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Divalproex Sodium (Divalproex Sodium)

Trade Name : Divalproex Sodium

NCS HealthCare of KY, Inc dba Vangard Labs

TABLET, FILM COATED, EXTENDED RELEASE

Strength 250 mg/1

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

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Divalproex Sodium (Divalproex Sodium) which is also known as Divalproex Sodium and Manufactured by NCS HealthCare of KY, Inc dba Vangard Labs. It is available in strength of 250 mg/1 per ml. Read more

Divalproex Sodium (Divalproex Sodium) 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Hepatotoxicity: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months.
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  • 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 divalproex sodium extended-release tablets are 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 following exposure.
  • Valproate is therefore contraindicated in pregnant women treated for prophylaxis of migraine Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.
  • u00a0u00a0
  • Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate .
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  • A Medication Guide describing the risks of valproate is available for patients n
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  • 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 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 ()
  • Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ (, , )
  • Pancreatitis, including fatal hemorrhagic cases ()
  • Divalproex sodium extended-release tablets are an anti-epileptic drug indicated for:
  • Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features ()
  • 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 ()
  • Prophylaxis of migraine headaches ()
  • Divalproex sodium extended-release tablets are an extended-release product intended for once-a-day oral administration. Divalproex sodium extended-release tablets should be swallowed whole and should not be crushed or chewed.
  • Divalproex sodium extended-release tablets are intended for once-a-day oral administration. Divalproex sodium extended-release tablets 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 (, ).
  • Complex Partial Seizures: Start at 10 mg/kg/day to 15 mg/kg/day, increasing at 1 week intervals by 5 mg/kg/day 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 (, ).
  • Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week intervals by 5 mg/kg/day to 10 mg/kg/day until seizure control or limiting side effects (). The maximum recommended dosage is 60 mg/kg/day (, ).
  • Migraine: The recommended starting dose is 500 mg/day for 1 week, thereafter increasing to 1000 mg/day ().
  • Divalproex Sodium Extended-Release Tablets, USP are available containing divalproex sodium, USP equivalent to 250 mg or 500 mg of valproic acid.
  • Tablets: 250 mg and 500 mg ()
  • No data
  • Hepatic disease or significant hepatic dysfunction (, )
  • Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase u03b3 (POLG) (, )
  • Suspected POLG-related disorder in children under two years of age (, )
  • Known hypersensitivity to the drug (, )
  • Urea cycle disorders (, )
  • Pregnant patients treated for prophylaxis of migraine headaches (, )
  • No data
  • 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 or bipolar disorder if other medications are unacceptable; should not be administered to a woman of childbearing potential unless essential (, , )
  • Pancreatitis; divalproex sodium extended-release tablets should ordinarily be discontinued ()
  • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, 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 divalproex sodium extended-release tablets ()
  • Somnolence in the elderly can occur. Divalproex sodium extended-release tablets 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.
  • Information on pediatric adverse reactions is presented in section 8.
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Most common adverse reactions (reported > 5%) reported in adult studies are nausea, somnolence, dizziness, vomiting, asthenia, abdominal pain, dyspepsia, rash, diarrhea, increased appetite, tremor, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, amblyopia/blurred vision, ataxia, nystagmus, emotional lability, thinking abnormal, amnesia, flu syndrome, infection, bronchitis, rhinitis, ecchymosis, peripheral edema, insomnia, nervousness, depression, pharyngitis, dyspnea, tinnitus (, , , ).u00a0
  • The safety and tolerability of valproate in pediatric patients were shown to be comparable to those in adults ().
  • No data
  • Hepatic enzyme-inducing drugs (e.g., phenytoin, carbamazepine, primidone, phenobarbital, rifampin) can increase valproate clearance, while enzyme inhibitors (e.g., felbamate) can decrease valproate clearance. Therefore increased monitoring of valproate and concomitant drugu00a0 concentrations and dose adjustment is indicated whenever enzyme-inducing or inhibiting drugs are introduced or withdrawn ()
  • Aspirin, carbapenem antibiotics, estrogen-containing hormonal contraceptives: Monitoring of valproate concentrations is recommended ()
  • 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 ()
  • Patients stabilized on rufinamide should begin valproate therapy at a low dose, and titrate to clinically effective dose ()
