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Keppra interactions: Common and Rare Side Effects for Keppra oral

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2009-05-13T07:44:51-04:002009-04-30T13:25:58-04:002009-05-13T07:44:51-04:00application/pdf

  • Approved Label
  • Keppra (levetiracetam)
  • FDA
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    Keppra, Keppra XR, Roweepra (levetiracetam) Uses, Side Effects, Dosage & Interactions

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    oblong, yellow, imprinted with ucb 500

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    oblong, orange, imprinted with ucb 750

    Levetiracetam 1000 mg-AMN

    oval, white, imprinted with OL 1000

    Levetiracetam 1000 mg-TEV

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    Levetiracetam 750 mg-TEV

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    Keppra Consumer Medicine Information

    Revised: 11 June 2015

    Consumer Medicine Information

    Keppra

    ®

    levetiracetam tablets and oral solution
    What is in this leaflet

    This leaflet answers some common questions about Keppra.

    It does not contain all the available information. It does not take the place of talking to your doctor
    or pharmacist.

    All medicines have risks and benefits. Your doctor has weighed the risks of you taking Keppra against the
    benefits they expect it will have for you.

    If you have any concerns about taking this medicine, ask your doctor or pharmacist.

    Keep this leaflet with the medicine. You may need to read it again.

    What Keppra is used for

    Keppra is used to control epilepsy.

    Epilepsy is a condition where you have repeated seizures (fits). There are many different types of
    seizures, ranging from mild to severe.

    Keppra belongs to a group of medicines called antiepileptics. These medicines are thought to work by
    controlling brain chemicals which send signals to nerves so that seizures do not happen.

    Keppra may be used alone, or in combination with other medicines, to treat your condition.

    Your doctor may prescribe Keppra in addition to your current therapy.

    Ask your doctor if you have any questions about why Keppra has been prescribed for you.

    There is no evidence that Keppra is addictive.

    This medicine is available only with a doctor’s prescription.

    The safety and effectiveness of Keppra has not been established in patients less than 4 years of age.

    Before you take Keppra
    When you must not take it

    Do not take Keppra if you have an allergy to:

    If you are unsure whether any of the above conditions apply to you, ask your doctor.

    Keppra oral solution contains maltitol. Do not use Keppra oral solution if you have hereditary
    problems of fructose intolerance.

    Do not take Keppra if you are pregnant or intend to become pregnant, without talking to your
    doctor first.

    Like most antiepileptic medicines, Keppra is not recommended for use during pregnancy. However, it is
    very important to control your fits while you are pregnant. If it is necessary for you to take Keppra, your
    doctor can help you decide whether or not to take it during pregnancy.

    Do not breastfeed while taking Keppra.

    Keppra passes into breast milk.

    Do not take Keppra after the expiry date (EXP) printed on the pack.

    Do not take Keppra tablets if the packaging is torn or shows signs of tampering or if the tablets
    do not look quite right.

    Do not take Keppra oral solution if the solution is not clear or the bottle shows signs of
    tampering


    If Keppra has expired or is damaged, return to your pharmacist for disposal.

    If you are not sure whether you should start taking Keppra, talk to your doctor or pharmacist.

    Before you start to take it

    Tell your doctor or pharmacist if you have allergies to:

    • any other medicines, especially barbiturates or any other anticonvulsant medicines
    • any other substances, such as foods, preservatives or dyes

    Tell your doctor if you have or have had any medical conditions, especially the following:

    • kidney problems (renal damage, renal insufficiency, impaired renal function)
    • liver problems

    Tell your doctor if you are pregnant or intend to become pregnant.

    Keppra may affect your developing baby if you take it during pregnancy. However, it is very important to
    control your fits while you are pregnant. If it is necessary for you to take Keppra, your doctor can help
    you decide whether or not to take it during pregnancy.

    Tell your doctor if you are breast-feeding or plan to breast-feed.

    It is recommended that you do not breastfeed while taking Keppra.

    If you have not told your doctor or pharmacist about any of the above, tell them before you start
    taking Keppra.

    Taking other medicines

    Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy
    without a prescription from your pharmacy, supermarket or health food shop.

    Keppra does not interact with the oral contraceptive pill. However, you may be given Keppra together with
    other antiepileptic drugs that do interact and they may compromise contraceptive efficacy.

    Your doctor may advise you to use an additional method of contraception if you take Keppra with other
    antiepileptic drugs.

    How to take Keppra
    How much to take

    For patients 12 years of age and older, the dosage is generally between 1000mg and 3000mg each day.

    For children 4 to 11 years of age the dose is 20 mg/kg to 60 mg/kg each day.

    There is no data to support the use of Keppra for patients less than 4 years of age.

    Your doctor will tell you how much Keppra you will need to take each day. This may depend on your age,
    your condition and whether or not you are taking any other medicines.

    Your doctor may recommend that you start with a low dose of Keppra and slowly increase the dose to the
    lowest amount needed to control your epilepsy/seizures (fits).

    Follow all directions given to you by your doctor carefully.

    They may differ from the information contained in this leaflet.

    If you believe that the effect of Keppra is too weak, talk to your doctor.

    If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

    How to take it

    Keppra Tablets

    Swallow Keppra tablets whole with a glass of water.

    Keppra Oral Solution

    Swallow Keppra oral solution undiluted or diluted in a glass of water.

    To take a dose of the oral solution, open the bottle by pressing the cap and turning it anticlockwise.

    Take the syringe and place it in the bottle.

    Fill the syringe with the liquid by pulling the piston up to the graduation mark corresponding to the
    dose in milligrams (mg) prescribed by your doctor

    Remove the syringe from the bottle and take the dose (undiluted or diluted in a glass of water).


    .

    When to take it

    Keppra must be taken two times a day, once in the morning and once in the evening, at about the
    same time each day.

    Taking Keppra at the same time each day will have the best effect. It will also help you remember when to
    take the tablets/oral solution.

    It does not matter if you take Keppra before or after food.

    If you forget to take it

    Contact your doctor if you have missed one or more doses.

    Do not take a double dose to make up for the dose that you missed.

    This may increase the chance of you getting an unwanted side effect.

    If you are not sure what to do, ask your doctor or pharmacist.

    If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

    How long to take it

    Most anticonvulsant medicines take time to work, so do not be discouraged if you do not feel better
    straight away.

    Continue taking Keppra for as long as your doctor tells you to.

    Keppra helps control your condition, but does not cure it. Therefore you must take your medicine every day,
    even if you feel well.

    Do not stop taking Keppra, or change the dosage, without checking with your doctor. Do not let
    yourself run out of medicine over the weekend or on holidays.


    Stopping Keppra suddenly may cause unwanted effects or make your condition worse. Your doctor will slowly
    reduce your dose before you can stop taking it completely.

    If you take too much (overdose)

    Immediately telephone your doctor if you think that you or anyone else may have taken too much
    Keppra. Do this even if there are no signs of discomfort or poisoning.

    If you take too much Keppra you may feel drowsy.

    While you are using Keppra
    Things you must do

    Tell your doctor immediately if you notice an increase in seizures (fits).

    Tell your doctor immediately if you have symptoms of depression or thoughts of self harm.

    Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Keppra.

    If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that
    you are taking Keppra.

    Before you have any surgery or emergency treatment, tell your doctor or dentist that you are
    taking Keppra.

    Tell your doctor if you feel Keppra is not helping your condition.

    Your doctor may need to change your medicine.

    Tell your doctor if, for any reason, you have not taken Keppra exactly as prescribed.


    Otherwise, your doctor may change your treatment unnecessarily.

    If you become pregnant while taking Keppra, tell your doctor.

    Be sure to keep all of your doctor’s appointments so that your progress can be checked.


    Your doctor will check your progress and may want to take some tests from time to time. This helps to
    prevent unwanted side effects.

    Things you must not do

    Do not give Keppra to anyone else, even if their symptoms seem similar to yours or they have the
    same condition as you.

    Do not take Keppra to treat any other complaints unless your doctor tells you to.

    Do not stop using it unless your doctor tells you to.

    Things to be careful of

    Be careful driving or operating machinery until you know how Keppra affects you.

    As with other anticonvulsant medicines, Keppra may cause drowsiness in some people.

    This is more frequent at the beginning of treatment or at dosage increase.

    Make sure you know how you react to Keppra before you drive a car, operate machinery, or do anything else
    that could be dangerous if you are drowsy.

    Children should not ride a bike, climb trees or do anything else that could be dangerous if they
    are feeling drowsy or sleepy.


    Keppra may cause drowsiness and affect alertness.

    Be careful when drinking alcohol while taking Keppra.

    Combining Keppra and alcohol can make you more drowsy.

    Your doctor may suggest you avoid alcohol while you are being treated with Keppra.

    Side effects

    Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking
    Keppra.

    Keppra helps most people with epilepsy, but it may have unwanted side effects in a few people. All
    medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need
    medical treatment if you get some of the side effects.

    Ask your doctor or pharmacist to answer any questions you may have.

    If you get any side effects, do not stop taking Keppra without first talking to your doctor or
    pharmacist.

    Tell your doctor or pharmacist if you notice any of the following and they worry you:

    • dizziness
    • feeling weak
    • common cold and upper respiratory tract infections
    • feeling tired, drowsy or sleepy

    These are the more common side effects of Keppra. Mostly these are mild and short-lived.

    Other side-effects reported include:

    • mood changes such as depression, nervousness, aggression, anger, anxiety, confusion, hallucination,
      irritability

    Keppra oral solution includes methylhydroxybenzoate and parahydroxybenzoate which may cause allergic
    reactions, and maltitol which may have a mild laxative effect. Patients with rare hereditary problems of
    fructose intolerance should not take the oral solution.

    Keppra oral solution also contains glycerol which can cause headache, stomach upset and diarrhoea when
    ingested in doses greater than 10g. However, recommended doses of Keppra oral solution for children of 20kg
    or less contains less than 1.5g glycerol.

