex enteric coated tablets imprinted with “UL 250” on one side and plain on other side
500 mg:
Reddish pink colored, modified capsule shaped, biconvex enteric coated tablets imprinted with “UL 500” on one side and plain on other side
They are supplied by State of Florida DOH Central Pharmacy as follows:
|
NDC
|
Strength
|
Quantity/Form
|
Color
|
Source Prod. Code
|
| 53808-0940-1 |
250 MG |
30 Tablets in a Blister Pack |
PINK |
29300-139 |
PATIENT PACKAGE INSERT
id: 8ef9d12a-5b3f-4412-9c0a-94909e76aa80
displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3
Important Information for Women Who Could Become Pregnant About the Use of DIVALPROEX SODIUM DELAYED RELEASE TABLETS USP.
Please read this leaflet carefully before you take any of these medications. This leaflet provides a summary of important information about taking these medications to women who could become pregnant. If you have any questions or concerns, or want more information about these medications, contact your doctor or pharmacist.
Information For Women Who Could Become Pregnant
These medications can be obtained only by prescription from your doctor. The decision to use any of these medications is one that you and your doctor should make together, taking into account your individual needs and medical condition.
Before using any of these medications, women who can become pregnant should consider the fact that these medications have been associated with birth defects, in particular, with spina bifida and other defects related to failure of the spinal canal to close normally. Approximately 1 to 2% of children born to women with epilepsy taking DIVALPROEX SODIUM DELAYED RELEASE TABLETS 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 0.2%.
These medications have also been associated with other birth defects such as defects of the heart, the bones, and other parts of the body. Information suggests that birth defects may be more likely to occur with these medications than some other drugs that treat your medical condition.
Information For Women Who Are Planning to Get Pregnant
- Women taking any of these medications who are planning to get pregnant should discuss the treatment options with their doctor.
Information For Women Who Become Pregnant
- If you become pregnant while taking any of these medications you should contact your doctor immediately.
Other Important Information
- Your medication should be taken exactly as prescribed by your doctor to get the most benefit from your medication and reduce the risk of side effects.
- If you have taken more than the prescribed dose of your medication, contact your hospital emergency room or local poison center immediately.
- Your medication 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 of individuals not taking any medications or without any additional risk factors.
This summary provides important information about the use of DIVALPROEX SODIUM DELAYED RELEASE TABLETS to women who could become pregnant. If you would like more information about the other potential risks and benefits of these medications, 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 these medications, you should discuss them with your doctor.
PACKAGE LABEL
id: 8ebaf056-b489-498e-8fbb-f005b5c13660
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Label Image for 53808-0940
250mg
