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








WARNINGSPRECAUTIONS

DESCRIPTION


DESCRIPTION




INACTIVE INGREDIENT







CLINICAL PHARMACOLOGY


PHARMACODYNAMICS



PHARMACOKINETICS

Absorption/Bioavailability



DOSAGE AND ADMINISTRATION

Distribution

Protein Binding
Drug Interactions

CNS Distribution


Metabolism



Elimination



Special Populations

Effect of Age





DOSAGE AND ADMINISTRATION

Effect of Gender


Effect of Race


Effect of Disease

BOXED WARNINGCONTRAINDICATIONSWARNINGS



Plasma Levels and Clinical Effect



Epilepsy


Mania
DOSAGE AND ADMINISTRATION

Clinical Trials

Mania




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PHARMACOKINETICS




Migraine









PHARMACOKINETICS




Epilepsy




**

PHARMACOKINETICS





**

PHARMACOKINETICS



INDICATIONS & USAGE

Mania

Clinical Trials


Epilepsy



Migraine
Usage In PregnancyInformation for Patients
WARNINGS

CONTRAINDICATIONS



WARNINGS

WARNINGS

Hepatotoxicity
Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Liver function tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months. However, healthcare providers should not rely totally on serum biochemistry since these tests may not be abnormal in all instances, but should also consider the results of careful interim medical history and physical examination.
Caution should be observed when administering divalproex sodium products to patients with a prior history of hepatic disease. Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk. Experience has indicated that children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions. When divalproex sodium is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. Above this age group, experience in epilepsy has indicated that the incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.
The drug should be discontinued immediately in the presence of significant hepatic dysfunction, suspected or apparent. In some cases, hepatic dysfunction has progressed in spite of discontinuation of drug.


Pancreatitis
BOXED WARNING

Urea Cycle Disorders (UCD)
CONTRAINDICATIONSPRECAUTIONS

Usage In Pregnancy




HUMAN DATA

Congenital Malformations



Neural Tube Defects




GENERALWARNINGS
HEPATOTOXICITYBOX WARNING

ANIMAL DATA


Suicidal Behavior and Ideation










Interaction with Carbapenem Antibiotics
Drug Interations

Somnolence in the Elderly
DOSAGE AND ADMINISTRATION

Thrombocytopenia
PRECAUTIONS

PRECAUTIONS

Hepatic Dysfunction
BOXED WARNINGCONTRAINDICATIONSWARNINGS

Pancreatitis
BOXED WARNINGWARNINGS

Hypothermia
Drug Interactions

Hyperammonemia
HypothermiaCONTRAINDICATIONSUrea Cycle Disorders(UCD)Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use)
CONTRAINDICATIONSUrea Cycle DisordersHyperammonemia

Hyperammonemia and Encephalopathy Associated with Concomitant Topiramate Use
HypothermiaCONTRAINDICATIONSUrea Cycle DisordersHyperammonemia

General
WARNINGS
Drug Interactions





Multi-organ Hypersensitivity Reaction


INFORMATION FOR PATIENTS




Hyperammonemia




Pregnancy

Suicidal Thinking and Behavior
WARNINGS

Multi-organ Hypersensitivity Reaction
Multi-organ Hypersensitivity Reaction

DRUG INTERACTIONS












WARNINGS





































CONTRAINDICATIONSUrea CycleDisordersHyperammonemiaHyperammonemia and Encephalopathy Associated with Concomitant TopiramateUseHypothermiaHyperammonemia
















CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY








PREGNANCY

WARNINGS


NURSING MOTHERS



PEDIATRIC USE

BOXED WARNING






GERIATRIC USE


Somnolence in the ElderlyDOSAGE AND ADMINISTRATION


ADVERSE REACTIONS

Mania



*
*

Body as a Whole


Cardiovascular System


Digestive System


Hemic and Lymphatic System


Metabolic and Nutritional Disorders


Musculoskeletal System


Nervous System


Respiratory System


Skin and Appendages


Special Senses


Urogenital System


Migraine

Table 3

*
*

Body as a Whole


Cardiovascular System


Digestive System


Hemic and Lymphatic System


Metabolic and Nutritional Disorders


Musculoskeletal System


Nervous System


Respiratory System


Skin and Appendages


Special Senses


Urogenital System


Epilepsy






*
*

Body as a Whole


Cardiovascular System


Digestive System


Hemic and Lymphatic System


Metabolic and Nutritional Disorders


Musculoskeletal System


Nervous System


Respiratory System


Skin and Appendages


Special Senses


Urogenital System


Other Patient Populations


Gastrointestinal


CNS Effects
WARNINGSPRECAUTIONS


Dermatologic
PRECAUTIONS

Psychiatric


Musculoskeletal


Hematologic
GeneralDrug Interactions

Hepatic
WARNINGS

Endocrine
PRECAUTIONS


Pancreatic
WARNINGS

Metabolic
PRECAUTIONS




Genitourinary


Special Senses


Other


OVERDOSAGE





DOSAGE & ADMINISTRATION

Mania



Epilepsy
PRECAUTIONS

Complex Partial Seizures


Monotherapy (Initial Therapy)



Conversion to Monotherapy


Adjunctive Therapy

CLINICAL STUDIESDrug InteractionsPRECAUTIONS

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
















STORAGE AND HANDLING




INFORMATION FOR PATIENTS

Patient Information Leaflet







  • ●     Women taking divalproex sodium delayed-release tablets who are planning to get pregnant should discuss the treatment options with their doctor.

  • ●     If you become pregnant while taking divalproex sodium delayed-release tablets 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, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-405(NDC:64679-725)
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
AMMONIA
SILICON DIOXIDE
DIBUTYL SEBACATE
ETHYLCELLULOSES
HYPROMELLOSES
OLEIC ACID
POLYDEXTROSE
polyethylene glycol
cellulose, microcrystalline
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
gray 19 mm W;725 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-405-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077296 2011-07-20


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