    You may not experience any of these side-effects.

    If you experience any other side-effects, tell your doctor immediately.

    If you experience more frequent or more severe seizures (fits), or thoughts of self harm tell your doctor
    immediately or go to Accident and Emergency at your nearest hospital.

    Tell your doctor if you notice anything else that is making you feel unwell.

    Other side effects not listed above may happen in some people.

    Some of these side effects can only be found when your doctor does tests from time to time to check your
    progress.

    After using Keppra
    Storage

    Keep your tablets in the pack or your solution in its original bottle until it is time to take
    it.


    If you take the tablets or solution out of their packs they will not keep well.

    Keep your tablets in a cool dry place where the temperature stays below 25°C.

    Keep your oral solution in a cool place where the temperature stays below 25°C and protect from
    light.

    Do not store Keppra or any other medicine in the bathroom or near a sink.

    Do not leave it on a window sill or in the car on hot days.

    Heat and dampness can destroy some medicines.

    Keep it where children cannot reach it.

    A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

    Disposal

    If your doctor or pharmacist tells you to stop taking Keppra or they have passed their expiry
    date, ask your pharmacist what to do with any that is left over.

    Product description
    What it looks like

    Keppra tablets are available in three strengths:

    • 250mg – blue, oblong, scored tablet with ucb and 250 stamped on one side
    • 500mg – yellow, oblong, scored tablet with ucb and 500 stamped on one side
    • 1000mg – white, oblong, scored, tablet with ucb and 1000 stamped on one side

    Keppra oral solution is available in a 100 mg/mL strength and is supplied in an amber bottle with
    a child resistant cap. It is also supplied with a measuring syringe for dosing.

    Ingredients

    Each Keppra tablet contains either 250 mg, 500mg, or 1000mg of levetiracetam as the active
    ingredient.

    Other ingredients in Keppra tablets include:

    • croscarmellose sodium
    • macrogol
    • magnesium stearate
    • silica colloidal anhydrous

    Keppra tablets are film-coated. The coating for each tablet strength contains polyvinyl alcohol, macrogol,
    talc and titanium dioxide.

    The following strengths also contain:

    • 250mg – indigo carmine
    • 500mg -iron oxide yellow

    Keppra tablets do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

    Keppra oral solution contains 100 mg/mL levetiractam as the active ingredient.

    Other ingredients in Keppra oral solution include:

    • sodium citrate
    • citric acid monohydrate
    • methylhyroxybenzoate
    • parahydroxybenzoate
    • ammonium glycyrrhizate
    • glycerol
    • maltitol solution
    • acesulfame potassium
    • grape flavour
    Sponsor:

    UCB Pharma

    A division of UCB Australia Pty Ltd

    Level 1, 1155 Malvern Road

    Malvern Vic 3144, Australia

    Keppra 250mg – AUST R 120508

    Keppra 500mg – AUST R 120509

    Keppra 1000mg – AUST R 120513

    Keppra oral solution – AUST R 120499 (not available in New Zealand)

    Date of preparation:

    23rd May 2008

    Mxing Alcohol & Keppra | The Recovery Village

    When people take medicines, whether prescription or otherwise, they often wonder if interactions with other drugs or substance — like alcohol — are possible. One such example is alcohol and Keppra. Read on for more information about the relationship between alcohol and the drug Keppra, and additional details about the side effects and withdrawal seizures related to this medicine.

    What Is Keppra?

    Keppra is a prescription medicine used to control the symptoms of epilepsy. Epilepsy refers to a condition where a person has repeated seizures, but the types of seizure can vary from mild to severe. This medicine is part of a class of drugs called antiepileptics, and it’s believed they work by controlling certain chemicals in the brain to make sure that seizures don’t happen. Sometimes Keppra is used alone, and other times it’s used in conjunction with other drugs. This anti-convulsant goes by the generic name levetiracetam, and it can be used in children and adults.

    There are a number of risks associated with Keppra, one of the worst being suicidal thoughts. Doctors warn patients to make sure they monitor their mood when they’re prescribed this medicine, watch for any changes and report them as they experience them. Keppra can also impair your reaction or confuse your thinking, so you should be aware of this if you take it and need to do something requiring you to be alert, such as driving.

    The makers of Keppra warn that if you become pregnant, it’s important to continue using this medicine unless your doctor says otherwise. This is because having a seizure while pregnant can be extremely dangerous for your baby.

    Outside of possible side effects of combining alcohol and Keppra, possible general side effects can include:

    • Feeling drowsy or weak
    • Bruising
    • Tingling and numbness
    • Muscle weakness
    • Changes in mood or behavior
    • Confusion
    • Hallucinations
    • Coordination problems
    • Problems with walking or movement
    • Skin reactions
    • Signs of infection

    If any of these side effects become severe, it’s important that you seek medical attention right away.

    Side Effects and Withdrawal Seizures

    There are two primary ways to approach conversations about alcohol and Keppra. The first thing people wonder about is whether or not you can use alcohol and Keppra at the same time, and what possible side effects might be. Then there’s the consideration of how Keppra is used as an alcoholic seizure treatment.

    Generally, it’s advised that you don’t take alcohol and Keppra at the same time. Both alcohol and Keppra effect the nervous system and they can heighten the side effects of each other. For example, if you were to combine alcohol and Keppra you could impair your judgment and thinking, and experience extreme dizziness, drowsiness, and problems with concentration. People are advised regarding alcohol and Keppra to limit their drinking while they’re taking the medication, particularly if they don’t know the effect it will have on them.

    There’s also something else related to alcohol and Keppra to consider. Keppra can be used to treat the side effects and withdrawal seizures associated with alcohol detox. Doctors and treatment centers often look for different options aside from benzodiazepines, because people can become addicted to them. In some cases, Keppra might be a safer option. Keppra is just one of the potential anticonvulsants that may be used during alcohol detox to manage potential seizures that can occur, and other options are available.

    With Keppra, one of the biggest risks is the possibility of mood swings and increases in suicidal thoughts. This is why a medically-supervised detox is so important during alcohol withdrawal. Your medical team can give you the medicines they think will be most appropriate for your symptoms, while also monitoring you for any potential side effects of those medications.

    Summing Up

    To sum up, what is Keppra? Keppra is an anti-seizure trmedicine. Alcohol and Keppra shouldn’t be used together because they can lead to intensified symptoms of intoxication, since both impact the central nervous system. There are some uses of Keppra to deal with the side effects and withdrawal seizures that come with alcohol detox, but this is something that should be monitored by a physician.

    Medical Disclaimer: The Recovery Village aims to improve the quality of life for people struggling with a substance use or mental health disorder with fact-based content about the nature of behavioral health conditions, treatment options and their related outcomes. We publish material that is researched, cited, edited and reviewed by licensed medical professionals. The information we provide is not intended to be a substitute for professional medical advice, diagnosis or treatment. It should not be used in place of the advice of your physician or other qualified healthcare provider.

    Side effects and Dosage
    – Relievet

    With more than 5% of dogs suffering from seizures at some point in their life, there is a constant push to find safer and more effective ways to treat them. Seizures tend to occur when there is a change in brain activity, e.g. waking up, excited, and dog seizures while sleeping are also possible. Seizures are most common in dogs with epilepsy, which involves abnormal brain activity.

    Keppra for dogs is a relatively new drug often used alongside conventional anti-seizure medications, and it presents some benefits.

    We will explore Keppra’s side effects in dogs and how they compare to those of traditional anticonvulsant drugs.  

    What is Keppra for Dogs?

    Keppra is one of the brands which manufacture the drug Levetiracetam, a relatively new anticonvulsant used for dogs, cats, and people.

    Keppra for dogs is often used in combination with Phenobarbital or Potassium Bromide to treat seizures or epilepsy that is not responsive to these drugs, or for animals that have an adverse reaction to these drugs.

    Keppra differs from traditional anti-seizure medication in the fact that it does not contain either Potassium Bromide or Phenobarbital, which means it has a wider margin of safety, especially for dogs suffering from a damaged liver, or liver problems.  

    Keppra Dosage

    As a prescription drug, your veterinarian will direct you on the proper dosage of Keppra for dogs. Keppra comes in a tablet form ranging from 250mg to 1000mg, the extended-release pill comes in either 500mg or 750mg, and it is also available in an oral or injectable solution.

    The liver doesn’t process Keppra in the same way as traditional anticonvulsants, and it leaves the body more quickly. Because of this, it has a half-life of around four to six hours, meaning that it usually has to be dosed three times a day. While giving medication this often can be difficult, receiving each dose on time is important for controlling seizures.

    Like many drugs veterinarians prescribe to animals, Keppra is off label, meaning that the dosage and directions probably won’t match those on the label; this is common as drugs are usually developed for humans and then used on animals.  

    How long for Keppra to work in dogs?

    Keppra starts to work almost right away, and the regular tablets last around 8 hours. The extended-release tablets can last as long as 12 hours.

    Be aware that you cannot split the extended-release tablets; if you do, they will be absorbed too quickly and could lead to potential problems.  

    Side Effects of Keppra

    Similar to other anti-seizure medications such as Gabapentin for dogs, the most often experienced side effects of Keppra in dogs are drowsiness and loss of coordination.

    Unlike these drugs, Keppra isn’t thought to harm the liver or liver enzymes and is generally believed to have a better safety profile.

    Here are some other side effects to watch out for: 

    • Decrease Appetite
    • Drooling
    • Persistent Vomiting
    • Sudden Changes In Behavior

    Drug Interactions to be Aware of:

    You should always make your veterinarian aware of any other drugs your dog is taking, as Keppra can have potentially harmful interactions when used with the following medicines:

    Keppra overdose in dogs 

    You mustn’t stop giving Keppra (or other traditional anticonvulsants) to your dog suddenly, as this can cause withdrawal seizures. Always follow your veterinarian’s recommendations for dosage and on how to taper your dog off of this drug.

    Don’t give Keppra to dogs who are allergic to Levetiracetam and give cautiously to animals that are pregnant or suffer from kidney problems.  

