Stavzor

Name: Stavzor

What are some other side effects of Stavzor?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Dizziness.
  • Feeling sleepy.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Belly pain.
  • Not able to sleep.
  • Feeling more or less hungry.
  • Weight gain or loss.
  • Hair loss.
  • Feeling tired or weak.
  • Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Indications and Usage for Stavzor

Mania

Stavzor is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility.

The efficacy of valproate was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)].

The safety and effectiveness of valproate for long-term use in mania, i.e., more than 3 weeks, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use Stavzor for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient.

Epilepsy

Stavzor is indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Stavzor is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.

Migraine

Stavzor is indicated for prophylaxis of migraine headaches. There is no evidence that Stavzor is useful in the acute treatment of migraine headaches.

Important Limitations

Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition [see Warnings and Precautions (5.2),(5.3),(5.4), Use in Specific Populations (8.1), and Patient Counseling Information (17)].

Stavzor is contraindicated for prophylaxis of migraine headaches in women who are pregnant.

Adverse Reactions

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Mania

The incidence of adverse reactions has been ascertained based on combined data from 2 placebo-controlled clinical trials of valproate in the treatment of manic episodes associated with bipolar disorder. The adverse reactions were usually mild or moderate in intensity, but sometimes were serious enough to interrupt treatment. In clinical trials, the rates of premature termination due to intolerance were not statistically different between placebo, valproate, and lithium carbonate. A total of 4%, 8% and 11% of patients discontinued therapy due to intolerance in the placebo, valproate, and lithium carbonate groups, respectively.

Table 2 summarizes those adverse reactions reported for patients in these trials where the incidence rate in the valproate -treated group was greater than 5% and greater than the placebo incidence, or where the incidence in the valproate -treated group was statistically significantly greater than the placebo group. Vomiting was the only event that was reported by significantly (p≤ 0.05) more patients receiving valproate compared to placebo.

Table 2. Adverse Reactions Reported by >5% of Valproate-Treated Patients During Placebo-Controlled Trials of Acute Mania*
Adverse Reaction Valproate
(n=89)
Placebo
(n=97)
* The following adverse reactions occurred at an equal or greater incidence for placebo than for valproate: back pain, headache, constipation, diarrhea, tremor, and pharyngitis.
Nausea 22% 15%
Somnolence 19% 12%
Dizziness 12% 4%
Vomiting 12% 3%
Asthenia 10% 7%
Abdominal Pain 9% 8%
Dyspepsia 9% 8%
Rash 6% 3%

The following additional adverse reactions were reported by greater than 1% but not more than 5% of the 89 valproate-treated patients in controlled clinical trials:

Body as a Whole: Chest pain, chills, chills and fever, fever, neck pain, neck rigidity.

Cardiovascular System: Hypertension, hypotension, palpitations, postural hypotension, tachycardia, vasodilation.

Digestive System: Anorexia, fecal incontinence, flatulence, gastroenteritis, glossitis, periodontal abscess.

Hemic and Lymphatic System: Ecchymosis.

Metabolic and Nutritional Disorders: Edema, peripheral edema.

Musculoskeletal System: Arthralgia, arthrosis, leg cramps, twitching.

Nervous System: Abnormal dreams, abnormal gait, agitation, ataxia, catatonic reaction, confusion, depression, diplopia, dysarthria, hallucinations, hypertonia, hypokinesia, insomnia, paresthesia, reflexes increased, tardive dyskinesia, thinking abnormalities, vertigo.

Respiratory System: Dyspnea, rhinitis.

Skin and Appendages: Alopecia, discoid lupus erythematosus, dry skin, furunculosis, maculopapular rash, seborrhea.

Special Senses: Amblyopia, conjunctivitis, deafness, dry eyes, ear pain, eye pain, tinnitus.

Urogenital System: Dysmenorrhea, dysuria, urinary incontinence.

Epilepsy

Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, valproate was generally well tolerated with most adverse reactions rated as mild to moderate in severity. Intolerance was the primary reason for discontinuation in the valproate -treated patients (6%), compared to 1% of placebo-treated patients.

