Divalproex Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Divalproex Sodium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING





WARNINGSINFORMATION FOR PATIENTS


WARNINGSPRECAUTIONS

DIVALPROEX SODIUM DESCRIPTION


Divalproex Sodium



CLINICAL PHARMACOLOGY

Pharmacodynamics


Pharmacokinetics

Absorption/Bioavailability



DOSAGE AND ADMINISTRATION


PRECAUTIONSDrug Interactions















DOSAGE AND ADMINISTRATION






BOX WARNINGCONTRAINDICATIONSWARNINGS



Plasma Levels and Clinical Effect





DOSAGE AND ADMINISTRATION

Clinical Trials

Mania




YMRS Total ScoreGroupBaseline*BL to Wk 3DifferenceBPRS-A Total ScoreGroupBaseline*BL to Wk 3DifferenceGAS ScoreGroupBaseline*BL to Wk 3Difference*







MRS Total ScoreGroupBaseline*BL to Day 21DifferenceMSS Total ScoreGroupBaseline*BL to Day 21DifferenceBIS Total ScoreGroupBaseline*BL to Day 21Difference*





Divalproex Sodium

Migraine








Divalproex Sodium




Epilepsy




Add-on TreatmentNumber of PatientsBaseline IncidenceExperimental Incidence**


Divalproex Sodium





TreatmentNumber ofBaselineRandomized PhasePatientsIncidenceIncidence**


Divalproex Sodium



INDICATIONS & USAGE

Mania

Clinical TrialsCLINICAL PHARMACOLOGY


Epilepsy



Migraine
WARNINGSUsage In PregnancyPRECAUTIONSInformation for Patients
WARNINGS

DIVALPROEX SODIUM CONTRAINDICATIONS



WARNINGS

WARNINGS

Hepatotoxicity




Pancreatitis
BOX WARNING

Urea Cycle Disorders (UCD)
CONTRAINDICATIONSPRECAUTIONS

Usage In Pregnancy




HUMAN DATA

Congenital Malformations



Neural Tube Defects




Other Adverse Pregnancy Effects
PRECAUTIONSGeneralWARNINGS
WARNINGSHepatotoxicityBOX WARNING

ANIMAL DATA


Suicidal Behavior and Ideation










Drug Interactions

DOSAGE AND ADMINISTRATION

PRECAUTIONS

PRECAUTIONS

Hepatic Dysfunction
BOXED WARNINGCONTRAINDICATIONSWARNINGS

Pancreatitis
BOXED WARNINGWARNINGS

Hypothermia


Hyperammonemia
HypothermiaCONTRAINDICATIONSWARNINGSUrea Cycle Disorders(UCD)PRECAUTIONSHyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use
CONTRAINDICATIONSWARNINGSUrea Cycle DisordersPRECAUTIONSHyperammonemia

Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use
HypothermiaCONTRAINDICATIONSWARNINGSUrea Cycle DisordersPRECAUTIONSHyperammonemia

General
WARNINGS
PRECAUTIONSDrug Interactions





Multi-organ Hypersensitivity Reaction


INFORMATION FOR PATIENTS

Pancreatits


Hyperammonemia
PRECAUTIONSHyperammonemia

CNS Depression


Birth Defects
Patient Information Leaflet
Pregnancy

WARNINGS

PRECAUTIONSMulti-organ Hypersensitivity Reaction

DRUG INTERACTIONS

Effects of Co-Administered Drugs on Valproate Clearance:





Drugs for which a potentially important interaction has been observed:

Aspirin


Felbamate


Carbapenem Antibiotics


Rifampin


Drugs for which either no interaction or a likely clinically unimportant interaction has been observed:

Antacids


Chlorpromazine


Haloperidol


Cimetidine and Ranitidine


Effects of Valproate on Other Drugs:



Drugs for which a potentially important valproate interaction has been observed:



Carbamazepine/carbamazepine-10,11-Epoxide


Clonazepam


Diazepam


Ethosuximide


Lamotrigine


Phenobarbital




Phenytoin



Tolbutamide


Topiramate
CONTRAINDICATIONSWARNINGSUrea Cycle DisordersPRECAUTIONSHyperammonemiaHyperammonemia and Encephalopathy Associated with Concomitant Topiramate UseHypothermia and Hyperammonemia

