Keppra 100 mg/mL

levetiracetam · INJECTION, SOLUTION, CONCENTRATE · UCB, Inc.

1 Recall on Record

Plain English

Keppra is a injection, solution, concentrate containing levetiracetam at 100 mg/mL, taken intravenous. Manufactured by UCB, Inc..

Key Facts

Brand Name: Keppra
Generic Name: levetiracetam
NDC Code (Product): 50474-002
Manufacturer: UCB, Inc.
Strength: 100 mg/mL
Dosage Form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Marketing Status
Application #: NDA021872
Marketing Start: 08/23/2006

Recall History

1 Recall on Record

Class II07/18/2019

Ucb, Inc

Failed Dissolution Specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

seizure15,686 reports

drug ineffective12,078 reports

off label use9,236 reports

fatigue5,501 reports

convulsion4,078 reports

somnolence4,066 reports

epilepsy4,047 reports

fall3,710 reports

headache3,674 reports

maternal exposure during pregnancy3,614 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE KEPPRA XR ® is indicated for the treatment of partial-onset seizures in patients 12 years of age and older. KEPPRA XR is indicated for the treatment of partial-onset seizures in patients 12 years of age and older ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Initiate treatment with a dose of 1000 mg once daily; increase by 1000 mg every 2 weeks to a maximum recommended dose of 3000 mg once daily ( 2 ) See full prescribing information for use in patients with impaired renal function ( 2.1 ) 2.1 Recommended Dosing For adults and adolescent patients, the recommended dosing for monotherapy and adjunctive therapy is the same; as outlined below. Adults and Adolescents 12 Years of Age and Older Weighing 50 kg or More Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks to a maximum recommended daily dose of 3000 mg/day once daily. Administration KEPPRA XR is administered once daily. KEPPRA XR tablets should be swallowed whole. The tablets should not be chewed, broken, or crushed. 2.2 Dosage Adjustments in Adult Patients with Renal Impairment KEPPRA XR dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculate…

Contraindications

4 CONTRAINDICATIONS KEPPRA XR 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 )

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more details in other sections of labeling: Behavioral 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) ] Most common adverse reactions (incidence ≥5% more than placebo) include: somnolence and irritability ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at (844) 599-CARE (2273) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another …

Frequently Asked Questions

What is Keppra used for?

Keppra contains levetiracetam. It is a injection, solution, concentrate taken intravenous. Consult your doctor for specific uses.

Is Keppra a controlled substance?

Keppra is not classified as a controlled substance by the DEA.

What is the generic name for Keppra?

The generic name for Keppra is levetiracetam. There are 12 other brand versions of levetiracetam.

What is the NDC code for Keppra 100 mg/mL?

The NDC (National Drug Code) for Keppra 100 mg/mL is 50474-002, listed by UCB, Inc..

Product NDC

50474-002

Package NDC

50474-002-63

Other Levetiracetam Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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