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

Divalproex Sodium Delayed Release

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING





WARNINGSINFORMATION FOR PATIENTS


WARNINGSPRECAUTIONS

DESCRIPTION


DESCRIPTION



















PHARMACODYNAMICS



PHARMACOKINETICS

Absorption/Bioavailability



DOSAGE AND ADMINISTRATION

Distribution

Protein Binding
PRECAUTIONSDrug Interactions

CNS Distribution


Metabolism


Elimination



Special Populations

Effect of Age

Neonates


Children


Elderly
DOSAGE AND ADMINISTRATION

Effect of Gender


Effect of Race


Effect of Disease

Liver Disease
BOXED WARNINGCONTRAINDICATIONSWARNINGS

Renal Disease


Plasma Levels and Clinical Effect



Epilepsy


Mania
DOSAGE AND ADMINISTRATION

CLINICAL PHARMACOLOGY

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

CLINICAL PHARMACOLOGY





Migraine









CLINICAL PHARMACOLOGY



Epilepsy




*Add-on TreatmentNumber of PatientsBaseline IncidenceExperimental Incidence*
CLINICAL PHARMACOLOGY







*TreatmentNumber ofBaseline IncidenceRandomized PhasePatientsIncidence*




CLINICAL PHARMACOLOGY


INDICATIONS & USAGE

Mania

Clinical TrialsCLINICAL PHARMACOLOGY


Epilepsy



Migraine
WARNINGSUsage In PregnancyPRECAUTIONSInformation for Patients
WARNINGS

CONTRAINDICATIONS



WARNINGS

WARNINGS



Hepatotoxicity




Pancreatitis
BOXED 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







Indication Placebo Drug PatientsRelative Risk: IncidenceRisk Difference:Patients w/with Eventsof Events in Drug Patients/Additional Drug PatientsEvents PerPer 1000Incidence in Placebowith Events Per 10001000 PatientsPatientsPatientsPatients



Interaction with Carbapenem Antibiotics
Drug Interactions

Somnolence in the Elderly
DOSAGE AND ADMINISTRATION

Thrombocytopenia
PRECAUTIONS

PRECAUTIONS

Hepatic Dysfunction
BOXED WARNINGCONTRAINDICATIONSWARNINGS

Pancreatitis
BOXED WARNINGWARNINGS

Hypothermia
Drug InteractionsTopiramate

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

Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use
PRECAUTIONSHypothermiaCONTRAINDICATIONSWARNINGSUrea Cycle DisordersPRECAUTIONSHyperammonemia

General
WARNINGS
PRECAUTIONSDrug Interactions





Multi-organ Hypersensitivity Reaction


INFORMATION FOR PATIENTS

Pancreatitis


Hyperammonemia
PRECAUTIONSHyperammonemia

CNS Depression


Birth Defects

PRECAUTIONSPregnancy

Suicidal Thinking and Behavior
WARNINGS

Multi-organ Hypersensitivity Reaction
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
WARNINGS

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

Amitriptyline/Nortriptyline


Carbamazepine/carbamazepine 10,11-Epoxide


Clonazepam


Diazepam


Ethosuximide


Lamotrigine


Phenobarbital




Phenytoin



Tolbutamide


Topiramate
CONTRAINDICATIONSWARNINGSUrea Cycle DisordersPRECAUTIONSHyperammonemia and Encephalopathy Associated with Concomitant Topiramate UsePRECAUTIONSHypothermiaHyperammonemia

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

Pregnancy category D


NURSING MOTHERS



PEDIATRIC USE

BOXED WARNING






GERIATRIC USE


WARNINGSSomnolence in the ElderlyDOSAGE AND ADMINISTRATION


ADVERSE REACTIONS

Mania



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























Migraine



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























Epilepsy




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

*
*Body System/EventHigh Dose (%) (n = 131)Low Dose (%) (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 STUDIESDrug InteractionsPRECAUTIONSDrug Interactions

Simple and Complex Absence Seizures

CLINICAL PHARMACOLOGY
PRECAUTIONS



Migraine


General Dosing Advice

Dosing in Elderly Patients
WARNINGS

Dose-Related Adverse Events
PRECAUTIONS

G.I. Irritation


HOW SUPPLIED






















SPL PATIENT PACKAGE INSERT

PATIENT INFORMATION









  • ●Women taking any of these medications who are planning to get pregnant should discuss the treatment options with their doctor.
  • ●Information For Women Who Become Pregnant

  • ●Other Important Information

  • ●If you have taken more than the prescribed dose of your medication, 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














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION



Divalproex Sodium Delayed Release

Divalproex Sodium Delayed Release TABLET, DELAYED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-196(NDC:62756-798)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Divalproex sodium valproic acid 500 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
POVIDONE K30
HYPROMELLOSES
titanium dioxide
triacetin
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
talc
TRIETHYL CITRATE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 6
FERRIC OXIDE YELLOW

Product Characteristics

Color Size Imprint Code Shape
pink 19 mm 798 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-196-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078597 2011-04-20


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