Divalproex Sodium
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- DIVALPROEX SODIUM DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- DIVALPROEX SODIUM CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- DIVALPROEX SODIUM ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- SPL PATIENT PACKAGE INSERT
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
DIVALPROEX SODIUM DESCRIPTION
CLINICAL PHARMACOLOGY
PharmacodynamicsPharmacokinetics
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*
Migraine
Epilepsy
Add-on TreatmentNumber of PatientsBaseline IncidenceExperimental Incidence**
TreatmentNumber ofBaselineRandomized PhasePatientsIncidenceIncidence**
INDICATIONS & USAGE
ManiaClinical TrialsCLINICAL PHARMACOLOGY
Epilepsy
Migraine
WARNINGSUsage In PregnancyPRECAUTIONSInformation for Patients
WARNINGS
DIVALPROEX SODIUM CONTRAINDICATIONS
WARNINGS
WARNINGS
HepatotoxicityPancreatitis
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 DysfunctionBOXED 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
PancreatitsHyperammonemia
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
CarcinogenesisMutagenesis
Fertility
PREGNANCY
WARNINGSNURSING MOTHERS
PEDIATRIC USE
BOX WARNINGGERIATRIC USE
Geriatric UseSomnolence 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
ManiaEpilepsy
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 INSERTImportant 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.
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● 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 INGREDIENTSCOLLOIDAL 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 SodiumDivalproex Sodium TABLET, DELAYED RELEASE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!