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VALPROIC ACID
Overview
What is VALPROIC ACID?
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 USP is an antiepileptic for oral administration and contains the equivalent of 250 mg valproic acid per 5 mL as the sodium salt.
What does VALPROIC ACID look like?
What are the available doses of VALPROIC ACID?
Valproic acid oral solution USP: Equivalent of 250 mg valproic acid per 5 mL as the sodium salt (
)
What should I talk to my health care provider before I take VALPROIC ACID?
How should I use VALPROIC ACID?
Valproic acid 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 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
for statement regarding fatal hepatic dysfunction.
Valproic acid is intended for oral administration.
Patients should be informed to take valproic acid 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
.
What interacts with VALPROIC ACID?
Sorry No Records found
What are the warnings of VALPROIC ACID?
Sorry No Records found
What are the precautions of VALPROIC ACID?
Sorry No Records found
What are the side effects of VALPROIC ACID?
Sorry No records found
What should I look out for while using VALPROIC ACID?
Hepatic disease or significant hepatic dysfunction (
,
)
Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) (
,
)
Suspected POLG-related disorder in children under two years of age (
,
)
Known hypersensitivity to the drug (
,
)
Urea cycle disorders (
,
)
What might happen if I take too much VALPROIC ACID?
Overdosage with valproate may result in somnolence, heart block, deep coma, and hypernatremia. Fatalities have been reported; however, patients have recovered from valproate levels as high as 2,120 mcg/mL.
In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug. The benefit of gastric lavage or emesis will vary with the time since ingestion. General supportive measures should be applied with particular attention to the maintenance of adequate urinary output.
Naloxone has been reported to reverse the CNS depressant effects of valproate overdosage. Because naloxone could theoretically also reverse the antiepileptic effects of valproate, it should be used with caution in patients with epilepsy.
How should I store and handle VALPROIC ACID?
Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage and HandlingIn the dry state store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]Protect from light.Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Valproic Acid Oral Solution USP is available as a red, cherry flavored oral solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt and supplied in the following oral dosage forms:NDC 0121-0675-16: 16 fl oz (473 mL) bottleNDC 0121-4675-05: 5 mL unit dose cup NDC 0121-4675-40: Case contains 40 unit dose cups of 5 mL (0121-4675-05) packaged in 4 trays of 10 unit dose cups each. NDC 0121-4675-00: Case contains 100 unit dose cups of 5 mL (0121-4675-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1350-10: 10 mL unit dose cup NDC 0121-1350-00: Case contains 100 unit dose cups of 10 mL (0121-1350-10) packaged in 10 trays of 10 unit dose cups each. Valproic Acid Oral Solution USP is available as a red, cherry flavored oral solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt and supplied in the following oral dosage forms:NDC 0121-0675-16: 16 fl oz (473 mL) bottleNDC 0121-4675-05: 5 mL unit dose cup NDC 0121-4675-40: Case contains 40 unit dose cups of 5 mL (0121-4675-05) packaged in 4 trays of 10 unit dose cups each. NDC 0121-4675-00: Case contains 100 unit dose cups of 5 mL (0121-4675-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1350-10: 10 mL unit dose cup NDC 0121-1350-00: Case contains 100 unit dose cups of 10 mL (0121-1350-10) packaged in 10 trays of 10 unit dose cups each. Valproic Acid Oral Solution USP is available as a red, cherry flavored oral solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt and supplied in the following oral dosage forms:NDC 0121-0675-16: 16 fl oz (473 mL) bottleNDC 0121-4675-05: 5 mL unit dose cup NDC 0121-4675-40: Case contains 40 unit dose cups of 5 mL (0121-4675-05) packaged in 4 trays of 10 unit dose cups each. NDC 0121-4675-00: Case contains 100 unit dose cups of 5 mL (0121-4675-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1350-10: 10 mL unit dose cup NDC 0121-1350-00: Case contains 100 unit dose cups of 10 mL (0121-1350-10) packaged in 10 trays of 10 unit dose cups each. Valproic Acid Oral Solution USP is available as a red, cherry flavored oral solution containing the equivalent of 250 mg valproic acid per 5 mL as the sodium salt and supplied in the following oral dosage forms:NDC 0121-0675-16: 16 fl oz (473 mL) bottleNDC 0121-4675-05: 5 mL unit dose cup NDC 0121-4675-40: Case contains 40 unit dose cups of 5 mL (0121-4675-05) packaged in 4 trays of 10 unit dose cups each. NDC 0121-4675-00: Case contains 100 unit dose cups of 5 mL (0121-4675-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1350-10: 10 mL unit dose cup NDC 0121-1350-00: Case contains 100 unit dose cups of 10 mL (0121-1350-10) packaged in 10 trays of 10 unit dose cups each.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Valproic acid dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Non-Clinical Toxicology
Hepatic disease or significant hepatic dysfunction ( , )Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) ( , )
Suspected POLG-related disorder in children under two years of age ( , )
Known hypersensitivity to the drug ( , )
Urea cycle disorders ( , )
With potassium supplements and potassium-sparing diuretics:
With lithium:
With antacids:
Gold:
Non-steroidal anti-inflammatory agents including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors):
The antihypertensive effect of ACE inhibitors, including fosinopril may be attenuated by NSAIDs.
Agents that inhibit mTOR:
Dual Blockade of the Renin-Angiotensin System (RAS):
Do not co-administer aliskiren with fosinopril in patients with diabetes. Avoid use of aliskiren with fosinopril in patients with renal impairment (GFR <60 ml/min).
Other:
In a pharmacokinetic interaction study with warfarin, bioavailability parameters, the degree of protein binding, and the anticoagulant effect (measured by prothrombin time) of warfarin were not significantly changed.
Hepatotoxicity; evaluate high risk populations and monitor serum liver tests ( )
Birth defects and decreased IQ following exposure; only use to treat pregnant women with epilepsy if other medications are unacceptable; should not be administered to a woman of childbearing potential unless essential ( , , )
Pancreatitis; Valproic acid should ordinarily be discontinued ( )
Suicidal behavior or ideation; Antiepileptic drugs, including Valproic Acid, increase the risk of suicidal thoughts or behavior ( )
Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests ( )
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 ( , , )
Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramate ( )
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reaction; discontinue valproic acid ( )
Somnolence in the elderly can occur. Valproic acid dosage should be increased slowly and with regular monitoring for fluid and nutritional intake ( )
The following serious adverse reactions are described below and elsewhere in the labeling:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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