levetiracetam 5 mg/mL
levetiracetam · INJECTION · Baxter Healthcare Corporation
Levetiracetam injection is a prescription antiepileptic medication used to treat seizures when oral medication cannot be given. It is administered directly into a vein and comes in a concentration of 5 mg/mL.
Key Facts
- Brand Name
- levetiracetam
- Generic Name
- levetiracetam
- NDC Code (Product)
36000-352- Manufacturer
- Baxter Healthcare Corporation
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA217059
- Marketing Start
- 10/02/2023
Recall History
AuroMedics Pharma LLC
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
EYWA PHARMA INC
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
AuroMedics Pharma LLC
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Akorn, Inc.
Defective container: Customer complaints for oral solution leaking from bottles.
Dr. Reddy's Laboratories, Inc.
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Hetero Labs, Ltd. - Unit III
Presence of foreign substance (screw)
X-Gen Pharmaceuticals Inc.
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam 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 tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam tablets are indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.
Dosage & Administration
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 < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily ( 2.2 ) 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily ( 2.2 ) 4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily ( 2.2 ) Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily ( 2.2 ) Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily ( 2.3 ) Primary Generalized Tonic-Clonic Seizures 6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/…
Contraindications
4 CONTRAINDICATIONS Levetiracetam tablets are 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 )
Adverse Reactions
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 Precautions (5.10) ] Most common adverse reactions (incidence ≥ 5% more than placebo) include: Adult patients: somnolence, asthenia, infection and dizziness (6.1) Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability (6.1) 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. 6.1 Clinical Trials Experienc…
Frequently Asked Questions
What is levetiracetam used for?
Levetiracetam injection is a prescription antiepileptic medication used to treat seizures when oral medication cannot be given. It is administered directly into a vein and comes in a concentration of 5 mg/mL.
Is levetiracetam a controlled substance?
levetiracetam is not classified as a controlled substance by the DEA.
What is the generic name for levetiracetam?
The generic name for levetiracetam is levetiracetam. There are 11 other brand versions of levetiracetam.
What is the NDC code for levetiracetam 5 mg/mL?
The NDC (National Drug Code) for levetiracetam 5 mg/mL is 36000-352, listed by Baxter Healthcare Corporation.
Other levetiracetam Dosages
Other Levetiracetam Brands
See all →- Levetiracetam250 mg/172205-094
- Levetiracetam500 mg/172205-095
- Levetiracetam250 mg/172865-187
- Levetiracetam250 mg/176494-528
- Levetiracetam1000 mg/116714-310
- Levetiracetam in Sodium Chloride5 mg/mL0143-9281
- LEVETIRACETAM100 mg/mL42571-331
- Levetiracetam500 mg/143063-617
- Levetiracetam5 mg/mL43598-635
- Levetiracetam1000 mg/150090-7770
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)