valproic acid 250 mg/1
valproic acid · CAPSULE · Upsher-Smith Laboratories, LLC
valproic acid is a capsule containing valproic acid at 250 mg/1, taken oral. Manufactured by Upsher-Smith Laboratories, LLC.
Key Facts
- Brand Name
- valproic acid
- Generic Name
- valproic acid
- NDC Code (Product)
0832-0310- Manufacturer
- Upsher-Smith Laboratories, LLC
- Strength
- 250 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA073229
- Drug Class
- Anti-epileptic Agent [EPC]; Mood Stabilizer [EPC]
- Marketing Start
- 10/29/2011
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Morton Grove Pharmaceuticals, Inc.
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
American Health Packaging
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Upsher Smith Laboratories, Inc.
Labeling: Label Error On Declared Strength; Some bottles of product were missing the color-coded strength on the primary display panel of the label.
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 Valproic acid oral solution is indicated for: Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures ( 1 ) 1.1 Epilepsy Valproic acid oral solution is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid oral solution is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. See Warnings and Precautions ( 5.1 ) for statement regarding fatal hepatic dysfunction. 1.2 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorder…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Valproic acid oral solution is intended for oral administration. ( 2.1 ) Simple and Complex Absence Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/week until seizure control or limiting side effects ( 2.1 ) Safety of doses above 60 mg/kg/day is not established ( 2.1 , 2.2 ) 2.1 Epilepsy Valproic acid oral solution is intended for oral administration. Patients should be informed to take valproic acid oral solution 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 is 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 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…
Contraindications
4 CONTRAINDICATIONS Valproic acid should not be administered to patients with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions ( 5.1 )] . Valproic acid is 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 is contraindicated in patients with known hypersensitivity to the drug [see Warnings and Precautions ( 5.12 )] . Valproic acid is contraindicated in patients with known urea cycle disorders [see Warnings and Precautions ( 5.6 )] . For use in prophylaxis of migraine headaches: Valproic acid is contraindicated in women who are pregnant and 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 POLG-related disorder…
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: 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 valproic acid ( 7.2 ) Topiramate: Hyperammonemia and encephalopathy ( 5.10 , 7.3 ) 7.1 Effects of Co-Administered Drugs on Valproate Clearance Drugs that affect the level o…
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 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. Most common adverse reactions (reported >5%) are abdominal pain, alopecia, amblyopia/blurre…
Frequently Asked Questions
What is valproic acid used for?
valproic acid contains valproic acid. It is a capsule taken oral. Consult your doctor for specific uses.
Is valproic acid a controlled substance?
valproic acid is not classified as a controlled substance by the DEA.
What is the generic name for valproic acid?
The generic name for valproic acid is valproic acid. There are 10 other brand versions of valproic acid.
What is the NDC code for valproic acid 250 mg/1?
The NDC (National Drug Code) for valproic acid 250 mg/1 is 0832-0310, listed by Upsher-Smith Laboratories, LLC.
Other valproic acid Dosages
Other Valproic Brands
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- VALPROIC ACID250 mg/5mL71335-2250
- Valproic Acid250 mg/5mL0116-4021
- VALPROIC ACID250 mg/5mL0121-4675
- Valproic Acid250 mg/169452-150
- VALPROIC ACID250 mg/5mL70752-202
- Valproic Acid250 mg/117856-0152
- Valproic Acid250 mg/163629-2454
- VALPROIC ACID250 mg/5mL0121-0675
- Valproic Acid250 mg/143353-279
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)