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Divalproex Sodium (Divalproex Sodium)

Trade Name : Divalproex Sodium

Safecor Health, LLC

TABLET, EXTENDED RELEASE

Strength 500 mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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 Safecor Health, LLC. It is available in strength of 500 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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About GNH

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
  • 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 ()
  • Fetal Risk, particularly neural tube defects, other major malformations, and decreased IQ (, , ) Pancreatitis, including fatal hemorrhagic cases ()
  • Divalproex sodium extended-release tablet is an anti-epileptic drug 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
  • Divalproex sodium extended-release tablet is 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.n
  • 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 (, ).n
  • 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
  • Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed u201cRu201d on one side and u201c533u201d on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 250 mg of valproic acid.n
  • Divalproex sodium extended-release tablets USP, 500mg are available as grey colored, oval shaped, beveled edge, biconvex coated tablets debossed u201cRu201d on one side and u201c534u201d on other side. Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to 500 mg of valproic acid.n
  • 250 mg Tablets ()
  • 500 mg Tablets ()
  • Divalproex sodium extended-release tablets should not be administered to patients with hepatic disease or significant hepatic dysfunction [see].n
  • Divalproex sodium extended-release tablets are contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase u03b3 (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder [see ].n
  • Divalproex sodium extended-release tablets are contraindicated in patients with known hypersensitivity to the drug. [see ].n
  • Divalproex sodium extended-release tablets are contraindicated in patients with known urea cycle disorders [see ].n
  • Divalproex sodium extended-release tablets are contraindicated for use in prophylaxis of migraine headaches in pregnant women [see ].n
  • 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
  • Pregnant patients treated for prophylaxis of migraine headaches (, )n
  • No data
  • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests ()n
  • Birth defects and decreased IQ following in utero 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 (, , )n
  • Pancreatitis; Divalproex sodium extended-release tablets should ordinarily be discontinued ()n
  • Suicidal behavior or ideation; Antiepileptic drugs, including divalproex sodium extended-release tablets, 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 divalproex sodium extended-release tablets ()n
  • 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 ()n
  • 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.n
  • Information on pediatric adverse reactions is presented in section 8.n
  • The following serious adverse reactions are described below and elsewhere in the labeling: Hepatic failure [see ]n
  • Birth defects [see ]n
  • Decreased IQ following in utero exposure [see ] Pancreatitis [see ]n
  • Hyperammonemic encephalopathy [see ] Suicidal behavior and ideation [see ]n
  • Bleeding and other hematopoietic disorders [see ] Hypothermia [see ]n
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions [see ]n
  • Somnolence in the elderly [see ]n
  • To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc., at 1-888-375-3784 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 (, , ).n
  • The safety and tolerability of valproate in pediatric patients were shown to be comparable to those in adults ().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 divalproex sodium extended-release tablets ()n
  • Topiramate: Hyperammonemia and encephalopathy (, )n
  • No data
  • Pregnancy: Divalproex sodium extended-release tablets can cause congenital malformations including neural tube defects and decreased IQ (, , )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.n
  • 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.n
  • 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.n
  • Divalproex sodium USP 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 USP has the following structure:n
  • Divalproex sodium USP occurs as a white to off white powder with a characteristic odor, very soluble in chloroform, freely soluble in methanol and ethyl ether, soluble in acetone, practically insoluble in acetonitrile.n
  • Divalproex sodium extended-release tablets USP, 250 mg and 500 mg are for oral administration. Divalproex sodium extended-release tablets USP, contain divalproex sodium USP in a once-a-day extended-release formulation equivalent to either 250 mg or 500 mg of valproic acid.n
  • Inactive Ingredients
  • Divalproex sodium extended-release tablets USP, 250 mg: Hydroxy ethyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, and titanium dioxide.n
  • Divalproex sodium extended-release tablets USP, 500 mg: Hydroxy ethyl cellulose, hydroxy propyl cellulose, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, silicon dioxide, and titanium dioxide.n
  • Divalproex sodium extended-release tablets meets USP .n
  • 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.n
  • Divalproex sodium extended-release tablets USP, 250 mg are available as white to off white, round shaped, beveled edge, biconvex coated tablets debossed u201cRu201d on one side and u201c533u201d on other side.n
  • Divalproex sodium extended-release tablets USP, 500 mg are available as grey colored, oval shaped, beveled edge, biconvex coated tablets debossed u201cRu201d on one side and u201c534u201d on other side.n
  • Each divalproex sodium extended-release tablet contains divalproex sodium equivalent to either 250 mg or 500 mg of valproic acid and are supplied in unit dose package of 100 (10 x 10).n