  • Dosage adjustment of amitriptyline/nortriptyline, propofol, warfarin, and zidovudine may be necessary if used concomitantly with divalproex sodium extended-release tablets ()
  • Topiramate: Hyperammonemia and encephalopathy (, )
  • No data
  • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects and decreased IQ (, , )
  • Pediatric: Children under the age of two years are at considerably higher risk of fatal hepatotoxicity (, )
  • Geriatric: Reduce starting dose; increase dosage more slowly; monitor fluid and nutritional intake, and somnolence (, )
  • 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.
  • 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, USP occurs as a white crystalline powder with a characteristic odor.
  • Divalproex sodium extended-release 250 mg and 500 mg tablets are for oral administration. Divalproex sodium extended-release tablets, USP contain divalproex sodium in a once-a-day extended-release formulation equivalent to 250 mg or 500 mg of valproic acid.
  • Inactive Ingredients: ammonium hydroxide, colloidal anhydrous silica, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hydroxyethyl cellulose, hypromellose, oleic acid, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide and triacetin.
  • Meets USP Dissolution Test 3.
  • No data
  • No data
  • No data
  • 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.
  • Divalproex Sodium Extended-Release Tablets, USP are available containing divalproex sodium, USP equivalent to 250 mg or 500 mg of valproic acid.
  • The 250 mg tablets are white, film-coated, round, unscored tablets debossed with over on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0615-8242-39blistercards of 30 tablets
  • The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with on one side of the tablet and blank on the other side.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • PHARMACIST:
  • Advise the patient to read the FDA-approved patient labeling ().
  • Hepatotoxicity:n- [see ]
  • Pancreatitis:n- [see ].
  • Birth Defects and Decreased IQ:n- [see , , u00a0andn- Array
  • 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 patients to enroll in the 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 .
  • Suicidal Thinking and Behavior:n- [see ]
  • Hyperammonemia:n- [see , ].
  • CNS Depression:
  • Multiorgan Hypersensitivity Reaction:n- [see ].
  • Medication Residue in the Stool:n- [see ]
  • Divalproex Sodium Extended-Release Tablets, USPn- (dye valu2032 proe ex soeu2032 dee um)
  • Read this Medication Guide before you start taking divalproex sodium extended-release tablets 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 divalproex sodium extended-release tablets?
  • Do not stop taking divalproex sodium extended-release tabletsn- without first talking to your healthcare provider.
  • Stopping divalproex sodium extended-release tablets suddenly can cause serious problems.
  • Divalproex sodium extended-release tabletsn- can cause serious side effects, including:
  • What are divalproex sodium extended-release tablets?
  • Divalproex Sodium Extended-Release Tablets
  • Who should not take divalproex sodium extended-release tablets?
  • What should I tell my healthcare provider before taking divalproex sodium extended-release tablets?
  • Tell your healthcare provider about all the medicines you take,
  • Taking divalproex sodium extended-release tablets 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 divalproex sodium extended-release tablets?
  • What should I avoid while taking divalproex sodium extended-release tablets?
  • What are the possible side effects of divalproex sodium extended-release tablets?
  • Divalproex sodium extended-release tablets may cause other serious side effects including:
  • Call your healthcare provider right away, if you have any of the symptoms listed above.
  • The common side effects of divalproex sodium extended-release tabletsn- 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 divalproex sodium extended-release tablets?
  • Keep divalproex sodium extended-release tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of divalproex sodium extended-release tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use divalproex sodium extended-release tablets for a condition for which it was not prescribed. Do not give divalproex sodium extended-release tablets 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 divalproex sodium extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about divalproex sodium extended-release tablets that is written for health professionals.
  • For more information, call Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
  • What are the ingredients in divalproex sodium extended-release tablets?
  • Active ingredient: divalproex sodium
  • Inactive ingredients: ammonium hydroxide, colloidal anhydrous silica, colloidal silicon dioxide, dibutyl sebacate, ethylcellulose, hydroxyethyl cellulose, hypromellose, oleic acid, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, titanium dioxide and triacetin.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • The brands listed are trademarks of their respective owners.
  • Mylan Pharmaceuticals Inc.
  • Revised: 4/2017DIVER:R19mpbmh
  • No data

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