Keppra XR (Oral)

Levetiracetam is used by itself or with other medicines to help manage certain kinds of seizures (for example, partial seizures, myoclonic seizures, or tonic-clonic seizures) in treating epilepsy. This medicine cannot cure epilepsy and will only help control seizures as long as you keep using it.

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

It is very important for your doctor to check on you or your child's progress regularly, especially during the first few months of using this medicine. This is to ensure the medicine is working well and to adjust the dose if needed. Blood tests might be necessary to look for any unwanted effects.

You should inform your doctor if you become pregnant while taking this medicine. Your doctor may suggest that you join a pregnancy registry for patients on seizure medications.

Levetiracetam may lead to changes in mood or behavior, issues with coordination, or unusual tiredness or weakness. Tell your doctor immediately if you or your child start to feel depressed, anxious, angry, easily upset, restless, or have thoughts of self-harm. Report any unusual thoughts or behaviors that concern you, especially if they are new or worsening quickly.

This medicine may make some people feel dizzy, drowsy, tired, or less alert than usual. Do not drive or do anything else that could be dangerous until you understand how this medicine affects you.

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

Serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) can happen with this medicine. Contact your doctor immediately 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 using this medicine.

Do not stop taking levetiracetam without first consulting your doctor. Stopping the medicine suddenly may cause your seizures to return or happen more often. Your doctor may want you to slowly decrease the amount you are taking before stopping it completely.

Ensure that any doctor or dentist treating you is aware that you are using this medicine. This medicine may affect the results of certain medical tests.

In deciding to use a medicine, you and your doctor should consider the risks of the medicine against the benefits it may provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know about any other allergies you may have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how levetiracetam oral solution, tablets, or tablets for suspension affect children younger than 1 month of age (Keppra®) or children younger than 4 years old who weigh less than 20 kilograms (Spritam®, Spritam® tablets for oral suspension), and levetiracetam extended-release tablets in children younger than 12 years old (Elepsia™ XR) or (Keppra XR®). Safety and effectiveness have not been established in these age groups.

Geriatric

Current studies have not found any specific problems in elderly patients that would limit the use of levetiracetam. However, older adults are more likely to have kidney issues related to aging, which may require careful monitoring and possible dose adjustments for those taking levetiracetam.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction could happen. In these cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential importance and are not all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may adjust the dose or frequency for one or both medicines.

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

Using this medicine with any of the following may increase the risk of certain side effects, but it may be necessary to use both. If both medicines are prescribed, your doctor may modify the dose or frequency for one or both medicines.

• Carbamazepine
• Ginkgo

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific foods due to potential interactions. Consuming alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to inform your doctor about any other medical problems you have, especially:

• History of depression
• High blood pressure (hypertension)
• History of mental illness—Use with caution. May worsen these conditions.

• Moderate to severe kidney disease—Use is not recommended for patients with this condition.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor right away 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.

In the U.S.

• Elepsia XR
• Keppra
• Keppra XR

Available Dosage Forms:

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

Therapeutic Class: Anticonvulsant

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.