    How much does Keppra for Dogs Cost?

    According to a popular discount prescription drug website, the average retail price of one 500mg tablet of Keppra is $41.99, with the lowest price being $15.97.

    However, there is a generic version of this drug, which is significantly cheaper; its average price comes in at $13.87, with the lowest price being $1.19 for a 500mg tablet.  

    Are there any Natural Alternatives?

    As with many drugs for the treatment of animals, we often look to human medication to see what the latest medications are; this is also true for natural alternative medicines.

    The FDA recently approved a drug called Epidiolex to treat people with seizures caused by two rare and severe forms of epilepsy. This drug’s active ingredient is CBD, which is an entirely natural hemp-derived compound.

    CBD has become widely available in recent years, in part due to its anti-seizure properties, and lack of severe side effects.

    CBD may have the potential to help some dogs suffering from seizures, but as with any serious health problem, you should never attempt to treat it without the guidance of your veterinarian.

    References:

    https://www.ncbi.nlm.nih.gov

    https://pubmed.ncbi.nlm.nih.gov

    https://www.rxlist.com

    Keppra

    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.

    Effect of Antiepileptic Drugs on Oral Contraceptives – FPIN’s Clinical Inquiries

    1. Back DJ,
    Bates M,
    Bowden A,

    et al.
    The interaction of phenobarbital and other anticonvulsants with oral contraceptive therapy. Contraception.
    1980;22(5):495–503….

    2. Sonnen AEH. Sodium valproate and the pill. In: Epilepsy International Symposium, Akimoto H, eds. Advances in Epileptology: The XIIIth Epilepsy International Symposium. New York, NY: Raven Press, 1982: 429–432.

    3. Crawford P,
    Chadwick DJ,
    Martin C,
    Tjia J,
    Back DJ,
    Orme M.
    The interaction of phenytoin and carbamazepine with combined oral contraceptive steroids. Br J Clin Pharmacol.
    1990;30(6):892–896.

    4. Saano V,
    Glue P,
    Banfield CR,

    et al.
    Effects of felbamate on the pharmacokinetics of low-dose combination oral contraceptive. Clin Pharmocal Ther.
    1995;58(5):523–531.

    5. Klosterkov Jensen P,
    Saano V,

    et al.
    Possible interaction between oxcarbazepine and an oral contraceptive. Epilepsia.
    1992;33(6):1149–1152.

    6. Fattore C,
    Cipolla G,
    Gatti G,

    et al.
    Induction of ethinylestradiol and levonorgestrel metabolism by oxcarbazepine in healthy women. Epilepsia.
    1999;40(6):783–787.

    7. Rosenfeld WE,
    Doose DR,
    Walker SA,
    Nayak RK.
    Effect of topiramate on the pharmacokinetics of an oral contraceptive containing nor-ethindrone and ethinyl estradiol in patients with epilepsy. Epilepsia.
    1997;38(3):317–323.

    8. Crawford P,
    Chadwick D,
    Cleland P,

    et al.
    The lack of effect of sodium valproate on the pharmacokinetics of oral contraceptive steroids. Contraception.
    1986;33(1):23–29.

    9. Eldon MA,
    Underwood BA,
    Randinitis EJ,
    Sedman AJ.
    Gabapentin does not interact with a contraceptive regimen of norethindrone acetate and ethinyl estradiol. Neurology.
    1998;50(4):1146–1148.

    10. Holdich T,
    Whiteman P,
    Orme M,
    Back D,
    Ward S.
    Effect of lamotrigine on the pharmacology of the combined oral contraceptive pill. 19th International Epilepsy Congress. Rio de Janeiro, Brazil; October 14–19, 1991. Epilepsia.
    1991;32(suppl 1):96.

    11. Sidhu J,
    Job S,
    Singh S,
    Philipson R.
    The pharmacokinetic and phar-macodynamic consequences of the co-administration of lamotrigine and a combined oral contraceptive in healthy female subjects. Br J Clin Pharmacol.
    2006;61(2):191–199.

    12. Giuliano RA,
    Hiersemenzel R,
    Baltes E,

    et al.
    Influence of a new anti-epileptic drug (levetiracetam) on the pharmacokinetics and pharmacodynamics of oral contraceptives. 2nd Congress of Epileptology. The Hague, Netherlands; September 1–5, 1996. Epilepsia.
    1996;37(suppl 4):90.

    13. Ragueneau-Majlessi I,
    Levy RH,
    Janik F.
    Levetiracetam does not alter the pharmacokinetics of an oral contraceptive in healthy women. Epilepsia.
    2002;43(7):697–702.

    14. Mengel HB,
    Houston A,
    Back DJ.
    An evaluation of the interaction between tiagabine and oral contraceptives in female volunteers. J Pharm Med.
    1994;4(3):141–150.

    15. Griffith SG,
    Dia Y.
    Effect of zonisamide on the pharmacokinetics and pharmacodynamics of a combination ethinyl estradionor-ethindrone oral contraceptive in healthy women. Clin Ther.
    2004;26(12):2056–2065.

    16. ACOG practice bulletin. No. 73: use of hormonal contraception in women with coexisting medical conditions. Obstet Gynecol.
    2006;107(6):1453–1472.

    17. Practice parameter: management issues for women with epilepsy (summary statement). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Epilepsia.
    1998;39(11):1226–1231.

    18. World Health Organization. Medical eligibility criteria for contraceptive use, 2004. 3rd ed. http://www.who.int/reproductive-health/publications/mec/mec.pdf. Accessed July 7, 2008.

    Levetiracetam: Pediatric Medication | Memorial Sloan Kettering Cancer Center

    This document, provided by Lexicomp ® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

    Trade names: USA

    Elepsia XR; Keppra; Keppra XR; Roweepra; Roweepra XR [DSC]; Spritam

    Trade names: Canada

    APO-Levetiracetam; Auro-Levetiracetam; BIO-Levetiracetam; DOM-Levetiracetam; JAMP-Levetiracetam; Keppra; MINT-Levetiracetam; NAT-Levetiracetam; PDP-Levetiracetam; PMS-Levetiracetam; Priva-Levetiracetam; PRO-Levetiracetam-250; PRO-Levetiracetam-500; PRO-Levetiracetam-750; RAN-Levetiracetam [DSC]; RIVA-Levetiracetam; SANDOZ Levetiracetam; TEVA-Levetiracetam; VAN-Levetiracetam [DSC]

    What is this drug used for?

    • Used to treat seizures.

    What should I tell my doctor BEFORE my child takes this drug?

    • If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances. Tell your doctor about the allergy and how your child has it.
    • If your child has kidney disease or is on dialysis.

    This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

    Talk to your doctor or pharmacist about all medications your child is taking (prescription and over-the-counter, natural products, and vitamins) and any health concerns. You need to make sure that this drug is safe for your child’s illness and in combination with other drugs that he or she is already taking. You should not start, stop, or change the dosage of any drug your child is taking without talking to your doctor.

    What do I need to know or do while my child is taking this drug?

    All forms of issue:

    • Tell all health care providers for your child that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
    • Have your child avoid tasks or activities that require attention until you see how this drug is working for your child.This includes cycling, playing sports, or using items such as scissors, lawn mowers, electric scooters, toy cars, or motorized vehicles.
    • Alcohol may interact with this drug. Make sure your child does not drink alcohol.
    • Consult with your child’s doctor before using marijuana, other forms of cannabis, prescription or over-the-counter drugs that may slow down your child’s actions.
    • Perform blood tests as directed by your doctor. Please consult your doctor.
    • Talk to your doctor if your seizures change or get worse after you start taking this drug.
    • Do not suddenly stop giving this drug to your child without talking to your doctor. This can increase the risk of seizures. If your child needs this drug, stop taking this drug gradually, as directed by the doctor.
    • A very severe reaction called angioedema has occurred with this drug. Sometimes this reaction can be life-threatening. Symptoms may include swelling of the hands, face, lips, eyelids, tongue, or throat, difficulty breathing or swallowing, or uncharacteristic hoarseness. Call your doctor right away if your child has any of these symptoms.
    • If the patient is a child, use this medication with caution.In children, the risk of some side effects may be higher.
    • Not all drugs are suitable for every child. Talk to your doctor before giving this drug to a child.

    If your daughter is pregnant or breastfeeding:

    • Consult a doctor if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her child will need to be discussed.
    • The effectiveness of this drug in controlling seizures may be reduced during pregnancy.If you have any questions, please consult your doctor.

    Extended release tablets:

    • Something that looks like a pill can be seen in your child’s stool. This is normal and not a cause for concern. If you have questions, talk with your child’s doctor.

    What side effects should I report to my child’s healthcare provider right away?

    WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people.Call your child’s doctor right away or get medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

    • Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
    • Hallucinations (a person sees or hears something that is not in reality).
    • Severe dizziness or fainting.
    • Balance change.
    • Difficulty walking.
    • Like other drugs for the treatment of seizures, this drug in rare cases may increase the risk of suicidal ideation or behavior. This risk may be higher in people who have attempted suicide or have had suicidal thoughts in the past. See your doctor right away if you develop or worsen symptoms such as depression, nervousness, anxiety, irritability, panic attacks, or other mood or behavior disorders.In case of suicidal thoughts or attempted suicide, contact your doctor immediately.
    • Possible severe skin reaction (Stevens-Johnson syndrome / toxic epidermal necrolysis). This can lead to serious and permanent health problems and sometimes death. Get medical help right away if your child has symptoms such as redness, skin swelling with blistering or scaling (with or without a high fever), redness or irritation of the eyes, painful sores on the lining of the mouth, throat, nose, or eyes …
    • Cases of decreased blood cell count have been reported during treatment with this drug. A marked decrease in the number of blood cells can lead to bleeding, infection, or anemia. See your doctor right away if your child develops symptoms of an infection, such as high fever, chills, or sore throat; any unexplained bruising or bleeding; or when you are very tired or weak.

