Levetiracetam

Levetiracetamis used with other medications to treat seizures (epilepsy). It belongs to a class of drugs known as anticonvulsants. Levetiracetam may decrease the number of seizures you have.

Levetiracetam is available under the following different brand names:Keppra,Keppra XR, andSpritam.

Adult and Pediatric Dosage Forms and Strengths

Tablet, immediate-release (Keppra,Generic)

• 250 mg
• 500 mg
• 750 mg
• 1 g

3-D tablet, immediate-release (Spritam)

• 250 mg
• 500 mg
• 750 mg
• 1 g

Tablet, extended-release (Keppra XR)

• 500 mg
• 750 mg

Oral solution (Keppra, Generic)

• 100 mg/mL

Injectable solution

• 5 mg/mL
• 10 mg/mL
• 15 mg/mL
• 100 mg/mL

Dosage Considerations – Should be Given as Follows:

Myoclonic Seizures

Adult

• Immediate-release (Keppra, Spritam): 500 mg intravenously (IV)/orally every 12 hours; may increase every 2 weeks by 500 mg/dose to recommended dose of 1500 mg every 12 hours
• Effectiveness of doses less than 3000 mg/day has not been adequately studied

Pediatric

Keppra, Spritam

• Children under 12 years: Safety and efficacy not established
• Children 12 years and older: 500 mg orally every 12 hours; increase by 500 mg every 12 hours every 2 weeks to recommended dose of 1500 mg every 12 hours
• Effectiveness of doses less than 3000 mg/day has not been studied

Partial OnsetSeizure

Used as adjunctive therapy

Adult

• Immediate-release (Keppra, Spritam): 500 mg orally every 12 hours; may increase every 2 weeks by 500 mg/dose; not to exceed 3000 mg/day
• Extended-release (Keppra XR): 1000 mg orally once/day; may increase every 2 weeks by 1000 mg/day; not to exceed 3000 mg/day
• Intravenous (IV): 500 mg every 12 hours; may increase every 2 weeks by 500 mg/dose; not to exceed 3000 mg/day

Pediatric

Immediate-release tablets (Keppra)

• Children under 1 month: Safety and efficacy not established
• Children 1-6 months: 7 mg/kg orally every 12 hours; increase by increments of 7 mg/kg every 12 hours every 2 weeks to recommended dose of 21 mg/kg every 12 hours
• Children 6 months-4 years: 10 mg/kg orally every 12 hours, increase in increments of 10 mg/kg every 12 hours every 2 weeks to recommended dose of 25 mg/kg every 12 hours
• Children 4-16 years: 10 mg/kg orally every 12 hours; increase every 2 weeks by 10 mg/kg/dose to 30 mg/kg every 12 hours
• Children over 16 years: 500 mg orally every 12 hours, increase by 500 mg every 12 hours every 2 weeks to recommended dose of 1500 mg every 12 hours

Immediate-release 3-D tablets (Spritam)

• Children under 4 years: Safety and efficacy not established
• Children 4 years and older weighing 20-40 kg: 250 mg orally twice daily initially; increase the daily dose every 2 weeks by increments of 500 mg (250 mg twice daily) to a maximum recommended daily dose of 1500 mg (750 mg twice daily)
• Children 4 years and older weighing greater than 40 kg: 500 mg orally twice daily initially; increase the daily dose every 2 weeks by increments of 1000 mg (500 mg twice daily) to a maximum recommended daily dose of 3000 mg (1500 mg twice daily)

延长释放平板电脑(Keppra XR)

• Children under 12 years: Safety and efficacy not established
• Children 12 years and older: 1000 mg orally once/day initially; may adjust dose by 1000 mg increments every 2 weeks to a maximum of 3000 mg/day

Primary Generalized Tonic Clonic Seizures

Adult

• Immediate-release (Keppra, Spritam): 500 mg intravenously (IV)/orally every 12 hours; may increase every 2 weeks by 500 mg/dose to recommended dose of 1500 mg every 12 hours
• Effectiveness of doses less than 3000 mg/day has not been adequately studied

Pediatric

• Children under 6 years: Safety and efficacy not established
• Keppra
• Children 6-16 years: 10 mg/kg orally every 12 hours; increase every 2 weeks by 10 mg/kg/dose to recommended dose of 30 mg/kg every 12 hours; efficacy of doses less than 60 mg/kg/day not established
• Children over 16 years: 500 mg orally every 12 hours, increase by 500 mg every 12 hours every 2 weeks to recommended dose of 1500 mg every 12 hours

Spritam

• Children 6 years and older weighing 20-40 kg: 250 mg orally twice daily initially; increase the daily dose every 2 weeks by increments of 500 mg (250 mg twice daily) to a maximum recommended daily dose of 1500 mg/day (750 mg twice daily)
• Children 6 years and older weighing greater than 40 kg: 500 mg orally twice daily initially; increase the daily dose every 2 weeks by increments of 1000 mg (500 mg twice daily) to a maximum recommended daily dose of 3000 mg (1500 twice daily)
• Effectiveness of doses less than 3000 mg/day has not been adequately studied

