Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Neurology | Family Medicine | Genetic Disease
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved November 1999
Treatment Area: Antiepileptic drug indicated in the treatment of partial onset seizures in adults with epilepsy
Keppra is an antiepileptic drug to be used as an adjunctive
therapy in adult patients with epilepsy for whom current therapies
have not been effective in controlling partial seizures. Partial
seizures, which are the most common type of seizures in adults, may
be characterized by impaired consciousness, loss of awareness,
involuntary motor behaviors, and other non-conscious, involuntary
events. For physicians and patients, the attraction of Keppra is
that it increases seizure control without adverse interaction with
co-administered antiepileptic drugs.
Epilepsy is caused by excessive electrical activity in the
brain. Those who suffer from the disorder (2.3 million in America
alone) experience recurring seizures. Even with treatment, only
about 50% of epilepsy patients have complete control of their
seizures, and 600,000 patients do not respond at all to the
previously available therapies.
Three clinical studies compared 3 distinct dosages of Keppra
(1000 mg/day, 2000 mg/day, or 3000 mg/day) with a placebo. All of
the 1393 epilepsy patients who participated in the trials had
continued to experience seizures during the baseline period despite
their being treated with 1-2 antiepileptic drugs. Concomitant AED
regimens were held constant during administration of Keppra.
Effectiveness of the Keppra therapy was measured primarily by
reduction in weekly partial seizure frequency for the entire
Results of the trials indicated that Keppra significantly
reduces the weekly seizure frequency over a placebo. Percent
reduction ranged from 17.1% to 30.1% depending on the study number
and the dose of Keppra in the treatment. In general, higher doses
yielded greater reduction in number of seizures, although results
varied over trials.
Another appealing result of the trials was the overall lack of
negative interaction when taken in conjunction with other AEDs.
Although Keppra was well tolerated by participants, the
following adverse events were reported during trials:
- asthenia (lack or loss of strength)
15% of patients receiving Keppra, compared to 11.6% of patients
receiving the placebo treatment discontinued therapy or had the
dose reduced as a result of an adverse effect.
Exercise caution when giving Keppra to patients
with moderate and severe renal impairment and patients undergoing
hemodialysis, since levetiracetam is substantially excreted by the
Mechanism of Action
Keppra is rapidly absorbed after oral administration and food
does not affect the extent of bioavailability. Pharmacokinetics are
linear and steady state is achieved after two days of multiple
twice daily dosing. Keppra is not protein bound (<10 percent
bound) and its metabolism is not liver cytochrome P450 dependent,
with sixty-six percent (66 percent) of the dose renally excreted
unchanged. Plasma half-life of the medication is approximately 6 to
8 hours but is increased in the elderly (due to age-related
decrease in renal function) and in patients with renal impairment.
Keppra is unlikely to produce, or be subject to, pharmacokinetic
drug interactions. (From Doctor's Guide to Medical and Other
For more information about epilepsy, visit the official
web site of the Epilepsy Foundation, a non-profit volunteer agency
devoted to research, education, advocacy, and services in the
community for people with epilepsy and their
To read more about UCB Pharma, Inc., the company that
developed Keppra, visit the UCB web site:
This is what the Epilepsy Foundation says to do
and not to do if you encounter a person having an
What To Do:
What Not To Do:
- Look for medical identification.
- Protect from nearby hazards.
- Loosen ties or shirt collars.
- Protect head from injury.
- Turn on side to keep airway clear unless injury exists.
- Reassure as consciousness returns.
- If a single seizure lasted less than 5 minutes, ask if hospital
- If there are multiple seizures, or if one seizure lasts longer
than 5 minutes, call an ambulance.
- If person is pregnant, injured, or diabetic, call for aid at
- Don't put any hard implement in the mouth.
- Don't try to hold tongue. It can't be swallowed.
- Don't try to give liquids during or just after
- Don't use artificial respiration unless breathing is absent
after muscle jerks subside, or unless water has been inhaled.
- Don't restrain.