Valproic Acid is an anti-epileptic agent sold in the U.S. under 3 brand and generic names, for alzheimer disease, bipolar disorder and epilepsy. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Depakene (application NDA018081). Other valproic acid products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
2.1 Epilepsy Valproic acid capsules are intended for oral administration. Valproic acid capsules should be swallowed whole without chewing to avoid local irritation of the mouth and throat. Patients should be informed to take valproic acid capsules 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. Valproic acid capsules are indicated as monotherapy and adjunctive therapy in complex partial seizures in adults and pediatric patients down to the age of 10 years, and in simple and complex absence seizures. As the valproic acid capsules dosage is titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, and/or phenytoin may be affected [see DRUG INTERACTIONS (7.2)]. Complex Partial Seizures For adults and children 10 years of age or older. Monotherapy (Initial Therapy) Valproic acid capsules have not been systematically studied as initial therapy. Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to…
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)] Somnolence in the elderly [see WARNINGS AND PRECAUTIONS (5.14)] 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 practice. 6.1 Epilepsy The data described in the following section were obtained using divalproex sodium tablets. Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, divalproex sodium tablets were generally well tolerated with most adverse reactions rated as mild to moderate in severity.…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | 70/100 | Prescription | Syrup | Generic | $1 | View → | |
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| VALPROIC;250 | 250 mg | white | capsule | — |
| PA2120 | 250 mg | white | oval | — |
| PA2120 | 250 mg | white | oval | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Valproic acid capsules should not be administered to patients with hepatic disease or significant hepatic dysfunction [see WARNINGS AND PRECAUTIONS (5.1)]. Valproic acid capsules are contraindicated in patients 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)]. Valproic acid capsules are contraindicated in patients with known hypersensitivity to the drug [see WARNINGS AND PRECAUTIONS (5.12)]. Valproic acid capsules are contraindicated in patients with known urea cycle disorders [see WARNINGS AND PRECAUTIONS (5.6)].
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 be, since new interactions are continuously being reported. Drugs for which a potentially important interaction has been observed Aspirin A study involving the coadministration of aspirin at…
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| 3 | Not yet rated | Prescription | Capsule | Generic | $1 | View → |