Table 3 lists treatment-emergent adverse reactions which were reported by ≥5% of valproate -treated patients and for which the incidence was greater than in the placebo group, in the placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures. Since patients were also treated with other antiepilepsy drugs, it is not possible, in most cases, to determine whether the following adverse reactions can be ascribed to valproate alone, or the combination of valproate and other antiepilepsy drugs.

Table 3. Adverse Reactions Reported by > 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures
Body System/Event Valproate (%)
(n = 77)
Placebo (%)
(n = 70)
Body as a Whole
Headache 31 21
Asthenia 27 7
Fever 6 4
Gastrointestinal System
Nausea 48 14
Vomiting 27 7
Abdominal pain 23 6
Diarrhea 13 6
Anorexia 12 0
Dyspepsia 8 4
Constipation 5 1
Nervous System
Somnolence 27 11
Tremor 25 6
Dizziness 25 13
Diplopia 16 9
Amblyopia/Blurred Vision 12 9
Ataxia 8 1
Nystagmus 8 1
Emotional Lability 6 4
Thinking Abnormal 6 0
Amnesia 5 1
Respiratory System
Flu Syndrome 12 9
Infection 12 6
Bronchitis 5 1
Rhinitis 5 4
Other
Alopecia 6 1
Weight Loss 6 0

Table 4 lists treatment-emergent adverse reactions which were reported by ≥ 5% of patients in the high dose valproate group, and for which the incidence was greater than in the low dose group, in a controlled trial of valproate monotherapy treatment of complex partial seizures. Since patients were being titrated off another antiepilepsy drug during the first portion of the trial, it is not possible, in many cases, to determine whether the following adverse reactions can be ascribed to valproate alone, or the combination of valproate and other antiepilepsy drugs.

Table 4. Adverse Reactions Reported by >5% of Patients in the High-Dose Group in the Controlled Trial of Valproate Monotherapy for Complex Partial Seizures*
Body System/Event High Dose (%)
(n = 131)
Low Dose (%)
(n = 134)
* Headache was the only adverse event that occurred in ≥5% of patients in the high-dose group and at an equal or greater incidence in the low-dose group.
Body as a Whole
Asthenia 21 10
Digestive System
Nausea 34 26
Diarrhea 23 19
Vomiting 23 15
Abdominal pain 12 9
Anorexia 11 4
Dyspepsia 11 10
Hemic/Lymphatic System
Thrombocytopenia 24 1
Ecchymosis 5 4
Metabolic/Nutritional
Weight Gain 9 4
Peripheral Edema 8 3
Nervous System
Tremor 57 19
Somnolence 30 18
Dizziness 18 13
Insomnia 15 9
Nervousness 11 7
Amnesia 7 4
Nystagmus 7 1
Depression 5 4
Respiratory System
Infection 20 13
Pharyngitis 8 2
Dyspnea 5 1
Skin and Appendages
Alopecia 24 13
Special Senses
Amblyopia/Blurred Vision 8 4
Tinnitus 7 1

The following additional adverse reactions were reported by greater than 1% but less than 5% of the 358 patients treated with valproate in the controlled trials of complex partial seizures:

Body as a Whole: Back pain, chest pain, malaise.

Cardiovascular System: Tachycardia, hypertension, palpitation.

Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.

Hemic and Lymphatic System: Petechia.

Metabolic and Nutritional Disorders: SGOT increased, SGPT increased.

Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia.

Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.

Respiratory System: Sinusitis, cough increased, pneumonia, epistaxis.

Skin and Appendages: Rash, pruritus, dry skin.

Special Senses: Taste perversion, abnormal vision, deafness, otitis media.

Urogenital System: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.

Migraine

Based on 2 placebo-controlled clinical trials and their long-term extension, valproate was generally well tolerated with most adverse reactions rated as mild to moderate in severity. Of the 202 patients exposed to valproate in the placebo-controlled trials, 17% discontinued for intolerance. This is compared to a rate of 5% for the 81 placebo patients. Including the long-term extension study, the adverse reactions reported as the primary reason for discontinuation by ≥1% of 248 valproate-treated patients were alopecia (6%), nausea and/or vomiting (5%), weight gain (2%), tremor (2%), somnolence (1%), elevated SGOT and/or SGPT (1%), and depression (1%).

