Levetiracetam Oral
Generic Name: levetiracetam oral
Brand Names:
Levetiracetam
11 DESCRIPTION Levetiracetam is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs).
Overview
11 DESCRIPTION Levetiracetam is an antiepileptic drug available as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8 H 14 N 2 O 2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs).
Uses
1 INDICATIONS AND USAGE Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) 1.1 Partial-Onset Seizures Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
Dosage
2 DOSAGE AND ADMINISTRATION • Use the oral solution for pediatric patients with body weight ≤ 20 kg ( 2.1 ) • For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) ( 2.1 ) Partial-Onset Seizures (monotherapy or adjunctive therapy) • 1 Month to 80 500 to 1,500 Every 12 hours Mild 50 to 80 500 to 1,000 Every 12 hours Moderate 30 to 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ---- 500 to 1,000* Every 24 hours * * Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in more details in other sections of labeling: • Behavior Abnormalities and Psychotic Symptoms [see Warnings and Precautions ( 5.1 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.2 )] • Somnolence and Fatigue [see Warnings and Precautions ( 5.3 )] • Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.4 )] • Serious Dermatological Reactions [see Warnings and Precautions ( 5.5 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.6 )] • Coordination Difficulties [see Warnings and Precautions ( 5.7 )] • Hematologic Abnormalities [see Warnings and Precautions ( 5.9 )] • Increase in Blood Pressure [see Warnings and Precaution...
Warnings
5 WARNINGS AND PRECAUTIONS • Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms ( 5.1 ) • Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior ( 5.2 ) • Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam (5.3 ) • Serious Dermatological Reactions: Discontinue levetiracetam at the first sign of rash unless clearly not drug related (5.5) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiolog... 4 CONTRAINDICATIONS Levetiracetam oral solution is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4 , 5.4 )
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including levetiracetam, during pregnancy. Encourage women who are taking levetiracetam during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Levetiracetam oral solution USP, 100 mg/mL is a clear, colorless, grape-flavored liquid. It is supplied in 16 fl. oz. white HDPE bottles (NDC 31722-574-47). 16.2 Storage Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Levetiracetam Oral used for?▼
1 INDICATIONS AND USAGE Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) 1.1 Partial-Onset Seizures Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
What are the side effects of Levetiracetam Oral?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in more details in other sections of labeling: • Behavior Abnormalities and Psychotic Symptoms [see Warnings and Precautions ( 5.1 )] • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.2 )] • Somnolence and Fatigue [see Warnings and Precautions ( 5.3 )] • Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.4 )] • Serious Dermatological Reactions [see Warnings and Precautions ( 5.5 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.6 )] • Coordination Difficulties [see Warnings and Precautions ( 5.7 )] • Hematologic Abnormalities [see Warnings and Precautions ( 5.9 )] • Increase in Blood Pressure [see Warnings and Precaution...
Can I take Levetiracetam Oral during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including levetiracetam, during pregnancy. Encourage women who are taking levetiracetam during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
What are the important warnings for Levetiracetam Oral?▼
5 WARNINGS AND PRECAUTIONS • Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms ( 5.1 ) • Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior ( 5.2 ) • Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam (5.3 ) • Serious Dermatological Reactions: Discontinue levetiracetam at the first sign of rash unless clearly not drug related (5.5) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiolog... 4 CONTRAINDICATIONS Levetiracetam oral solution is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4 , 5.4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.