    What are some other side effects of this drug?

    Any drug can have side effects.However, many people have little or no side effects. Call your child’s doctor or get medical help if any of these or other side effects bothers your child or does not go away:

    • Abdominal pain or diarrhea.
    • Feeling dizzy, sleepy, tired, or weak.
    • Nose or throat irritation.
    • Sleep disorders.
    • Lack of hunger.
    • Nausea or vomiting.
    • Headache.
    • Flu-like symptoms.

    This list of potential side effects is not exhaustive. If you have any questions about side effects, talk to your child’s doctor. Talk to your child’s doctor about side effects.

    You can report side effects to the National Health Office.

    What is the best way to give this drug?

    Give this drug to your child as directed by the doctor.Read all the information provided to you. Follow all instructions strictly.

    All oral preparations:

    • Give this drug with or without food.
    • Continue giving this drug as directed by your child’s doctor or other healthcare professional, even if your child is well.
    • Give this drug at the same time of the day.

    Orally disintegrating tablets / tablets for oral suspension:

    • Tell your child not to swallow the tablet.
    • Make sure your child does not chew, break or crush the drug.
    • Do not give broken or chipped tablets to your child.
    • Do not squeeze a tablet out of the foil when opening. The tablet should be removed from the foil with dry hands. Place on your child’s tongue and drink with a small sip of liquid before swallowing. Let your child swallow the tablet only after it dissolves.
    • Whole tablet (s) may also be mixed in a cup with a small amount of liquid, such as 1 tablespoon (15 ml) of liquid, or just enough liquid to cover the drug.Wait for the tablet (s) to dissolve completely and give the mixture to your child to drink right away. If there is some medicine left in the cup, rinse it with a little liquid, stir by rotating the container, and let your child drink the mixture.

    Liquid:

    • Measure liquid doses with care. Use the dispenser that comes with the medicine. If a dispenser is not included in the package, ask your pharmacist for a dosing product for this drug.
    • This medication should not be measured with a regular teaspoon or tablespoon. This can lead to exceeding the dose of the drug.

    All tablet formulations:

    • Have your child swallow whole. Tell your child not to chew or crumble.

    Immediate-release tablets:

    • You can break a tablet in half. Tell your child not to chew or crush the tablet.

    Extended release tablets:

    • Do not break or crush the tablet.
    • When you get a new prescription, check your child’s drug to make sure you have the correct drug. If you think you have been given the wrong drug or are not sure what your child’s drug should look like, contact your doctor right away.

    Injection:

    • This drug is administered by intravenous infusion continuously over a period of time.

    What if my child misses a dose of a drug?

    All oral preparations:

    • Give the missed dose as soon as possible.
    • If it is time for your child to take the next dose, do not take the missed dose and then return to your child’s normal schedule.
    • Do not give a double dose at the same time or additional doses.

    Injection:

    • Contact your child’s doctor to find out what to do next.

    How do I store and / or discard this drug?

    All oral preparations:

    • Store at room temperature in a dry place. Do not store in the bathroom.
    • Do not expose to heat and light.

    Injection:

    • If you need to store this drug at home, check with your child’s doctor, nurse, or pharmacist for information about how it is stored.

    All forms of production:

    • Store all medicines in a safe place.Keep all medicines out of the reach of children and pets.
    • Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

    General information on medicinal products

    • If your child’s symptoms or health problems do not improve, or if they get worse, see your child’s doctor.
    • Do not share your child’s medication with others or give anyone else’s medication to your child.
    • Some medicines may have different patient information sheets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other healthcare professional.
    • A separate patient instruction sheet is attached to the product. Please read this information carefully.Reread it every time you replenish your supply. If you have questions about this drug, talk with your doctor, pharmacist, or other healthcare professional.
    • If you think there has been an overdose of a drug, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

    Use of information by consumer and limitation of liability

    This information should not be used to make decisions about taking this or any other drug.Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug.This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional. Check with your doctor for complete information on the possible risks and benefits of taking this drug. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

    Copyright

    © UpToDate, Inc.and its affiliates and / or licensors, 2021. All rights reserved.

    Keppra film-coated tablets 500mg No. 30 (Levetiracetam)

    Epilepsy (focal epileptic seizures with or without transition to secondary large seizures) – as part of complex therapy.

    Hypersensitivity (including to other pyrrolidone derivatives), lactation period, age up to 4 years.With care. Pregnancy.

    Active ingredient: Levetiracetam.
    Release form: 1. Film coated tablets 250 mg No. 30; 2. Tablets, film-coated 500 mg No. 30; 3. Tablets, film-coated 1000 mg No. 30.

    Inside with a sufficient amount of liquid, regardless of food intake, 2 times a day. For adults and adolescents over 16 years of age, the initial dose is 500 mg 2 times a day, from the first day of treatment.Depending on the clinical response and tolerability, the daily dose can be increased to 1500 mg 2 times a day (an increase of 500 mg is possible every 2-4 weeks).

    Special instructions: Do not use during pregnancy unless absolutely necessary (given that interruptions in anticonvulsant therapy can lead to an exacerbation of the disease, harmful to the mother and fetus). The drug, like other antiepileptic drugs, should be canceled gradually (for example, a dose reduction of 500 mg when taken 2 times a day every 2-4 weeks).During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

    Interaction with other drugs: It is possible to use it together with other antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, gabapentin and primidone), with oral contraceptive drugs (ethinylestradiol and levonorgestrel) – at a daily dose of 1 gettiracetam, levetiracetam, 1 gettiracetin; with digoxin and warfarin – with a daily dose of levetiracetam up to 2 g.Side effects: Drowsiness, asthenia, dizziness, rarely – headache, loss of appetite, diarrhea, dyspepsia, nausea, ataxia, convulsions, depressive syndrome, emotional lability, aggressiveness, insomnia, nervousness, diplopia, tremor, skin rash. Overdose. Symptoms: there is no data on drug overdose (at doses exceeding 5 g / day). Treatment: after an acute overdose – gastric lavage, there is no special antidote, hemodialysis is possible, symptomatic therapy.

    Keppra® 500 mg No. 30 tab.p.p.

    Instructions for medical use

    medicinal product

    Keppra®

    Trade name

    Keppra®

    INTERNATIONAL NON-PATENTED NAME
    LEETHYRACETAMS

    MEDICINAL POTENTIAL

    One tablet of 250 mg contains
    active substance – levetiracetam 250 mg,

    excipients: croscarmellose sodium, macrogol 6000, colloidal anhydrous silicon dioxide, magnesium stearate,

    composition of the shell Opadray 85F20694 blue: FD&C dye blue No. 2 / aluminum lacquer (E132), macrogol / polyethylene glycol 3350, polyvinyl alcohol, partially hydrolyzed; talc, titanium dioxide (E171).

    One 500 mg tablet contains
    active substance – levetiracetam 500 mg,

    excipients: croscarmellose sodium, macrogol 6000, colloidal anhydrous silicon dioxide, magnesium stearate,

    shell composition Opadrai 85F32004 yellow: iron oxide yellow (E172) / polyethylene glycol 3350, polyvinyl alcohol, partially hydrolyzed; talc, titanium dioxide (E171).

    One 1000 mg tablet contains

    active substance – levetiracetam 1000 mg,

    excipients: croscarmellose sodium, macrogol 6000, colloidal anhydrous silicon dioxide, magnesium stearate,

    shell composition Opadrai 85 F 18422 white: macrogol / polyethylene glycol polyvinyl alcohol, partially hydrolyzed; talc, titanium dioxide (E171).

    DESCRIPTION
    250 mg tablets

    TABLETS elongated shape, film-coated BLUE, at the risk of faults, squeezed out inscription «UCB» and numerals “250” on one side TABLETS

    TABLETS 500 MG

    TABLETS elongated shape COATED FILM CASING YELLOW COLOR, WITH RISK FOR BREAKING, EXPRESSED WITH THE LEGEND “UCB” AND THE NUMBER “500” ON ONE SIDE OF THE TABLET

    TABLETS 1000 MG, TROWELED TABLETS, LONG-TREATED UCB “AND THE NUMBER” 1000 “ON ONE SIDE OF THE TABLET

    PHARMACOTHERAPEUTIC GROUP

    ANTIEPILEPTIC DRUGS.ANTIEPILEPTIC DRUGS OTHER. LEVETIRACETS.

    ATX CODE N03AX14

    Pharmacological properties
    Pharmacokinetics
    Absorption

    After oral administration, levetiracetam is rapidly absorbed from the gastrointestinal tract. Absorption is complete and linear, which makes it possible to predict the concentration of the drug in serum based on the dose of levetiracetam taken, expressed in mg / kg of body weight. The degree of absorption does not depend on the dose and food intake. Bioavailability is about 100%.The maximum serum concentration (Cmax) is reached 1.3 hours after oral administration of a dose of 1000 mg and is 31 μg / ml; after a repeated dose – 43 μg / ml. The equilibrium state is reached after 2 days, the concentration is 270 ng / ml; after repeated use of a dose of 1000 mg – 308 ng / ml. Constant concentrations are achieved after 2 days when applied twice a day.

    Pharmacokinetics of levetiracetam in children is linear in the dose range 20–60 mg / kg / day; Cmax is reached after 0.5-1 hours.

    Distribution

    The degree of binding of levetiracetam and its main metabolite with blood plasma proteins is less than 10%. The volume of distribution (Vd) is approximately 0.5-0.7 l / kg, which is similar to the total volume of body fluid.

    Metabolism

    Levetiracetam is not extensively metabolized in the human body. The main metabolic mechanism (24%) is the enzymatic hydrolysis of the acetamide group, the metabolites of which are found in most tissues, including blood cells.The formation of the main, pharmacologically inactive metabolite (ucb L057) occurs without the participation of liver cytochrome P450.

