Divalproex Sodium (Page 14 of 15)

15 REFERENCES

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

Divalproex sodium delayed-release tablets USP are supplied as:

The 250 mg tablets are orange colored, oval shaped, biconvex coated tablets imprinted ‘797’ with black ink on one side and plain on the other side.

NDC: 70518-0463-00

NDC: 70518-0463-01

NDC: 70518-0463-02

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

Recommended Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].

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625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Hepatotoxicity

Warn patients and guardians that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly [see Warnings and Precautions (5.1)].

Pancreatitis

Warn patients and guardians that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly [see Warnings and Precautions (5.5)].

Birth Defects and Decreased IQ

Inform pregnant women and women of childbearing potential (including girls beginning the onset of puberty) that use of valproate during pregnancy increases the risk of birth defects, decreased IQ, and neurodevelopmental disorders in children who were exposed in utero. Advise women to use effective contraception while taking valproate. When appropriate, counsel these patients about alternative therapeutic options. This is particularly important when valproate use is considered for a condition not usually associated with permanent injury or death such as prophylaxis of migraine headache [see Contraindications (4)]. Advise patients to read the Medication Guide, which appears as the last section of the labeling [see Warnings and Precautions (5.2, 5.3, 5.4) and Use in Specific Populations (8.1)].

Pregnancy Registry

Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.

Encourage women who are taking divalproex sodium delayed-release tablets to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 or visit the website, http://www.aedpregnancyregistry.org/ [see Use in Specific Populations (8.1)].

Suicidal Thinking and Behavior

Counsel patients, their caregivers, and families that AEDs, including divalproex sodium delayed-release tablets, may increase the risk of suicidal thoughts and behavior and to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Instruct patients, caregivers, and families to report behaviors of concern immediately to the healthcare providers [see Warnings and Precautions (5.7)].

Hyperammonemia

Inform patients of the signs and symptoms associated with hyperammonemic encephalopathy and to notify the prescriber if any of these symptoms occur [see Warnings and Precautions (5.9, 5.10)].

CNS Depression

Since valproate products may produce CNS depression, especially when combined with another CNS depressant (e.g., alcohol), advise patients not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.

Multiorgan Hypersensitivity Reactions

Instruct patients that a fever associated with other organ system involvement (rash, lymphadenopathy, etc.) may be drug-related and should be reported to the physician immediately [see Warnings and Precautions (5.12)].

Medication Residue in the Stool

Instruct patients to notify their healthcare provider if they notice a medication residue in the stool [see Warnings and Precautions (5.18)].

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MEDICATION GUIDE

Divalproex Sodium
(dye val’ proe ex soe’ dee um)
Delayed-Release Tablets, USP
Read this Medication Guide before you start taking divalproex sodium delayed-release tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about divalproex sodium delayed-release tablets?
Do not stop taking divalproex sodium delayed-release tablets without first talking to your healthcare provider.
Stopping divalproex sodium delayed-release tablets suddenly can cause serious problems.
Divalproex sodium delayed-release tablets can cause serious side effects, including:
1. Serious liver damage that can cause death, especially in children younger than 2 years old. 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:

  • nausea or vomiting that does not go away
  • loss of appetite
  • pain on the right side of your stomach (abdomen)
  • dark urine
  • swelling of your face
  • yellowing of your skin or the whites of your eyes

In some cases, liver damage may continue despite stopping the drug.
2. Divalproex sodium delayed-release tablets may harm your unborn baby.

  • If you take divalproex sodium delayed-release tablets during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. 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 tablets 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 tablets 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 tablets. If the decision is made to use divalproex sodium delayed-release tablets, you should use effective birth control (contraception).
  • Tell your healthcare provider right away if you become pregnant while taking divalproex sodium delayed-release tablets. You and your healthcare provider should decide if you will continue to take divalproex sodium delayed-release tablets while you are pregnant.
  • Pregnancy Registry: If you become pregnant while taking divalproex sodium delayed-release tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug 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. Inflammation 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

4. Like other antiepileptic drugs, divalproex sodium delayed-release tablets 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
  • attempts to commit suicide
  • 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.
Do not stop divalproex sodium delayed-release tablets without first talking to a healthcare provider.
Stopping divalproex sodium delayed-release tablets 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).
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 tablets?
Divalproex sodium delayed-release tablets are prescription medicines used:

  • to treat manic episodes associated with bipolar disorder
  • alone or with other medicines to treat:
    • complex partial seizures in adults and children 10 years of age and older
    • simple and complex absence seizures, with or without other seizure types
  • to prevent migraine headaches

