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Keppra

Generic Name: Levetiracetam
Drug Category: Antiepileptic
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 1 month old for a maximum duration of 3 years.

Approved Uses

Indicated for:

Partial-Onset Seizures:

• The treatment of partial-onset seizures in patients 1 month of age and older. 

Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy:

• Adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. 

Primary Generalized Tonic-Clonic Seizures:

• Adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. 

There is no evidence that doses greater than 3000 mg/day confer additional benefit in adults 16 years of age and older.

Monitor patients 1 month to <4 years of age for increases in diastolic blood pressure.

There are no data to support the physical compatibility of KEPPRA injection with antiepileptic drugs other than Lorazepam, Diazepam, and Valproate sodium.

Antiepileptic drugs, including KEPPRA, should be withdrawn gradually to minimize the potential of increased seizure frequency.

Antiepileptic drugs (AEDs), including KEPPRA, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

KEPPRA may cause behavioral abnormalities and psychotic symptoms (aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesia, irritability, nervousness, neurosis, and personality disorder).

KEPPRA can cause anaphylaxis or angioedema after the first dose or at any time during treatment.

Serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in both pediatric and adult patients treated with KEPPRA. The median time of onset is reported to be 14 to 17 days, but cases have been reported at least four months after initiation of treatment.

KEPPRA may cause coordination difficulties.

KEPPRA may cause somnolence and fatigue. Patients should be monitored for these signs and symptoms and advised not to drive or operate machinery until they have gained sufficient experience on KEPPRA to gauge whether it adversely affects their ability to drive or operate machinery.

KEPPRA can cause hematologic abnormalities. Hematologic abnormalities occurred in clinical trials and included decreases in white blood cell (WBC), neutrophil, and red blood cells counts (RBC); decreases in hemoglobin and hematocrit; and increases in eosinophil counts. Cases of agranulocytosis, pancytopenia, and thrombocytopenia have been reported in the postmarketing setting.

There are no adequate and well-controlled studies in pregnant women. Animal studies: developmental toxicity, including teratogenic effects.

Levetiracetam is excreted in human milk with potential for serious adverse reactions in nursing infants.

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Off-label Uses

• Use in patients under 1 month of age. GoToSource

• Bipolar disorder. GoToSource

• Meige’s syndrome. GoToSource

• Segmental and generalized dystonia. GoToSource

• Tardive dyskinesia. GoToSource

• Cerebellar tremor in patients with multiple sclerosis. GoToSource

• Panic disorder. GoToSource

• Post‐ischaemic holmes’ tremor. GoToSource

• Prophylactic therapy for migraines. GoToSource

• Epileptic encephalopathies including ohtahara syndrome, west syndrome, dravet syndrome, doose syndrome, lennox-gastaut syndrome, landau-kleffner syndrome and electrical status epilepticus during sleep. GoToSource

• Acute mania. GoToSource

• Refractory epilepsy. GoToSource

• Idiopathic hemifacial spasm. GoToSource

• Social anxiety disorder. GoToSource

• Chorea in huntington’s disease. GoToSource

• Tourette syndrome. GoToSource

• Hot flashes in female patients. GoToSource

• Post herpetic neuralgia. GoToSource

• Alcohol withdrawal syndrome. GoToSource

• Levodopa-induced dyskinesias in parkinson’s disease. GoToSource

• Enhancement of cognitive function. GoToSource

• Posthypoxic and postencephalitic myoclonus. GoToSource

• Autism. GoToSource

• Refractory schizophrenic patients. GoToSource

• Refractory post-traumatic stress disorder. GoToSource

• Restless legs syndrome. GoToSource

Adverse Events

Dispensing errors between Keppra and Kaletra. GoToSource

Suicidal thoughts and behaviors. GoToSource

Acceleration of atherosclerosis and increased risk of vascular diseases. GoToSource

Somnolence (sleepiness), convulsions, anorexia (eating disorder), hostility, personality disorders, urinary tract infections, depression, aggression, anxiety, upper respiratory tract infection and acne. GoToSource

Significant elevation in serum alkaline phosphatase level. GoToSource

Aggravation of myoclonic seizures. GoToSource

Drug reaction with eosinophilia and systemic symptoms syndrome (severe drug reaction). GoToSource

Reversible autistic regression. GoToSource

Loss of libido and anhedonia (inability to experience pleasure). GoToSource

Decreased bone mineral density. GoToSource

Angioedema (rapid swelling). GoToSource

Interstitial nephritis (kidney disorder). GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Birth defects. GoToSource

Leukopenia (decreased white blood cells),anemia and pancytopenia (deficiency of red cells, white cells and platelets). GoToSource

Hyponatremia (low blood sodium level). GoToSource

Kidney failure. GoToSource

Liver failure. GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Significant weight loss. GoToSource

Litigation

Lawsuits filed for suicide and birth defects.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 29, 2024