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Keppra is used to treat partial onset seizures in adults and children who are at least 1 month old.
It is also used to treat tonic-clonic seizures in adults and children who are
at least 6 years old, and myoclonic seizures in adults and children who are at
least 12 years old.
INSTRUCTIONS
Take Keppra
exactly as prescribed by your doctor. Do not take in larger or smaller amounts
or for longer than recommended. Follow the directions on your prescription
label.
Your doctor may occasionally change your dose to make sure you get the best
results.
Keppra is usually taken twice per day. Take the medicine at the same time each
day. You may take Keppra with or without food.
Measure liquid medicine with a special dose-measuring spoon or medicine cup,
not with a regular table spoon. If you do not have a dose-measuring device, ask
your pharmacist for one.
Do not crush, chew, or break a controlled release, delayed-release, or
extended-release tablet. Swallow it whole. Breaking the pill may cause too much
of the drug to be released at one time.
Use Keppra regularly to get the most benefit. Get your prescription refilled
before you run out of medicine completely.
Do not stop using Keppra without first talking to your doctor, even if you feel
fine. You may have increased seizures if you stop using this medicine suddenly.
You may need to use less and less before you stop the medication completely.
Seizures are often treated with a combination of different drugs. Use all
medications as directed by your doctor. Read the medication guide or patient
instructions provided with each medication. Do not change your doses or
medication schedule without your doctor's advice. .
Wear a medical alert tag or carry an ID card stating that you take Keppra. Any
medical care provider who treats you should know that you take seizure
medication.
To be sure Keppra is not causing harmful effects, your kidney function may need
to be tested. Visit your doctor regularly.
If you missed a
dose - take the missed dose as soon as you remember. Skip the missed dose if it
is almost time for your next scheduled dose. Do not take extra medicine to make
up the missed dose.
DOSAGE
Important Administration Instructions
Keppra is given orally with or without food. The Keppra 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).
Keppra tablets should be swallowed whole. Keppra tablets should not be chewed
or crushed.
Pediatric Patients
·
1 Month To 6
Months
Treatment should
be initiated with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice
daily). The daily dose should be increased 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
Treatment should
be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice
daily). The daily dose should be increased 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
Treatment should
be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice
daily). The daily dose should be increased 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 efficacy trial, the mean daily dose was 44 mg/kg. The
maximum daily dose was 3000 mg/day.
For Keppra tablet dosing in pediatric patients weighing 20 to 40 kg, treatment
should be initiated with a daily dose of 500 mg given as twice daily dosing
(250 mg twice daily). The daily dose should be increased every 2 weeks by
increments of 500 mg to a maximum recommended daily dose of 1500 mg (750 mg
twice daily).
For Keppra tablet dosing in pediatric patients weighing more than 40 kg,
treatment should be initiated with a daily dose of 1000 mg/day given as twice
daily dosing (500 mg twice daily). The daily dose should be increased every 2
weeks by increments of 1000 mg/day to a maximum recommended daily dose of 3000
mg (1500 mg twice daily).
Partial Onset Seizures
Adults 16 Years And Older
In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as
twice-daily dosing were shown to be effective. Although in some studies there
was a tendency toward greater response with higher dose [see Clinical Studies],
a consistent increase in response with increased dose has not been shown.
Treatment should be initiated 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. Doses greater than 3000 mg/day have been used in open-label
studies for periods of 6 months and longer. There is no evidence that doses
greater than 3000 mg/day confer additional benefit.
Myoclonic Seizures In Patients 12 Years of Age and
Older With Juvenile Myoclonic Epilepsy
Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily
dosing (500 mg twice daily). Dosage should be increased 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.
Primary Generalized Tonic-Clonic Seizures
Adults 16 Years And Older
Treatment should be initiated with a dose of 1000 mg/day, given as twice-daily
dosing (500 mg twice daily). Dosage should be increased 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 Ages 6 To< 16 Years
Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses
(10 mg/kg twice daily). The daily dose should be increased 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.
Adult Patients With Impaired Renal Function
Keppra dosing must be individualized according to the patient's renal function
status.
STORAGE
Store Keppra at
room temperature away from moisture, heat, and light.
Side effects
· Get emergency
medical help if you have any of these signs of an allergic reaction to Keppra:
hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior
changes, depression, anxiety, or if you feel agitated, hostile, irritable,
hyperactive (mentally or physically), or have thoughts about suicide or hurting
yourself.
Call your doctor at once if you have a serious side effect such as:
- hallucinations,
unusual thoughts or behavior;
- bruising,
severe tingling, numbness, pain, muscle weakness;
- feeling
very weak or tired;
- fever,
chills, body aches, flu symptoms, sores in your mouth and throat;
- problems
with walking or movement;
- the
first sign of any skin rash, no matter how mild; or
- severe
skin reaction -- fever, sore throat, swelling in your face or tongue,
burning in your eyes, skin pain, followed by a red or purple skin rash
that spreads (especially in the face or upper body) and causes blistering
and peeling.
·
Less serious
Keppra side effects may include:
- mild
dizziness or drowsiness;
- mild
tired feeling;
- loss of
appetite; or
- stuffy
nose.
· This is not a
complete list of side effects and others may occur. Tell your doctor about any
unusual or bothersome side effect.
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