Divalproex Sodium - Er (Depakote)

Trade Name : Depakote

AbbVie Inc.

TABLET, EXTENDED RELEASE

Strength 250 mg/1

Storage and handling for Depakote

DIVALPROEX SODIUM Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Divalproex Sodium - Er (Depakote) which is also known as Depakote and Manufactured by AbbVie Inc.. It is available in strength of 250 mg/1 per ml. Read more

Divalproex Sodium - Er (Depakote) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Hepatotoxicity
Arrayn- Array
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 Depakote ER is used in this patient group, it 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.
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Fetal Risk
Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores n- Arrayn- following exposure.
Valproate is therefore contraindicated for prophylaxis of migrainen- Arrayn- Arrayn- Valproate should control or are otherwise unacceptable.
Arrayn- 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 .
WARNING: 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 n
Arrayn- Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ , , n
Pancreatitis, including fatal hemorrhagic cases n

No data

Depakote ER is indicated for:

Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features n
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 n
Prophylaxis of migraine headaches n

Depakote ER is an extended-release product intended for once-a-day oral administration. Depakote ER tablets should be swallowed whole and should not be crushed or chewed.

Depakote ER is intended for once-a-day oral administration. Depakote ER should be swallowed whole and should not be crushed or chewed , .
Mania: Initial dose is 25 mg/kg/day, increasing as rapidly as possible to achieve therapeutic response or desired plasma level . The maximum recommended dosage is 60 mg/kg/day , n
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 . The maximum recommended dosage is 60 mg/kg/day , n
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 . The maximum recommended dosage is 60 mg/kg/day , n
Migraine: The recommended starting dose is 500 mg/day for 1 week, thereafter increasing to 1,000 mg/day n

Depakote ER 250 mg is available as white ovaloid tablets with the u201cau201d logo and the code (HF). Each Depakote ER tablet contains divalproex sodium equivalent to 250 mg of valproic acid.
Depakote ER 500 mg is available as gray ovaloid tablets with the u201cau201d logo and the code HC. Each Depakote ER tablet contains divalproex sodium equivalent to 500 mg of valproic acid.
Tablets: 250 mg and 500 mg n

No data

Hepatic disease or significant hepatic dysfunction , n
Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase u03b3 (POLG) ,n
Suspected POLG-related disorder in children under two years of age , n
Known hypersensitivity to the drug , n
Urea cycle disorders , n
Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception , n

No data

Hepatotoxicity; evaluate high risk populations and monitor serum liver tests n
Birth defects, decreased IQ, and neurodevelopmental disorders following 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 , , n
Pancreatitis; Depakote ER should ordinarily be discontinued n
Suicidal behavior or ideation; Antiepileptic drugs, including Depakote ER, increase the risk of suicidal thoughts or behavior n
Bleeding and other hematopoietic disorders; monitor platelet counts and coagulation tests n
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 , , n
Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramate n
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reaction; discontinue Depakote ER n
Somnolence in the elderly can occur. Depakote ER dosage should be increased slowly and with regular monitoring for fluid and nutritional intake n

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.
Information on pediatric adverse reactions is presented in section 8.
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To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Most common adverse reactions (reported >5%) are abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspnea, dyspepsia, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss , , ).
The safety and tolerability of valproate in pediatric patients were shown to be comparable to those in adults .n n

No data

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 n
Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended n
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 n
Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose n
Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with Depakote ER n
Topiramate: Hyperammonemia and encephalopathy , n

No data

Pregnancy: Depakote ER can cause congenital malformations including neural tube defects, decreased IQ, and neurodevelopmental disorders , , n
Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity , n
Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence , n

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.

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:
Divalproex sodium occurs as a white powder with a characteristic odor.
Depakote ER 250 and 500 mg tablets are for oral administration. Depakote ER tablets contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 and 500 mg of valproic acid.
Inactive Ingredients
Depakote ER 250 and 500 mg tablets: FD&C Blue No. 1, hypromellose, lactose, microcrystalline cellulose, polyethylene glycol, potassium sorbate, propylene glycol, silicon dioxide, titanium dioxide, and triacetin.
In addition, 500 mg tablets contain iron oxide and polydextrose.
Meets USP Dissolution Test 2.