Renal Impairment

Immediate Release and Intravenous (IV) Formulations

• CrCl greater than 80 mL/min/1.73 m²: Dose adjustment not required
• CrCl 50-80 mL/min/1.73 m²: 500-1000 mg orally every 12 hours
• CrCl 30-50 mL/min/1.73 m²: 250-750 mg orally every 12 hours
• CrCl less than 30 mL/min/1.73 m²: 250-500 mg orally every 12 hours
• Dialysis(conventional): 500-1000 mg orally once/day, THEN 250-500 mg supplemental dose after dialysis

Extended Release Tablets

• CrCl greater than 80 mL/min/1.73 m²: Dose adjustment not required
• CrCl 50-80 mL/min/1.73 m²: 1000-2000 mg orally every 24 hours
• CrCl 30-50 mL/min/1.73 m²: 500-1500 mg orally every 24 hours
• CrCl less than 30 mL/min/1.73 m²: 500-1000 mg orally every 24 hours
• End-stage renal diseaserequiringhemodialysis: Immediate release formulation recommended

Common side effects of levetiracetam include:

Weakness/lack of energy

Headache

Infection

Increased blood pressure

Drowsiness

Fatigue

Loss of appetite

Runny orstuffy nose

Cough

Viral infection

Asthma

Dizziness

Nervousness

Amnesia

Anxiety

Loss of control of bodily movements

Depression

Hostility

Numbness and tingling

Sinusinfection (sinusitis)

Double vision

Lazy eye

Conjunctivitis

Albuminuria

Tiredness

Sleepiness

Accidental injury

Less common side effects of levetiracetam include:

• Abnormal hepatic function tests
• Involuntarymuscle movements
• Eczema
• Lowwhite blood cell count(neutropenia,leukopenia)
• Decreasedhematocrit
• Suicidal tendencies
• Hepatitis
• Pancreatitis
• Bone marrowsuppression
• Epidermalnecrolysis

Postmarketing side effects of levetiracetam reported include:

• Hepatic: Abnormal liver function tests, hepatic failure, hepatitis, pancreatitis
• Skin: Hair loss,erythema multiforme; drug rash witheosinophiliaand systemic syndrome (DRESS)
• Neurologic: Choreoathetosis,dyskinesia
• Hematology: Leukopenia, neutropenia,pancytopenia,thrombocytopenia
• Skeletomuscular: Muscle weakness
• Psychological: Panic attack
• General: Weight loss
• Low blood sodium (hyponatremia)
• Acute kidney injury

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.

Levetiracetam has no known severe or serious interactions with other drugs.

Moderate interactions of levetiracetam include:

• deutetrabenazine
• lurasidone
• orlistat
• sevelamer

Levetiracetam has mild interactions with at least 21 different drugs.

这个文档做es not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains levetiracetam. Do not take Keppra, Keppra XR, or Spritam if you are allergic to levetiracetam or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity

Effects of Drug Abuse

• No information available

Short-Term Effects

• Drowsiness (somnolence) and weakness/lack of energy (asthenia) occurred most frequently within first 4 weeks of treatment; patients should be monitored for signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects ability to drive or operate machinery.
• See "What Are Side Effects Associated with Using Levetiracetam?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Levetiracetam?"

Cautions

• Drowsiness (somnolence) and weakness/lack of energy (asthenia) occurred most frequently within first 4 weeks of treatment; patients should be monitored for signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects ability to drive or operate machinery.
• Withdraw gradually.
• Psychiatric reactions: 13.3% of adults and 37.6% of children treated with levetiracetam reported nonpsychotic behavioral symptoms (e.g., aggression, agitation, anger, anxiety, apathy, depersonalization,lability, hostility, hyperkinesis, irritability, nervousness,neurosis, andpersonality disorder) compared to 6.2% and 18.6% of adult and pediatric placebo patients respectively; dose reduction or discontinuation may be required.
• Monitor patients for behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, aggressive behavior, and for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior.
• Serious dermatological reactions, includingStevens-Johnson syndrome(SJS) andtoxic epidermal necrolysis(TEN) reported; median time of onset is reported to be 14-17 days; if signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.
• Drug rash with eosinophilia and systemic syndrome (DRESS) reported.
• May impair ability to operate heavy machinery.
• Decreases in red blood cell count, hematocrit,hemoglobin, neutrophils, and white blood cell counts reported.
• Increases in eosinophil counts observed.
• Monitor patients 1 month to under 4 years of age for increases indiastolicblood pressure.
• Seizure control during pregnancy: Physiological changes during pregnancy may gradually decrease therapeutic plasma concentrations, this is particularly pronounced during the 3rd trimester; closely monitor serum levels during pregnancy and through thepostpartumperiod.
• Agranulocytosisreported; in pediatric patients (4 to under 16 years of age), statistically significant decreases in white blood cell (WBC) andneutrophilcounts were seen in patients treated with immediate-release levetiracetam; no patient was discontinued secondary to low WBC or neutrophil counts.
• One percent of adult patients and 2% of pediatric patients (4 to 16 years of age) treated with immediate-release levetiracetam experienced psychotic symptoms (paranoia).
• Use caution in renal impairment; adjust dose; use immediate release formulation, instead of the extended release formulation, in patients withend stagerenal disease (ESRD) requiring hemodialysis.

怀孕和哺乳

• Use levetiracetam with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done. As with all antiepileptic drugs, physiological changes (i.e., intravascular volume expansion) during pregnancy may affect therapeutic levels and result in decreased serum concentrations.
• Levetiracetam is excreted in breast milk; it is not recommended for use while breastfeeding.