Complete SPL Sections#
WARNING: LIFE THREATENING ADVERSE REACTIONS
BOXED WARNING SECTION
RECENT MAJOR CHANGES
RECENT MAJOR CHANGES SECTION
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
Divalproex sodium delayed-release capsules is contraindicated in patients: with hepatic disease or significant hepatic dysfunction [see Warnings and Precautions ( 5.1 )]. known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder [see Warnings and Precautions ( 5.1 )] . with known hypersensitivity to divalproex sodium, sodium valproate, or valproic acid. Reactions have included multiorgan hypersensitivity, serious dermatologic reactions, and angioedema [see Warnings and Precautions ( 5.12 , 5.13 , 5.14 )]. with known urea cycle disorders [see Warnings and Precautions ( 5.6 )]. being treated for prophylaxis of migraine headaches: who are pregnant or in women of childbearing potential who are not using effective contraception [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 ) and Use in Specific Populations ( 8.1 )].
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
11 DESCRIPTION
DESCRIPTION SECTION
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
15 REFERENCES
REFERENCES SECTION
1. Meador KJ, Baker GA, Browning N, et al. Fetal antiepileptic drug exposure and cognitive outcomes at age 6 years (NEAD study): a prospective observational study. Lancet Neurology 2013; 12 (3):244-252.
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Divalproex Sodium Delayed-Release Capsules, USP equivalent to 125 mg of valproic acid are white to off-white free flowing pellets filled in size '0' hard gelatin capsules with blue colored cap printed with "ZA66" in black ink and white body printed with "125mg" in black ink and are supplied as follows: NDC: 70518-1749-00 NDC: 70518-1749-01 PACKAGING: 1 in 1 POUCH PACKAGING: 100 in 1 BOX Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
This Instructions for Use has been approved by the U.S Food and Drug Administration. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
SPL MEDGUIDE
SPL MEDGUIDE SECTION
MEDICATION GUIDE Divalproex Sodium (dye val' proe ex soe' dee um) Delayed-Release Capsules, USP What is the most important information I should know about divalproex sodium delayed-release capsules? Do not stop divalproex sodium delayed-release capsules without first talking to a healthcare provider.Stopping divalproex sodium delayed-release capsules suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Divalproex sodium delayed-release capsules can cause serious side effects, including: 1. Serious liver damage that can cause death, especially in children younger than 2 years old and patients with mitochondrial disorders.The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. Call your healthcare provider right away if you get any of the following symptoms: feeling very weak, tired, or uncomfortable (malaise) swelling of your face not feeling hungry nausea or vomiting that does not go away diarrhea pain on the right side of your stomach (abdomen) dark urine yellowing of your skin or the whites of your eyes loss of seizure control in people with epilepsy In some cases, liver damage may continue even though the medicine is stopped. Your healthcare provider will do blood tests to check your liver before and during treatment with divalproex sodium delayed-release capsules. 2. Divalproex sodium delayed-release capsules may harm your unborn baby. If you take divalproex sodium delayed-release capsules during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord (such as spina bifida or neural tube defects). These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Decreased hearing or hearing loss can also happen. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect. If you take divalproex sodium delayed-release capsules during pregnancy for any medical condition, your child is at risk for having lower IQ and may be at risk for developing autism or attention deficit/hyperactivity disorder. There may be other medicines to treat your condition that have a lower chance of causing birth defects, decreased IQ, or other disorders in your child. Women who are pregnant must not take divalproex sodium delayed-release capsules to prevent migraine headaches. All women of childbearing age (including girls from the start of puberty) should talk to their healthcare provider about using other possible treatments instead of divalproex sodium delayed-release capsules. If the decision is made to use divalproex sodium delayed-release capsules you should use effective birth control (contraception). Tell your healthcare provider right away if you become pregnant while taking divalproex sodium delayed-release capsules. You and your healthcare provider should decide if you will continue to take divalproex sodium delayed-release capsules while you are pregnant. Pregnancy Registry:If you become pregnant while taking divalproex sodium delayed-release capsules talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can enroll in this registry by calling toll-free 1-888-233-2334 or by visiting the website, http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. 3. Swelling (Inflammation) and bleeding (hemorrhaging) of your pancreas that can cause death. Call your healthcare provider right away if you have any of these symptoms: severe stomach pain that you may also feel in your back nausea or vomiting that does not go away not feeling hungry 4. Like other antiepileptic drugs, divalproex sodium delayed-release capsules may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying suicide attempt new or worse depression new or worse anxiety feeling agitated or restless panic attacks trouble sleeping (insomnia) new or worse irritability acting aggressive, being angry, or violent acting on dangerous impulses an extreme increase in activity and talking (mania) other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. What are divalproex sodium delayed-release capsules? Divalproex sodium delayed-release capsules are prescription medicines used: alone or with other medicines to treat: o complex partial seizures in adults and children 10 years of age and older o simple and complex absence seizures with other medications to treat: o patients with multiple seizure types that include absence seizures Do not take divalproex sodium delayed-release capsules if you: have liver problems. have or think you have a genetic liver problem caused by a mitochondrial disorder such as Alpers-Huttenlocher syndrome. are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in divalproex sodium delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in divalproex sodium delayed-release capsules. have a genetic problem called a urea cycle disorder. are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control (contraception). Before taking divalproex sodium delayed-release capsules, tell your healthcare provider about all of your medical conditions including if you: have or have had liver problems. have or think you have a genetic liver problem caused by a mitochondrial disorder such as Alpers-Huttenlocher syndrome. drink alcohol. have or have had depression, suicidal thoughts or behavior, unusual changes in mood, or thoughts about self-harm are male and plan to father a child. divalproex sodium delayed-release capsules may cause fertility problems, which may affect your ability to father a child. Talk to your healthcare provider if this is a problem for you. are pregnant or may become pregnant. divalproex sodium delayed-release capsules may harm your unborn baby. See " 2. divalproex sodium delayed-release capsules may harm your unborn baby" above for more information. are breastfeeding. divalproex sodium delayed-release capsules can pass into breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take divalproex sodium delayed-release capsules. Tell your healthcare provider about all the medicines you take,including prescription and over-the -counter medicines, vitamins and herbal supplements. Divalproex sodium delayed-release capsules may affect the way other medicines work, and other medicines may affect how divalproex sodium delayed-release capsules works. Using divalproex sodium delayed-release capsules with other medicines can cause serious side effects. Do notstart or stop other medicines without talking to your healthcare provider...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DRUG: divalproex sodium GENERIC: divalproex sodium DOSAGE: CAPSULE, COATED PELLETS ADMINSTRATION: ORAL NDC: 70518-1749-0 NDC: 70518-1749-1 COLOR: blue SHAPE: CAPSULE SCORE: No score SIZE: 22 mm IMPRINT: ZA66;125mg PACKAGING: 1 in 1 POUCH OUTER PACKAGING: 100 in 1 BOX ACTIVE INGREDIENT(S): DIVALPROEX SODIUM 125mg in 1 INACTIVE INGREDIENT(S): WATER TITANIUM DIOXIDE TALC SODIUM LAURYL SULFATE SILICON DIOXIDE SHELLAC PROPYLENE GLYCOL POTASSIUM HYDROXIDE TRIETHYL CITRATE METHACRYLIC ACID HYPROMELLOSES GELATIN FERROSOFERRIC OXIDE FD&C BLUE NO. 1 CELLULOSE, MICROCRYSTALLINE BUTYL ALCOHOL AMMONIA ISOPROPYL ALCOHOL ALCOHOL