    In vitro levetiracetam and its primary metabolites are not suppressed by cytochrome P450 isoforms (CYP3A4, 2A6, 2C9, 2C19, 2D6, 2E1, 1A2), glucuronide transferases (UGT1A1, UGT1A6) and epoxide hydroxylase. Levetiracetam does not affect valproic acid glucuronidation.

    In hepatocyte cell culture, levetiracetam has no or very low effect on CYP2B6 and CYP3A4.No significant interaction is expected between levetiracetam and oral contraceptives, warfarin, and digoxin. Therefore, interactions of levetiracetam with other substances are unlikely.

    Excretion

    The half-life (T½) in adults is 7 ± 1 hour and does not depend on the route of administration and the mode of use. The average systemic clearance is 0.96 ml / min / kg. 95% of the drug is excreted by the kidneys. Excretion in faeces is about 0.3% of the dose taken. The cumulative excretion of levetiracetam and its primary metabolites in the urine is 24-66% of the dose taken, mainly during the first 48 hours.The renal clearance of levetiracetam and its metabolite is 0.6 and 4.2 ml / min / kg, respectively.

    No changes in clearance are observed after repeated administration.

    Gender, race

    Gender and race do not affect the pharmacokinetics of levetiracetam.

    Elderly patients

    In elderly patients, T½ increases by 40% (up to 10-11 hours), which is associated with deterioration of renal functions in patients of this group.

    Renal impairment

    In patients with impaired renal function, the clearance of levetiracetam and its main metabolite correlates with creatinine clearance; therefore, it is recommended that the dose be adjusted in accordance with creatinine clearance in patients with renal insufficiency.In adults with end-stage renal failure, the T1 / 2 is 25 hours between dialysis sessions and 3.1 hours during dialysis. During a 4-hour dialysis session, up to 51% of levetiracetam is eliminated.

    Liver dysfunction

    In patients with mild to moderate hepatic dysfunction, no significant changes in the clearance of levetiracetam are observed. In most cases, with severe liver dysfunction and concomitant renal failure, the clearance of levetiracetam is reduced by 50%, mainly due to a concomitant deterioration in renal clearance.

    Children

    T½ in children (from 6 to 12 years old) after oral administration of a single dose of 20 mg / kg is about 5-6 hours. Systemic clearance in children is approximately 30% higher than in adults and is directly dependent on body weight. After repeated oral administration of the drug (from 20 to 60 mg / kg / day) by children with epilepsy (from 6 to 12 years), levetiracetam is rapidly absorbed. The peak plasma concentration is observed from 0.5 to 1.0 hours after taking the drug. There was a linear and dose-proportional increase in peak plasma concentration and area under the curve.The half-life is approximately 5 hours. The apparent clearance was 1.1 ml / min / kg.

    Pharmacodynamics
    Levetiracetam, the active ingredient of Keppra®, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidineacetamide), which differs from known antiepileptic drugs in structure. The mechanism of action of levetiracetam is not fully understood, but obviously differs from the mechanisms of action of existing antiepileptic drugs.

    Data from in vitro and in vivo studies suggest that levetiracetam does not affect basic cellular characteristics and normal neurotransmission.

    In vitro studies have shown that levetiracetam affects the concentration of Ca2 + ions in neurons, partially inhibiting the flow of Ca2 + ions through the N-type channels and suppressing the release of calcium from intraneuronal stores. In addition, levetiracetam partially restores the current through GABA and glycine-dependent channels, inhibited by the action of zinc and β-carbolines.

    One of the proposed mechanisms of action is based on the proven binding of the compound to the glycoprotein of SV2A synaptic vesicles located in the gray matter of the brain and spinal cord.Presumably, this explains the anticonvulsant effect, which is expressed in the prevention of hypersynchronization of neural activity. In addition, levetiracetam acts on GABA and glycine receptors, modulating them through various endogenous compounds. Levetiracetam does not affect normal neurotransmission, but it suppresses epileptiform neuronal outbreaks induced by the GABA agonist bicuculline, as well as the excitation of glutamate receptors. The activity of the drug has been proven in relation to both focal and generalized epileptic seizures (epileptiform manifestations / photoparoxysmal reaction).

    INDICATIONS
    as monotherapy in the treatment of:

    – partial seizures with secondary generalization OR WITHOUT adults and adolescents 16 years and older with newly diagnosed epilepsy

    as an auxiliary therapy for:

    – partial seizures With secondary generalization without it, adults, teenagers and children over 1 year with epilepsy

    – myoclonic seizures in adults and children over 12 years of age with juvenile myoclonic epilepsy

    – primary generalized tonic-clonic seizures in adults and children over 12 years WITH IDIOPATIC GENERALIZED EPILEPSY

    IN PATIENTS WITH DIFFICULT IN SWALLOWING IT IS POSSIBLE TO USE THE PREPARATION IN THE FORM OF INJECTION (ADULTS AND CHILDREN OVER 4 YEARS OLD).

    DOSAGE AND METHOD OF APPLICATION
    THERAPY MAY BEGIN WITH INTRAVENOUS OR Oral administration. TRANSITION TO ANOTHER FORM OF ADMINISTRATION SHOULD BE DIRECTED WITHOUT DOSE TITLING. IT IS NECESSARY TO ADHERE TO THE TOTAL DAILY DOSE AND THE FREQUENCY OF ADMINISTRATION. TABLETS OF THE PREPARATION KEPPRA® TAKE ORAL, REGARDLESS OF FOOD. DAILY DOSE IS DIVIDED INTO TWO SAME RECEPTIONS. TABLETS SHOULD BE DRINKED WITH SUFFICIENT QUANTITY OF LIQUID.

    Monotherapy
    Treatment of adults and adolescents over 16 years old begins with a daily dose of 500 mg, divided into two doses (½ tablet of 500 mg 2 times a day).After 2 weeks, the dose can be increased to an initial therapeutic dose of 1000 mg (500 mg twice a day). In the future, the dose may be increased by 250 mg every 2 weeks, depending on the clinical response to therapy. The maximum daily dose is 3000 mg (1500 mg twice a day).

    As adjunctive therapy

    Adults and adolescents 18 years and older and adolescents 12 to 17 years old weighing 50 kg or more

    Treatment should be started with a daily dose of 1000 mg, divided into two doses (500 mg twice per day).This dose should be administered on the first day of the course.

    Depending on the clinical response and tolerability of the drug, the dose can be increased to 1500 mg, administered twice a day. Dose adjustments (decrease or increase) in steps of 500 mg twice a day can be done every 2-4 weeks.

    Children

    The doctor should prescribe the drug in the most appropriate dosage form and dosage, based on the patient’s body weight, age and the required therapeutic dose.

    The tablet form of the drug is not intended for use in children under 6 years of age.Also, the tablet form of the drug is not suitable for children weighing less than 25 kg, patients who have difficulty swallowing, or those who are shown to prescribe a dose of less than 250 mg. In all of the above cases, it is necessary to use the drug in the form of a solution for oral administration.

    Monotherapy

    The efficacy and safety of Keppra® in children and adolescents under 16 years of age as monotherapy has not been established.

    Adjunctive therapy for children and adolescents weighing less than 50 kg

    The initial dose is 10 mg / kg of body weight twice a day.Depending on the clinical response and tolerability of the drug, the dose can be increased to 30 mg / kg body weight twice a day. The dose step for correction should not exceed 10 mg / kg of body weight twice a day every 2 weeks. The minimum effective dose should be used.

    The dose of the drug in children weighing 50 kg and above is similar to that for adults.

    Dosing recommendations for children and adolescents

    Weight

    Starting dose: 10 mg / kg twice a day

    Maximum dose: 30 mg / kg twice a day

    25 kg (1)

    250 mg twice a day

    750 mg twice a day

    from 50 kg (2)

    500 mg twice a day

    1500 mg twice a day

    (1) – children under 25 kg or less, start treatment with levetiracetam solution for administration inside 100 mg / ml

    (2) – the dosage for children and adolescents weighing 50 kg or more is the same as in adults.

    Elderly patients

    Dose adjustment is recommended in case of impaired renal function.

    Patients with renal impairment

    The daily dose should be individualized according to the degree of renal dysfunction.

    Since levetiracetam is excreted by the kidneys, patients with renal insufficiency need to adjust the dose based on creatinine clearance.

    Creatinine clearance (CC) for adults and adolescents weighing more than 50 kg can be calculated based on the serum creatinine concentration using the following formula:

    [140 – age (years)] × body weight (kg)

    CC (ml / min) = ———————————————- ——–

    72 × serum CC (mg / dL)

    The creatinine clearance in women is calculated by multiplying the value obtained by 0.85.

    Correction for body surface area (BST) is performed according to the following formula:

    CC (ml / min)

    CC (ml / min / 1.73 m2) = ———– ————— x 1.73

    Patient PPT (m2)

    Dosing regimen for adults and adolescents weighing 50 kg or more with impaired renal function

    Renal failure

    CK ( ml / min)

    (ml / min / 1.73 m2)

    Dosing regimen

    Normal renal function

    > 80

    500-1500 mg twice daily

    Minor degree of impairment

    50-79

    500-1000 mg twice daily

    Moderate impairment

    30-49

    250-750 mg twice daily

    Severe impairment

    <30

    250-500 mg twice daily

    Terminal stage – patients on dialysis *

    5 00-1000 mg once a day **

    * On the first day of treatment, it is recommended to take a saturating dose of 750 mg

    ** After dialysis, it is recommended to take an additional dose of 250-500 mg

    Liver failure

    With mild and moderate impairment of liver function dose adjustment is not required.In patients with severely impaired liver function, a decrease in creatinine clearance may not fully reflect the degree of impaired renal function, therefore, in patients with creatinine clearance <60 ml / min / 1.73 m2, it is recommended to reduce the daily dose by 50%.

    In children with impaired renal function, the dose of levetiracetam should be adjusted according to the degree of renal impairment.