Warfarin


Zidovudine


Drugs for which either no interaction or a likely clinically unimportant interaction has been observed:

Acetaminophen


Clozapine


Lithium


Lorazepam


Oral Contraceptive Steroids


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis


Mutagenesis


Fertility


PREGNANCY

WARNINGS


NURSING MOTHERS



PEDIATRIC USE

BOX WARNING






GERIATRIC USE

Geriatric Use

Somnolence in the ElderlyDOSAGE AND ADMINISTRATION


DIVALPROEX SODIUM ADVERSE REACTIONS

Mania



*
Adverse EventDivalproex Sodium Delayed-Placebo (n=97)release Tablets (n = 89)*














Migraine



*
Body System EventDivalproex Sodium Delayed- Placeborelease Tablets(N = 81)(n = 202)Gastrointestinal SystemNervous SystemOther*














Epilepsy




Body System/EventDivalproex Sodium Delayed-Placebo (%)release Tablets (%)(n = 70)(n = 77)Body as a WholeGastrointestinal SystemNervous SystemRespiratory SystemOther



*
High Dose (%)Low Dose (%)Body System/Event(n = 131)(n = 134)Body as a WholeDigestive SystemHemic/Lymphatic SystemMetabolic/NutritionalNervous SystemRespiratory SystemSkin and AppendagesSpecial Senses*














Other Patient Populations


Gastrointestinal:


CNS Effects:
WARNINGSUrea Cycle DisordersPRECAUTIONS


Dermatologic:
PRECAUTIONSDrug Interactions

Psychiatric:


Musculoskeletal:


Hematologic:
PRECAUTIONSGeneralDrug Interactions

Hepatic:
WARNINGS

Endocrine:
PRECAUTIONS


Pancreatic:
WARNINGS

Metabolic:
PRECAUTIONS




Genitourinary:


Special Senses:


Other:


OVERDOSAGE





DOSAGE & ADMINISTRATION

Mania



Epilepsy
PRECAUTIONSDrug Interactions

Complex Partial Seizures:


Monotherapy (Initial Therapy):



Conversion to Monotherapy:


Adjunctive Therapy:

Clinical studyDrug InteractionsPRECAUTIONSDrug Interactions

Simple and Complex Absence Seizures:

CLINICAL PHARMACOLOGY
PRECAUTIONS



Migraine


General Dosing Advice
WARNINGS
PRECAUTIONS


SPL PATIENT PACKAGE INSERT

SPL PATIENT PACKAGE INSERT

Important Information for Women Who Could Become Pregnant About the Use of Divalproex Sodium Delayed-release Tablets


Information For Women Who Could Become Pregnant




Information For Women Who Are Planning to Get Pregnant
  • ●      Women taking divalproex sodium delayed-release tablets who are planning to get pregnant should discuss the treatment options with their doctor.

Information For Women Who Become Pregnant
  • ●      If you become pregnant while taking divalproex sodium delayed-release tablets, you should contact your doctor immediately.

Other Important Information
  • ●      Divalproex sodium delayed-release tablets should be taken exactly as prescribed by your doctor to get the most benefits from divalproex sodium delayed-release tablets and reduce the risk of side effects.
  • ●     If you have taken more than the prescribed dose of divalproex sodium delayed-release tablets, contact your hospital emergency room or local poison center immediately.
  • ●     Your medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others.

Facts About Birth Defects



INACTIVE INGREDIENT

INACTIVE INGREDIENTS

COLLOIDAL SILICON DIOXIDE

HYPROMELLOSE
MAGNESIUM STEARATE
METHACRYLIC ACID
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TRIETHYL CITRATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Divalproex Sodium

Divalproex Sodium

Divalproex Sodium

Divalproex Sodium TABLET, DELAYED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-238(NDC:68180-265)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Divalproex sodium valproic acid 125 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
SILICON DIOXIDE
D&C RED NO. 30
FD&C BLUE NO. 2
FERROSOFERRIC OXIDE
hydroxypropyl cellulose
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
HYPROMELLOSES
MAGNESIUM STEARATE
propylene glycol
SHELLAC
STARCH, CORN
talc
titanium dioxide
TRIETHYL CITRATE

Product Characteristics

Color Size Imprint Code Shape
pink 14 mm L;005 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-238-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078790 2011-03-18


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