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STAVZOR
Migraine and headache
Mood disorders
Seizure disorders
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Drug Name:

STAVZOR Rx

Generic Name and Formulations:
Valproic acid 125mg, 250mg, 500mg; delayed release caps.

Company:
Noven Therapeutics

e-Prescribe this drug via Surescripts


Therapeutic Use:

Indications for STAVZOR:

Migraine prophylaxis.

Adult Dose for STAVZOR:

Swallow whole. Initially 250mg twice daily; usual max 1g/day.

Children's Dose for STAVZOR:

Not recommended.

Contraindications:

Hepatic disease or significant hepatic dysfunction. Urea cycle disorders.

Warnings/Precautions:

Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, or hyperammonemia occurs. History of liver disease; monitor liver function and clinical symptoms (esp. for 1st 6 months). Reevaluate periodically. Avoid abrupt cessation. Evaluate for urea cycle disorders. Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, in children <2 years of age. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reevaluate periodically. May affect viral load in HIV or CMV infection. Suicidal tendencies (monitor). Elderly (reducing starting dose, titrate slowly; monitor fluid and nutritional intake, and for dehydration, somnolence, tremor, other adverse reactions). Pregnancy (Cat.D): apprise female patients of childbearing potential of risks to fetus (eg, neural tube defects). Nursing mothers: not recommended.

Interactions:

Monitor levels of valproate, ethosuximide, other anticonvulsants, and when an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, ethosuximide, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline. Potentiated by aspirin, felbamate. Levels reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenem antibiotics. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy. May interfere with urine ketone and thyroid tests. Others: see literature.

Adverse Reactions:

GI upset, somnolence, dizziness, asthenia, abdominal pain, rash, increased appetite, tremor, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, blurred vision, ataxia, nystagmus, emotional lability, abnormal thinking, amnesia, flu syndrome, infection, bronchitis, rhinitis, ecchymosis, peripheral edema, insomnia, nervousness, depression, pharyngitis, dyspnea, tinnitus; hepatotoxicity, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, multi-organ hypersensitivity syndrome.

How Supplied:

Caps—100

Indications for STAVZOR:

Acute mania associated with bipolar disorder.

Adult Dose for STAVZOR:

Swallow whole. Initially 750mg daily in divided doses; titrate rapidly to lowest effective dose; max 60mg/kg per day.

Children's Dose for STAVZOR:

Not recommended.

Contraindications:

Hepatic disease or significant hepatic dysfunction. Urea cycle disorders.

Warnings/Precautions:

Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, or hyperammonemia occurs. History of liver disease; monitor liver function and clinical symptoms (esp. for 1st 6 months). Reevaluate periodically. Avoid abrupt cessation. Evaluate for urea cycle disorders. Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, in children <2 years of age. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reevaluate periodically. May affect viral load in HIV or CMV infection. Suicidal tendencies (monitor). Elderly (reducing starting dose, titrate slowly; monitor fluid and nutritional intake, and for dehydration, somnolence, tremor, other adverse reactions). Pregnancy (Cat.D): apprise female patients of childbearing potential of risks to fetus (eg, neural tube defects). Nursing mothers: not recommended.

Interactions:

Monitor levels of valproate, ethosuximide, other anticonvulsants, and when an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, ethosuximide, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline. Potentiated by aspirin, felbamate. Levels reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenem antibiotics. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy. May interfere with urine ketone and thyroid tests. Others: see literature.

Adverse Reactions:

GI upset, somnolence, dizziness, asthenia, abdominal pain, rash, increased appetite, tremor, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, blurred vision, ataxia, nystagmus, emotional lability, abnormal thinking, amnesia, flu syndrome, infection, bronchitis, rhinitis, ecchymosis, peripheral edema, insomnia, nervousness, depression, pharyngitis, dyspnea, tinnitus; hepatotoxicity, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, multi-organ hypersensitivity syndrome.

How Supplied:

Caps—100

Indications for STAVZOR:

Monotherapy or adjunct in complex partial seizures; simple or complex absence seizures. Adjunct in multiple seizure types.

Adults and Children's Dose:

Swallow whole. Partial seizures: <10yrs: not recommended. ≥10yrs: initially 10–15mg/kg per day. Conversion to monotherapy: see literature. Absence seizures: initially 15mg/kg per day. All: give in 2–3 divided doses if total daily dose >250mg; increase weekly if needed by 5–10mg/kg per day; max 60mg/kg per day.

Contraindications:

Hepatic disease or significant hepatic dysfunction. Urea cycle disorders.

Warnings/Precautions:

Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, or hyperammonemia occurs. History of liver disease; monitor liver function and clinical symptoms (esp. for 1st 6 months). Reevaluate periodically. Avoid abrupt cessation. Evaluate for urea cycle disorders. Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, in children <2 years of age. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reevaluate periodically. May affect viral load in HIV or CMV infection. Suicidal tendencies (monitor). Elderly (reducing starting dose, titrate slowly; monitor fluid and nutritional intake, and for dehydration, somnolence, tremor, other adverse reactions). Pregnancy (Cat.D): apprise female patients of childbearing potential of risks to fetus (eg, neural tube defects). Nursing mothers: not recommended.

Interactions:

Monitor levels of valproate, ethosuximide, other anticonvulsants, and when an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, ethosuximide, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline. Potentiated by aspirin, felbamate. Levels reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenem antibiotics. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy. May interfere with urine ketone and thyroid tests. Others: see literature.

Adverse Reactions:

GI upset, somnolence, dizziness, asthenia, abdominal pain, rash, increased appetite, tremor, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, blurred vision, ataxia, nystagmus, emotional lability, abnormal thinking, amnesia, flu syndrome, infection, bronchitis, rhinitis, ecchymosis, peripheral edema, insomnia, nervousness, depression, pharyngitis, dyspnea, tinnitus; hepatotoxicity, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, multi-organ hypersensitivity syndrome.

How Supplied:

Caps—100

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