Divalproex Sodium D/R 250 mg/1
Divalproex Sodium D/R · TABLET, DELAYED RELEASE · Direct_Rx
Divalproex Sodium D/R is a prescription tablet, delayed release containing divalproex sodium d/r at 250 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Divalproex Sodium D/R
- Generic Name
- Divalproex Sodium D/R
- NDC Code (Product)
72189-636- Manufacturer
- Direct_Rx
- Strength
- 250 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA078597
- Drug Class
- Anti-epileptic Agent [EPC]; Decreased Central Nervous System Disorganized Electrical Activity [PE]
- Marketing Start
- 07/28/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1.1 Mania Divalproex sodium is a valproate and is 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 was 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 the drug for the individual patient. 1.2 Epilepsy Divalproex sodium delayed-release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seiz…
Dosage & Administration
Divalproex sodium delayed-release tablets are intended for oral administration. Divalproex sodium delayed-release tablets should be swallowed whole and should not be crushed or chewed. Patients should be informed to take divalproex sodium delayed-release tablets every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose. 2.1 Mania Divalproex sodium delayed-release tablets are administered orally. The recommended initial dose is 750 mg daily in divided doses. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect or the desired range of plasma concentrations. In placebo-controlled clinical trials of acute mania, patients were dosed to a clinical response with a trough plasma concentration between 50 and 125 mcg/mL. Maximum concentrations were generally achieved within 14 days. The maximum recommended dosage is 60 mg/kg/day. There is no body of evidence available from controlled trials to guide a clinician in the longer term management of a patient who improves during diva…
Contraindications
Divalproex sodium is 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)].
Drug Interactions
7.1 Effects of Coadministered Drugs on Valproate Clearance Drugs that affect the level of expression of hepatic enzymes, particularly those that elevate levels of glucuronosyltransferases (such as ritonavir), may increase the clearance of valproate. For example, phenytoin, carbamazepine, and phenobarbital (or primidone) can double the clearance of valproate. Thus, patients on monotherapy will generally have longer half-lives and higher concentrations than patients receiving polytherapy with antiepilepsy drugs. In contrast, drugs that are inhibitors of cytochrome P450 isozymes, e.g., antidepressants, may be expected to have little effect on valproate clearance because cytochrome P450 microsomal mediated oxidation is a relatively minor secondary metabolic pathway compared to glucuronidation and beta-oxidation. Because of these changes in valproate clearance, monitoring of valproate and concomitant drug concentrations should be increased whenever enzyme inducing drugs are introduced or withdrawn. The following list provides information about the potential for an influence of several commonly prescribed medications on valproate pharmacokinetics. The list is not exhaustive nor could it …
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 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 studies of another drug and may not reflect the rates observed in …
Frequently Asked Questions
What is Divalproex Sodium D/R used for?
Divalproex Sodium D/R contains Divalproex Sodium D/R. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.
Is Divalproex Sodium D/R a controlled substance?
Divalproex Sodium D/R is not classified as a controlled substance by the DEA.
What is the generic name for Divalproex Sodium D/R?
The generic name for Divalproex Sodium D/R is Divalproex Sodium D/R. There are no other listed brand versions of Divalproex Sodium D/R.
What is the NDC code for Divalproex Sodium D/R 250 mg/1?
The NDC (National Drug Code) for Divalproex Sodium D/R 250 mg/1 is 72189-636, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)