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Home » Directories » FDA Approved Drugs » Keppra

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Keppra

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Currently Enrolling Trials

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    General Information

    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.

    Clinical Results

    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 treatment period.

    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.

    Side Effects

    Although Keppra was well tolerated by participants, the following adverse events were reported during trials:


    • somnolence
    • asthenia (lack or loss of strength)
    • infection
    • dizziness

    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 kidney.

    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 News)

    Literature References

    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 families:
    www.efa.org

    To read more about UCB Pharma, Inc., the company that developed Keppra, visit the UCB web site:
    www.ucb.com

    Additional Information

    This is what the Epilepsy Foundation says to do and not to do if you encounter a person having an epileptic seizure:

    What 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 evaluation wanted.
    • 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 once.
    What Not To Do:

    • 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 seizure,
    • Don't use artificial respiration unless breathing is absent after muscle jerks subside, or unless water has been inhaled.
    • Don't restrain.
    Approval Date: 1999-11-01
    Date Created: 1999-12-20 12:00:00
    Company Name: UCB
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