  • 250 mg
  • Unit Dose Blister (NDC 48433-126-01)n
  • Box of 100 Unit Dose (NDC 48433-126-10)n
  • 500mg
  • Unit Dose Blister (NDC 48433-125-01)n
  • Box of 100 Unit Dose (NDC 48433-125-10)n
  • Recommended Storage
  • Store tablets at 20u00b0-25u00b0C (68u00b0-77u00b0F) [See USP Controlled Room Temperature].n
  • Advise the patient to read the FDA-approved patient labeling ().n
  • MEDICATION GUIDE
  • Divalproex Sodium Extended-Release Tablets USP, 250 mg and 500 mg
  • (dye val' proe ex soe' 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.n
  • What is the most important information I should know about divalproex sodium extended-release tablets?
  • Do not stop taking divalproex sodium extended-release tablets without first talking to your healthcare provider.
  • Stopping divalproex sodium extended-release tablets suddenly can cause serious problems.n
  • Divalproex sodium extended-release tablets can cause serious side effects, including:
  • 1. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment.n
  • Call your healthcare provider right away if you get any of the following symptoms:
  • In some cases, liver damage may continue despite stopping the drug.n
  • 2.nn- Divalproex sodium extended-release tablets may harm your unborn baby.
  • Pregnancy Registry
  • 3.nn- Inflammation of your pancreas that can cause death.
  • Call your healthcare provider right away if you have any of these symptoms:
  • 4.nn- Like other antiepileptic drugs, divalproex sodium extended-release tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
  • Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • How can I watch for early symptoms of suicidal thoughts and actions?
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.n
  • Do not stop divalproex sodium extended-release tablets without first talking to a healthcare provider.
  • 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.n
  • What are divalproex sodium extended-release tablets?
  • Who should not take divalproex sodium extended-release tablets?
  • Do not take divalproex sodium extended-release tablets if you:n
  • What should I tell my healthcare provider before taking divalproex sodium extended-release tablets?
  • Before you take divalproex sodium extended-release tablets, tell your healthcare provider if you: have an
  • 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.n
  • 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.n
  • 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 can cause serious side effects including:n
  • Call your healthcare provider right away, if you have any of the symptoms listed above. The common side effects of divalproex sodium extended-release tablets include:
  • These are not all of the possible side effects of . For more information, ask your healthcare provider or pharmacist.n
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.n
  • 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?
  • Store divalproex sodium extended-release tablets at 20u00b0-25u00b0C (68u00b0-77u00b0F)n
  • 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.n
  • 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.n
  • For more information call Dr. Reddy's Laboratories Inc. at 1-888-375-3784.n
  • What are the ingredients in divalproex sodium extended-release tablets?
  • Active ingredient: divalproex sodium Inactive ingredients:n
  • Divalproex sodium extended-release tablets (250 mg):
  • Divalproex sodium extended-release tablets (500 mg):
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.n
  • Call your doctor for medical advice about side effects. You may report side effects to Dr. Reddy's Laboratories Inc. at 1-888-375-3784 or to FDA at 1-800-FDA-1088.n
  • All registered trademarks are the property of their respective owners.n
  • R OnlyThis Package is Not Child ResistantFor Institutional Use Onlyn
  • Packaged by:n
  • Manufactured by:n
  • Revised: 02/2019 PN5643n
  • Principal Display Panel 250 mg Box Label
  • SAFECORHEALTHn
  • Divalproex Sodium ERn
  • 250 mg Tabletn
  • These unit dose packages meet USP specifications for light resistance.n
  • The package design is not child resistant.n
  • For institutional use only.n
  • Each Tablet Contains Divalproex Sodium USP equivalent to Valproic Acid 500 mgn
  • Store at 20u00b0 to 25u00b0 (68u00b0 to 77u00b0F). See USP Controlled Room Temperaturen
  • ONCE-DAILY DOSINGn
  • See Package Insertn
  • Rx ONLYn
  • NDC: 48433-126-10n
  • 3 48433 12610 3n
  • GTIN: 00348433126103n
  • SN:n
  • Exp:n
  • Lot:n
  • Mfg BY: Dr. Reddy's, Laboratories Limited,n
  • Bachupally u2013 500 090 INDIAn
  • www.safecorhealth.com
  • Questions call 1-800-447-1006n
  • Principal Display Panel 250 mg Blister Pack Label
  • Divalproex Sodium ER
  • 250 mg Tablet
  • Once Daily
  • Mfg: Dr. Reddy'sn
  • Lot: 18A0106n
  • Exp: 12/10/20n
  • PKG BY: Safecor Healthn
  • Woburn, MAn
  • 4843312601n
  • Principal Display Panel 500 mg Box Label
  • SAFECORHEALTHn
  • Divalproex Sodium ERn
  • 250 mg Tabletn
  • These unit dose packages meet USP specifications for light resistance.n
  • The package design is not child resistant.n
  • For institutional use only.n
  • Each Tablet Contains Divalproex Sodium USP equivalent to Valproic Acid 500 mgn
  • Store at 20u00b0 to 25u00b0 (68u00b0 to 77u00b0F). See USP Controlled Room Temperaturen
  • ONCE-DAILY DOSINGn
  • See Package Insertn
  • Rx ONLYn
  • NDC: 48433-125-10n
  • 3 48433 12510 6n
  • GTIN: 00348433125106n
  • SN:n
  • Exp:n
  • Lot:n
  • Mfg BY: Dr. Reddy's, Laboratories Limited,n
  • Bachupally u2013 500 090 INDIAn
  • www.safecorhealth.com
  • Questions call 1-800-447-1006n
  • Principal Display Panel 500 mg Blister Pack Label
  • Divalproex Sodium ER
  • 250 mg Tablet
  • Once Daily
  • Mfg: Dr. Reddy'sn
  • Lot: 18A0106n
  • Exp: 12/10/20n
  • PKG BY: Safecor Healthn
  • Woburn, MAn
  • 4843312501n

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