No data

Carcinogenesis
Valproate was administered orally to rats and mice at doses of 80 and 170 mg/kg/day (less than the maximum recommended human dose on a mg/m basis) for two years. The primary findings were an increase in the incidence of subcutaneous fibrosarcomas in high-dose male rats receiving valproate and a dose-related trend for benign pulmonary adenomas in male mice receiving valproate.
Mutagenesis
Valproate was not mutagenic in an bacterial assay (Ames test), did not produce dominant lethal effects in mice, and did not increase chromosome aberration frequency in an cytogenetic study in rats. Increased frequencies of sister chromatid exchange (SCE) have been reported in a study of epileptic children taking valproate; this association was not observed in another study conducted in adults.
Impairment of Fertility
In chronic toxicity studies in juvenile and adult rats and dogs, administration of valproate resulted in testicular atrophy and reduced spermatogenesis at oral doses of 400 mg/kg/day or greater in rats (approximately equal to or greater than the maximum recommended human dose (MRHD) on a mg/m basis) and 150 mg/kg/day or greater in dogs (approximately equal to or greater than the MRHD on a mg/m basis). Fertility studies in rats have shown no effect on fertility at oral doses of valproate up to 350 mg/kg/day (approximately equal to the MRHD on a mg/m basis) for 60 days.

No data

No data

Depakote ER 250 mg is available as white ovaloid tablets with the u201cau201d logo and the code (HF). Each Depakote ER tablet contains divalproex sodium equivalent to 250 mg of valproic acid in the following package sizes:
Bottles of 100u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026..(NDC 0074-3826-13).
Unit Dose Packages of 100..................u2026u2026u2026u2026u2026u2026u2026..(NDC 0074-3826-11).
Depakote ER 500 mg is available as gray ovaloid tablets with the u201cau201d logo and the code HC. Each Depakote ER tablet contains divalproex sodium equivalent to 500 mg of valproic acid in the following packaging sizes:
Bottles of 100...................................................................(NDC 0074-7126-13).
Bottles of 500...................................................................(NDC 0074-7126-53).
Unit Dose Packages of 100...............................................(NDC 0074-7126-11).
Recommended Storage: Store tablets at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
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 . Advise women to use effective contraception while taking valproate. When appropriate, counsel these patients about alternative therapeutic options. This is particularly important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headache . Advise patients to read the Medication Guide, which appears as the last section of the labeling .
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 Depakote ER 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 Depakote ER, 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 .
Medication Residue in the Stool
Instruct patients to notify their healthcare provider if they notice a medication residue in the stool .
u00a92000-2019 AbbVie Inc.
Revised: December 2019
03-C084-R31

DEPAKOTE ER
DEPAKOTE
DEPAKOTE
DEPAKENE
Read this Medication Guide before you start taking Depakote or Depakene and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about Depakote and Depakene?
Do not stop taking Depakote or Depakene without first talking to your healthcare provider.
Stopping Depakote or Depakene suddenly can cause serious problems.
Depakote and Depakene can cause serious side effects, including:
What are Depakote and Depakene?
Depakote and Depakene come in different dosage forms with different usages.
Depakote Tablets and Depakote Extended-Release Tablets
Depakene (solution and liquid capsules) and Depakote Sprinkle Capsules
Who should not take Depakote or Depakene?
Do not take Depakote or Depakene if you:
What should I tell my healthcare provider before taking Depakote or Depakene?
Before you take Depakote or Depakene, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,
Taking Depakote or Depakene 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 Depakote or Depakene?
What should I avoid while taking Depakote or Depakene?
What are the possible side effects of Depakote or Depakene?
Depakote or Depakene can cause serious side effects including:
Call your healthcare provider right away, if you have any of the symptoms listed above.
The common side effects of Depakote and Depakene include:
These are not all of the possible side effects of . For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
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 Depakote or Depakene?
Keep Depakote or Depakene and all medicines out of the reach of children.
General information about the safe and effective use of Depakote or Depakene
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Depakote or Depakene for a condition for which it was not prescribed. Do not give Depakote or Depakene 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 Depakote or Depakene. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Depakote or Depakene that is written for health professionals.
For more information, go to www.rxabbvie.com or call 1-800-633-9110.
What are the ingredients in Depakote or Depakene?
Depakote:
Active ingredient: divalproex sodium
Inactive ingredients:
Depakene:
Active ingredient: valproic acid
Inactive ingredients:
Depakote ER:n- 250 mgn- 500 mg
Depakote Tablets:
Depakote Sprinkle Capsules:
Depakene Capsules:
Depakene Oral Solution:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
u00a92000-2019 AbbVie Inc.
Revised: December 2019
03-C084-R31

NDC 0074-3826-13
100 Tablets
Once-Daily Dosing
DEPAKOTE ER
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS
250 mg Valproic Acid Activity
Dispense the accompanying Medication Guide to each patient.
Rx only abbvie
NDC 0074-7126-11
100 Tablets
TO OPEN
Tear Back Along Perforation
Dispense the accompanying Medication Guide to each patient.
Rx only
Once-Daily Dosing
DEPAKOTE ER
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS
500 mg Valproic Acid Activity
Tamper-Evident: Do not accept if opened or seal has been broken.
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
NDC 0074-7126-13
100 Tablets
Once-Daily Dosing
DEPAKOTE ER
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS
500 mg Valproic Acid Activity
Dispense the accompanying Medication Guide to each patient.
Rx only abbvie

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