Brand Name
Valproic
View Brand InformationFDA approval date: January 13, 1995
Classification: Anti-epileptic Agent
Form: Capsule, Solution
What is Valproic?
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
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Brand Information
Valproic (Valproic Acid)
WARNING: LIFE THREATENING ADVERSE REACTIONS
Hepatotoxicity
General Population:Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives.
Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When Valproic Acid products are used in this patient group, they should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
Patients with Mitochondrial Disease:There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g. Alpers Huttenlocher Syndrome).Valproic Acidis contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected ofhaving a mitochondrial disorder[see Contraindications (4)].In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease,Valproic Acidshould only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment withValproic Acidfor the development of acute liver injury with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice[see Warnings and Precautions (5.1)].
Fetal Risk
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores and neurodevelopmental disorders following
Valproate is therefore contraindicated for prophylaxis of migraine headaches in pregnant women and in women of childbearing potential who are not using effective contraception
Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. In such situations, effective contraception should be used
A Medication Guide describing the risks of valproate is available for patients
Pancreatitis
Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate. Some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death. Cases have been reported shortly after initial use as well as after several years of use. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternative treatment for the underlying medical condition should be initiated as clinically indicated[see Warnings and Precautions (5.5)].
1DOSAGE FORMS AND STRENGTHS
Valproic Acid Capsules, USP, 250 mg. Each off-white colored soft gelatin capsule is imprinted with VALPROIC 250.
2CONTRAINDICATIONS
- Valproic Acid should not be administered to patients with hepatic disease or significant hepatic dysfunction
- 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
- Valproic Acid is contraindicated in patients with known hypersensitivity to the drug
- Valproic Acid is contraindicated in patients with known urea cycle disorders
- 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
3ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in the labeling:
- Hepatic failure
- Birth defects
- Decreased IQ following
- Pancreatitis
- Hyperammonemic encephalopathy
- Suicidal behavior and ideation
- Bleeding and other hematopoietic disorders
- Hypothermia
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions
- Somnolence in the elderly
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.
3.1Epilepsy
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 was generally well tolerated with most adverse reactions rated as mild to moderate in severity. Intolerance was the primary reason for discontinuation in the divalproex sodium treated patients (6%), compared to 1% of placebo-treated patients.
Table 3 lists treatment-emergent adverse reactions which were reported by ≥ 5% of divalproex sodium- treated patients and for which the incidence was greater than in the placebo group, in a placebo-controlled trial of adjunctive therapy for the treatment of complex partial seizures. Since patients were also treated with other antiepilepsy drugs, it is not possible, in most cases, to determine whether the following adverse reactions can be ascribed to divalproex sodium alone, or the combination of divalproex sodium and other antiepilepsy drugs.
Table 4 lists treatment-emergent adverse reactions which were reported by ≥ 5% of patients in the high dose divalproex sodium group, and for which the incidence was greater than in the low dose group, in a controlled trial of divalproex sodium monotherapy treatment of complex partial seizures. Since patients were being titrated off another antiepilepsy drug during the first portion of the trial, it is not possible, in many cases, to determine whether the following adverse reactions can be ascribed to divalproex sodium alone, or the combination of divalproex sodium and other antiepilepsy drugs.
The following additional adverse reactions were reported by greater than 1% but less than 5% of the 358 patients treated with divalproex sodium in the controlled trials of complex partial seizures:
Body as a Whole: Back pain, chest pain, malaise.
Cardiovascular System: Tachycardia, hypertension, palpitation.
Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.
Hemic and Lymphatic System: Petechia.
Metabolic and Nutritional Disorders: SGOT increased, SGPT increased.
Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia.
Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.
Respiratory System: Sinusitis, cough increased, pneumonia, epistaxis.
Skin and Appendages: Rash, pruritus, dry skin.
Special Senses: Taste perversion, abnormal vision, deafness, otitis media.
Urogenital System: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.
3.2Mania
Although Valproic Acid has not been evaluated for safety and efficacy in the treatment of manic episodes associated with bipolar disorder, the following adverse reactions not listed above were reported by 1% or more of patients from two placebo-controlled clinical trials of divalproex sodium tablets.
Body as a Whole: Chills, neck pain, neck rigidity.
Cardiovascular System: Hypotension, postural hypotension, vasodilation.
Digestive System: Fecal incontinence, gastroenteritis, glossitis.
Musculoskeletal System: Arthrosis.
Nervous System: Agitation, catatonic reaction, hypokinesia, reflexes increased, tardive dyskinesia, vertigo.
Skin and Appendages: Furunculosis, maculopapular rash, seborrhea.
