Levetiracetam Injection USP (Omega Laboratories): Uses, Side Effects and Dosage

What is Levetiracetam Injection USP used for?

Levetiracetam Injection USP is used to help reduce the number of your seizures, or your child’s seizures when taken together with other seizure medications.

Levetiracetam Injection USP may be given for several days when you or your child are unable to take seizure medications by mouth.

How does Levetiracetam Injection USP work?

Levetiracetam Injection USP belongs to the family of medicines called antiepileptics. The exact way that Levetiracetam Injection USP works to treat seizures is not known.

What are the ingredients in Levetiracetam Injection USP?

Medicinal ingredients: Levetiracetam

Non-medicinal ingredients: Glacial Acetic Acid (to adjust pH), Sodium acetate trihydrate, Sodium Chloride, Water for injection.

Levetiracetam Injection USP comes in the following dosage forms:

IV Solution for Injection: 100 mg/mL

Do not use Levetiracetam Injection USP if:

• you or your child are allergic to levetiracetam; or to any of the other ingredients in Levetiracetam Injection USP (see What are the ingredients in Levetiracetam Injection USP?).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you are given, or your child is given Levetiracetam Injection USP. Talk about any health conditions or problems you or your child may have, including if you (or your child):

• have or have had a history of any heart problems or problems with the way your heart beats. You may develop these even if you’ve never had a heart problem before;
• take any medicines that affect the heart or how it beats;
• take certain medicines that can cause an electrolyte imbalance;
• have any health problems, including ones you or your child have had in the past;
• have kidney disease;
• have had an allergic reaction such as swelling of the face, lips, eyes, tongue, and throat; trouble swallowing or breathing, and hives (anaphylaxis or angioedema) to other antiepileptic medicines in the past;
• are taking any medication, including ones you can get without a prescription;
• have recurrent infections or blood coagulation disorders;

• are pregnant or thinking about becoming pregnant. Taking more than one antiepileptic medication during pregnancy increases the risk of your baby having birth defects.

  • You and your doctor will have to decide if Levetiracetam Injection USP is right for you while you are pregnant.

  • If you decide to take Levetiracetam Injection USP while you are pregnant, ask your healthcare provider about joining the North American Antiepileptic Drug

    Pregnancy Registry. You can join by calling the toll-free number 1- 888 233-2334. Women who are pregnant and planning to take Levetiracetam Injection USP should join the pregnancy registry. It will enable the collection of valuable data about Levetiracetam Injection USP use in pregnancy;

• are breast-feeding or planning to breast-feed. Levetiracetam Injection USP is known to pass into breast milk and may harm your baby. You and your doctor should decide whether you should take Levetiracetam Injection USP or breast-feed, but not both.

Other warnings you should know about:

Changes in behaviour: You should pay attention to any mental changes, especially sudden changes in you or your child’s mood, behaviours, thoughts, or feelings. These changes are seen more commonly in children than in adults.

Call your doctor or your child’s doctor right away, if you or your child have any changes in behaviour that are new, worse, or worry you. These changes could include:

• feeling depressed, nervous, or anxious
• feeling angry, agitated or hostile
• in some people, psychotic symptoms, such as hallucinations (seeing or hearing things that are not really there), delusions (false or strange thoughts or beliefs), and unusual behaviour.

A small number of people may have thoughts of suicide (harming or killing themselves) when taking antiepileptic drugs such as Levetiracetam Injection USP. If at any time you or your child have these thoughts, get medical help right away. Do NOT stop Levetiracetam Injection USP on your own.

Trouble with coordination and driving and operating machinery: Levetiracetam Injection USP may affect your or your child’s coordination. It may also make you or your child feel sleepy and tired. It is more likely to happen at the beginning of your or your child’s treatment or after an increase in the dose. You should not drive or operate machinery until you know how Levetiracetam Injection USP affects you.

Severe Allergic Reaction Involving the Skin and Other Organs: There is no way to tell if a mild skin rash will become a severe reaction. The following serious skin reactions have been reported with levetiracetam:

• Stevens-Johnson Syndrome (SJS)
• Toxic Epidermal Necrolysis (TEN);
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Although very rare, severe forms of these reactions may lead to death.

Get medical help right away if you develop any combination of the following:

• a rash or any serious skin reaction such as blistering or peeling of the lips, eyes or mouth;
• fever;
• swollen glands;
• joint pain;
• problems related to the liver, kidneys, heart, lungs, or other organs;
• a serious allergic reaction (anaphylaxis or angioedema) such as swelling of the face, lips, eyes, tongue, and throat; trouble swallowing or breathing, and hives.

Tell your healthcare professional about all the medicines you or your child take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.

The following may interact with Levetiracetam Injection USP:

• other antiepileptic medicines (such as carbamazepine, topiramate);
• Oral contraceptives (used for birth control);
• Methotrexate (used to treat certain types of cancer and arthritis).

How Levetiracetam Injection USP is given to you or your child:

Levetiracetam Injection USP will be given to you or your child:

• by a doctor or nurse;
• as an infusion into a vein (intravenous infusion);
• twice a day for several days.

Usual dose:

Your doctor will decide how much Levetiracetam Injection USP you or your child will need. The dose you or your child will be given will depend on your or your child’s age, weight, and medical history.

Stopping treatment: If your doctor decides to stop your or your child’s treatment with Levetiracetam Injection USP, he/she will decrease the dose slowly. This is to prevent your or your child’s symptoms from coming back again or becoming worse.

Overdose:

If you think you or your child has been given too much Levetiracetam Injection USP, your doctor or nurse will take appropriate treatment and monitoring measures.

What are possible side effects from using Levetiracetam Injection USP?

These are not all the possible side-effects you or your child may have when given Levetiracetam Injection USP. If you or your child experience any side effects not listed here, tell your healthcare professional.

Side effects include:

• Feeling sleepy and tired / feeling tired. This side effect generally occurs in the first few weeks of treatment and may improve over time; however, it may return if you are taking Levetiracetam Injection USP for a long period of time.
• Headache
• Lack or loss of strength
• Feeling irritated
• Infection
• Bruising
• Feeling dizzy
• Sore throat
• Runny and stuffy nose, sneezing
• Vomiting
• Abdominal pain
• Diarrhea

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Levetiracetam Injection USP will be stored by your doctor.

Keep out of reach and sight of children.

If you want more information about Levetiracetam Injection USP:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website https://www.omegapharma.ca, or by calling 1 -800- 363- 0584.

Last revised: JUL 31, 2024