Depakote Sprinkles 125 mg/1

Divalproex Sodium · CAPSULE · AbbVie Inc.

No Recall History

Plain English

Depakote Sprinkles is a capsule containing divalproex sodium at 125 mg/1, taken oral. Manufactured by AbbVie Inc..

Key Facts

Brand Name: Depakote Sprinkles
Generic Name: Divalproex Sodium
NDC Code (Product): 0074-6114
Manufacturer: AbbVie Inc.
Strength: 125 mg/1
Dosage Form: CAPSULE
Route: ORAL
Marketing Status
Application #: NDA019680
Marketing Start: 09/12/1989

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,809 reports

seizure2,327 reports

weight increased1,963 reports

nausea1,911 reports

off label use1,892 reports

pain1,793 reports

fatigue1,763 reports

somnolence1,695 reports

fall1,598 reports

tremor1,598 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Depakote Sprinkle Capsules are an anti-epileptic drug indicated for: 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 ) 1.1 Epilepsy Depakote Sprinkle Capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote Sprinkle Capsules are also 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 that 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. 1.2 Important Limitations Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and othe…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Depakote Sprinkle Capsules may be swallowed whole or the contents may be sprinkled on soft food. The drug/food mixture should be swallowed immediately (avoid chewing) ( 2.2 ) Safety of doses above 60 mg/kg/day is not established ( 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 ( 2.1 ) 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 ( 2.1 ) 2.1 Epilepsy Depakote Sprinkle Capsules are administered orally. As Depakote 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) Depakote Sprinkle Capsules has not been systematically studied as initial therapy. Patients should initiate therapy…

Contraindications

4 CONTRAINDICATIONS Depakote Sprinkle Capsules 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 )] . 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…

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 Depakote Sprinkle Capsules ( 7.2 ) Topiramate: Hyperammonemia and encephalopathy ( 5.10 , 7.3 ) Cannabidiol: ALT and/or AST elevation ( 7.4 ) 7.1 Effects of C…

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 Depakote Sprinkles used for?

Depakote Sprinkles contains Divalproex Sodium. It is a capsule taken oral. Consult your doctor for specific uses.

Is Depakote Sprinkles a controlled substance?

Depakote Sprinkles is not classified as a controlled substance by the DEA.

What is the generic name for Depakote Sprinkles?

The generic name for Depakote Sprinkles is Divalproex Sodium. There are 12 other brand versions of Divalproex Sodium.

What is the NDC code for Depakote Sprinkles 125 mg/1?

The NDC (National Drug Code) for Depakote Sprinkles 125 mg/1 is 0074-6114, listed by AbbVie Inc..

Product NDC

0074-6114

Package NDC

0074-6114-13

Other Divalproex Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)