Special Senses: Conjunctivitis, dry eyes, eye pain.
Urogenital System: Dysuria.
3.3Migraine
Although Valproic Acid has not been evaluated for safety and efficacy in the treatment of prophylaxis of migraine headaches, the following adverse reactions not listed above were reported by 1% or more of patients from two placebo-controlled clinical trials of divalproex sodium tablets.
Body as a Whole: Face edema.
Digestive System: Dry mouth, stomatitis.
Urogenital System: Cystitis, metrorrhagia, and vaginal hemorrhage.
3.4Post-Marketing Experience
The following adverse reactions have been identified during post approval use of divalproex sodium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome.
Psychiatric: Emotional upset, psychosis, aggression, psychomotor hyperactivity, hostility, disturbance in attention, learning disorder, and behavioral deterioration.
Neurologic: Paradoxical convulsion, parkinsonism.
There have been several reports of acute or subacute cognitive decline and behavioral changes (apathy or irritability) with cerebral pseudoatrophy on imaging associated with valproate therapy; both the cognitive/behavioral changes and cerebral pseudoatrophy reversed partially or fully after valproate discontinuation.
There have been reports of acute or subacute encephalopathy in the absence of elevated ammonia levels,elevated valproate levels, or neuroimaging changes. The encephalopathy reversed partially or fully after valproate discontinuation.
Musculoskeletal: Fractures, decreased bone mineral density, osteopenia, osteoporosis, and weakness.
Hematologic: Relative lymphocytosis, macrocytosis, leucopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.
Endocrine: Irregular menses, secondary amenorrhea, hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.
There have been rare reports of Fanconi’s syndrome occurring chiefly in children.
Metabolism and nutrition: Weight gain.
Reproductive: Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology.
Genitourinary: Enuresis and urinary tract infection.
Special Senses: Hearing loss.
Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis.
4OVERDOSAGE
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 2120 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.
5DESCRIPTION
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 Capsules, USP are antiepileptics for oral administration. Each soft gelatin capsule contains 250 mg valproic acid.
Inactive Ingredients:peanut oil, gelatin, glycerin, and titanium dioxide.
6CLINICAL STUDIES
The studies described in the following section were conducted using divalproex sodium tablets.
6.1Epilepsy
The efficacy of divalproex sodium in reducing the incidence of complex partial seizures (CPS) that occur in isolation or in association with other seizure types was established in two controlled trials.
In one, multi-clinic, placebo controlled study employing an add-on design (adjunctive therapy), 144 patients who continued to suffer eight or more CPS per 8 weeks during an 8 week period of monotherapy with doses of either carbamazepine or phenytoin sufficient to assure plasma concentrations within the "therapeutic range" were randomized to receive, in addition to their original antiepilepsy drug (AED), either divalproex sodium or placebo. Randomized patients were to be followed for a total of 16 weeks. The following Table presents the findings.
Figure 1 presents the proportion of patients (X axis) whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the adjunctive therapy study. A positive percent reduction indicates an improvement (i.e., a decrease in seizure frequency), while a negative percent reduction indicates worsening. Thus, in a display of this type, the curve for an effective treatment is shifted to the left of the curve for placebo. This Figure shows that the proportion of patients achieving any particular level of improvement was consistently higher for divalproex sodium than for placebo. For example, 45% of patients treated with divalproex sodium had a ≥ 50% reduction in complex partial seizure rate compared to 23% of patients treated with placebo.
Figure 1
The second study assessed the capacity of divalproex sodium to reduce the incidence of CPS when administered as the sole AED. The study compared the incidence of CPS among patients randomized to either a high or low dose treatment arm. Patients qualified for entry into the randomized comparison phase of this study only if 1) they continued to experience 2 or more CPS per 4 weeks during an 8 to 12 week long period of monotherapy with adequate doses of an AED (i.e., phenytoin, carbamazepine, phenobarbital, or primidone) and 2) they made a successful transition over a two week interval to divalproex sodium. Patients entering the randomized phase were then brought to their assigned target dose, gradually tapered off their concomitant AED and followed for an interval as long as 22 weeks. Less than 50% of the patients randomized, however, completed the study. In patients converted to divalproex sodium monotherapy, the mean total valproate concentrations during monotherapy were 71 and 123 mcg/mL in the low dose and high dose groups, respectively.
The following Table presents the findings for all patients randomized who had at least one post-randomization assessment.
