Divalproex Sodium

Divalproex Sodium

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Divalproex sodium delayed release tablets are an anti-epileptic drug indicated for:

  • Treatment of manic episodes associated with bipolar disorder (1.1)
  • 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 (1.2)
  • Prophylaxis of migraine headaches (1.3)

 

Divalproex sodium delayed release tablets are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.

The efficacy of divalproex sodium delayed release tablets were established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)].

The safety and effectiveness of divalproex sodium delayed release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium delayed release tablets for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.

 

Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex sodium delayed release tablets are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.

 

Divalproex sodium delayed release tablets are indicated for prophylaxis of migraine headaches. There is no evidence that divalproex sodium delayed release tablets are useful in the acute treatment of migraine headaches.

 

Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2, 5.3, 5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17.3)]. 

Divalproex sodium delayed release tablets are contraindicated for prophylaxis of migraine headaches in women who are pregnant.

 

History

There is currently no drug history available for this drug.

Other Information

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:

MM1

Divalproex sodium occurs as a white powder with a characteristic odor.

Divalproex sodium delayed release tablets are for oral administration. Divalproex sodium delayed release tablets are supplied in three dosage strengths containing divalproex sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid.

Inactive Ingredients

Divalproex Sodium Delayed Release Tablets: Microcrystalline cellulose, silicon dioxide, pregelatinized starch, povidone, talc, opadry II white 33G28707, simethicone and vanillin.

Opadry II white 33G28707 consists of hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide and triacetin.

Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, ethanol and isopropyl alcohol.

In addition, individual tablet contain:

125 mg tablets: Acryl EZE Orange which consists of FD & C Yellow No. 6, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate & yellow iron oxide.

250 mg tablets: Acryl EZE Pink which consists of D & C Red No. 30, FD & C Blue No. 2, iron oxide red, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

500 mg tablets: Acryl EZE Pink which consists of FD & C Red No. 40, methacrylic acid copolymer, silica, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

 

