Divalproex Sodium 500 mg/1
Divalproex Sodium · TABLET, EXTENDED RELEASE · REMEDYREPACK INC.
Divalproex Sodium is a tablet, extended release containing divalproex sodium at 500 mg/1, taken oral. Manufactured by REMEDYREPACK INC..
Key Facts
- Brand Name
- Divalproex Sodium
- Generic Name
- Divalproex Sodium
- NDC Code (Product)
70518-2036- Manufacturer
- REMEDYREPACK INC.
- Strength
- 500 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203730
- Marketing Start
- 04/24/2019
Recall History
Dr. Reddy's Laboratories, Inc.
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications
Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Unichem Pharmaceuticals Usa Inc
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Zydus Pharmaceuticals USA Inc
Failed Dissolution Specifications
Teva North America
Failed Tablet/Capsule Specifications
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Divalproex sodium extended-release tablets are indicated for: • Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ( 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 ) 1.1 Mania Divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. 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. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). The efficacy of divalproex sodium extended-rel…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Divalproex sodium extended-release tablets are an extended-release product intended for once-a-day oral administration. Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed. • Divalproex sodium extended-release tablets are intended for once-a-day oral administration. Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed ( 2.1 , 2.2 ). • Mania: Initial dose is 25 mg/kg/day, increasing as rapidly as possible to achieve therapeutic response or desired plasma level ( 2.1 ). The maximum recommended dosage is 60 mg/kg/day ( 2.1 , 2.2 ). • Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response; if response is not satisfactory, check valproate plasma level; see full prescribing information for conversion to monotherapy ( 2.2 ). The maximum recommended dosage is 60 mg/kg/day ( 2.1 , 2.2 ). • Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day until seizure control or limiting side effects ( 2.2 ). The maximum recommended dosage is 60 …
Contraindications
4 CONTRAINDICATIONS Divalproex sodium extended-release tablets are contraindicated in patients: • with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions (5.1) ] . • known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder [see Warnings and Precautions (5.1) ] . • with known hypersensitivity to divalproex sodium, sodium valproate, or valproic acid. Reactions have included multiorgan hypersensitivity, serious dermatologic reactions, and angioedema [see Warnings and Precautions (5.12 , 5.13 , 5.14) ] . • with known urea cycle disorders [see Warnings and Precautions (5.6) ] . • being treated for prophylaxis of migraine headaches: who are pregnant or in women of childbearing potential who are not using effective contraception [see Warnings and Precautions (5.2 , 5.3 , 5.4) and Use in Specific Populations (8.1) ] . • Hepatic disease or significant hepatic dysfunction ( 4 , 5.1 ) • Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) ( 4 , 5.1 ) • Suspected …
Drug Interactions
7 DRUG INTERACTIONS • Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, phenobarbital, primidone, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can decrease valproate clearance. Therefore, increased monitoring of valproate and concomitant drug concentrations and dosage adjustment are indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn ( 7.1 ) • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives, methotrexate: Monitoring of valproate concentrations is recommended ( 7.1 ) • Co-administration of valproate can affect the pharmacokinetics of other drugs (e.g., diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement ( 7.2 ) • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose ( 7.2 ) • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets ( 7.2 ) • Topiramate: Hyperammonemia and encephalopathy ( 5.10 , 7.3 ) • Cannabidiol: ALT and/or AST ele…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: • Hepatic Failure [see Warnings and Precautions (5.1) ] • Birth Defects [see Warnings and Precautions (5.2) ] • Decreased IQ and Neurodevelopmental Disorders following in utero exposure [see Warnings and Precautions (5.3) ] • Pancreatitis [see Warnings and Precautions (5.5) ] • Hyperammonemic Encephalopathy [see Warnings and Precautions (5.6 , 5.9 , 5.10) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.7) ] • Bleeding and Other Hematopoietic Disorders [see Warnings and Precautions (5.8) ] • Hypothermia [see Warnings and Precautions (5.11) ] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.12) ] • Serious Dermatologic Reactions [see Warnings and Precautions (5.13) ] • Angioedema [see Warnings and Precautions (5.14) ] • Somnolence in the Elderly [see Warnings and Precautions (5.16) ] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical…
Frequently Asked Questions
What is Divalproex Sodium used for?
Divalproex Sodium contains Divalproex Sodium. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Divalproex Sodium a controlled substance?
Divalproex Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Divalproex Sodium?
The generic name for Divalproex Sodium is Divalproex Sodium. There are 5 other brand versions of Divalproex Sodium.
What is the NDC code for Divalproex Sodium 500 mg/1?
The NDC (National Drug Code) for Divalproex Sodium 500 mg/1 is 70518-2036, listed by REMEDYREPACK INC..