Figure 2 presents the proportion of patients (X axis) whose percentage reduction from baseline in complex partial seizure rates was at least as great as that indicated on the Y axis in the monotherapy study. A positive percent reduction indicates an improvement (i.e., a decrease in seizure frequency), while a negative percent reduction indicates worsening. Thus, in a display of this type, the curve for a more effective treatment is shifted to the left of the curve for a less effective treatment. This Figure shows that the proportion of patients achieving any particular level of reduction was consistently higher for high dose divalproex sodium than for low dose divalproex sodium. For example, when switching from carbamazepine, phenytoin, phenobarbital or primidone monotherapy to high dose divalproex sodium monotherapy, 63% of patients experienced no change or a reduction in complex partial seizure rates compared to 54% of patients receiving low dose divalproex sodium.
Figure 2
Information on pediatric studies presented in section 8.
7REFERENCES
1. Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurology 2013; 12 (3):244-252.
8HOW SUPPLIED/STORAGE AND HANDLING
Valproic Acid Capsules, USP, 250 mg. Each off-white colored soft gelatin capsule is imprinted with VALPROIC 250 and made available in bottles of 100 capsules (
Store capsules at controlled room temperature 15° to 30°C (59° to 86°F), see USP. Dispense in tight, light-resistant container.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Hepatotoxicity
Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly
Pancreatitis
Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly
Birth Defects and Decreased IQ
Inform pregnant women and women of childbearing potential (including girls beginning the onset of puberty) that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed
Pregnancy Registry
Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.
Encourage women who are taking Valproic Acid to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 or visit the website, http://www.aedpregnancyregistry.org/
Suicidal Thinking and Behavior
Counsel patients, their caregivers, and families that AEDs, including Valproic Acid, may increase the risk of suicidal thoughts and behavior and to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to the healthcare providers
Hyperammonemia
Inform patients of the signs and symptoms associated with hyperammonemic encephalopathy and to notify the prescriber if any of these symptoms occur
CNS Depression
Since valproate products may produce CNS depression, especially when combined with another CNS depressant (e.g., alcohol), advise patients not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.
Multiorgan Hypersensitivity Reactions
Instruct patients that a fever associated with other organ system involvement (rash, lymphadenopathy, etc.) may be drug-related and should be reported to the physician immediately
Manufactured by:
Manufactured for:
Revised: May 2021
10MEDICATION GUIDE
Valproic Acid (val-proé-ik-as íd) Capsules
Read this Medication Guide before you start taking Valproic Acid Capsules and each time you get a refill. There may be new information.
What is the most important information I should know about Valproic Acid Capsules? Stopping valproic acid suddenly can cause serious problems.
Valproic Acid Capsules can cause serious side effects, including:
1. Serious liver damage that can cause death, especially in children younger than 2 years old. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.
Call your healthcare provider right away if you get any of the following symptoms:
Call your healthcare provider right away if you get any of the following symptoms:
- nausea or vomiting that does not go away
- loss of appetite
- pain on the right side of your stomach (abdomen)
- dark urine
- swelling of your face
- yellowing of your skin or the whites of your eyes
In some cases, liver damage may continue despite stopping the drug.
2. Valproic Acid Capsules may harm your unborn baby.
- If you take Valproic Acid Capsules during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Decreased hearing or hearing loss can also happen.
Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect. If you take Valproic Acid Capsules during pregnancy for any medical condition, your child is at risk for having a lower IQ and may be at risk for developing autism or attention deficit/hyperactivity disorder. There may be other medicines to treat your condition that have a lower chance of causing birth defects and decreased IQ in your child, or other disorders in your child. Women who are pregnant must not take Valproic Acid Capsules to prevent migraine headaches. All women of child-bearing age (including girls from the start of puberty) should talk to their healthcare provider about using other possible treatments instead of Valproic Acid Capsules. If the decision is made to use Valproic Acid Capsules, you should use effective birth control (contraception). Tell your healthcare provider right away if you become pregnant while taking Valproic Acid Capsules. You and your healthcare provider should decide if you will continue to take Valproic Acid Capsules while you are pregnant. Pregnancy Registry:If you become pregnant while taking Valproic Acid Capsules, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or by visiting the website, http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
3. Inflammation of your pancreas that can cause death.
- severe stomach pain that you may also feel in your back
- nausea or vomiting that does not go away
4. Like other antiepileptic drugs, Valproic Acid Capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not stop Valproic Acid Capsules without first talking to a healthcare provider.Stopping Valproic Acid suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that do not stop (status epilepticus). Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
What are Valproic Acid Capsules? Valproic Acid Capsules come in capsule dosage form.
