Pronunciation:

lee-va-tye-RA-se-tam

Brand Names:

• Keppra

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anticonvulsant

Uses of This Medicine:

Levetiracetam injection is used alone or together with other medicines to help control certain types of seizures (eg, partial-onset 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 to be given only by or under the direct supervision of a doctor.

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 injection in children younger than 1 month 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 injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution or an adjustment in the dose for patients receiving levetiracetam injection.

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

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital. Levetiracetam is given through an IV catheter that is placed in one of your veins. The medicine must be injected slowly, so your IV 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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely, especially for the first few months of 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 starts to feel depressed, anxious, or angry, getting upset easily, restless, or if you have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you or your child, 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.

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS).

Do not interrupt or stop receiving 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 lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

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 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

chest pain

darkened urine

diarrhea

difficulty having a bowel movement

fast heartbeat

general tiredness and weakness

indigestion

itching

joint or muscle pain

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

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

swollen glands

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

dizziness

headache

lack or loss of strength

pain

stuffy or 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.