Elepsia XR
- Generic Name: levetiracetam extended-release tablets
- Brand Name: Elepsia XR
Elepsia XR(Levetiracetam Extended-release Tablets) side effects drug center
Elepsia XR Side Effects Center
What Is Elepsia XR?
Elepsia XR (levetiracetam) Extended-release is an antiepileptic drug indicated as adjunctive therapy in the treatment of partial onset seizures in patients ≥ 12 years of age with epilepsy.
What Are Side Effects of Elepsia XR?
Common side effects of Elepsia XR include:
- nausea,
- influenza,
- runny or stuffy nose,
- sore throat,
- drowsiness,
- dizziness,
- irritability,
- weakness,
- headache,
- infection,
- pain,
- loss of appetite,
- depression,
- nervousness,
- loss of balance and coordination,
- vertigo,
- amnesia,
- anxiety,
- numbness and tingling,
- mood changes,
- cough,
- sinus infection, and
- double vision.
Dosage for Elepsia XR
The starting dose of Elepsia XR is 1,000 mg once daily. The once daily dosage may be adjusted in increments of 1,000 mg every 2 weeks to a maximum recommended once daily dose of 3,000 mg.
What Drugs, Substances, or Supplements Interact with Elepsia XR?
Elepsia XR may interact with other drugs. Tell your doctor all medications and supplements you use.
Elepsia XR During Pregnancy and Breastfeeding
During pregnancy, Elepsia XR should be used only if prescribed; it is unknown if it could affect a fetus. Tell your doctor if you become pregnant or intend to become pregnant while taking Elepsia XR. Patients are encouraged to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. Elepsia XR passes into breast milk. Breastfeeding while taking Elepsia XR is not recommended. Antiepileptic drugs, including Elepsia XR, should be withdrawn gradually to minimize the potential of increased seizure frequency.
Additional Information
Our Elepsia XR (levetiracetam) Extended-release tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Elepsia XR Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
- unusual changes in mood or behavior (unusual risk-taking behavior, being irritable or talkative);
- confusion, hallucinations, extreme drowsiness, feeling very weak or tired;
- loss of balance or coordination, problems with walking or movement;
- a skin rash, no matter how mild;
- easy bruising, unusual bleeding; or
- fever, chills, weakness, or other signs of infection.
Common side effects may include:
- dizziness, drowsiness, tiredness, weakness;
- feeling aggressive or irritable;
- loss of appetite;
- stuffy nose; or
- infection.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Elepsia XR (Levetiracetam Extended-release Tablets)
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Elepsia XR Professional Information
SIDE EFFECTS
The following serious adverse reactions are discussed in more detail in other sections of labeling:
- Behavioral Abnormalities and Psychotic Symptoms [see WARNINGS AND PRECAUTIONS]
- Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
- Somnolence and Fatigue [see WARNINGS AND PRECAUTIONS]
- Anaphylaxis and Angioedema [see WARNINGS AND PRECAUTIONS]
- Serious Dermatological Reactions [see WARNINGS AND PRECAUTIONS]
- Coordination Difficulties [see WARNINGS AND PRECAUTIONS]
- Hematologic Abnormalities [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Levetiracetam Extended-Release Tablets
In the controlled clinical study in patients with partial-onset seizures, the most common adverse reactions in patients receiving levetiracetam extended-release tablets in combination with other AEDs, for events with rates greater than placebo, were irritability and somnolence.
Table 3 lists adverse reactions that occurred in at least 5% of epilepsy patients receiving levetiracetam extended-release tablets in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either levetiracetam extended-release tablets or placebo was added to concurrent AED therapy.
Table 3: Adverse Reactions in the Placebo-Controlled, Add-On Study in Patients Experiencing Partial-Onset Seizures
| Adverse Reactions | Levetiracetam Extended-Release Tablets (N=77) % | Placebo (N=79) % |
| Influenza | 8 | 4 |
| Somnolence | 8 | 3 |
| Irritability | 7 | 0 |
| Nasopharyngitis | 7 | 5 |
| Dizziness | 5 | 3 |
| Nausea | 5 | 3 |
Discontinuation or Dose Reduction in the Levetiracetam Extended-Release Tablets Controlled Clinical Study
In the controlled clinical study, 5% of patients receiving levetiracetam extended-release tablets and 3% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions that resulted in discontinuation and that occurred more frequently in levetiracetam extended-release tablet-treated patients than in placebo-treated patients were asthenia, epilepsy, mouth ulceration, rash, and respiratory failure. Each of these adverse reactions led to discontinuation in a levetiracetam extended-release tablet-treated patient and no placebo-treated patients.
Immediate-Release Levetiracetam Tablets
Table 4 lists the adverse reactions in the controlled studies of immediate-release levetiracetam tablets in adult patients experiencing partial-onset seizures. Although the pattern of adverse reactions in the levetiracetam extended-release tablets study seems somewhat different from that seen in partial-onset seizure controlled studies for immediate-release levetiracetam tablets, this is possibly due to the much smaller number of patients in this study compared to the immediate-release tablet studies. The adverse reactions for levetiracetam extended-release tablets are expected to be similar to those seen with immediate-release levetiracetam tablets.
