Levetiracetam ER 500mg Tablets

The precise mechanism of action of levetiracetam is unknown. It differs from other antiepileptic drugs. In vitro and in vivo studies suggest that levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting that it selectively prevents hypersynchronization of epileptiform burst firing and propagation of seizure activity. A proposed mechanism involves binding to the synaptic vesicle protein 2A (SV2A), which is thought to modulate neurotransmitter release.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Hallucinations (seeing or hearing things that are not there)
Severe dizziness or fainting
Changes in balance or coordination
Difficulty walking
Suicidal thoughts or actions (especially if you have a history of suicidal thoughts or actions)
New or worsening symptoms of depression, anxiety, or mood changes, such as:
+ Feeling nervous, restless, or irritable
+ Panic attacks
+ Other changes in mood or behavior

Like other medications used to treat seizures, this drug may increase the risk of suicidal thoughts or actions. If you experience any of these symptoms, contact your doctor right away.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These reactions can be life-threatening and may affect other organs in the body. Seek medical help immediately if you experience:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Low Blood Cell Counts

This medication can cause low blood cell counts, which can increase the risk of bleeding problems, infections, or anemia. Contact your doctor right away if you experience:

Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak

Angioedema

A severe reaction called angioedema can occur with this medication. This reaction can be life-threatening and may cause:

Swelling of the hands, face, lips, eyes, tongue, or throat
Trouble breathing
Trouble swallowing
Unusual hoarseness

Seek medical help immediately if you experience any of these symptoms.

Other Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor side effects. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Nose or throat irritation
Trouble sleeping
Headache
Flu-like symptoms

This is not a complete list of possible side effects. If you have questions about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have kidney disease or are undergoing dialysis.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you. Consult your doctor before consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may impair your reactions.

Regularly undergo blood tests and other laboratory examinations as directed by your doctor. If you experience changes in the frequency or severity of seizures after initiating this medication, discuss these changes with your doctor.

Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of seizures. If you need to stop taking this drug, your doctor will instruct you on how to gradually taper off the medication to minimize potential risks.

You may notice what appears to be a tablet in your stool; however, this is a normal occurrence and not a cause for concern. If you have any questions or concerns, consult your doctor.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. Similarly, when administering this drug to children, use it with caution, as they may have a higher risk of experiencing certain side effects. Not all formulations of this medication are suitable for all children, so consult your doctor before giving it to a child.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby. Be aware that this medication may be less effective in controlling seizures during pregnancy. If you have any questions or concerns, consult your doctor.

• Alcohol (increased CNS depression)
• Other CNS depressants (e.g., opioids, benzodiazepines, sedating antihistamines, tricyclic antidepressants) - increased CNS depression

• Dizziness
• Somnolence/fatigue
• Irritability
• Aggression
• Anxiety
• Depression
• Suicidal thoughts or behavior
• Mood changes
• Coordination difficulties
• Rash
• Fever
• Swollen lymph nodes
• Unusual bleeding or bruising
• Signs of infection

Levetiracetam is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients should be enrolled in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

Levetiracetam is excreted into human breast milk. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Monitor breastfed infants for drowsiness, irritability, and poor feeding.

Levetiracetam ER is not indicated for pediatric patients younger than 16 years of age. For pediatric patients 4 years and older, immediate-release levetiracetam oral solution or tablets are available.

No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have decreased renal function, which necessitates dose adjustment based on creatinine clearance. Elderly patients may also be more susceptible to CNS adverse effects (e.g., dizziness, somnolence).

• Levetiracetam ER is taken once daily. Emphasize that tablets should be swallowed whole and not crushed, chewed, or broken.
• Patients should be advised about potential behavioral changes (e.g., aggression, irritability, depression, suicidal ideation) and to report these immediately.
• Renal function is the primary determinant for dose adjustment; hepatic impairment generally does not require adjustment unless accompanied by significant renal impairment.
• Levetiracetam has a favorable drug interaction profile compared to many other AEDs, making it a good choice for polytherapy.
• Sudden discontinuation can precipitate seizures; doses should be tapered gradually under medical supervision.

• Immediate-release Levetiracetam (Keppra)
• Other antiepileptic drugs for partial-onset seizures: Lamotrigine (Lamictal), Carbamazepine (Tegretol), Oxcarbazepine (Trileptal), Lacosamide (Vimpat), Topiramate (Topamax), Zonisamide (Zonegran), Phenytoin (Dilantin), Valproic Acid (Depakote)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.