Keppra, Keppra XR

This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.

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

This product is available in the following dosage forms:

• Tablet, Extended Release


• Tablet


• Solution

Before Using

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levetiracetam tablets or oral solution in children above 4 years of age. However, safety and efficacy of levetiracetam extended-release tablets in the pediatric population have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of levetiracetam have not been performed in the geriatric population, geriatric-specific problems are not expected to 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

Breastfeeding

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.

Drug Interactions

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:

• Kidney problemsa€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use

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.

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

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.

The oral solution is to be taken by mouth even if it comes in a dropper bottle . The amount you take should be measured with the special dropper provided with the bottle .

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

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 seizures:
  
  
  
  • For oral dosage form (extended-release tablets):
    
    
    
    • Adultsa€”At first, 1000 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 3000 mg per day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For oral dosage form (solution or tablets):
    
    
    
    • Adultsa€”At first, 500 milligrams (mg) two times a day, one tablet in the morning and one at bedtime. Your doctor may adjust your dose if needed. However, the dose is usually not more than 3000 mg per day.
    
    
    • Children 4 years of age and abovea€”Dose is based on body weight and must be determined by your doctor . At first, the dose is usually 10 milligrams (mg) per kilogram (kg) of body weight two times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 60 mg/kg of body weight per day.
    
    
    • Children below 4 years of agea€”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

It is 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 levetiracetam. This is necessary to allow dose adjustments and to reduce any unwanted effects.

Levetiracetam may cause changes in mood or behavior, clumsiness or unsteadiness, or unusual tiredness or weakness. Tell your doctor right away if you or your child start to feel depressed, anxious, angry, irritable, 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 drowsy, dizzy, 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 are not alert.

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.

Side Effects

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, 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


• Nervousness


• 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


• Fear or nervousness


• 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 or wheezing


• 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


• Bloating


• Blood in the urine or stools


• Bloody, black, or tarry stools


• Blurred vision


• Chest pain


• Constipation


• Dark urine


• Difficulty in moving


• Fast heartbeat


• General feeling of tiredness or weakness


• High fever


• Increase in body movements


• Indigestion


• 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


• Sores, ulcers, or white spots on the lips or in the mouth


• Stomach pain, continuing


• Swollen glands


• Swollen joints


• Trouble with balance


• Unexplained bleeding or bruising


• Unusual bleeding or bruising


• Upper right abdominal 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 in swallowing


• Unusual weak feeling


• Voice changes

Less common

• Body aches or pain


• Burning, dry, or itching eyes


• Change in the color of skin


• Change in vision


• Congestion


• Cough increased


• Rash


• Sneezing

Incidence not known

• Hair loss or thinning of hair


• Itching


• 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.