Levetiracetam ER 500 mg/1

Levetiracetam · TABLET, FILM COATED, EXTENDED RELEASE · Proficient Rx LP

No Recall History

Plain English

Levetiracetam ER is a tablet, film coated, extended release containing levetiracetam at 500 mg/1, taken oral. Manufactured by Proficient Rx LP.

Key Facts

Brand Name: Levetiracetam ER
Generic Name: Levetiracetam
NDC Code (Product): 71205-728
Manufacturer: Proficient Rx LP
Strength: 500 mg/1
Dosage Form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: ANDA205130
Marketing Start: 09/30/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective8,852 reports

seizure8,689 reports

off label use6,282 reports

maternal exposure during pregnancy3,015 reports

epilepsy2,711 reports

foetal exposure during pregnancy2,474 reports

drug interaction2,445 reports

fatigue2,412 reports

condition aggravated2,222 reports

status epilepticus2,030 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Levetiracetam extended-release tablets are indicated for the treatment of partial-onset in patients 12 years of age and older.

Dosage & Administration

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 1,000 mg once daily. The once daily dosage may be adjusted in increments of 1,000 mg every 2 weeks to a maximum recommended daily dose of 3,000 mg/day once daily. Administration Levetiracetam extended-release tablets are administered once daily. Levetiracetam extended-release tablets should be swallowed whole. The tablets should not be chewed, broken, or crushed. 2.2 Dosage Adjustments in Adult Patients with Renal Impairment Levetiracetam extended-release tablets 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 calculated. To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula: [clcr 2] [clcr 2] Table 1: Dosage Adjustment …

Contraindications

Levetiracetam extended-releasetablets are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)].

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)] • Coordination Difficulties [see Warnings and Precautions (5.6)] • Hematologic Abnormalities [see Warnings and Precautions (5.8)] 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 drug and may not reflect the rates observed in practice. Levetiracetam Extended-Release Tablets In the controlled clinical study in patients with partial-onset seizures [see CLINICAL STUDIES (14.1)], the most common adverse reactions in patients receiving levetiracetam extended-release tablets in combination with other AEDs, for events with rates greater than placebo, were irrita…

Frequently Asked Questions

What is Levetiracetam ER used for?

Levetiracetam ER contains Levetiracetam. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is Levetiracetam ER a controlled substance?

Levetiracetam ER is not classified as a controlled substance by the DEA.

What is the generic name for Levetiracetam ER?

The generic name for Levetiracetam ER is Levetiracetam. There are 12 other brand versions of Levetiracetam.

What is the NDC code for Levetiracetam ER 500 mg/1?

The NDC (National Drug Code) for Levetiracetam ER 500 mg/1 is 71205-728, listed by Proficient Rx LP.

Product NDC

71205-728

Package NDC

71205-728-30

Other Levetiracetam Brands

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

Data from openFDA · Public domain (CC0 1.0)