Table 5 includes those adverse reactions reported for patients in the placebo-controlled trials where the incidence rate in the valproate-treated group was greater than 5% and was greater than that for placebo patients.

Table 5. Adverse Reactions Reported by >5% of Valproate-Treated Patients During Migraine Placebo-Controlled Trials With a Greater Incidence Than Patients Taking Placeboa
Body System Event Valproate
(n=202)
Placebo
(n=81)
Gastrointestinal System
Nausea 31% 10%
Dyspepsia 13% 9%
Diarrhea 12% 7%
Vomiting 11% 1%
Abdominal pain 9% 4%
Increased appetite 6% 4%
Nervous System
Asthenia 20% 9%
Somnolence 17% 5%
Dizziness 12% 6%
Tremor 9% 0%
Other
Weight gain 8% 2%
Back pain 8% 6%
Alopecia 7% 1%

The following additional adverse reactions were reported by greater than 1% but not more than 5% of the 202 valproate-treated patients in the controlled clinical trials:

Body as a Whole: Chest pain, chills, face edema, fever and malaise.

Cardiovascular System: Vasodilatation.

Digestive System: Anorexia, constipation, dry mouth, flatulence, gastrointestinal disorder (unspecified), and stomatitis.

Hemic and Lymphatic System: Ecchymosis.

Metabolic and Nutritional Disorders: Peripheral edema, SGOT increase, and SGPT increase.

Musculoskeletal System: Leg cramps and myalgia.

Nervous System: Abnormal dreams, amnesia, confusion, depression, emotional lability, insomnia, nervousness, paresthesia, speech disorder, thinking abnormalities, and vertigo.

Respiratory System: Cough increased, dyspnea, rhinitis, and sinusitis.

Skin and Appendages: Pruritus and rash.

Special Senses: Conjunctivitis, ear disorder, taste perversion, and tinnitus.

Urogenital System: Cystitis, metrorrhagia, and vaginal hemorrhage.

Post Marketing Experience

The following adverse reactions have been identified during post approval use of Stavzor. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Dermatologic: Photosensitivity, erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome.

Psychiatric: Emotional upset, psychosis, aggression, hyperactivity, hostility, and behavioral deterioration.

Musculoskeletal: Fractures, decreased bone mineral density, osteopenia, osteoporosis, and weakness.

Hematologic: Relative lymphocytosis, macrocytosis, hypofibrinogenemia, leukopenia, eosinophilia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.

Endocrine: Irregular menses, secondary amenorrhea, breast enlargement, galactorrhea, polycystic ovary disease, and parotid gland swelling, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.

Genitourinary: Enuresis and urinary tract infection.

Special Senses: Hearing loss.

Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis.

Overdosage

Overdosage with valproate may result in somnolence, heart block, and deep coma. Fatalities have been reported; however patients have recovered from valproate levels as high as 2120 mcg/mL.

In overdose situations, the fraction of drug not bound to protein is high and hemodialysis or tandem hemodialysis plus hemoperfusion may result in significant removal of drug. The benefit of gastric lavage or emesis will vary with the time since ingestion. General supportive measures should be applied with particular attention to the maintenance of adequate urinary output.

Naloxone has been reported to reverse the CNS depressant effects of valproate overdosage. Because naloxone could theoretically also reverse the antiepileptic effects of valproate, it should be used with caution in patients with epilepsy.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Valproate was administered orally to rats and mice at doses of 80 and 170 mg/kg/day (less than the maximum human dose on a mg/m2 basis) for 2 years. The primary findings were an increase in the incidence of subcutaneous fibrosarcomas in high-dose male rats receiving valproate and a dose-related trend for benign pulmonary adenomas in male mice receiving valproate. The significance of these findings for humans is unknown.

Mutagenesis

Valproate was not mutagenic in an in vitro bacterial assay (Ames test), did not produce dominant lethal effects in mice, and did not increase chromosome aberration frequency in an in vivo cytogenetic study in rats. Increased frequencies of sister chromatid exchange (SCE) have been reported in a study of epileptic children taking valproate, but this association was not observed in another study conducted in adults. There is some evidence that increased SCE frequencies may be associated with epilepsy. The biological significance of an increase in SCE frequency is not known.

