Depakote Sprinkle Capsules

DRUG DESCRIPTION

Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:

Depakote (divalproex sodium) structural formula illustration

Divalproex sodium occurs as a white powder with a characteristic odor. Depakote Sprinkle Capsules (divalproex sodium sprinkle capsules) are for oral administration. Depakote Sprinkle Capsules contain specially coated particles of divalproex sodium equivalent to 125 mg of valproic acid in a hard gelatin capsule.

Inactive Ingredients

125 mg Depakote Sprinkle Capsules (divalproex sodium sprinkle capsules) : cellulosic polymers, D&C Red No. 28, FD&C Blue No. 1, gelatin, iron oxide, magnesium stearate, silica gel, titanium dioxide, and triethyl citrate.

What are the possible side effects of divalproex sodium (Depakote, Depakote ER, Depakote Sprinkles)?

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive...

Read All Potential Side Effects and See Pictures of Depakote Sprinkle Capsules

What are the precautions when taking divalproex sodium sprinkle capsules (Depakote Sprinkle Capsules)?

See also Warning section.

Before taking divalproex sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or valproate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this drug, consult your doctor or pharmacist if you have: liver disease, pancreatitis, certain metabolic disorders (urea cycle disorders).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol abuse, bleeding problems, brain disease (dementia), kidney disease, low body water (dehydration), poor...

Read All Potential Precautions of Depakote Sprinkle Capsules


Depakote Sprinkle Capsules Consumer (continued)

SIDE EFFECTS: See also Warning section.

Diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness, weight changes may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: signs of infection (e.g., fever, persistent sore throat).

Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, easy bruising/unexplained bleeding, fast/irregular heartbeat, swelling of hands/feet, uncontrolled eye movement (nystagmus).

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes or skin.

Severe (sometimes fatal) brain disorder (encephalopathy) has rarely occurred, particularly in patients with certain metabolic disorders (urea cycle disorders). Tell your doctor immediately if you develop unexplained weakness and vomiting or sudden mental changes.

If you notice coated particles in your stool, they are harmless. These specially coated particles do not completely dissolve and may be passed in the stool.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking divalproex sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or valproate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this drug, consult your doctor or pharmacist if you have: liver disease, pancreatitis, certain metabolic disorders (urea cycle disorders).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol abuse, bleeding problems, brain disease (dementia), kidney disease, low body water (dehydration), poor nutrition.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially drowsiness or tremor.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Your doctor may switch the type of medication you use during pregnancy.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Depakote Sprinkle Capsules Patient Information Including Side Effects

Brand Names: Depakote, Depakote ER, Depakote Sprinkles

Generic Name: divalproex sodium (Pronunciation: dye val PRO ex)

  • What is divalproex sodium (Depakote Sprinkle Capsules)?
  • What are the possible side effects of divalproex sodium (Depakote Sprinkle Capsules)?
  • What is the most important information I should know about divalproex sodium (Depakote Sprinkle Capsules)?
  • What should I discuss with my healthcare provider before taking divalproex sodium (Depakote Sprinkle Capsules)?
  • How should I take divalproex sodium (Depakote Sprinkle Capsules)?
  • What happens if I miss a dose (Depakote Sprinkle Capsules)?
  • What happens if I overdose (Depakote Sprinkle Capsules)?
  • What should I avoid while taking divalproex sodium (Depakote Sprinkle Capsules)?
  • What other drugs will affect divalproex sodium (Depakote Sprinkle Capsules)?
  • Where can I get more information?

What is divalproex sodium (Depakote Sprinkle Capsules)?

Divalproex sodium affects chemicals in the body that may be involved in causing seizures.

Divalproex sodium is used to treat various types of seizure disorders. Divalproex sodium is sometimes used together with other seizure medications.

Divalproex sodium may also be used for other purposes not listed in this medication guide.

What are the possible side effects of divalproex sodium (Depakote Sprinkle Capsules)?

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • unexplained weakness with vomiting and confusion or fainting;
  • easy bruising or bleeding, blood in your urine;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • fever, chills, body aches, flu symptoms;
  • urinating less than usual;
  • hallucinations (seeing things that aren't there);
  • extreme drowsiness, lack of coordination; or
  • double vision or back-and-forth movements of the eyes.

Less serious side effects may include:

  • mild drowsiness or weakness;
  • diarrhea, constipation, upset stomach;
  • depression, anxiety, or other emotional changes;
  • changes in your menstrual periods;
  • enlarged breasts;
  • tremor (shaking);
  • hair loss;
  • weight changes;
  • vision changes; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about divalproex sodium (Depakote Sprinkle Capsules)?

In rare cases, divalproex sodium has caused life-threatening liver failure, especially in children younger than 2 years old. Children may be at even greater risk for liver problems if they use more than one seizure medication, if they have a metabolic disorder, or if they have a brain disease causing mental impairment (such as Creutzfeldt-Jacob disease, Huntington disease, multiple sclerosis, or a brain injury or infection).

Seek emergency medical attention if the person taking this medicine has nausea, vomiting, stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis.

Divalproex sodium can cause birth defects. Do not use this medication without your doctor's consent if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

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