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

Divalproex Sodium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

BOX WARNING




WARNINGSINFORMATION FOR PATIENTS


WARNINGSPRECAUTIONS

DESCRIPTION


DESCRIPTION

















CLINICAL PHARMACOLOGY

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 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*





CLINICAL PHARMACOLOGY



Migraine








CLINICAL PHARMACOLOGY



Epilepsy




Add-on TreatmentNumber of PatientsBaseline IncidenceExperimental Incidence**


CLINICAL PHARMACOLOGY






TreatmentNumber ofBaseline IncidenceRandomized PhasePatientsIncidence**


CLINICAL PHARMACOLOGY





INDICATIONS & USAGE

INDICATIONS AND USAGE

Mania

Clinical TrialsCLINICAL PHARMACOLOGY


Epilepsy



Migraine
WARNINGSUsage In PregnancyPRECAUTIONSInformation for Patients
WARNINGS

CONTRAINDICATIONS

CONTRAINDICATIONS


WARNINGS

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







Indi-Placebo PatientsDrug PatientsRelative Risk: Incidence ofRisk Difference:cati-with Events Perwith Events PerEvents in Drug Patients/Additional Drug Patientson1000 Patients1000 PatientsIncidence in Placebo Patientswith Events Per 1000Patients



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 DisordersPRECAUTIONS,Hyperammonemia.)

General
Because of reports of thrombocytopenia (seeWARNINGS), inhibition of the secondary phase of platelet aggregation, and abnormal coagulation parameters, (e.g., low fibrinogen), platelet counts and coagulation tests are recommended before initiating therapy and at periodic intervals. It is recommended that patients receiving divalproex sodium delayed-release tablets be monitored for platelet count and coagulation parameters prior to planned surgery. In a clinical trial of divalproex sodium delayed-release tablets as monotherapy in patients with epilepsy, 34/126 patients (27%) receiving approximately 50 mg/kg/day on average, had at least one value of platelets75 x 109/L. Approximately half of these patients had treatment discontinued, with return of platelet counts to normal. In the remaining patients, platelet counts normalized with continued treatment. In this study, the probability of thrombocytopenia appeared to increase significantly at total valproate concentrations of110(females) or135(males). Evidence of hemorrhage, bruising, or a disorder of hemostasis/coagulation is an indication for reduction of the dosage or withdrawal of therapy.
Since divalproex sodium delayed-release tablets may interact with concurrently administered drugs which are capable of enzyme induction, periodic plasma concentration determinations of valproate and concomitant drugs are recommended during the early course of therapy. (SeePRECAUTIONS,Drug Interactions.)
Valproate is partially eliminated in the urine as a keto-metabolite which may lead to a false interpretation of the urine ketone test.
There have been reports of altered thyroid function tests associated with valproate. The clinical significance of these is unknown.
Suicidal ideation may be a manifestation of certain psychiatric disorders, and may persist until significant remission of symptoms occurs. Close supervision of high risk patients should accompany initial drug therapy.
There are in vitro studies that suggest valproate stimulates the replication of the HIV and CMV viruses under certain experimental conditions. The clinical consequence, if any, is not known. Additionally, the relevance of these in vitro findings is uncertain for patients receiving maximally suppressive antiretroviral therapy. Nevertheless, these data should be borne in mind when interpreting the results from regular monitoring of the viral load in HIV infected patients receiving valproate or when following CMV infected patients clinically.

Multi-organ Hypersensitivity Reaction


INFORMATION FOR PATIENTS

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

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
Valproate had no effect on any of the pharmacokinetic parameters of acetaminophen when it was concurrently administered to three epileptic patients.

Clozapine
In psychotic patients (n = 11), no interaction was observed when valproate was co-administered with clozapine.

Lithium
Co-administration of valproate (500 mg BID) and lithium carbonate (300 mg TID) to normal male volunteers (n = 16) had no effect on the steady-state kinetics of lithium.

Lorazepam
Concomitant administration of valproate (500 mg BID) and lorazepam (1 mg BID) in normal male volunteers (n = 9) was accompanied by a 17% decrease in the plasma clearance of lorazepam.

Oral Contraceptive Steroids
Administration of a single-dose of ethinyloestradiol (50(250to 6 women on valproate (200 mg BID) therapy for 2 months did not reveal any pharmacokinetic interaction.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis


Mutagenesis


Fertility


PREGNANCY

Pregnancy category D


NURSING MOTHERS

Nursing Mothers


PEDIATRIC USE

Pediatric Use
BOXED WARNING






GERIATRIC USE

Geriatric Use

WARNINGSSomnolence in the ElderlyDOSAGE AND ADMINISTRATION


ADVERSE REACTIONS

ADVERSE REACTIONS

Mania



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

























Migraine



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

























Epilepsy




Body System/EventDivalproex Sodium Delayed-Release TabletsPlacebo(%) (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.

  • ●     If you become pregnant while taking any of these medications, you should contact your doctor immediately.

  • ●     Your medication should be taken exactly as prescribed by your doctor to get the most benefit from your medication and reduce the risk of side effects.
  • ●     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.
















PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION



Divalproex Sodium

Divalproex Sodium TABLET, DELAYED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-139(NDC:62756-798-13)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Valproic Acid 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
D&C RED NO. 30
FD&C BLUE NO. 2
ferric oxide red

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:49349-139-02 30 in 1 BLISTER PACK

Marketing Information

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


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