Who should not take divalproex sodium delayed-release tablets?
Do not take divalproex sodium delayed-release tablets if you:

  • have liver problems
  • have or think you have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
  • are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in divalproex sodium delayed-release tablets. See the end of this leaflet for a complete list of ingredients in divalproex sodium delayed-release tablets.
  • have a genetic problem called 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)

What should I tell my healthcare provider before taking divalproex sodium delayed-release tablets?
Before you take divalproex sodium delayed-release tablets, tell your healthcare provider if you:

  • have a genetic liver problem caused by a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome)
  • drink alcohol
  • are pregnant or breastfeeding. Valproate can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take divalproex sodium delayed-release tablets.
  • have or have had depression, mood problems, or suicidal thoughts or behavior
  • have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements and medicines that you take for a short period of time.
Taking divalproex sodium delayed-release tablets with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.
How should I take divalproex sodium delayed-release tablets?

  • Take divalproex sodium delayed-release tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how many divalproex sodium delayed-release tablets to take and when to take it.
  • Your healthcare provider may change your dose.
  • Do not change your dose of divalproex sodium delayed-release tablets without talking to your healthcare provider.
  • Do not stop taking divalproex sodium delayed-release tablets without first talking to your healthcare provider. Stopping divalproex sodium delayed-release tablets suddenly can cause serious problems.
  • Swallow divalproex sodium delayed-release tablets whole. Do not crush or chew divalproex sodium delayed-release tablets. Tell your healthcare provider if you can not swallow divalproex sodium delayed-release tablets whole. You may need a different medicine.
  • If you take too many divalproex sodium delayed-release tablets, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking divalproex sodium delayed-release tablets?

  • Divalproex sodium delayed-release tablets can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking divalproex sodium delayed-release tablets, until you talk with your doctor. Taking divalproex sodium delayed-release tablets with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do not drive a car or operate dangerous machinery until you know how divalproex sodium delayed-release tablets affect you. Divalproex sodium delayed-release tablets can slow your thinking and motor skills.

What are the possible side effects of divalproex sodium delayed-release tablets?

  • See “What is the most important information I should know about divalproex sodium delayed-release tablets?”

Divalproex sodium delayed-release tablets can cause serious side effects including:

  • Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.
  • High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.
  • Low body temperature (hypothermia): drop in your body temperature to less than 95°F, feeling tired, confusion, coma.
  • Allergic (hypersensitivity) reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.
  • Drowsiness or sleepiness in the elderly. This extreme drowsiness may cause you to eat or drink less than you normally would. Tell your doctor if you are not able to eat or drink as you normally do. Your doctor may start you at a lower dose of divalproex sodium delayed-release tablets.

Call your healthcare provider right away, if you have any of the symptoms listed above.

The common side effects of divalproex sodium delayed-release tablets include:

  • nausea
  • headache
  • sleepiness
  • vomiting
  • weakness
  • tremor
  • dizziness
  • stomach pain
  • blurry vision
  • double vision
  • diarrhea
  • increased appetite
  • weight gain
  • hair loss
  • loss of appetite
  • problems with walking or coordination

These are not all of the possible side effects of divalproex sodium delayed-release tablets. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store divalproex sodium delayed-release tablets?
Store divalproex sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30° C (59° to 86° F).
Keep divalproex sodium delayed-release tablets and all medicines out of the reach of children.
General information about the safe and effective use of divalproex sodium delayed-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use divalproex sodium delayed-release tablets for a condition for which it was not prescribed. Do not give divalproex sodium delayed-release tablets to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about divalproex sodium delayed-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about divalproex sodium delayed-release tablets that is written for health professionals.
For more information, call 1-800-818-4555.
What are the ingredients in divalproex sodium delayed-release tablets?
Active ingredient: divalproex sodium
Inactive ingredients:
Divalproex sodium delayed-release tablets: colloidal silicon dioxide, corn starch, povidone, pregelatinized maize starch, hypromellose, titanium dioxide, triacetin, methacrylic acid copolymer type C, talc, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, and sodium lauryl sulfate.
Imprinting ink contains shellac glaze, iron oxide black, N-butyl alcohol, propylene glycol, and ammonium hydroxide.
Individual tablets also contain:
125 mg tablets: FD&C Red #40, and FD&C Blue #2
250 mg tablets: FD&C Yellow #6, and iron oxide yellow
500 mg tablets: D&C Red #30, FD&C Blue #2, and iron oxide red
This Medication Guide has been approved by the U.S. Food and Drug Administration. * All trademarks are the property of their respective owners.

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