Country: United States
Language: English
Source: NLM (National Library of Medicine)
DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)
Medsource Pharmaceuticals
DIVALPROEX SODIUM
VALPROIC ACID 500 mg
ORAL
PRESCRIPTION DRUG
Divalproex sodium delayed release tablets are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. The efficacy of divalproex sodium delayed release tablets were established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies ( 14.1)] . The safety and effectiveness of divalproex sodium delayed release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed release tablets for extended periods should continually reevaluate the long-term usefulness of t
Divalproex Sodium Delayed Release Tablets USP are supplied as: 125 mg: Orange colored, modified capsule shaped, biconvex enteric coated tablets imprinted with "UL 125" on one side and plain on other side: Bottles of 100………………NDC 29300-138-01 Bottles of 500………………NDC 29300-138-05 Bottles of 1000……………NDC 29300-138-10 250 mg : Pink colored, oval shaped, biconvex enteric coated tablets imprinted with "UL 250" on one side and plain on other side: Bottles of 100………………NDC 29300-139-01 Bottles of 500………………NDC 29300-139-05 Bottles of 1000……………NDC 29300-139-10 500 mg : Reddish pink colored, modified capsule shaped, biconvex enteric coated tablets imprinted with "UL 500" on one side and plain on other side Bottles of 100………………NDC 29300-140-01 Bottles of 500………………NDC 29300-140-05 Bottles of 1000……………NDC 29300-140-10 Recommended storage Store at 20 0 to 25 0 C (68 0 to 77 0 F) [See USP controlled Room Temperature].
Abbreviated New Drug Application
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE Medsource Pharmaceuticals ---------- MEDICATION GUIDE Divalproex Sodium Delayed Release Tablets USP (dye val' proe ex soe' dee um) Read this Medication Guide before you start taking divalproex sodium delayed release tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about divalproex sodium delayed release tablets? Do not stop divalproex sodium delayed release tablets without first talking to your healthcare provider. Stopping divalproex sodium delayed release tablets suddenly can cause serious problems. Divalproex sodium delayed release tablets can cause serious side effects, including: 1.Serious liver damage that can cause death, especially in children younger than 2 years old. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. Call your healthcare provider right away if you get any of the following symptoms: • nausea or vomiting that does not go away • loss of appetite • pain on the right side of your stomach (abdomen) • dark urine • swelling of your face • yellowing of your skin or the whites of your eyes In some cases, liver damage may continue despite stopping the drug. 2. Divalproex sodium delayed release tablets may harm your unborn baby. • If you take divalproex sodium delayed release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (ur Read the complete document
DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE MEDSOURCE PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIVALPROEX SODIUM DELAYED RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DIVALPROEX SODIUM DELAYED RELEASE TABLETS. DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP FOR ORAL USE. INITIAL U.S. APPROVAL: 1983 WARNINGS: LIFE THREATENING ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. HEPATOTOXICITY, INCLUDING FATALITIES, USUALLY DURING THE FIRST 6 MONTHS OF TREATMENT. CHILDREN UNDER THE AGE OF TWO YEARS AND PATIENTS WITH MITOCHONDRIAL DISORDERS ARE AT HIGHER RISK. MONITOR PATIENTS CLOSELY, AND PERFORM SERUM LIVER TESTING PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER ( 5.1) FETAL RISK, PARTICULARLY NEURAL TUBE DEFECTS, OTHER MAJOR MALFORMATIONS, AND DECREASED IQ ( 5.2, 5.3, 5.4 ) PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES ( 5.5) RECENT MAJOR CHANGES Warnings and Precautions, Birth Defects ( 5.2) 1/2015 Warnings and Precautions, Bleeding and Other Hematopoietic Disorders ( 5.8) 1/2015 Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions ( 5.12) 1/2015 INDICATIONS AND USAGE Divalproex sodium delayed release tablets are an anti-epileptic drug indicated for: Treatment of manic episodes associated with bipolar disorder ( 1.1) Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1.2) Prophylaxis of migraine headaches ( 1.3) DOSAGE AND ADMINISTRATION Divalproex sodium delayed release tablets are administered orally in divided doses. Divalproex sodium delayed release tablets should be swallowed whole and should not be crushed or chewed ( 2.1, 2.2). Mania: Initial dose is 750 mg daily, increasing as rapidly as possible to achieve therapeutic re Read the complete document