    Creatinine clearance (CC) in ml / min / 1.73 m2 in adolescents, children and infants can be calculated from serum creatinine levels (mg / dL) using the following formula (Schwartz formula):

    Height (cm) x ks

    CC (ml / min / 1.73 m2) = ————————-

    Serum creatinine (mg / dL)

    Ks = 0.55 for children under 13 and adolescent girls; in the case of adolescent boys, ks = 0.7.

    Dosing regimen in children and adolescents weighing less than 50 kg with impaired renal function

    Stage

    Creatinine clearance (ml / min / 1.73 m2)

    Dose and frequency of use

    Children and adolescents weighing

    body less than 50 kg

    Normal renal function

    > 80

    10-30 mg / kg twice a day

    Minor degree of impairment

    50-79

    10-20 mg / kg twice a day

    Moderate degree of impairment

    30-49

    5-15 mg / kg twice a day

    Severe impairment

    <30

    5-10 mg / kg twice a day

    Patients with end-stage renal disease on dialysis

    10–20 mg / kg once a day (1) (2)

    (1) On the first day of using levetiracetam, a loading dose of 15 mg / kg is recommended.

    (2) After dialysis, an additional dose of 5-10 mg / kg is recommended.

    SIDE EFFECTS
    PROFILE OF ADVERSE REACTIONS BASED ON ANALYSIS OF DATA FROM PLACEBO-CONTROLLED CLINICAL STUDIES WITH A COVERAGE OF 3416 PATIENTS. THE MOST FREQUENT ADVERSE REACTIONS WERE NAZOPHARYNGITIS, FATIGUE, HEADACHE, SLEEPY, DIEDIA.
    ADVERSE REACTIONS BELOW ARE LISTED IN ACCORDANCE WITH DAMAGE TO ORGANS AND ORGAN SYSTEMS AND FREQUENCY OF OCCURRENCE. THE FREQUENCY OF OCCURRENCE IS DETERMINED AS FOLLOWS: VERY FREQUENTLY (≥ 1/10), FREQUENTLY (≥ 1/100 AND <1/10), RARE (≥ 1/1000 AND <1/100), RARE (≥ 1/10 000 AND <1/1000), VERY RARE (<1/10000).

    LOT

    – nasopharyngitis

    – DROWSINESS

    – HEADACHE

    Frequently

    – ANOREXIA (often with concomitant administration of C topiramate)

    – depression, aggression, anxiety, insomnia, nervousness, irritability, emotional lability / CHANGE OF MOOD,

    – CONVILANCES, DISTURBANCE OF EQUILIBRIUM, Dizziness, LETARGY, TREMOR

    – VERTIGO

    – COUGH

    – PAIN IN THE AREA OF ABDOMINAL REGION, DYSHEPSYMA 9000, TOMATOUS 9000, TOMES 9000

    infrequently

    – leukopenia, thrombocytopenia

    – DECREASE / INCREASE IN WEIGHT

    – suicide attempt, suicidal ideation, psychotic disorders, behavioral disorders, hallucinations, anger, confusion, panic attack, emotional lability / mood swings, agitation

    – AMNESIA, MEMORY DISTURBANCES, ATX / COORDINATION DISTURBANCES, PARESTHESIS And, attention disorders

    – diplopia, blurred vision

    – an abnormal liver function test

    – alopecia (REGRESSION remove the drug), eczema, pruritus

    – muscle weakness, myalgia

    – INJURY

    RARE

    – INFECTION

    – pancytopenia (in some cases is accompanied by myelosuppression bone marrow), neutropenia, agranulocytosis

    – DRUG REACTIONS AS eosinophilia and systemic reactions (DRESS)

    – hyponatremia

    – sUICIDE, pathological THINKING, personality disorder,

    – choreoathetosis , dyskinesia, hyperkinesia

    – Pancreatitis

    – hepatic failure, hepatitis

    – toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme

    IN COMPARISON DATA GENERATED IN THE TREATMENT 645 children ages 4 to 16 years, it was revealed WHAT IS THE PROFILE OF ADVERSE REACTIONS BETWEEN CHILDREN AND ADULT? YMI IS SIMILAR WITH THE EXCEPTION OF BEHAVIORAL AND MENTAL DISORDERS, WHICH ARE MORE FREQUENCY IN CHILDREN.IN THIS COHORTE, THE FOLLOWING ADVERSE REACTIONS ARE COMMONED MORE MORE THAN IN ADULTS: VOMITING, ANXIETY, MOOD CHANGES, LABILITY, AGGRESSION, ATYPICAL BEHAVIOR, SICKNESS.

    CONTRA
    – hypersensitivity to levetiracetam, other derivatives of pyrrolidone or any auxiliary formulation components

    – Children’s age 6 (RECOMMENDED USAGE preparation as oral solution)

    – childhood and adolescence to 18 years (for tablets DOSE 250 MG)

    DRUG INTERACTIONS antiepileptic drug levetiracetam
    NOT AFFECT concentrations of known antiepileptic drugs in the blood serum (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, topiramate, gabapentin and primidone).

    AS IN THE ADULTS, IN THE CHILDREN’S POPULATION, NO SIGNIFICANT INTERACTIONS OF MEDICINAL PREPARATIONS HAS BEEN OBSERVED WHEN THE KEPPRA® PREPARED AT A DOSE OF 60 MG / KG / DAY.

    EVALUATION OF PHARMACOKINETICS IN CHILDREN AND ADOLESCENTS WITH EPILEPSY (4-17 YEARS OLD) CONFIRMED THAT ADDITIONAL THERAPY WITH CEPPRA® WHEN TAKING INTO OUR CAPPENTAVEVETACIMO, CAPPANEVENTAL Likewise, LEVETIRACETAM CLEARANCE IN CHILDREN WHO RECEIVED ENZYME-INDUCED ANTIEPILEPTICS WAS 20% HIGHER THAN IN CHILDREN WHO WAS NOT TAKING SUCH DRUGS.DOSE CORRECTION IS NOT REQUIRED.

    PROBENECID

    PROBENECID (RENAL TUBULE SECRETION BLOCKER) AT 500 MG APPLICATION FOUR TIMES A DAY INHIBITS RENAL CLEARANCE OF PRIMARY METABOLITIS, BUT NOT LETHAMA. NO LESS, THE CONCENTRATION OF THIS METABOLITE REMAINS LOW. IT IS EXPECTED THAT OTHER DRUGS EXCREATED BY ACTIVE TUBULAR SECRETION MAY ALSO REDUCE RENAL CLEARANCE OF METABOLITIS. THE EFFECT OF LEVETIRACETAM ON THE PHARMACOKINETICS OF PROBENECID AND OTHER ACTIVELY SECRETED DRUGS, SUCH AS NON-STEROID ANTI-INFLAMMATORY MEDICINES, SULFONAMIDES AND METOTREXATE IS UNKNOWN.

    ORAL CONTRACEPTIVES, DIGOXIN AND WARFARIN

    KEPPRA® IN A DAILY DOSE OF 1000 MG DOES NOT AFFECT THE PHARMACOKINETICS OF ORAL CONTRACEPTIVES (ETHYLESTRADIOL).

    KEPPRA® PREPARATION IN A DAILY DOSE OF 2000 MG DOES NOT AFFECT THE PHARMACOKINETICS OF DIGOXIN AND WARFARIN.

    DIGOXIN, ORAL CONTRACEPTIVES AND WARFARIN DO NOT AFFECT THE PHARMACOKINETICS OF LEVETIRACETAM.

    ANTACIDES

    NO DATA ON THE INFLUENCE OF ANTACIDES ON THE LEVETIRACETAM ABSORPTION PROCESS.

    LEAKING

    AT SIMULTANEOUS ADMISSION WITH OSMOTIC LEAKING MACROHOL – LEVETIRACETAM EFFICIENCY DECREASES DUE TO WHAT THE MACROGOL SHOULD BE TAKEN IN 1 HOUR.

    FOOD AND ALCOHOL

    MEALING DOESN’T AFFECT LEVETIRACETAM ABSORPTION RATE, BETWEEN THE SUCCESS RATE IS Slightly Delayed. THERE IS NO DATA ABOUT THE INTERACTION OF KEPPRA® WITH ALCOHOL.

    SPECIAL INSTRUCTIONS
    WITHDRAWAL OF THE PREPARATION
    IN ACCORDANCE WITH CURRENT CLINICAL PRACTICE, IN CASE OF THE CASE OF THE PREPARATION CANCELLATION IT IS NECESSARY TO PRODUCE GRADUALLY BY 2-4 COSTAINS BY BOUT 500IN CHILDREN AND ADOLESCENTS LESS THAN 50 KG DOSE REDUCTION SHOULD NOT EXCEED 10 MG / KG BODY WEIGHT TWICE PER DAY EVERY 2 WEEKS.

    RENAL OR LIVER INSUFFICIENCY

    PURPOSING OF KEPPRA® FOR PATIENTS WITH RENAL OR LIVER INSUFFICIENCY MAY REQUIRE DOSE CORRECTION. IN PATIENTS WITH SEVERE LIVER INSUFFICIENCY, KIDNEY FUNCTIONS SHOULD BE ESTIMATED BEFORE STARTING THERAPY.

    Depression / suicidal thoughts

    Based on the REPORTING case of suicide, suicidal ideation and suicide attempts during treatment with antiepileptic drugs, including levetiracetam, patients and persons who take care of them, should be warned about the need to report doctor about the appearance of any SYMPTOMS OF DEPRESSION OR SUICIDAL INTENTION.PATIENTS SHOULD BE UNDER MEDICAL OBSERVATION FOR THE OCCURRENCE OF SUICIDAL INTENTIONS AND ATTEMPTED SUICIDES, ALTHOUGH ASSESSING THE RISK OF INCREASING DISORDERS IN THE BACKGROUND OF ADMINISTRATION OF ANTICISCIDAL PREPARACY. THE MECHANISM OF THE OCCURRENCE OF THESE RISKS IS UNKNOWN.

    CHILDREN

    TABLETED KEPPRA® IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER 6 YEARS OLD.