Fertility

Chronic toxicity studies of valproate in juvenile and adult rats and dogs demonstrated reduced spermatogenesis and testicular atrophy at oral doses of 400 mg/kg/day or greater in rats (approximately equivalent to or greater than the maximum recommended human dose (MRHD) on a mg/m2 basis) and 150 mg/kg/day or greater in dogs (approximately 1.4 times the MRHD or greater on a mg/m2 basis). Fertility studies in rats have shown no effect on fertility at oral doses of valproate up to 350 mg/kg/day (approximately equal to the MRHD on a mg/m2 basis) for 60 days. The effect of valproate on testicular development and on sperm production and fertility in humans is unknown.

Medication Guide

Stavzor® (STAV- ZOR)
(valproic acid)
Delayed Release Capsules

Read this Medication Guide before you start taking Stavzor 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 Stavzor?

Do not stop taking Stavzor without first talking to your healthcare provider.

Stopping Stavzor suddenly can cause serious problems.

Stavzor 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. Stavzor may harm your unborn baby.
  • If you take Stavzor during pregnancy for any medical condition, your baby is at risk for serious birth defects. The most common birth defects with Stavzor 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 can 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 Stavzor during pregnancy for any medical condition, your child is at risk for having a lower IQ.
  • There may be other medicines to treat your condition that have a lower chance of birth defects and decreased IQ in your child.
    • Women who are pregnant must not take Stavzor to prevent migraine headaches.
  • All women of child-bearing age should talk to their healthcare provider about using other possible treatments instead of Stavzor. If the decision is made to use Stavzor, you should use effective birth control (contraception).
  • Tell your healthcare provider right away if you become pregnant while taking Stavzor. You and your healthcare provider should decide if you will continue to take Stavzor while you are pregnant.
  • Pregnancy Registry: If you become pregnant while taking Stavzor, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. 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, Stavzor 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 Stavzor without first talking to a healthcare provider. Stopping Stavzor suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that do 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 is Stavzor?

Stavzor is a prescription medicine 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 Stavzor?

Do not take Stavzor if you:

  • have liver problems
  • are allergic to valproic acid, divalproex sodium, sodium valproate, or any of the ingredients in Stavzor. See the end of this leaflet for a complete list of ingredients in Stavzor.
  • have a genetic problem called a urea cycle disorder
  • are pregnant for the prevention of migraine headaches

What should I tell my healthcare provider before taking Stavzor?

Before you take Stavzor, tell your healthcare provider if you:

  • drink alcohol
  • are pregnant or breastfeeding. Stavzor can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Stavzor.
  • 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 Stavzor 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 Stavzor?

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

What should I avoid while taking Stavzor?

  • Stavzor can make you sleepy or dizzy. Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking Stavzor, until you talk to your doctor. Taking Stavzor with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
  • Do not drive, operate heavy machinery, or do other dangerous activities until you know how Stavzor affects you. Stavzor can slow your thinking and motor skills.

What are the possible side effects of Stavzor?

See "What is the most important information I should know about Stavzor?".

Stavzor may cause other serious side effects including:

  • Low blood count: red or purple spots on your skin, bruising, bleeding from your mouth, teeth or nose.
  • High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.
  • Low body temperature (hypothermia): drop in body temperature to less then 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 Stavzor.

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

The most common side effects of Stavzor 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 Stavzor. 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 Stavzor?

  • Store Stavzor between 59°F to 86°F (15°C to 30°C)

Keep Stavzor and all medicines out of the reach of children.

General Information about Stavzor

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Stavzor for a condition for which it was not prescribed. Do not give Stavzor 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 Stavzor. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Stavzor that is written for health professionals.

For more information, go to www.Stavzor.com or call 1-800-455-8070

What are the ingredients in Stavzor?

