Keppra Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

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

How to use Keppra

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking levetiracetam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take the liquid and regular-release tablets by mouth as directed by your doctor, usually twice daily with or without food. Crushing or chewing the tablet may cause a bitter taste.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If you are using the extended-release tablets, take this medication as directed by your doctor, usually once daily. Swallow the extended-release tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.

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

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug 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 become worse when the drug is suddenly stopped. Your dose should be gradually decreased.

Tell your doctor if your seizures lasts, change, or gets worse.

Side Effects

Drowsiness, dizziness, unusual tiredness, or weakness may occur. These side effects are more common during the first 4 weeks and usually lessen as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is 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 (such as difficulty walking and controlling muscles), mental/mood changes (such as irritability, aggression, agitation, anger, anxiety), signs of infection (such as sore throat that doesn’t go away, fever, chills), signs of anemia (such as unusual tiredness that doesn’t go away, pale skin, fast breathing, fast heartbeat), easy bruising/bleeding.

A small number of people who take 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 about harming yourself.

Levetiracetam can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any 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 list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www. fda.gov/medwatch.

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

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, which can 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 of: 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 (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, ride a bicycle, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

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

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

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

A product that may interact with this drug is: orlistat.

Does Keppra interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include slow/shallow breathing, loss of consciousness.

Do not share this medication with others.

Lab and/or medical tests (such as kidney function, complete blood count) may be done while you are taking this medication. In children younger than 4 years, blood pressure may also be monitored. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

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

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Keppra 1,000 mg tablet

Color: whiteShape: oblongImprint: ucb 1000

This medicine is a white, oblong, scored, film-coated, tablet imprinted with “ucb 1000”.

Keppra 750 mg tablet

Color: orangeShape: oblongImprint: ucb 750

This medicine is a white, oblong, scored, film-coated, tablet imprinted with “ucb 1000”.

Keppra 250 mg tablet

Color: blueShape: oblongImprint: ucb 250

This medicine is a white, oblong, scored, film-coated, tablet imprinted with “ucb 1000”.

Keppra 500 mg tablet

Color: yellowShape: oblongImprint: ucb 500

This medicine is a white, oblong, scored, film-coated, tablet imprinted with “ucb 1000”.

Keppra 100 mg/mL oral solution

Color: colorlessShape: Imprint:

This medicine is a white, oblong, scored, film-coated, tablet imprinted with “ucb 1000”.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Levetiracetam | Epilepsy Foundation

Very few people have serious side effects from levetiracetam. It is important to be aware of possible reactions and what to do if they happen. 

• Read the package insert for more information.
• Call your provider’s office right away if any of these problems occur.

Allergic reactions: Allergic reactions happen rarely, but can cause symptoms such as low blood pressure, hives, rash, breathing difficulties, and swelling. It can happen after the first dose or any time when taking levetiracetam. Since this can be life-threatening, if these symptoms occur, get immediate medical help.  

Coordination problems: A small number of people may have unsteady walking or coordination problems when taking levetiracetam. This medicine may also worsen coordination or walking problems that were present before starting the drug.  Adjusting the dose of levetiracetam may help. 

Changes in behavior, mood, or thoughts: Levetiracetam may cause changes in behavior, mood, or thoughts. This has been seen more often in young children than in adults taking this medicine. The dose of levetiracetam may need to be lowered or stopped. Examples of changes seen include:

• Anger, aggression
• Decreased ability to cope with daily life
• Depression
• Excessive emotional reactions or frequent mood swings or changes
• Severe anxiety, agitation, or confused thoughts
• Thoughts of suicide

Severe skin reactions: Rare but serious skin reactions, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with levetiracetam. These conditions may start with a fever and flu-like symptoms. Then a rash develops. Ulcers or lesions of the mucous membranes may be seen and develop into painful blisters. 

• Report any fever or rash to a health care provider as this can be a life-threatening condition.  
• These types of skin reactions happen most commonly in the second or third week after starting the medicine, though it can happen at other times too.  

Suicidal thoughts and behavior:  In 2008, the Food and Drug Administration (FDA) reviewed data from drug studies that showed a possible relationship between many seizure medicines and suicidal thoughts and behavior. Together, these thoughts and behavior are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance – 3.5 of 1,000 people taking a seizure medicine had suicidality compared to 1 of 1,000 people taking a placebo.

• Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
• Do not make any changes to the medicines without first talking to the prescribing health care provider.
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions
• Contact your health care provider before stopping any seizure meicine. This could possibly lead to worsening of seizure and mood. 

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2050100All

Keppra film-coated tablets 500 mg blister #60

Keppra® tablets are used for the following indications: -years of age who were diagnosed with epilepsy for the first time; as an additional therapy in the treatment of: partial seizures with or without secondary generalization in adults, adolescents and children over 6 years of age with epilepsy; myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; primary generalized convulsive (tonic-clonic) seizures in adults and adolescents over 12 years of age with idiopathic generalized epilepsy.

Composition

Active ingredient – levetiracetam (one tablet contains 500 mg of levetiracetam).

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

Film coating: Opadry 85F32004: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, iron oxide yellow (E172).

Contraindications

Hypersensitivity to levetiracetam or other pyrrolidone derivatives, or to any excipients of the drug.

Directions for use

Tablets should be taken orally with plenty of liquid, with or without food. When taken orally, levetiracetam may have a bitter taste. Divide the daily dose into two equal doses.

Monotherapy

Adults and adolescents over 16 years of age. Monotherapy in adults and children over 16 years of age should begin with the recommended dose of 500 mg/day (250 mg 2 times a day) followed by an increase in the initial therapeutic dose to 1000 mg/day (up to 500 mg 2 times a day) after two weeks. It is possible to increase the dose by 500 mg / day (250 mg 2 times a day) every two weeks, depending on the clinical effect. The maximum daily dose is 3000 mg / day (1500 mg 2 times a day).

Children and adolescents under 16 years of age. The safety and efficacy of Keppra® in children and adolescents under 16 years of age as monotherapy have not been established. No data available.

Adjunctive therapy

Adjunctive therapy for adults (≥ 18 years of age) and adolescents (aged 12 to 17 years) weighing 50 kg or more. The initial therapeutic dose is 1000 mg / day (500 mg 2 times a day). This is the starting dose given on the first day of treatment. Depending on the clinical picture and tolerability of the drug, the daily dose can be increased to a maximum of 3000 mg / day (1500 mg 2 times a day). Dose adjustments of 1000 mg/day (500 mg twice daily) can be made every 2 to 4 weeks.

Complementary therapy for children 6 years of age and older and adolescents (12 to 17 years of age) weighing less than 50 kg. The lowest effective dose should be used. The initial dose for a child or adolescent weighing 25 kg should be 250 mg twice a day, the maximum dose is 750 mg twice a day. For children weighing more than 50 kg, doses are prescribed according to the scheme given for adults. For infants and children under 6 years of age, it is advisable to use Keppra® in the form of an oral solution.

Application notes

Pregnant women

Special advice should be given to women of reproductive age. Treatment with levetiracetam should be reconsidered if a woman is planning a pregnancy. As with all antiepileptic drugs, abrupt withdrawal of levetiracetam should be avoided, as this can lead to an attack of seizures, which can have serious consequences for the woman and the unborn child. Monotherapy should be preferred whenever possible, as treatment with multiple antiepileptic drugs may be associated with a higher risk of birth defects than with monotherapy, depending on the drug combination.

Levetiracetam may be used during pregnancy if considered clinically necessary after careful evaluation. In this case, it is recommended to use the lowest effective dose.

Levetiracetam passes into a woman’s breast milk. Therefore, breastfeeding is not recommended. However, if levetiracetam is to be used during breastfeeding, the benefits and risks of treatment should be weighed against the importance of breastfeeding.

No effects on reproduction in animal studies. The potential risk to humans is unknown because there are no clinical data available.

Children

The physician must prescribe the most appropriate dosage form, dosage and form of release, depending on age, body weight and calculated dose.

The tablet formulation is not recommended for use in children under 6 years of age.

Drivers

Levetiracetam slightly or moderately affects the ability to drive vehicles and operate other mechanisms. Due to possible individual sensitivity, some patients may experience drowsiness or other symptoms associated with effects on the central nervous system, especially at the beginning of treatment or during dose increases.