Adults
In controlled clinical studies of immediate-release levetiracetam tablets as adjunctive therapy to other AEDs in adults with partial-onset seizures, the most common adverse reactions, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness.
Table 4 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving immediate-release levetiracetam tablets in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either immediate-release levetiracetam tablets or placebo was added to concurrent AED therapy.
Table 4: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Adults Experiencing Partial-Onset Seizures
| Adverse Reactions | Immediate-Release Levetiracetam Tablets (N=769) % | Placebo (N=439) % |
| Asthenia | 15 | 9 |
| Somnolence | 15 | 8 |
| Headache | 14 | 13 |
| Infection | 13 | 8 |
| Dizziness | 9 | 4 |
| Pain | 7 | 6 |
| Pharyngitis | 6 | 4 |
| Depression | 4 | 2 |
| Nervousness | 4 | 2 |
| Rhinitis | 4 | 3 |
| Anorexia | 3 | 2 |
| Ataxia | 3 | 1 |
| Vertigo | 3 | 1 |
| Amnesia | 2 | 1 |
| Anxiety | 2 | 1 |
| Cough Increased | 2 | 1 |
| Diplopia | 2 | 1 |
| Emotional Lability | 2 | 0 |
| Hostility | 2 | 1 |
| Paresthesia | 2 | 1 |
| Sinusitis | 2 | 1 |
Pediatric Patients 4 Years to <16 Years
In a pooled analysis of two controlled pediatric clinical studies in children 4 to 16 years of age with partial-onset seizures, the adverse reactions most frequently reported with the use of immediate-release levetiracetam tablets in combination with other AEDs, and with greater frequency than in patients on placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.
Table 5 lists adverse reactions that occurred in at least 2% of pediatric patients treated with immediate -release levetiracetam tablets and were more common than in pediatric patients on placebo. In these studies, either immediate-release levetiracetam tablets or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.
Table 5: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Pediatric Patients Ages 4 to 16 Years Experiencing Partial-Onset Seizures
| Adverse Reaction | Immediate-Release Levetiracetam Tablets (N=165) % | Placebo (N=131) % |
| Headache | 19 | 15 |
| Nasopharyngitis | 15 | 12 |
| Vomiting | 15 | 12 |
| Somnolence | 13 | 9 |
| Fatigue | 11 | 5 |
| Aggression | 10 | 5 |
| Abdominal Pain Upper | 9 | 8 |
| Cough | 9 | 5 |
| Nasal Congestion | 9 | 2 |
| Decreased Appetite | 8 | 2 |
| Abnormal Behavior | 7 | 4 |
| Dizziness | 7 | 5 |
| Irritability | 7 | 1 |
| Pharyngolaryngeal Pain | 7 | 4 |
| Diarrhea | 6 | 5 |
| Lethargy | 6 | 2 |
| Insomnia | 5 | 3 |
| Agitation | 4 | 1 |
| Anorexia | 4 | 3 |
| Head Injury | 4 | 0 |
| Constipation | 3 | 1 |
| Contusion | 3 | 1 |
| Depression | 3 | 1 |
| Fall | 3 | 2 |
| Influenza | 3 | 1 |
| Mood Altered | 3 | 1 |
| Affect Lability | 2 | 1 |
| Anxiety | 2 | 1 |
| Arthralgia | 2 | 0 |
| Confusional State | 2 | 0 |
| Conjunctivitis | 2 | 0 |
| Ear Pain | 2 | 1 |
| Gastroenteritis | 2 | 0 |
| Joint Sprain | 2 | 1 |
| Mood Swings | 2 | 1 |
| Neck Pain | 2 | 1 |
| Rhinitis | 2 | 0 |
| Sedation | 2 | 1 |
In controlled pediatric clinical studies in patients 4 to 16 years of age, 7% of patients treated with immediate-release levetiracetam tablets and 9% of patients on placebo discontinued as a result of an adverse event.
In addition, the following adverse reactions were seen in other controlled studies of immediate-release levetiracetam tablets: balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and blurred vision.
Comparison of Gender, Age and Race
There are insufficient data for levetiracetam extended-release tablets to support a statement regarding the distribution of adverse reactions by gender, age, and race.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of immediate-release levetiracetam tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The listing is alphabetized: abnormal liver function test, acute kidney injury, anaphylaxis, angioedema, agranulocytosis, choreoathetosis, drug reaction with eosinophilia and systemic symptoms (DRESS), dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, muscular weakness, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, weight loss, and worsening of seizures. Alopecia has been reported with immediate-release levetiracetam tablet use; recovery was observed in majority of cases where immediate-release levetiracetam tablets were discontinued.
Read the entire FDA prescribing information for Elepsia XR (Levetiracetam Extended-release Tablets)
&Copy; Elepsia XR Patient Information is supplied by Cerner Multum, Inc. and Elepsia XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.