Levetiracetam Injection
Generic Name: levetiracetam injection
Brand Names:
Levetiracetam
11 DESCRIPTION Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs).
Overview
11 DESCRIPTION Levetiracetam in Sodium Chloride Injection is an antiepileptic drug available as a clear, colorless, sterile solution for intravenous administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs).
Uses
1 INDICATIONS AND USAGE Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures ( 1.1 ) Myoclonic seizures in patients with juvenile myoclonic epilepsy ( 1.2 ) Primary generalized tonic-clonic seizures ( 1.3 ) 1.1 Partial-Onset Seizures Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
Dosage
2 DOSAGE AND ADMINISTRATION For intravenous infusion only ( 2.1 ) Do not dilute prior to its use ( 2.1 ) Administer dose-specific bag intravenously over 15-minutes ( 2.1 ) Initial Exposure to Levetiracetam Partial Onset Seizures : Initial dose is 500 mg twice daily.Increase by 500 mg twice daily evry 2 weeks to a maximum recommended dose of 1,500 mg twice daily. ( 2.2 ). Myoclonic Seizures in Patients with Juvenile Myoc/onic Epilepsy : Initial dose is 500 mg twice daily. Increase by 500 mg every 2 weeks to the recommended daily dose of 1,500 mg twice daily. ( 2.2 ) Primary Generalized Tonic-Clonic Seizures : Initial dose is 500 mg twice daily. Increase by 500 mg twice daily every 2 weeks to the recommended dose of 1,500 mg twice daily.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more details in other sections of labeling: Psychiatric Reactions [see Warnings and Precautions ( 5.1 )] Somnolence and Fatigue [see Warnings and Precautions ( 5.2 )] Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.3 )] Serious Dermatological Reactions [see Warnings and Precautions ( 5.4 )] Coordination Difficulties [see Warnings and Precautions ( 5.5 )] Withdrawal Seizures [see Warnings and Precautions ( 5.6 )] Hematologic Abnormalities [see Warnings and Precautions ( 5.7 )] Seizure Control During Pregnancy [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence in levetiracetam-treated patients is ≥5% more than in placebo-treated patients) include: somnolence, asthenia, infec...
Warnings
5 WARNINGS AND PRECAUTIONS PsychiatricReactions: Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed. Monitor patients for psychiatric signs and symptoms ( 5.1 ) Somnolence and Fatigue: Monitor patients for these symptoms and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam ( 5.2 ) Serious Dermatological Reactions: Discontinue Levetiracetam at the first sign of rash unless clearly not drug related. ( 5.4 ) Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. 4 CONTRAINDICATIONS Levetiracetam in Sodium Chloride Injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.3 )]. Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4 )
Storage
16.2 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Levetiracetam Injection used for?▼
1 INDICATIONS AND USAGE Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial onset seizures ( 1.1 ) Myoclonic seizures in patients with juvenile myoclonic epilepsy ( 1.2 ) Primary generalized tonic-clonic seizures ( 1.3 ) 1.1 Partial-Onset Seizures Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
What are the side effects of Levetiracetam Injection?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more details in other sections of labeling: Psychiatric Reactions [see Warnings and Precautions ( 5.1 )] Somnolence and Fatigue [see Warnings and Precautions ( 5.2 )] Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.3 )] Serious Dermatological Reactions [see Warnings and Precautions ( 5.4 )] Coordination Difficulties [see Warnings and Precautions ( 5.5 )] Withdrawal Seizures [see Warnings and Precautions ( 5.6 )] Hematologic Abnormalities [see Warnings and Precautions ( 5.7 )] Seizure Control During Pregnancy [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence in levetiracetam-treated patients is ≥5% more than in placebo-treated patients) include: somnolence, asthenia, infec...
What are the important warnings for Levetiracetam Injection?▼
5 WARNINGS AND PRECAUTIONS PsychiatricReactions: Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed. Monitor patients for psychiatric signs and symptoms ( 5.1 ) Somnolence and Fatigue: Monitor patients for these symptoms and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam ( 5.2 ) Serious Dermatological Reactions: Discontinue Levetiracetam at the first sign of rash unless clearly not drug related. ( 5.4 ) Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. 4 CONTRAINDICATIONS Levetiracetam in Sodium Chloride Injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.3 )]. Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 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.