What is Levetiracetam and how is it used?
Levetiracetam is a prescription medicine used to treat the symptoms of partial onset seizures, tonic-clonic seizures and myoclonic seizures. Levetiracetam may be used alone or with other medications.
Levetiracetam belongs to a class of drugs called Anticonvulsants.
It is not known if Levetiracetam is safe and effective in children younger than 1 month of age when used to treat partial onset seizures, 6 years old for tonic-clonic seizures, and 12 when used to treat myoclonic seizures.
What are the possible side effects of Levetiracetam?
Levetiracetam may cause serious side effects including:
- unusual changes in mood or behavior,
- loss of balance or coordination,
- extreme drowsiness,
- feeling very weak or tired,
- difficulty walking or moving,
- skin rash, no matter how mild,
- easily bruising,
- unusual bleeding,
- weakness, and
- other signs of infection
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Levetiracetam include:
- feeling aggressive or irritable,
- loss of appetite,
- stuff nose, and
Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Levetiracetam. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
LEVETIRACETAM is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration.
The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:
Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.)
LEVETIRACETAM tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below:
250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake
500 mg tablets: iron oxide yellow
750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red
LEVETIRACETAM oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor.
Indications & Dosage
LEVETIRACETAM is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy
LEVETIRACETAM is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
Primary Generalized Tonic-Clonic Seizures
LEVETIRACETAM is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
Limitations Of Use
LEVETIRACETAM injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
DOSAGE AND ADMINISTRATION
Dosing For Partial-Onset Seizures
The recommended dosing for monotherapy and adjunctive therapy is the same as outlined below.
There is no clinical study experience with administration of intravenous levetiracetam for a period longer than 4 days.
Adults 16 Years Of Age And Older
Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.
1 Month To < 6 Months
Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily). In the clinical trial, the mean daily dose was 35 mg/kg in this age group.
6 Months To < 4 Years
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.
4 Years To < 16 Years
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.
Dosing For Myoclonic Seizures In Patients With Juvenile Myoclonic Epilepsy
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.
Dosing For Primary Generalized Tonic-Clonic Seizures
Adults 16 Years Of Age And Older
Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
Pediatric Patients 6 To <16 Years Of Age
Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg (10 mg/kg twice daily) to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied.
Switching From Oral Dosing
When switching from oral LEVETIRACETAM, the initial total daily intravenous dosage of LEVETIRACETAM should be equivalent to the total daily dosage and frequency of oral LEVETIRACETAM.
Switching To Oral Dosing
At the end of the intravenous treatment period, the patient may be switched to LEVETIRACETAM oral administration at the equivalent daily dosage and frequency of the intravenous administration.
Preparation And Administration Instructions
LEVETIRACETAM injection is for intravenous use only and should be diluted in 100 mL of a compatible diluent prior to administration. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution. Consideration should also be given to the total daily fluid intake of the patient. LEVETIRACETAM injection should be administered as a 15-minute IV infusion. One vial of LEVETIRACETAM injection contains 500 mg levetiracetam (500 mg/5 mL).
LEVETIRACETAM injection may be mixed with the following diluents and antiepileptic drugs and may be stored in polyvinyl chloride (PVC) bags. The diluted solution should not be stored for more than 4 hours at controlled room temperature [15-30°C (59-86°F)].
Sodium chloride (0.9%) injection, USP
Lactated Ringerâ€™s injection
Dextrose 5% injection, USP
Other Antiepileptic Drugs
There are no data to support the physical compatibility of LEVETIRACETAM injection with antiepileptic drugs that are not listed above.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product with particulate matter or discoloration should not be used.
Any unused portion of the LEVETIRACETAM injection vial contents should be discarded.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].