Divalproex Sodium Manufacturers


  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Delayed Release [Remedyrepack Inc. ]
  • Cardinal Health
    Divalproex Sodium Tablet, Delayed Release [Cardinal Health]
  • Direct Rx
    Divalproex Sodium Tablet, Delayed Release [Direct Rx]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Delayed Release [Remedyrepack Inc. ]
  • Direct Rx
    Divalproex Sodium Tablet, Delayed Release [Direct Rx]
  • State Of Florida Doh Central Pharmacy
    Divalproex Sodium Tablet, Delayed Release [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Divalproex Sodium Tablet, Delayed Release [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Divalproex Sodium Tablet, Delayed Release [State Of Florida Doh Central Pharmacy]
  • Major Pharmaceuticals
    Divalproex Sodium Tablet, Extended Release [Major Pharmaceuticals]
  • Major Pharmaceuticals
    Divalproex Sodium Tablet, Extended Release [Major Pharmaceuticals]
  • American Health Packaging
    Divalproex Sodium Tablet, Delayed Release [American Health Packaging]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Delayed Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Remedyrepack Inc. ]
  • Sun Pharmaceutical Industries Limited
    Divalproex Sodium Tablet, Delayed Release [Sun Pharmaceutical Industries Limited]
  • Dr. Reddy’s Laboratories Ltd
    Divalproex Sodium Tablet, Delayed Release [Dr. Reddy’s Laboratories Ltd]
  • State Of Florida Doh Central Pharmacy
    Divalproex Sodium Tablet, Delayed Release [State Of Florida Doh Central Pharmacy]
  • State Of Florida Doh Central Pharmacy
    Divalproex Sodium Tablet, Delayed Release [State Of Florida Doh Central Pharmacy]
  • Global Pharmaceuticals, Division Of Impax Laboratories Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]
  • Contract Pharmacy Services-pa
    Divalproex Sodium Tablet, Film Coated, Extended Release [Contract Pharmacy Services-pa]
  • Contract Pharmacy Services-pa
    Divalproex Sodium Tablet, Delayed Release [Contract Pharmacy Services-pa]
  • Physicians Total Care, Inc.
    Divalproex Sodium Tablet, Delayed Release [Physicians Total Care, Inc.]
  • Wockhardt Limited
    Divalproex Sodium Tablet, Delayed Release [Wockhardt Limited]
  • Wockhardt Usa Llc
    Divalproex Sodium Tablet, Delayed Release [Wockhardt Usa Llc]
  • Watson Pharma, Inc.
    Divalproex Sodium Tablet, Delayed Release [Watson Pharma, Inc.]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Delayed Release [Remedyrepack Inc. ]
  • Cadila Healthcare Limited
    Divalproex Sodium Capsule, Coated Pellets [Cadila Healthcare Limited]
  • Remedyrepack Inc.
    Divalproex Sodium (Divalproex Sodium) Tablet, Delayed Release [Remedyrepack Inc. ]
  • Cadila Healthcare Limited
    Divalproex Sodium Tablet, Delayed Release [Cadila Healthcare Limited]
  • Remedyrepack Inc.
    Divalproex Sodium (Divalproex Sodium) Tablet, Delayed Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Divalproex Sodium (Divalproex Sodium ) Tablet, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Divalproex Sodium (Divalproex Sodium ) Tablet, Extended Release [Remedyrepack Inc. ]
  • Physicians Total Care, Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Physicians Total Care, Inc.]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Extended Release [Remedyrepack Inc. ]
  • Pd-rx Pharmaceuticals, Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Pd-rx Pharmaceuticals, Inc.]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Delayed Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Delayed Release [Remedyrepack Inc. ]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Divalproex Sodium Tablet, Film Coated, Extended Release [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Mckesson Contract Packaging
    Divalproex Sodium Tablet, Film Coated, Extended Release [Mckesson Contract Packaging]
  • Mckesson Contract Packaging
    Divalproex Sodium Tablet, Delayed Release [Mckesson Contract Packaging]
  • Mckesson Contract Packaging
    Divalproex Sodium Capsule [Mckesson Contract Packaging]
  • Mylan Institutional Inc.
    Divalproex Sodium Capsule [Mylan Institutional Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Divalproex Sodium Tablet, Film Coated, Extended Release [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Bryant Ranch Prepack
    Divalproex Sodium Tablet, Delayed Release [Bryant Ranch Prepack]
  • Mylan Institutional Inc.
    Divalproex Sodium Tablet, Delayed Release [Mylan Institutional Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Divalproex Sodium Tablet, Delayed Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Remedyrepack Inc. ]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Divalproex Sodium Tablet, Delayed Release [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Cardinal Health
    Divalproex Sodium Tablet, Film Coated, Extended Release [Cardinal Health]
  • Cadila Healthcare Limited
    Divalproex Sodium Tablet, Film Coated, Extended Release [Cadila Healthcare Limited]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Divalproex Sodium Capsule [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Upsher-smith Laboratories, Inc.
    Divalproex Sodium Tablet, Delayed Release [Upsher-smith Laboratories, Inc.]
  • American Health Packaging
    Divalproex Sodium Tablet, Film Coated, Extended Release [American Health Packaging]
  • Unit Dose Services
    Divalproex Sodium Tablet, Delayed Release [Unit Dose Services]
  • Major Pharmaceuticals
    Divalproex Sodium Tablet, Film Coated, Extended Release [Major Pharmaceuticals]
  • Citron Pharma Llc
    Divalproex Sodium Tablet, Delayed Release [Citron Pharma Llc]
  • Aidarex Pharmaceuticals Llc
    Divalproex Sodium Tablet, Delayed Release [Aidarex Pharmaceuticals Llc]
  • American Health Packaging
    Divalproex Sodium Capsule, Coated Pellets [American Health Packaging]
  • Unichem Pharmaceuticals (Usa), Inc.
    Divalproex Sodium Tablet, Delayed Release [Unichem Pharmaceuticals (Usa), Inc.]
  • Upsher-smith Laboratories, Inc.
    Divalproex Sodium Tablet, Delayed Release [Upsher-smith Laboratories, Inc.]
  • Mylan Pharmaceuticals Inc.
    Divalproex Sodium Capsule, Delayed Release [Mylan Pharmaceuticals Inc.]
  • State Of Florida Doh Central Pharmacy
    Divalproex Sodium Tablet, Film Coated, Extended Release [State Of Florida Doh Central Pharmacy]
  • Cardinal Health
    Divalproex Sodium Tablet, Delayed Release [Cardinal Health]
  • Aphena Pharma Solutions – Tennessee, Llc
    Divalproex Sodium Tablet, Film Coated, Extended Release [Aphena Pharma Solutions – Tennessee, Llc]
  • Mylan Institutional Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Mylan Institutional Inc.]
  • Clinical Solutions Wholesale
    Divalproex Sodium Tablet, Delayed Release [Clinical Solutions Wholesale]
  • Carilion Materials Management
    Divalproex Sodium Tablet, Delayed Release [Carilion Materials Management]
  • Mylan Pharmaceuticals Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Mylan Pharmaceuticals Inc.]
  • Mylan Pharmaceutical Inc.
    Divalproex Sodium Tablet, Delayed Release [Mylan Pharmaceutical Inc.]
  • Teva Pharmaceuticals Usa Inc
    Divalproex Sodium Tablet, Delayed Release [Teva Pharmaceuticals Usa Inc]
  • Cardinal Health
    Divalproex Sodium Capsule, Coated Pellets [Cardinal Health]
  • Cardinal Health
    Divalproex Sodium Tablet, Film Coated, Extended Release [Cardinal Health]
  • Cardinal Health
    Divalproex Sodium Tablet, Delayed Release [Cardinal Health]
  • Remedyrepack Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Remedyrepack Inc. ]
  • Zydus Pharmaceuticals (Usa) Inc.
    Divalproex Sodium Tablet, Delayed Release [Zydus Pharmaceuticals (Usa) Inc.]
  • Zydus Pharmaceuticals (Usa) Inc.
    Divalproex Sodium Tablet, Film Coated, Extended Release [Zydus Pharmaceuticals (Usa) Inc.]
  • Zydus Pharmaceuticals (Usa) Inc.
    Divalproex Sodium Capsule, Coated Pellets [Zydus Pharmaceuticals (Usa) Inc.]
  • Lupin Pharmaceuticals, Inc.
    Divalproex Sodium Tablet, Delayed Release [Lupin Pharmaceuticals, Inc.]
  • Tya Pharmaceuticals
    Divalproex Sodium Tablet, Film Coated, Extended Release [Tya Pharmaceuticals]
  • Bluepoint Laboratories
    Divalproex Sodium Tablet, Film Coated, Extended Release [Bluepoint Laboratories]
  • Tya Pharmaceuticals
    Divalproex Sodium Tablet, Delayed Release [Tya Pharmaceuticals]