Levetiracetam extended-release
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
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 calculated.
To do this, an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula: [See table below.] Then CLcr is adjusted for body surface area (BSA) as follows: [See table below.] [See table below.] Mild 50 – 80 1000 to 2000 Every 24 hours Moderate 30 – 50 500 to 1500 Every 24 hours Severe < 30 500 to 1000 Every 24 hours
| CLcr= | [140-age (years)] × weight (kg) -------------------------------------- | (× 0.85 for female patients) |
| 72 × serum creatinine (mg/dL) |
| CLcr (mL/min/1.73m 2)= | CLcr (mL/min) ------------------------- | × 1.73 |
| BSA subject (m 2) |
| Group | Creatinine Clearance (mL/min/1.73m 2) | Dosage (mg) | Frequency |
|---|---|---|---|
| Normal | > 80 | 1000 to 3000 | Every 24 hours |
| Mild | 50 – 80 | 1000 to 2000 | Every 24 hours |
| Moderate | 30 – 50 | 500 to 1500 | Every 24 hours |
| Severe | < 30 | 500 to 1000 | Every 24 hours |
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for levetiracetam extended-release. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including KEPPRA XR, during pregnancy. Encourage women who are taking KEPPRA XR during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary Prolonged experience with KEPPRA in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see Human Data ] .
In animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see Animal Data ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Clinical Considerations KEPPRA XR levels may decrease during pregnancy [see Warnings and Precautions (5.10) ]. Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more pronounced during the third trimester. Dose adjustments may be necessary to maintain clinical response. Data Human Data While available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage.
Animal Data When levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. There was no evidence of maternal toxicity. The no-effect dose for adverse effects on embryofetal developmental in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (MRHD) of 3000 mg on a body surface area (mg/m 2 ) basis. Oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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