Pronunciation:

lee-va-tye-RA-se-tam

Brand Names:

• Elepsia XR
• Keppra
• Keppra XR

Dosage Forms:

• Tablet, Extended Release
• Tablet
• Tablet for Suspension
• Solution

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Levetiracetam is used alone or together with other medicines to help control certain types of seizures (eg, partial seizures, myoclonic seizures, or tonic-clonic seizures) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to use it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of levetiracetam oral solution, tablets, or tablets for suspension in children younger than 1 month of age (Keppra®) or in children younger than 4 years of age and weighing less than 20 kilograms (Spritam®, Spritam® tablets for oral suspension), and levetiracetam extended-release tablets in children younger than 12 years of age (Elepsia™ XR) or (Keppra XR®). Safety and efficacy have not been established in these age groups.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levetiracetam in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving levetiracetam.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Apixaban
• Calcifediol
• Dabigatran Etexilate Mesylate
• Edoxaban
• Levoketoconazole
• Methotrexate
• Orlistat
• Rivaroxaban

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Ginkgo

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Hypertension (high blood pressure) or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Kidney disease, moderate to severe—Use is not recommended in patients with this condition.

• Kidney problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor, to help your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change your dose without checking first with your doctor.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Levetiracetam may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed. You should try to take this medicine at the same time each day.

Swallow the tablet or the extended-release tablet whole. Do not break, crush, or chew it. There is an oral liquid form of this medicine if you or your child cannot swallow the tablets.

Elepsia™ XR extended-release tablet has a blue and white to off-white layer. If you do not see the blue or white, off-white layer, do not take the tablet.

A part of the tablet may also pass into your stool. This is normal and is nothing to worry about.

If you are using the Spritam® tablet or the Spritam® tablet for suspension, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue and take a sip of water. After it has melted, swallow.

You may also add one whole Spritam® tablet for suspension to a small volume of liquid in a cup (1 tablespoon or enough to cover the medicine), and swirl gently. Swallow right away after it has dissolved. Then add a small volume of liquid to cup again, swirl gently, and swallow the liquid.

Measure the oral liquid with a marked measuring spoon, dropper, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. If you have any questions about this, ask your doctor or pharmacist.

This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you otherwise.

Take only the form of this medicine that your doctor prescribed. If you refill your prescription and your pills look different, do not take the medicine and tell your doctor or pharmacist right away.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  • For treatment of partial-onset seizures:
    • Adults and children 12 years of age and older and weighing 50 kilograms (kg) or more—At first, 1000 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (Keppra® solution or tablets):
  • For partial onset seizures:
    • Adults and children 16 years of age and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 4 to 15 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
    • Children 6 months to 3 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 mg per kg of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 50 mg per kg of body weight per day.
    • Children 1 to 5 months of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 7 mg per kg of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 42 mg per kg of body weight per day.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor.
  • For juvenile myoclonic seizures:
    • Children 12 years of age and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For primary generalized tonic-clonic seizures:
    • Adults and children 16 years of age and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 6 to 15 years of age—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 10 milligrams (mg) per kilogram (kg) of body weight 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per kg of body weight per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
• For oral dosage forms (Spritam® tablets, Spritam® tablets for suspension):
  • For partial onset seizures:
    • Adults and children 4 years of age and older weighing over 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 4 years of age and older weighing 20 to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 250 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children younger than 4 years of age and weighing less than 20 kg—Use is not recommended.
  • For juvenile myoclonic seizures:
    • Children 12 years of age and older—At first, 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For primary generalized tonic-clonic seizures:
    • Adults and children 6 years of age and older weighing over 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 500 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 6 years of age and older weighing 20 to 40 kg—Dose is based on body weight and must be determined by your doctor. The usual starting dose is 250 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children younger than 6 years of age and weighing less than 20 kg—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits, especially for the first few months you or your child are using this medicine. This is to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

It is important to tell your doctor if you become pregnant while using this medicine. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

Levetiracetam may cause changes in mood or behavior, problems with coordination, or unusual tiredness or weakness. Tell your doctor right away if you or your child start to feel depressed, anxious, angry, getting upset easily, restless, or have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you, especially if they are new or getting worse quickly.

This medicine may cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including anaphylaxis or angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

Do not stop using levetiracetam without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Aggressive or angry

anxiety

change in personality

chills

cough

crying

deep or fast breathing with dizziness

delusions of persecution, mistrust, suspiciousness, or combativeness

diarrhea

dry mouth

false or unusual sense of well-being

feeling of unreality

fever

general feeling of discomfort or illness

headache

hoarseness

irregular heartbeat

irritability

joint pain

loss of appetite

lower back or side pain

mental depression

muscle aches and pains

nausea

numbness of the feet, hands, and around the mouth

painful or difficult urination

quick to react or overreact emotionally

rapidly changing moods

restlessness

sense of detachment from self or body

shaking

shivering

sleepiness or unusual drowsiness

sore throat

stuffy or runny nose

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Bloody nose

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

clumsiness or unsteadiness

discouragement

dizziness or lightheadedness

double vision

earache

feeling of constant movement of self or surroundings

feeling sad or empty

increase in body movements

loss of bladder control

loss of memory

mood or mental changes

outburst of anger

pain or tenderness around the eyes and cheekbones

problems with memory

redness or swelling in the ear

seizures

sensation of spinning

shakiness and unsteady walk

shakiness in the legs, arms, hands, or feet

tightness of the chest

trembling or shaking of the hands or feet

trouble concentrating

unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

Agitation

attempts at killing oneself

being forgetful

bleeding gums

blistering, peeling, or loosening of the skin

bloating

blood in the urine or stools

bloody, black, or tarry stools

blurred vision

changes in vision

chest pain

coma

confusion

constipation

dark urine

decreased urine output

difficulty with moving

fast heartbeat

fever with or without chills

general feeling of tiredness or weakness

high fever

hostility

increased thirst

indigestion

itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

light-colored stools

muscle pains, stiffness, or twitching

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on the skin

red skin lesions, often with a purple center

red, irritated eyes

skin rash, encrusted, scaly, and oozing

sores, ulcers, or white spots on the lips or in the mouth

stomach pain, continuing

stupor

swelling of the face, ankles, or hands

swollen glands

swollen joints

thoughts or attempts at killing oneself

trouble with balance

twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

uncontrolled jerking or twisting movements of the hands, arms, or legs

uncontrolled movements of the lips, tongue, or cheeks

unexplained bleeding or bruising

unusual bleeding or bruising

upper right abdominal or stomach pain

weight loss

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Loss of strength or energy

muscle pain or weakness

pain

tender, swollen glands in the neck

trouble swallowing

unusual weak feeling

voice changes

Less common

Body aches or pain

burning, dry, or itching eyes

change in the color of the skin

congestion

cough increased

sneezing

Incidence not known

Hair loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.