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Levetiracetam (Oral route)

Pronunciation:

lee-va-tye-RA-se-tam

Brand Names:

  • Keppra
  • Keppra XR

Dosage Forms:

  • Tablet, Extended Release
  • Tablet
  • Solution

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Levetiracetam is used to help control certain types of 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 or tablets in children younger than 1 month of age, and levetiracetam extended-release tablets in children younger than 16 years of age. Safety and efficacy have not been established.

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 an adjustment in the dose for patients receiving levetiracetam.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

  • Ketorolac
  • Orlistat

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
  • Mental illness, history of—Use with caution. May make these conditions worse.
  • 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.

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 to stop.

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 partial onset seizures:
      • Adults and children 16 years of age and older—At first, 1000 milligrams (mg) once a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 3000 mg per day.
      • Children younger than 16 years of age—Use and dose must be determined by your doctor.
  • For oral dosage forms (solution or tablets):
    • For partial onset seizures:
      • Adults and children 16 years of age and older—At first, 500 milligrams (mg) two times a day. Your doctor may increase your dose as needed and tolerated. 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 milligram (mg) per kilogram (kg) of body weight two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 60 mg per kg of body weight per day (ie, 30 mg per kg of body weight twice a 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 two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 50 mg per kg of body weight per day (ie, 25 mg per kg of body weight twice a 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 two times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 42 mg per kg of body weight per day (ie, 21 mg per kg of body weight twice a 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) two times a day. Your doctor may increase your dose as needed and tolerated. 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) two times a day. Your doctor may increase your dose as needed and tolerated. 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 milligram (mg) per kilogram (kg) of body weight two times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 60 mg per kg of body weight per day (ie, 30 mg per kg of body weight twice a day).
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.

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 taking this medicine. This is necessary to allow dose adjustments and to reduce any unwanted effects.

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. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Do not stop taking 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 or hoarseness
crying
depersonalization
diarrhea
dry mouth
euphoria
fever
general feeling of discomfort or illness
headache
hyperventilation
irregular heartbeats
irritability
joint pain
loss of appetite
lower back or side pain
mental depression
muscle aches and pains
nausea
painful or difficult urination
paranoia
quick to react or overreact emotionally
rapidly changing moods
restlessness
shaking
shivering
shortness of breath
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
tiredness
trembling or shaking of the hands or feet
trouble concentrating
unsteadiness, trembling, or other problems with muscle control or coordination
Incidence not known
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
constipation
dark urine
difficulty with moving
fast heartbeat
general feeling of tiredness or weakness
high fever
increase in body movements
indigestion
itching
light-colored stools
muscle pains or stiffness
painful or difficult urination
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
sores, ulcers, or white spots on the lips or in the mouth
stomach pain, continuing
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
rash
sneezing
Incidence not known
Hair loss or thinning of the hair
skin rash, encrusted, scaly, and oozing

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.


Last Updated: 4/4/2014

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