DESCRIPTION
id: a9fcfadc-3fbe-4629-b39e-86b0000eabb1
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Divalproex sodium is a stable coordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. 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: 7d4828f7-11c2-4793-9fa1-0c7dec1c3d96
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: 60bbd9a7-61f9-45ef-83bc-133f5506b9d0
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 mcg/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: 85f3e537-b6d2-4130-a255-32be03738488
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Divalproex sodium delayed-release tablets USP, 500 mg are
available as dark pink, film-coated, oval shaped tablets, imprinted “93” and
“7441” with black ink, in:
| Bottles of 30
|
NDC 54868-6072-0
|
| Bottles of 60
|
NDC 54868-6072-2
|
| Bottles of 90
|
NDC 54868-6072-1
|
| Bottles of 100
|
NDC 54868-6072-3
|
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a
child-resistant closure (as required).
Maalox is a registered trademark of Novartis Consumer Health, Inc.
Trisogel is a registered trademark of Eli Lilly & Company.
Titralac is a registered trademark of 3M Pharmaceuticals.
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. C 6/2009
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa,
OK 74146
PATIENT INFORMATION LEAFLET
id: ed623be6-5e06-4a9c-98ec-5894b6133684
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 divalproex sodium delayed-release tablets. This leaflet provides a summary of important information about taking divalproex sodium delayed-release tablets to women who could become pregnant. If you have any questions or concerns, or want more information about divalproex sodium delayed-release tablets, contact your doctor or pharmacist.
Information For Women Who Could Become Pregnant
Divalproex sodium delayed-release tablets can be obtained only by prescription from your doctor. The decision to use divalproex sodium delayed-release tablets is one that you and your doctor should make together, taking into account your individual needs and medical condition.
Before using
divalproex sodium delayed-release tablets, women who can become pregnant should consider the fact that divalproex sodium delayed-release tablets 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 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%.
Divalproex sodium delayed-release tablets 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 divalproex sodium delayed-release tablets than some other drugs that treat your medical condition.
Information for Women Who Are Planning to Get Pregnant
- Women taking divalproex sodium delayed-release tablets 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 divalproex sodium delayed-release tablets, you should contact your doctor immediately.
Other Important Information
- Divalproex sodium delayed-release tablets 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 divalproex sodium delayed-release tablets, contact your hospital emergency room or local poison center immediately.
- Divalproex sodium delayed-release tablets 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 divalproex sodium delayed-release tablets, 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 divalproex sodium delayed-release tablets, you should discuss them with your doctor.
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Iss. 10/2007
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PRINCIPAL DISPLAY PANEL
id: f0d14910-cbcc-4cae-bf52-2e3ae6fc04bb
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
DIVALPROEX SODIUM
Delayed-Release
Tablets USP
500 mg*
Valproic Acid Activity
PHARMACIST: PLEASE DISPENSE WITH ATTACHED
PATIENT INFORMATION LEAFLET
Rx only
