Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Valproic Acid Oral Solution, USP is available as a clear, cherry-flavored red oral solution containing the equivalent of 250 mg of valproic acid per 5 mL as the sodium salt in the following oral dosage forms: 16 fl oz (473 mL) bottles (NDC 0116-4021-16). 5 mL unit dose cups (NDC 0116-4021-05) packaged in trays of 10 unit dose cups each with either 4 or 10 trays to a case 10 mL unit dose cups (NDC 0116-4021-10) packaged in trays of 10 unit dose cups each with 10 trays to a case RECOMMENDED STORAGE Store at 20°–25°C (68°–77°F) [See USP Controlled Room Temperature] . Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.; Product No.: 4021 Manufactured By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 4021VALINST REV. 06-25 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0116-4021-16 VALPROIC ACID ORAL SOLUTION, USP 250 mg/5 mL Alcohol less than 0.05% Each 5mL (teaspoonful) contains the equivalent of 250 mg Valproic Acid, USP (as the sodium salt) and less than 0.05% alcohol contributed by flavorings. PHARMACIST: PLEASE DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx Only NET: 1 Pint (480 mL) USUAL DOSAGE: See accompanying package insert for full prescribing information. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure. Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 4021VALP16LBL REV. 06-25 16 oz bottle UNIT DOSE Delivers 5 mL NDC 0116-4021-05 Valproic Acid Oral Solution USP, 250 mg/5 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL05LID 5 mL UD Cup Lid UNIT DOSE Delivers 10 mL NDC 0116-4021-10 Valproic Acid Oral Solution USP, 500 mg/10 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL10LID UD Cup Lid; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0116-4021-16 VALPROIC ACID ORAL SOLUTION, USP 250 mg/5 mL Alcohol less than 0.05% Each 5mL (teaspoonful) contains the equivalent of 250 mg Valproic Acid, USP (as the sodium salt) and less than 0.05% alcohol contributed by flavorings. PHARMACIST: PLEASE DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx Only NET: 1 Pint (480 mL) USUAL DOSAGE: See accompanying package insert for full prescribing information. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure. Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 4021VALP16LBL REV. 06-25 16 oz bottle UNIT DOSE Delivers 5 mL NDC 0116-4021-05 Valproic Acid Oral Solution USP, 250 mg/5 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL05LID 5 mL UD Cup Lid; UNIT DOSE Delivers 5 mL NDC 0116-4021-05 Valproic Acid Oral Solution USP, 250 mg/5 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL05LID 5 mL UD Cup Lid; UNIT DOSE Delivers 10 mL NDC 0116-4021-10 Valproic Acid Oral Solution USP, 500 mg/10 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL10LID UD Cup Lid
- 16 HOW SUPPLIED/STORAGE AND HANDLING Valproic Acid Oral Solution, USP is available as a clear, cherry-flavored red oral solution containing the equivalent of 250 mg of valproic acid per 5 mL as the sodium salt in the following oral dosage forms: 16 fl oz (473 mL) bottles (NDC 0116-4021-16). 5 mL unit dose cups (NDC 0116-4021-05) packaged in trays of 10 unit dose cups each with either 4 or 10 trays to a case 10 mL unit dose cups (NDC 0116-4021-10) packaged in trays of 10 unit dose cups each with 10 trays to a case RECOMMENDED STORAGE Store at 20°–25°C (68°–77°F) [See USP Controlled Room Temperature] . Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.