Valproic Acid Capsulesare a prescription medicines used alone or with other medicines, to treat:
Valproic Acid Capsulesare a prescription medicines used alone or with other medicines, to treat:
• complex partial seizures in adults and children 10 years of age and older
• simple and complex absence seizures, with or without other seizure types
Who should not take Valproic Acid Capsules? Do not take Valproic Acid Capsules if you:
- have liver problems
- have or think you have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
- are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in Valproic Acid Capsules. See the end of this leaflet for a complete list of ingredients in Valproic Acid Capsules.
- have a genetic problem called urea cycle disorder
- are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control (contraception)
What should I tell my healthcare provider before taking Valproic Acid Capsules? Before you take Valproic Acid Capsules, tell your healthcare provider if you:
- have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
- drink alcohol
- are pregnant or breastfeeding. Valproic Acid can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Valproic Acid Capsules.
- have or have had depression, mood problems, or suicidal thoughts or behavior
- have any other medical conditions
Tell your healthcare provider about all the medicines you take,including prescription and non-prescription medicines, vitamins, herbal supplements and medicines that you take for a short period of time. Taking Valproic Acid Capsules with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take Valproic Acid Capsules?
- Take Valproic Acid Capsules exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Valproic Acid Capsules to take and when to take it.
- Your healthcare provider may change your dose.
- Do not change your dose of Valproic Acid without talking to your healthcare provider.
- Do not stop taking Valproic Acid Capsules without first talking to your healthcare provider.Stopping Valproic Acid suddenly can cause serious problems.
- Swallow Valproic Acid Capsules whole. Do not crush or chew Valproic Acid Capsules. Tell your healthcare provider if you can not swallow Valproic Acid Capsules whole. You may need a different medicine.
- If you take too many Valproic Acid Capsules, call your healthcare provider or local Poison Control Center right away.
What should I avoid while taking Valproic Acid Capsules?
Valproic Acid Capsules can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Valproic Acid Capsules, until you talk with your doctor. Taking Valproic Acid Capsules with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse. Do not drive a car or operate dangerous machinery until you know how Valproic Acid Capsules affect you. Valproic acid can slow your thinking and motor skills.
What are the possible side effects of Valproic Acid Capsules?
• See
- Bleeding problems:red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.
High ammonia levels in your blood:feeling tired, vomiting, changes in mental status. Low body temperature (hypothermia):drop in your body temperature to less than 95°F, feeling tired, confusion, coma. Allergic (hypersensitivity) reactions:fever, skin rash, hives, sores in your mouth, skin blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing. Drowsiness or sleepiness in the elderly.This extreme drowsiness may cause you to eat or drink less than you normally would. Tell your doctor if you are not able to eat or drink as you normally do. Your doctor may start you at a lower dose of valproic acid.
Call your healthcare provider right away, if you have any of the symptoms listed above.
- nausea
- headache
- sleepiness
- vomiting
- weakness
- tremor
- dizziness
- stomach pain
- blurry vision
- double vision
- diarrhea
- increased appetite
- weight gain
- hair loss
- loss of appetite
- problems with walking or coordination
These are not all of the possible side effects of
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Valproic Acid Capsules?
How should I store Valproic Acid Capsules?
- Store Valproic Acid Capsules at 15° to 30°C (59° to 86°F).
Keep Valproic Acid Capsules and all medicines out of the reach of children.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Valproic Acid Capsules for a condition for which it was not prescribed. Do not give Valproic Acid Capsules to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Valproic Acid Capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Valproic Acid Capsules that is written for health professionals. For more information, call 1-888-838-2872.
What are the ingredients in Valproic Acid Capsules? valproic acid
Inactive ingredients: peanut oil, gelatin, glycerin, and titanium dioxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Inactive ingredients: peanut oil, gelatin, glycerin, and titanium dioxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Manufactured for:
Revised: May 2021
11REPACKAGING INFORMATION
Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
250mg
NDC 71610-906-30, Bottles of 30 Capsules
NDC 71610-906-53, Bottles of 60 Capsules
NDC 71610-906-60, Bottles of 90 Capsules
NDC 71610-906-70, Bottles of 120 Capsules
NDC 71610-906-80, Bottles of 180 Capsules
NDC 71610-906-90, Bottles of 240 Capsules
NDC 71610-906-30, Bottles of 30 Capsules
NDC 71610-906-53, Bottles of 60 Capsules
NDC 71610-906-60, Bottles of 90 Capsules
NDC 71610-906-70, Bottles of 120 Capsules
NDC 71610-906-80, Bottles of 180 Capsules
NDC 71610-906-90, Bottles of 240 Capsules
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20250523AMH
12PRINCIPAL DISPLAY PANEL - 250mg
NDC 71610-906 - Valproic Acid, USP 250mg Capsules - Rx Only