    THE EXISTING DATA ON THE USE OF THE PREPARATION IN CHILDREN DOES NOT INDICATE ANY ADVERSE EFFECTS ON DEVELOPMENT AND MATURITY.HOWEVER, THE LONGER CONSEQUENCES OF THE APPLICATION ON THE ABILITY TO LEARN, INTELLECTUAL DEVELOPMENT, GROWTH, FUNCTION OF ENDOCRINE GLANDS, MATURITY AND FERTILITY REMAIN UNKNOWN.

    EFFECTIVENESS AND SAFETY OF LEVETIRACETAM IN CHILDREN UNDER 1 YEARS OF AGE AS AN ADDITIONAL TREATMENT FOR PARCIAL SEIZURES WITH SECONDARY GENERALIZATION OR WITHOUT IT IS NOT ESTABLISHED.

    EFFICIENCY AND SAFETY OF LEVETIRACETAM AS AN ASSOCIATIVE THERAPY IN CHILDREN UNDER 12 YEARS OLD WITH JUVENILE MYOCLONIC EPILEPSY OR LIS OF IDIOPATHIC GENERALYSIS OF ELEPHYSTALYSIS.

    PREGNANCY AND LACTATION
    FERTILITY
    ANIMAL STUDIES HAVE NO EFFECT ON FERTILITY. NO CLINICAL DATA, POTENTIAL RISK TO HUMAN UNKNOWN.
    PREGNANCY
    CASES OF USE OF THE DRUG IN PREGNANT WOMEN IN THE FIRST TRIMESTER ARE DESCRIBED IN POST-MARKETING PROSPECTIVE REGISTERS. Despite the fact that, as a whole, there was no increase in the frequency of congenital anomalies as a result of these data, the teratogenic risk can not be excluded.WITH THE SIMULTANEOUS ADMINISTRATION OF SEVERAL ANTIEPILEPTIC MEDICINES, THE RISK OF CONNECTED ANOMALIES INCREASES, IN CONNECTION WITH WHAT MONOTHERAPY SHOULD BE CONSIDERED.
    ANIMAL STUDIES HAVE BEEN REPRODUCTIVE TOXICITY.
    IT IS NOT RECOMMENDED TO USE THE PREPARATION KEPPRA® IN PREGNANT WOMEN AND WOMEN OF FETAL AGE, NOT APPLYING METHODS OF CONTRACEPTION, EXCEPT IN CASES OF CLINICAL NECESSITY.

    AS WITH OTHER ANTIEPILEPTIC DRUGS, PHYSIOLOGICAL CHANGES DURING PREGNANCY MAY AFFECT THE CONCENTRATION OF LEVETIRACETAM (REDUCTION OF THE LEVEL IN BLOOD SERUM).THE MOST EXPRESSED DECREASE IS OBSERVED IN THE THIRD TRIMESTER (UP TO 60% OF THE BASIC CONCENTRATION).

    WOMEN WHO RECEIVED LEVETIRACETS DURING PREGNANCY MUST BE PROVIDED WITH APPROPRIATE CLINICAL EXAMINATIONS. INTERRUPTIONS IN TREATMENT WITH ANTI-EPILEPTIC MEDICINES CAN EXCEED THE DISEASE, WHICH COULD DAMAGE THE HEALTH OF THE MOTHER AND THE Fetus.

    LACTATION PERIOD

    LEVETIRACETAM IS EXCRETED INTO BREAST MILK. BREASTFEEDING IS NOT RECOMMENDED DURING THE TREATMENT PERIOD.HOWEVER, IF THE USE OF KEPPRA® IS REQUIRED BY NURSING MOTHERS, THE USE AND RISK OF ADMISSION / WITHDRAWAL OF THE MEDICINE SHOULD BE ESTIMATED.

    KEPPRA® IS NOT RECOMMENDED DURING THE LACTATION PERIOD UNLESS CLINICAL NEEDED.

    FEATURES effect of the drugs on ability to drive the vehicle or potentially dangerous machinery
    KEPPRA® effect of the drug on ability to drive or use machines not specifically studied.HOWEVER, IN CONNECTION WITH DIFFERENT INDIVIDUAL SENSITIVITY TO THE DRUG ON THE SIDE OF THE CENTRAL NERVOUS SYSTEM, ESPECIALLY AT THE BEGINNING OF THERAPY OR WHEN THE DOSE IS INCREASED, IT SHOULD BE ABSTAINED FROM THE MANAGEMENT OF THE AUTOMOTIVE DISEASE.

    OVERDOSE
    SYMPTOMS: SLEEPY, EXCITATION, SUPPRESSION OF CONSCIOUSNESS, SUPPRESSION OF RESPIRATION, COMA.

    TREATMENT: IN THE ACUTE PERIOD – ARTIFICIAL CALL FOR VOMITING AND FLUSHING THE STOMACH WITH THE FOLLOWING APPLICATION OF ACTIVATED CARBON.THERE IS NO SPECIFIC ANTIDOTE FOR LEVETIRACETAM. IF NECESSARY, PROVIDE SYMPTOMATIC TREATMENT IN THE CLINIC WITH THE USE OF HEMODIALYSIS (EFFICIENCY OF DIALYSIS FOR LEVETIRACETAM – 60%, FOR ITS BASIC METABOLITIS – 74%).

    FORM OF ISSUE AND PACKAGING
    TABLETS COVERED WITH A FILM COVER, 250 MG, 500 MG, 1000 MG.

    10 TABLETS ARE PLACED IN A CONTOUR CELL PACKAGING FROM POLYVINYL CHLORIDE AND ALUMINUM FILM. 3 OR 6 CONTOUR CELL PACKAGES TOGETHER WITH INSTRUCTIONS FOR MEDICAL APPLICATION IN THE STATE AND RUSSIAN LANGUAGES ARE PLACED IN A CARDBOARD BOX.

    STORAGE CONDITIONS
    STORE IN A DRY PLACE AT A TEMPERATURE NOT EXCEEDING 25 ° C.

    KEEP OUT OF THE REACH OF CHILDREN!

    SHELF LIFE
    3 YEARS

    DO NOT USE AFTER THE SHELF LIFE

    RELEASE CONDITIONS FROM PHARMACIES
    BY RECIPE

    MANUFACTURER
    YUSB DAUGHIJA REGIONE 2 S.A., 9000 BREECHLEDS REGISTOS 9000, BREEGLEGIJA ALLEE2 9000

    GLAXOSMITHKLINE EXPORT LTD., UK

    980 GREAT WEST ROAD, BRENTFORD, MIDDLESEX, TW8 9GS, UK

    address of the organization, HOST IN THE REPUBLIC OF KAZAKHSTAN claims from consumers on quality of production (goods)

    REPRESENTATIVE GlaxoSmithKline EXPORT LTD IN KAZAKHSTAN

    050059, ALMATY, ST. FURMANOVA, 273

    TELEPHONE NUMBER: +7 727 258 28 92, +7 727 259 09 96

    FAX NUMBER: + 7 727 258 28 90

    E-MAIL ADDRESS: [email protected]

    Keppra tab. p / pl. about. 500mg No. 60

    The daily dose is divided into 2 equal doses.

    Monotherapy

    For adults and adolescents over 16 years of age, the drug is prescribed in the form of tablets or oral solution in an initial dose of 500 mg, divided into 2 doses (250 mg 2 times / day). After 2 weeks, the dose can be increased to the initial therapeutic dose – 1 g (500 mg 2 times / day). The maximum daily dose is 3 g (1.5 g 2 times / day).

    As part of complex therapy

    For children aged 1 month to 6 months, the drug is prescribed in the form of a solution for oral administration. The initial therapeutic dose is 7 mg / kg 2 times / day. Depending on the clinical efficacy and tolerability, the dose may be increased to 21 mg / kg 2 times / day. Dose changes should not exceed plus or minus 7 mg / kg 2 times / day every 2 weeks. The minimum effective dose should be prescribed.

    Recommendations for the dosage of Keppra® in the form of an oral solution for children under 6 months of age are presented in the table.

    Body weight Initial dose: 7 mg / kg 2 times / day Maximum dose: 21 mg / kg 2 times / day 4 kg 28 mg (0.3 ml) 2 times / day 84 mg (0.85 ml) 2 times / day 5 kg 35 mg (0.35 ml) 2 times / day 105 mg (1.05 ml) 2 times / day 7 kg 49 mg (0.5 ml) 2 times / day 147 mg (1.5 ml) 2 times / day

    In children aged 6 months to 23 months, children aged 2 to 11 years and adolescents from 12 years to 17 years with a body weight of less than 50 kg, treatment should be started with a dose of 10 mg / kg of body weight, divided into 2 doses (10 mg / kg of body weight 2 times / day).Depending on the clinical response and tolerability of the drug, the daily dose may be increased to 30 mg / kg 2 times / day. A dose change of 10 mg / kg body weight can be done every 2 weeks. The minimum effective dose should be used.

    Doses for children weighing 50 kg or more are the same as for adults.

    Recommended doses for children from 6 months of age and adolescents are presented in the table.

    Body weight Initial dose: 10 mg / kg 2 times / day Maximum dose: 30 mg / kg 2 times / day 6 kg 60 mg (0.6 ml) 2 times / day 180 mg (1.8 ml) 2 times / day 10 kg 100 mg (1 ml) 2 times / day 300 mg (3 ml) 2 times / day 15 kg 150 mg (1.5 ml) 2 times / day 450 mg (4.5 ml) 2 times / day 20 kg 200 mg (2 ml) 2 times / day 600 mg (6 ml) 2 times / day 25 kg 250 mg 2 times / day 750 mg 2 times / day from 50 kg 500 mg 2 times / day 1500 mg 2 times / day

    Children over 4 years of age should begin treatment with a daily dose of 20 mg / kg of body weight, divided into 2 doses (10 mg / kg of body weight 2 times / day). A dose change of 20 mg / kg of body weight can be carried out every 2 weeks until the recommended daily dose is reached – 60 mg / kg of body weight (30 mg / kg of body weight 2 times / day).In case of intolerance to the recommended daily dose, it may be reduced. The minimum effective dose should be used.