- Product No.: 4021 Manufactured By: Xttrium Laboratories, Inc. Mount Prospect, IL 60056 4021VALINST REV. 06-25 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0116-4021-16 VALPROIC ACID ORAL SOLUTION, USP 250 mg/5 mL Alcohol less than 0.05% Each 5mL (teaspoonful) contains the equivalent of 250 mg Valproic Acid, USP (as the sodium salt) and less than 0.05% alcohol contributed by flavorings. PHARMACIST: PLEASE DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx Only NET: 1 Pint (480 mL) USUAL DOSAGE: See accompanying package insert for full prescribing information. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure. Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 4021VALP16LBL REV. 06-25 16 oz bottle UNIT DOSE Delivers 5 mL NDC 0116-4021-05 Valproic Acid Oral Solution USP, 250 mg/5 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL05LID 5 mL UD Cup Lid UNIT DOSE Delivers 10 mL NDC 0116-4021-10 Valproic Acid Oral Solution USP, 500 mg/10 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL10LID UD Cup Lid
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0116-4021-16 VALPROIC ACID ORAL SOLUTION, USP 250 mg/5 mL Alcohol less than 0.05% Each 5mL (teaspoonful) contains the equivalent of 250 mg Valproic Acid, USP (as the sodium salt) and less than 0.05% alcohol contributed by flavorings. PHARMACIST: PLEASE DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT. Rx Only NET: 1 Pint (480 mL) USUAL DOSAGE: See accompanying package insert for full prescribing information. WARNINGS: KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure. Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 4021VALP16LBL REV. 06-25 16 oz bottle UNIT DOSE Delivers 5 mL NDC 0116-4021-05 Valproic Acid Oral Solution USP, 250 mg/5 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL05LID 5 mL UD Cup Lid
- UNIT DOSE Delivers 5 mL NDC 0116-4021-05 Valproic Acid Oral Solution USP, 250 mg/5 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL05LID 5 mL UD Cup Lid
- UNIT DOSE Delivers 10 mL NDC 0116-4021-10 Valproic Acid Oral Solution USP, 500 mg/10 mL Rx Only Xttrium Laboratories, Inc. Mount Prospect IL 60056 SEE INSERT 4021VAL10LID UD Cup Lid
Overview
Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid has the following structure: Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/mL) and very soluble in organic solvents. Valproic Acid Oral Solution is an antiepileptic for oral administration. The oral solution contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt. valproic-01 Inactive Ingredients alcohol (less than 0.05%), artificial cherry flavor, artificial wild cherry flavor, corn syrup solids, FD&C Red No. 40, glycerin, hydrochloric acid, liquid sugar, methylparaben, potassium phosphate dibasic, propylene glycol, purified water, sodium benzoate and sodium hydroxide. The pH range is between 7.0 and 8.0.
Indications & 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)
Dosage & 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)
Warnings & Precautions
Hepatotoxicity; evaluate high risk populations and monitor serum liver tests (5.1) • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable (5.2, 5.3, 5.4) • Pancreatitis; Valproic Acid Oral Solution should ordinarily be discontinued (5.5) • Suicidal behavior or ideation; Antiepileptic drugs, including Valproic Acid Oral Solution, increase the risk of suicidal thoughts or behavior (5.7) Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests (5.8) Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use; consider discontinuation of valproate therapy (5.6, 5.9, 5.10) • Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramate (5.11) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reaction; discontinue Valproic Acid Oral Solution (5.12) • Somnolence in the elderly can occur. Valproic Acid Oral Solution dosage should be increased slowly and with regular monitoring for fluid and nutritional intake (5.14)
Boxed Warning
WARNINGS: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter (5.1) • Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ (5.2, 5.3, 5.4) • Pancreatitis, including fatal hemorrhagic cases (5.5)
Contraindications
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 in children under two years of age ( 4, 5.1) Known hypersensitivity to the drug ( 4, 5.12) Urea cycle disorders ( 4, 5.6) Prophylaxis of migraine headaches: Pregnant women , women of child bearing potential not using effective contraception ( 4, 8.1)
Adverse Reactions
• Most common adverse reactions (reported >5%) are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss. (6.1) • The safety and tolerability of valproate in pediatric patients were shown to be comparable to those in adults (8.4). To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc. at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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 Oral Solution (7.2) • Topiramate: Hyperammonemia and encephalopathy (5.10, 7.3)
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