LEVETIRACETAM - levetiracetam solution
Aurobindo Pharma Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use levetiracetam oral solution safely and effectively. See full prescribing information for levetiracetam oral solution.
Levetiracetam Oral Solution Initial U.S. Approval: 1999 RECENT MAJOR CHANGESINDICATIONS AND USAGELevetiracetam is an antiepileptic drug indicated for adjunctive therapy in the treatment of: DOSAGE AND ADMINISTRATION
Partial Onset Seizures
Myoclonic Seizures In Adults and Pediatric Patients 12 Years And Older
Primary Generalized Tonic-Clonic Seizures
Adult Patients with Impaired Renal Function DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost common adverse reactions (incidence in levetiracetam-treated patients is ≥ 5% more than in placebo-treated patients) include:
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 6/2012 |
Group | Creatinine Clearance (mL/min/1.73 m2) | Dosage (mg) | Frequency |
---|---|---|---|
1 Following dialysis, a 250 to 500 mg supplemental dose is recommended. |
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Normal | > 80 | 500 to 1,500 | Every 12 hours |
Mild | 50 – 80 | 500 to 1,000 | Every 12 hours |
Moderate | 30 – 50 | 250 to 750 | Every 12 hours |
Severe | < 30 | 250 to 500 | Every 12 hours |
ESRD patients using dialysis | ---- | 500 to 1,0001
| Every 24 hours1
|
Indication | Placebo Patients with Events Per 1000 Patients | Drug Patients with Events Per 1000 Patients | Relative Risk: Incidence of Events in Drug Patients/Incidence in Placebo Patients | Risk Difference: Additional Drug Patients with Events Per 1000 Patients |
---|---|---|---|---|
Epilepsy | 1 | 3.4 | 3.5 | 2.4 |
Psychiatric | 5.7 | 8.5 | 1.5 | 2.9 |
Other | 1 | 1.8 | 1.9 | 0.9 |
Total | 2.4 | 4.3 | 1.8 | 1.9 |
Body System/ Adverse Reaction | Levetiracetam (N=769) % | Placebo (N=439) % |
---|---|---|
Body as a Whole
| | |
Asthenia | 15 | 9 |
Headache | 14 | 13 |
Infection | 13 | 8 |
Pain | 7 | 6 |
Digestive System
| ||
Anorexia | 3 | 2 |
Nervous System
| ||
Somnolence | 15 | 8 |
Dizziness | 9 | 4 |
Depression | 4 | 2 |
Nervousness | 4 | 2 |
Ataxia | 3 | 1 |
Vertigo | 3 | 1 |
Amnesia | 2 | 1 |
Anxiety | 2 | 1 |
Hostility | 2 | 1 |
Paresthesia | 2 | 1 |
Emotional Lability | 2 | 0 |
Respiratory System
| ||
Pharyngitis | 6 | 4 |
Rhinitis | 4 | 3 |
Cough Increased | 2 | 1 |
Sinusitis | 2 | 1 |
Special Senses
| ||
Diplopia | 2 | 1 |
Adverse Reaction | Levetiracetam (N=769) % | Placebo (N=439) % |
---|---|---|
Dizziness | 1 | 0 |
Somnolence | 4 | 2 |
Body System/ Adverse Reaction | Levetiracetam (N=165) % | Placebo (N=131) % |
---|---|---|
Ear and Labyrinth Disorders
| |
|
Ear Pain | 2 | 1 |
Eye Disorders
| |
|
Conjunctivitis | 2 | 0 |
Gastrointestinal Disorders
| |
|
Vomiting | 15 | 12 |
Abdominal Pain Upper | 9 | 8 |
Diarrhea | 6 | 5 |
Constipation | 3 | 1 |
General Disorders and Administration Site Conditions
| |
|
Fatigue | 11 | 5 |
Infections and Infestations
| |
|
Nasopharyngitis | 15 | 12 |
Influenza | 3 | 1 |
Gastroenteritis | 2 | 0 |
Rhinitis | 2 | 0 |
Injury, Poisoning and Procedural Complications
| |
|
Head Injury | 4 | 0 |
Contusion | 3 | 1 |
Fall | 3 | 2 |
Joint Sprain | 2 | 1 |
Metabolism and Nutrition Disorders
| |
|
Decreased Appetite | 8 | 2 |
Anorexia | 4 | 3 |
Musculoskeletal and Connective Tissue Disorders
| |
|
Arthralgia | 2 | 0 |
Neck Pain | 2 | 1 |
Nervous System
| |
|
Headache | 19 | 15 |
Somnolence | 13 | 9 |
Dizziness | 7 | 5 |
Lethargy | 6 | 2 |
Sedation | 2 | 1 |
Psychiatric Disorders
| |
|
Aggression | 10 | 5 |
Abnormal Behavior | 7 | 4 |
Irritability | 7 | 1 |
Insomnia | 5 | 3 |
Agitation | 4 | 1 |
Depression | 3 | 1 |
Mood Altered | 3 | 1 |
Affect Lability | 2 | 1 |
Anxiety | 2 | 1 |
Confusional State | 2 | 0 |
Mood Swings | 2 | 1 |
Respiratory, Thoracic and Mediastinal Disorders
| | |
Cough | 9 | 5 |
Nasal Congestion | 9 | 2 |
Pharyngolaryngeal Pain | 7 | 4 |
Body System/ Adverse Reaction | Levetiracetam (N=60) % | Placebo (N=56) % |
---|---|---|
Nervous System
| ||
Somnolence | 13 | 2 |
Psychiatric Disorders
| ||
Irritability | 12 | 0 |
Table 7 lists adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with levetiracetam and were numerically more common than in patients treated with placebo. In this study, either levetiracetam or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.
