Keppra (Intravenous)

Levetiracetam injection is used to control partial onset seizures in adults and children 1 month of age and older who have epilepsy. It is also used to help treat myoclonic seizures in adults and children 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam injection is also used to help treat primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized 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 to be given only by or under the direct supervision of a doctor.

It is very important that your doctor checks your progress closely while you or your child is receiving this medicine. This will help your doctor see if the medicine is working properly and to monitor for 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 starts to feel depressed, anxious, or angry, gets upset easily, feels restless, or has thoughts about hurting yourself. Report any unusual thoughts or behavior that concern you or your child, especially if they are new or getting worse quickly.

This medicine may cause some people to feel dizzy, drowsy, tired, or less alert than usual. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are dizzy or not alert.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

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

Do not interrupt or stop using this medicine without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

This medicine may cause an increase in blood pressure in children 1 month to 4 years of age. If you notice any changes to your child's normal blood pressure, tell your child's doctor right away.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. Here are some important points to consider for this medicine:

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 if you have other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies to date have not shown any specific problems in children that would limit the use of levetiracetam injection for treating partial onset seizures in children aged 1 month to 16 years, or for treating myoclonic seizures in children aged 12 years and older with juvenile myoclonic epilepsy, or for treating primary generalized tonic-clonic seizures in children aged 6 years and older with idiopathic generalized epilepsy.

Geriatric

Studies to date have not shown any specific problems in elderly patients that would limit the use of levetiracetam injection. However, older adults are more likely to have kidney issues related to age, which may require caution or a dose adjustment for those receiving levetiracetam injection.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the following medicines. The following interactions are significant but not exhaustive.

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

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

Using this medicine with any of the following could increase the risk of certain side effects, but using both might be the best treatment for you. If both are prescribed, your doctor may adjust the dose or frequency of one or both.

• Carbamazepine
• Ginkgo

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Be sure to tell your doctor about any other medical problems, especially:

• Depression, history of—Use with caution. May worsen these conditions.
• Mental illness, history of—Use with caution. May worsen these conditions.
• Kidney problems—Use with caution. Effects may be increased due to slower elimination from the body.

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 or nurse immediately if any of the following side effects occur:

More common

• Cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination

Incidence not known

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• changes in behavior
• darkened urine
• diarrhea
• difficulty having a bowel movement (stool)
• fast heartbeat
• general tiredness and weakness
• indigestion
• itching
• joint or muscle pain
• light-colored stools
• loss of appetite
• nausea and vomiting
• 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
• restlessness or agitation
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• thoughts or attempts at killing oneself
• 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
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety
• attack, assault, or force
• decrease, loss, or change in consciousness
• difficult or troubled breathing
• dry mouth
• hyperventilation
• irregular, fast or slow, or shallow breathing
• irregular heartbeats
• irritability
• pale or blue lips, fingernails, or skin
• restlessness
• shaking
• sleepiness or unusual drowsiness
• trouble sleeping

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

• Body aches or pain
• congestion
• dizziness
• headache
• lack or loss of strength
• pain
• runny nose
• tender, swollen glands in the neck
• trouble swallowing
• voice changes

Less common

• Aggressive or angry
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• crying
• depersonalization
• discouragement
• double vision or seeing double
• dysphoria
• euphoria
• feeling of constant movement of self or surroundings
• feeling sad or empty
• lightheadedness
• loss of interest or pleasure
• loss of memory
• loss or lack of appetite
• pain or tenderness around the eyes and cheekbones
• paranoia
• problems with memory
• quick to react or overreact emotionally
• rapidly changing moods
• rash
• sensation of spinning
• shakiness and unsteady walk
• sneezing
• stuffy nose
• tiredness
• trouble concentrating
• unsteadiness, trembling, or other problems with muscle control or coordination
• weight loss

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.

• Keppra

Available Dosage Forms:

• Solution

Therapeutic Class: Anticonvulsant

A nurse or other trained health professional will give you or your child this medicine in a hospital. Levetiracetam is given through a needle that is placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 15 minutes.

Your doctor will give you or your child a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

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