    The drug should be prescribed in the most appropriate dosage form and dose, depending on the patient’s body weight and the required therapeutic dose.

    Children weighing ≤ 20 kg are recommended to start treatment with the drug in the form of an oral solution.

    For children weighing> 50 kg, dosing is carried out according to the scheme given for adults.

    Adults and adolescents over 16 years of age weighing more than 50 kg should begin treatment with a daily dose of 1 g, divided into 2 doses (500 mg 2 times / day). Depending on the clinical response and tolerability of the drug, the daily dose can be increased to a maximum of 3 g (1.5 g 2 times / day). A dose change of 500 mg 2 times / day can be carried out every 2-4 weeks.

    Since levetiracetam is excreted by the kidneys when the drug is prescribed to elderly patients and patients with renal insufficiency, the dose should be adjusted depending on the CC value.

    CC can be calculated from the serum creatinine concentration using the following formula.

    For men:

    CC (ml / min) = [140-age (years)] × body weight (kg) / 72 × serum creatinine (mg / dL)

    For women: obtained value x 0.85

    Renal failure CC (ml / min) Dose and frequency of administration Norm> 80 500-1500 mg 2 times / day Latent 50-79 500-1000 mg 2 times / day Compensated 30-49 250-750 mg 2 times / day Intermittent 250-500 mg 2 times / day Terminal stage (patients on hemodialysis) * – 500-1000 mg 1 time / day **

    * – on the first day of treatment with Keppra® it is recommended to take a saturating dose of 750 mg.

    ** – after dialysis it is recommended to take an additional dose of 250-500 mg.

    For children with renal impairment, the dose of levetiracetam should be adjusted according to the degree of renal impairment, using the recommendations given for adults.

    Patients with mild to moderate hepatic impairment do not need to adjust the dosage regimen. In patients with decompensated liver dysfunction and renal insufficiency, the CC value may not reflect the true degree of renal dysfunction, therefore, with CC

    Rules for using the drug

    Tablets should be taken orally with a sufficient amount of liquid, regardless of food intake.

    Dosing of the solution is carried out using a measuring syringe with a nominal capacity of 10 ml (corresponds to 1 g of levetiracetam) and with a graduation value of 25 mg (corresponds to 0.25 ml), which is included in the delivery kit of the drug. The measured dose of the drug is diluted in a glass of water (200 ml).

    To dispense the solution using a measuring syringe, open the bottle: to do this, press the cap and turn it counterclockwise. Insert the syringe adapter into the neck of the vial, then take the syringe and place it in the adapter.Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger up to remove any air bubbles. Pulling the plunger, fill the syringe with the solution until the division corresponds to the number of ml of solution prescribed by the doctor. Remove the syringe from the adapter. Introduce the contents of the syringe into a glass of water, pushing the plunger all the way. Drink the entire contents of the glass. Then rinse the syringe with water and close the bottle with a plastic cap.

    Keppra Oral: uses, side effects, interactions, pictures, warnings and dosing –

    Benefits

    Benefits

    Levetiracetam is used with other drugs to treat seizures (epilepsy).It belongs to a class of medications known as anticonvulsants. Levetiracetam may reduce the number of seizures you have.

    How to use Keppru

    Before you start taking levetiracetam and each time you receive a drug, read the Medication Guide and, if possible, the patient information leaflet provided by your pharmacist. If you have any questions, ask your doctor or pharmacist.

    Take liquid and regular-release tablets by mouth as directed by a healthcare practitioner, usually twice daily with or without food.Crushing or chewing a tablet can cause a bitter taste.

    If you are using the liquid form of this medication, carefully measure the dose with a special measuring instrument / spoon. Don’t use a homemade spoon because you can’t get the right dose.

    If you are using extended-release tablets, take this medication as directed by your doctor, usually once a day. Do not crush or chew extended-release tablets. This can cause all of the drugs to be released in one go, increasing the risk of side effects.Do not split tablets unless they have a rating line and your doctor or pharmacist tells you to do so. Swallow a whole or split tablet without crushing or chewing.

    The dosage depends on your medical condition and response to treatment. Dosage in children is also based on weight. To reduce the risk of side effects (such as dizziness and drowsiness), your doctor may instruct you to start taking this drug at a low dose and gradually increase your dose.Follow your doctor’s instructions carefully.

    Use this medication regularly to get the most out of it. To help you remember, take it at the same time every day.

    Do not increase your dose or use this medication more often or for longer than prescribed. Your condition will not improve any faster and your risk of side effects will increase.

    Do not stop taking this medication without consulting your doctor.Your seizures may get worse when the drug is suddenly stopped. Your dose should be reduced gradually.

    Tell your doctor if your seizures continue, change, or get worse.

    Related links

    What conditions does Keppra treat?

    Side effects

    Side effects

    Drowsiness, dizziness, unusual tiredness or weakness may occur. These side effects are more common during the first 4 weeks and usually diminish as your body adjusts to the medication.If any of these effects persist or worsen, tell your doctor or pharmacist right away.

    Remember that your doctor prescribed this medication for you because he or she thought the benefit to you was greater than the risk of side effects. Many people using this medication do not have serious side effects.

    Tell your doctor right away if you have any serious side effects such as: loss of coordination (eg, difficulty walking and muscle control), mental / mood changes (such as irritability, aggression, agitation, anger, anxiety), signs of infection (eg, sore throat that does not go away, fever, chills), signs of anemia (such as unusual tiredness that doesn’t go away, pale skin, rapid breathing, heart palpitations), easy bruising / bleeding

    A small number of people taking anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts / attempts, or other mental / mood problems.Tell your doctor right away if you or your family / caregiver notice any unusual / sudden changes in your mood, thoughts or behavior, including signs of depression, suicidal thoughts / attempts, thoughts of hurting yourself.

    Levetiracetam can commonly cause a rash that is usually not severe. However, you won’t be able to tell the difference from a rare rash that can be a sign of a serious reaction. Tell your doctor right away if you develop a rash.

    A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction such as: rash, itching / swelling (especially of the face / tongue / throat), severe dizziness, trouble breathing.

    This is not a complete listing of potential side effects. If you notice other effects not listed above, ask your doctor or pharmacist.

    In the USA –

    Ask your doctor about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088 or at www.fda.gov/medwatch.

    In Canada – Call your doctor for medical advice about side effects. You can report side effects to Health Canada at 1-866-234-2345.

    Related links

    List Keppra’s side effects by likelihood and severity.

    Precautions

    Precautions

    Before taking levetiracetam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients that may cause allergic reactions or other problems. Talk to your pharmacist for more details.

    Before using this medication, tell your doctor or pharmacist your medical history, especially about: kidney disease (such as dialysis treatment), mental / mood disorders (such as depression).

    This drug may make you dizzy or drowsy, especially during the first month of treatment. Alcohol or marijuana can make you dizzy or drowsy. Do not drive, operate machinery, ride a bicycle, or do anything that requires vigilance until you can do so safely. Alcoholic beverage limit. Talk to your doctor if you are using marijuana.

    Before surgery, tell your doctor or dentist about all products you use (including prescription, non-prescription, and herbal products).

    Children may be more sensitive to side effects of the drug, especially mental / mood changes (such as irritability, aggression, agitation, anger, anxiety, depression, suicidal thoughts). Children younger than 4 years old may be at greater risk of high blood pressure with this drug (see also the Notes section).

    The elderly may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, or loss of coordination.These side effects can increase your risk of falling.

    During pregnancy, this medication should be used only when necessary. It could harm the unborn baby. However, because untreated seizures are a serious medical condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning a pregnancy, become pregnant, or think you might become pregnant, talk to your doctor immediately about the benefits and risks of using this medication during pregnancy.

    This medicine passes into breast milk. Talk to your doctor before breastfeeding.

    Related links

    What should I know about pregnancy, care and Keppra prescribing to children or the elderly?

    interactions

    interactions

    Drug interactions may alter how your medications work or increase your risk of serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription / over-the-counter drugs and herbal products) and share with your doctor and pharmacist.Do not start, stop, or change the dosage of any medication without your doctor’s approval.

    Product that can interact with this drug: orlistat.

    Related links

    Does Keppra interact with other medicines?

    overdose

    overdose

    If someone has overdosed and has severe symptoms such as fainting or trouble breathing, call 911. Otherwise, contact a Poison Control Center immediately.US residents can call their local poison control center at 1-800-222-1222. Residents of Canada can call the provincial poison control center. Overdose symptoms may include slow / shallow breathing, loss of consciousness.

    Notes

    Do not share this medicine with others.

    Laboratory and / or medical tests (such as kidney function, CBC) may be done while you are taking this medicine. Blood pressure can also be monitored in children under 4 years of age.See your doctor for more details.

    Missed dose

    If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip their dose. Take your next dose at the usual time. Don’t double your dose to catch up.

    Storage

    Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medicines out of the reach of children and pets.

    Do not flush medicines down the toilet or pour them down the drain unless directed to do so. Correctly discard this product when it has expired or is no longer needed. Check with your pharmacist or local waste disposal company. The latest information was updated in October 2017. Copyright (c) 2017 First Databank, Inc.

    Images Keppra 100 mg / ml oral solution

    Keppra 100 mg / ml oral solution

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    colorless
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    No data.

    Keppra 250 mg tablet

    Keppra 250 mg tablet

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    blue
    form
    elongated
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    UCB 250

    Keppra 500 mg tablet

    5009mg yellow

    shape
    oblong
    imprint
    500 lbs

    Keppra 750 mg tablet

    Keppra 750 mg tablet

    color
    orange
    shape
    elongated
    mg tablet

    Keppra 1000 mg tablet

    color
    white
    form
    oblong
    imprint
    UCB 1000

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    9000

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