Divalproex Sodium Delayed-Release Tablets, USP

DESCRIPTION

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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, USP are for oral administration. Divalproex Sodium Delayed-Release Tablets, USP are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid. Inactive Ingredients

Divalproex Sodium Delayed-Release Tablets, USP contain the following inactive ingredients: methacrylic acid copolymer type C, povidone, pregelatinized corn starch, silicon dioxide, simethacone emulsion, sodium bicarbonate, sodium lauryl sulfate, talc, triethyl citrate, titanium dioxide, vanillin. The tablets are imprinted using a pharmaceutical ink. In addition, individual tablets contain:
125 mg tablets: FD&C Red No. 40.
250 mg tablets: FD&C Yellow No. 6 and iron oxide red.
500 mg tablets: FD&C Red No. 40.

CONTRAINDICATIONS

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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

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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

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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Divalproex Sodium Delayed-Release Tablets, USP are supplied as 125 mg, 250 mg and 500 mg tablets for oral administration. The 125 mg tablets are rose-colored, enteric-coated, capsule-shaped, with the imprint of “U-S 180” on one side of the tablets. The 250 mg tablets are peach-colored, enteric-coated, capsule-shaped, with the imprint of “U-S 181” on one side of the tablets. The 500 mg tablets are light pink-colored, enteric-coated, capsule-shaped, with the imprint of “U-S 182” on one side of the tablets.

Divalproex Sodium Delayed-Release Tablets, USP

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displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3

Patient Information Leaflet
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, USP. This leaflet provides a summary of important information about taking Divalproex Sodium Delayed-to women who could become pregnant. If you have any questions or concerns, or want more information about Divalproex Sodium Delayed-Release Tablets, USP, contact your doctor or pharmacist. Information For Women Who Could Become Pregnant

Divalproex Sodium Delayed-Release Tablets, USP can be obtained only by prescription from your doctor. The decision to use Divalproex Sodium Delayed-Release Tablets, USP 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, USP, women who can become pregnant should consider the fact that divalproex sodium has 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, USP 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%. This medication has 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 this medication 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, USP 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, USP you should contact your doctor immediately. Other Important Information Divalproex Sodium Delayed-Release Tablets, USP should be taken exactly as prescribed by your doctor to get the most benefit from the product and reduce the risk of side effects.
If you have taken more than the prescribed dose of Divalproex Sodium Delayed-Release Tablets, USP contact your hospital emergency room or local poison center immediately.
This 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, USPto women who could become pregnant. If you would like more information about the other potential risks and benefits ofDivalproex Sodium Delayed-Release Tablets, USP, 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, USP, you should discuss them with your doctor. Manufactured by
UPSHER-SMITH LABORATORIES, INC
Minneapolis, MN 55447 Revised 1209 Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA Original–09/2009–NJW Updated–08/2010–NJW

PRINCIPAL DISPLAY PANEL

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

PRINCIPAL DISPLAY PANEL

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displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4