Generic drug: levetiracetam
Brand name: Roweepra
What is Roweepra (levetiracetam), and how does it work?
Roweepra (levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat:
- partial onset seizures in people 1 month of age and older withepilepsy
- myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy.
It is not known if Roweepra is safe or effective in children under 1 month of age.
This Medication Guide summarizes the most important information about Roweepra. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Roweepra that is written for health professionals. You can call 1-800-273-6729 to get information about Roweepra.
What are the side effects of Roweepra?
Roweepra can cause serious side effects.
Call your healthcare provider right away if you have any of
these symptoms:
- mood and behavior changes such as aggression, agitation,
anger, anxiety, apathy, mood swings, depression, hostility,
and irritability.
A few people may get psychotic symptoms such as
hallucinations (seeing or hearing things that are really
not there), delusions (false or strange thoughts or beliefs)
and unusual behavior. - extreme sleepiness, tiredness, and weakness
- problems with muscle coordination (problems walking
and moving) - a skin rash. Serious skin rashes can happen after you start
taking Roweepra. There is no way to tell if a mild rash
will become a serious reaction.
The most common side effects seen in people who take
Roweepra include:
The most common side effects seen in children who take
Roweepra include, in addition to those listed above:
- tiredness
- acting aggressive
- nasal congestion
- decreased appetite
- irritability
These side effects can happen at any time but happen
more often within the first 4 weeks of treatment except for
infection.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
These are not all the possible side effects of Roweepra.
For more information, ask your healthcare provider or
pharmacist.
Call your doctor for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Roweepra?
Important Administration Instructions
- Roweepra is given orally with or without food. The Roweepra dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal
function. - Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.
- When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon).
- Roweepra tablets should be swallowed whole. Roweepra tablets should not be chewed or crushed.
Dosing For Partial Onset Seizures
Adults 16 Years And Older
- Initiate treatment with a daily dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1,000 mg/day additional
every 2 weeks) to a maximum recommended daily dose of 3,000 mg. There is no evidence that doses greater than 3,000 mg/day confer additional benefit.
Pediatric Patients
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. The effectiveness of lower doses
has not been studied.
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 3,000 mg/day. - For Roweepra tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily).
Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1,500 mg (750 mg twice daily). - For Roweepra tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1,000 mg/day given as twice daily dosing (500
mg twice daily). Increase the daily dose every 2 weeks by increments of 1,000 mg/day to a maximum recommended daily dose of 3,000 mg (1,500 mg twice daily).
Levetiracetam Oral Solution, USP Weight-Based Dosing Calculation For Pediatric Patients
The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:
Total daily dose (mL/day) =
Daily dose (mg/kg/day) x patient weight(kg)
100 mg/mL
Dosing For Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy
- Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1,000 mg/day every 2 weeks to the recommended
daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been studied.
Dosing For Primary Generalized Tonic-Clonic Seizures
Adults 16 Years And Older
- Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1,000 mg/day every 2 weeks to the recommended
daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been adequately studied.
Pediatric Patients Ages 6 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). - The effectiveness of doses lower than 60 mg/kg/day has not been
adequately studied. Patients with body weight =20 kg should be dosed with
oral solution. Patients with body weight above 20 kg can be dosed with
either tablets or oral solution. Only whole tablets should be administered.
Dosage Adjustments In Adult Patients With Renal Impairment
- Roweepra dosing must be individualized according to the patient’s renal function status.
- Recommended dosage adjustments for adults are shown in Table 1.
- In order
to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for
body surface area must be calculated. - To do this an estimate
of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
CLcr =
[140-age (years)] x weight (kg)
72 x serum creatinine (mg/dL)
x 0.85 for female patients)
Then CLcr is adjusted for body surface area (BSA) as follows:
CLcr (mL/min) =
CLcr (mL/min/1.73m2)
BSA subject (m2)
x 1.73
Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment
Group
Creatinine Clearance
(mL/min/1.73m2)
Dosage (mg)
Frequency
Normal
> 80
500 to 1,500
Every 12 hours
Mild
50 – 80
500 to 1,000
Every 12 hours
Moderate
30 – 50
250 to 750
Every 12 hours
Severe
< 30
250 to 500
Every 12 hours
ESRD patients using
dialysis
–
500 to 1,0001
Every 24 hours1
1 Following dialysis, a 250 to 500 mg supplemental dose is ecommended.
What drugs interact with Roweepra?
No Information Provided
Is Roweepra safe to use while pregnant or breastfeeding?
- There are no adequate and controlled studies in pregnant women.
Levetiracetam is excreted in human milk.
- Because of the potential for serious adverse reactions in nursing infants from
Roweepra, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.