Active ingredient: valproic acid

Inactive ingredient: ammonium hydroxide, gelatin, glycerin, methacrylic acid copolymer, triethyl citrate, water, and FD&C Yellow No. 6 as the colorant

Manufactured for:
Noven Therapeutics, LLC
Miami, FL 33186

Manufactured by:
Banner Pharmacaps, Inc.
High Point, NC 27265

8/2014

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL-125 mg-100 count

NDC 68968-3125-1

100 Capsules

Stavzor

(valproic acid delayed release capsule)

125 mg

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL-250 mg-100 count

NDC 68968-3250-1

100 Capsules

Stavzor

(valproic acid delayed release capsule)

250 mg

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL-500 mg-100 count

NDC 68968-3500-1

100 Capsules

Stavzor

(valproic acid delayed release capsule)

500 mg

Stavzor 
valproic acid capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68968-3125
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALPROIC ACID (VALPROIC ACID) VALPROIC ACID 125 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA  
GELATIN  
GLYCERIN  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
TRIETHYL CITRATE  
WATER  
FD&C YELLOW NO. 6  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code NVN
Contains     
Packaging
# Item Code Package Description
1 NDC:68968-3125-1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022152 08/01/2008 02/28/2015
Stavzor 
valproic acid capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68968-3250
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALPROIC ACID (VALPROIC ACID) VALPROIC ACID 250 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA  
GELATIN  
GLYCERIN  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
TRIETHYL CITRATE  
WATER  
FD&C YELLOW NO. 6  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 14mm
Flavor Imprint Code NVN1
Contains     
Packaging
# Item Code Package Description
1 NDC:68968-3250-1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022152 08/01/2008 02/28/2015
Stavzor 
valproic acid capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68968-3500
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALPROIC ACID (VALPROIC ACID) VALPROIC ACID 500 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA  
GELATIN  
GLYCERIN  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)  
TRIETHYL CITRATE  
WATER  
FD&C YELLOW NO. 6  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code NVN2
Contains     
Packaging
# Item Code Package Description
1 NDC:68968-3500-1 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022152 08/01/2008 02/28/2015
Labeler - Noven Therapeutics, LLC (166888268)
Registrant - Banner Pharmacaps (002193829)
Establishment
Name Address ID/FEI Operations
Banner Pharmacaps 945494508 MANUFACTURE(68968-3125, 68968-3250, 68968-3500), ANALYSIS(68968-3125, 68968-3250, 68968-3500)
Revised: 09/2014   Noven Therapeutics, LLC

What is Stavzor?

Stavzor (valproic acid) affects chemicals in the body that may be involved in causing seizures.

Stavzor is used to treat various types of seizure disorders. It is sometimes used together with other seizure medications.

Stavzor is also used to treat manic episodes related to bipolar disorder (manic depression), and to prevent migraine headaches.

Stavzor may also be used for purposes not listed in this medication guide.

Before taking this medicine

You should not use Stavzor if you are allergic to valproic acid, or if you have:

  • liver disease;

  • a urea cycle disorder; or

  • a genetic mitochondrial (MYE-toe-KON-dree-al) disorder such as Alpers' disease or Alpers-Huttenlocher syndrome, especially in a child younger than 2 years old.

Stavzor can cause liver failure that may be fatal, especially in children under age 2 and in people with liver problems caused by a genetic mitochondrial disorder.

To make sure Stavzor is safe for you, tell your doctor if you have:

  • liver problems caused by a genetic mitochondrial disorder;

  • a history of depression, mental illness, or suicidal thoughts or actions;

  • a family history of a urea cycle disorder or infant deaths with unknown cause; or

  • HIV or CMV (cytomegalovirus) infection.

Some young people have thoughts about suicide when first taking Stavzor. Your doctor will need to check your progress at regular visits while you are using this medicine. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not use Stavzor to prevent migraine headaches if you are pregnant.

If you take Stavzor for seizures or manic episodes: valproic acid can harm an unborn baby or cause birth defects, and may affect cognitive ability (reasoning, intelligence, problem-solving) later in the child's life. However, having a seizure during pregnancy could harm both the mother and the baby. Do not start or stop taking valproic acid during pregnancy without your doctor's advice.

Use effective birth control while using Stavzor, and tell your doctor right away if you become pregnant.

Tell your doctor if you start or stop using hormonal contraception that contains estrogen (birth control pills, injections, implants, skin patches, and vaginal rings). Estrogen can interact with valproic acid and make it less effective in preventing seizures.

Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking Stavzor. There may be other seizure medications that can be more safely used during pregnancy. Follow your doctor's instructions about taking Stavzor while you are pregnant.

Valproic acid can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

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