Body System/ Adverse Reaction | Levetiracetam(N=60) % | Placebo (N=60) % |
---|---|---|
Ear and Labyrinth Disorders
| |
|
Vertigo | 5 | 3 |
Infections and Infestations
| ||
Pharyngitis | 7 | 0 |
Influenza | 5 | 2 |
Musculoskeletal and Connective Tissue Disorders
| ||
Neck Pain | 8 | 2 |
Nervous System Disorders
| ||
Somnolence | 12 | 2 |
Psychiatric Disorders
| ||
Depression | 5 | 2 |
Adverse Reaction | Levetiracetam(N=60) % | Placebo (N=60) % |
---|---|---|
Anxiety | 3 | 2 |
Depressed Mood | 2 | 0 |
Depression | 2 | 0 |
Diplopia | 2 | 0 |
Hypersomnia | 2 | 0 |
Insomnia | 2 | 0 |
Irritability | 2 | 0 |
Nervousness | 2 | 0 |
Somnolence | 2 | 0 |
Body System/ Adverse Reaction | Levetiracetam (N=79) % | Placebo (N=84) % |
---|---|---|
Gastrointestinal Disorders
|
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Diarrhea | 8 | 7 |
General Disorders and Administration Site Conditions
|
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Fatigue | 10 | 8 |
Infections and Infestations
|
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Nasopharyngitis | 14 | 5 |
Psychiatric Disorders
|
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Irritability | 6 | 2 |
Mood Swings | 5 | 1 |
Placebo (N=95) | Levetiracetam 1000 mg/day (N=97) | Levetiracetam 3000 mg/day (N=101) |
|
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*statistically significant versus placebo |
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Percent reduction in partial seizure frequency over placebo | – | 26.1%* | 30.1%* |
Placebo (N=111) | Levetiracetam 1000 mg/day (N=106) | Levetiracetam 2000 mg/day (N=105) |
|
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*statistically significant versus placebo |
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Percent reduction in partial seizure frequency over placebo | – | 17.1%* | 21.4%* |
Placebo (N=104) | Levetiracetam 3000 mg/day (N=180) |
|
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*statistically significant versus placebo |
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Percent reduction in partial seizure frequency over placebo | – | 23.0%* |
Effectiveness In Partial Onset Seizures In Pediatric Patients 4 Years To 16 Years With Epilepsy
Placebo (N=97) | Levetiracetam (N=101) | |
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*statistically significant versus placebo |
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Percent reduction in partial seizure frequency over placebo | - | 26.8%* |
Effectiveness In Partial Onset Seizures In Pediatric Patients 1 Month To <4 Years With Epilepsy
Placebo (N=59) | Levetiracetam (N=54) |
|
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*statistically significant versus placebo |
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Percentage of responders | 23.7% | 60.4%* |
Placebo (N=84) | Levetiracetam (N=78) | |
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*statistically significant versus placebo |
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Percent reduction in PGTC seizure frequency | 44.6% | 77.6%* |
Do not stop levetiracetam oral solution without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions?
What is levetiracetam oral solution?
Levetiracetam oral solution is a prescription medicine taken by mouth that is used with other medicines to treat:
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.
What should I avoid while taking levetiracetam oral solution?
The most common side effects seen in people who take levetiracetam oral solution include:
The most common side effects seen in children who take levetiracetam oral solution include, in addition to those listed above:
LEVETIRACETAM
levetiracetam solution |
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Labeler - Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Aurobindo Pharma Limited | 918917642 | MANUFACTURE(65862-250), ANALYSIS(65862-250) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Aurobindo Pharma Limited | 918917626 | API MANUFACTURE(65862-250) |