Levetiracetam intravenous
Other products: Levetiracetam, Levetiracetam extended-release
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Dosing in kidney impairment
Dosage Adjustments in Adult Patients with Renal Impairment Levetiracetam injection dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults with renal impairment are shown in Table 2. Information is unavailable for dosage adjustments in pediatric patients with renal impairment.
In order to calculate the dose recommended for adult 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= [140-age (years)] x weight (kg) (x 0.85 for female patients) ----------------------------------------- 72 x serum creatinine (mg/dL) Then CLcr is adjusted for body surface area (BSA) as follows: CLcr (mL/min) CLcr (mL/min/1.73m 2 )= ------------------------ x
BSA subject (m 2 ) Table 2: Dosage Adjustment Regimen for Adult Patients with Renal Impairment [See table below.] 1 Following dialysis, a 250 to 500 mg supplemental dose is recommended.
| Group | Creatinine Clearance (mL/min/1.73m 2) | Dosage (mg) | Frequency |
| Normal | > 80 | 500 to 1,500 | Every 12 hours |
| Mild | 50 to 80 | 500 to 1,000 | Every 12 hours |
| Moderate | 30 to 50 | 250 to 750 | Every 12 hours |
| Severe | < 30 | 250 to 500 | Every 12 hours |
| ESRD patients using dialysis | ------ | 500 to 1,000 1 | Every 24 hours 1 |
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Preparation and administration
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Preparation and Administration Instructions Levetiracetam injection is for intravenous use only and should be diluted in 100 mL of a compatible diluent prior to administration. If a smaller volume is required (e.g. pediatric patients), the amount of diluent should be calculated to not exceed a maximum levetiracetam concentration of 15 mg per mL of diluted solution.
Consideration should also be given to the total daily fluid intake of the patient. Levetiracetam injection should be administered as a 15-minute IV infusion. One vial of levetiracetam injection contains 500 mg levetiracetam (500 mg/5 mL). Levetiracetam injection may be mixed with the following diluents and antiepileptic drugs and may be stored in polyvinyl chloride (PVC) bags.
The diluted solution should not be stored for more than 4 hours at controlled room temperature [15° to 30°C (59° to 86°F)]. Diluents: Sodium chloride (0.9%) injection, USP Lactated Ringer’s injection Dextrose 5% injection, USP Other Antiepileptic Drugs: Lorazepam Diazepam Valproate sodium There are no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Product with particulate matter or discoloration should not be used. Any unused portion of the levetiracetam injection vial contents should be discarded. Adults See Table 1 for the recommended preparation and administration of levetiracetam injection for adults to achieve a dose of 500 mg, 1000 mg, or 1500 mg.
Table 1: Preparation and Administration of Levetiracetam Injection for Adults [See table below.] 1000 mg 10 mL (two 5 mL vials) 100 mL 15 minutes 1500 mg 15 mL (three 5 mL vials) 100 mL 15 minutes For example, to prepare a 1000 mg dose, dilute 10 mL of levetiracetam injection in 100 mL of a compatible diluent and administer intravenously as a 15-minute infusion.
Pediatric Patients When using levetiracetam injection for pediatric patients, dosing is weight-based (mg per kg). The following calculation should be used to determine the appropriate daily dose of levetiracetam injection for pediatric patients: Daily dose (mg/kg/day) x patient weight (kg) Total daily dose (mL/day) = ------------------------------------------------------- 100 mg/mL
| Dose | Withdraw Volume | Volume of Diluent | Infusion Time |
| 500 mg | 5 mL (5 mL vial) | 100 mL | 15 minutes |
| 1000 mg | 10 mL (two 5 mL vials) | 100 mL | 15 minutes |
| 1500 mg | 15 mL (three 5 mL vials) | 100 mL | 15 minutes |
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- Levetiracetam intravenous
Contraindications
Levetiracetam injection is contraindicated in patients with a hypersensitivity to levetiracetam . Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.3) ]. Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4 , 5.3 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
CLikelihood score C: Probable rare cause of clinically apparent liver injury.
Levetiracetam is a relatively unique anticonvulsant that is typically used in combination with other antiepileptic medications for partial onset seizures. Levetiracetam has been linked to rare instances of serum aminotransferase and alkaline phosphatase elevations during treatment and to rare cases of clinically apparent drug induced liver disease.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
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 levetiracetam, during pregnancy. Encourage women who are taking levetiracetam 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 levetiracetam 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 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Levetiracetam blood 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…
Breastfeeding (LactMed)
Levels of levetiracetam in milk can be high in some women and can occasionally cause sedation and other adverse effects in their breastfed infants. A recent study found neurodevelopmental outcomes at age 6 years are comparable between children of women with epilepsy taking levetiracetam and unexposed infants. Levetiracetam is considered a preferred anticonvulsant for women with epilepsy who are breastfeeding. Monitor the infant for drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsants. Maternal serum level monitoring and dosage adjustment is advisable in the early postpartum period if the drug was taken throughout pregnancy and breastfeeding. Levetiracetam might reduce the maternal breastmilk supply in some women.
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