Drugplain

ELEPSIA XR 1000 MG 1000 mg/1

levetiracetam · TABLET, EXTENDED RELEASE · TRIPOINT THERAPEUTICS, LLC

No Recall History
Plain English

ELEPSIA XR 1000 MG is a tablet, extended release containing levetiracetam at 1000 mg/1, taken oral. Manufactured by TRIPOINT THERAPEUTICS, LLC.

Key Facts

Brand Name
ELEPSIA XR 1000 MG
Generic Name
levetiracetam
NDC Code (Product)
80705-100
Manufacturer
TRIPOINT THERAPEUTICS, LLC
Strength
1000 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA204417
Marketing Start
02/12/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective8,850 reports
seizure8,681 reports
off label use6,282 reports
maternal exposure during pregnancy3,015 reports
epilepsy2,711 reports
foetal exposure during pregnancy2,474 reports
drug interaction2,444 reports
fatigue2,405 reports
condition aggravated2,222 reports
status epilepticus2,029 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. ELEPSIA XR is indicated as adjunctive therapy 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 ( 2.1 ) ELEPSIA XR should be taken whole; do not split or cut tablets ( 2.1 ) Not recommended for use in patients with moderate or severe renal impairment; the maximum recommended dose in patients with mild renal impairment is 2000 mg ( 2.2 ) 2.1 Recommended Dosing ELEPSIA XR is administered orally once daily. 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. ELEPSIA XR should be taken whole; do not split or cut tablets. 2.2 Dosage Adjustment in Adult Patients with Renal Impairment ELEPSIA XR is not recommended for use in patients with moderate or severe renal impairment. Recommended doses and adjustment for patients with mild renal impairment 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 (CL cr ) in…

Contraindications

4 CONTRAINDICATIONS ELEPSIA 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 )

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail 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 Tripoint Therapeutics at (908) 928-4500 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…

Frequently Asked Questions

What is ELEPSIA XR 1000 MG used for?

ELEPSIA XR 1000 MG contains levetiracetam. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is ELEPSIA XR 1000 MG a controlled substance?

ELEPSIA XR 1000 MG is not classified as a controlled substance by the DEA.

What is the generic name for ELEPSIA XR 1000 MG?

The generic name for ELEPSIA XR 1000 MG is levetiracetam. There are 12 other brand versions of levetiracetam.

What is the NDC code for ELEPSIA XR 1000 MG 1000 mg/1?

The NDC (National Drug Code) for ELEPSIA XR 1000 MG 1000 mg/1 is 80705-100, listed by TRIPOINT THERAPEUTICS, LLC.

Product NDC

80705-100

Package NDC

80705-100-02

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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