Stavzor

DRUG DESCRIPTION

Valproic acid is a carboxylic acid designated as 2-propylpentanoic acid. It is also known as dipropylacetic acid. Valproic acid (pKa 4.8) has a molecular weight of 144 and occurs as a colorless liquid with a characteristic odor. It is slightly soluble in water (1.3 mg/ml) and very soluble in organic solvents. Valproic acid has the following structure

Stavzor (valproic acid) Structural Formula Illustration

Stavzor (valproic acid) delayed release capsules are for oral administration and are provided as orange-colored, oval-shaped capsules in 3 dosage strengths: 125 mg, 250 mg, 500 mg of valproic acid.

Inactive Ingredients

Stavzor (valproic acid) delayed release capsules also contain ammonium hydroxide, gelatin, glycerin, methacrylic acid copolymer, triethyl citrate, water, and FD&C Yellow No. 6 as the colorant. Each capsule is printed with Opacode WB as the black printing ink.

What are the possible side effects of valproic acid (Depakene, Stavzor)?

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...

Read All Potential Side Effects and See Pictures of Stavzor

What are the precautions when taking valproic acid (Stavzor)?

See also Warning section.

Before taking valproic acid, tell your doctor or pharmacist if you are allergic to it; or to divalproex 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 Stavzor


Stavzor 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.

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 valproic acid, tell your doctor or pharmacist if you are allergic to it; or to divalproex 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 valproic acid.

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.


Stavzor Patient Information Including Side Effects

Brand Names: Depakene, Stavzor

Generic Name: valproic acid (Pronunciation: val PRO ik A sid)

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

What is valproic acid (Stavzor)?

Valproic acid affects chemicals in the body that may be involved in causing seizures.

Valproic acid is used to treat various types of seizure disorders. Valproic acid is sometimes used together with other seizure medications.

Valproic acid may also be used for other purposes not listed in this medication guide.

What are the possible side effects of valproic acid (Stavzor)?

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;
  • fever, chills, skin rash, swollen glands, flu symptoms;
  • urinating less than usual;
  • blood in your urine;
  • weakness, lack of coordination;
  • a red, blistering, peeling skin rash;
  • extreme drowsiness; or
  • double vision or back-and-forth movements of the eyes.

Less serious side effects may include:

  • mild drowsiness;
  • diarrhea, constipation, upset stomach;
  • 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 valproic acid (Stavzor)?

In rare cases, valproic acid has caused life-threatening liver failure, especially in children younger than 2 years old. Children of this age 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).

Valproic acid has also caused rare cases of life-threatening pancreatitis (inflammation of the pancreas). Pancreatitis can come on suddenly and symptoms may start even after you have been taking valproic acid for several years.

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.

Valproic acid can cause birth defects. Do not use this medication without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. 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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