LEVETIRACETAM- levetiracetam in sodium chloride injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)

Disponible depuis:

Eugia US LLC

DCI (Dénomination commune internationale):

LEVETIRACETAM

Composition:

LEVETIRACETAM 500 mg in 100 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. Levetiracetam in Sodium Chloride Injection is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.3)]. 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 injection 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 (5.8)]. 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, 1,200, or 3,600 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 development in rats (1,200 mg/kg/day) is approximately 4 times the maximum recommended human dose (MRHD) of 3,000 mg on a body surface area (mg/m2 ) basis. Oral administration of levetiracetam (0, 200, 600, or 1,800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. The no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the MRHD on a mg/m2 basis. Oral administration of levetiracetam (0, 70, 350, or 1,800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. There was no evidence of maternal toxicity. The no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the MRHD on a mg/m2 basis. Oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1,800 mg/kg/day (6 times the MRHD on a mg/m2 basis). Risk Summary Levetiracetam is excreted in human milk. There are no data on the effects of levetiracetam on the breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for levetiracetam and any potential adverse effects on the breastfed infant from levetiracetam or from the underlying maternal condition. Safety and effectiveness of levetiracetam injection in patients below the age of 16 years have not been established. There were 347 subjects in clinical studies of levetiracetam that were 65 years old and over. No overall differences in safety were observed between these subjects and younger subjects. There were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam in these patients. Levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3)]. Clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see Clinical Pharmacology (12.3)] . Dosage adjustment is recommended for patients with impaired renal function and supplemental doses should be given to patients after dialysis [see Dosage and Administration (2.5) ] .

Descriptif du produit:

Levetiracetam in Sodium Chloride Injection is a clear, colorless, sterile solution that is available in a single-dose 100 mL dual port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. It is available in the following presentations: 500 mg per 100 mL (5 mg/mL) 100 mL Single-Dose Infusion Bags (overwrapped), packaged in a Carton of 10                                                                                NDC 55150-246-47 1,000 mg per 100 mL (10 mg/mL) 100 mL Single-Dose Infusion Bags (overwrapped), packaged in a Carton of 10                                                                                NDC 55150-247-47 1,500 mg per 100 mL (15 mg/mL) 100 mL Single-Dose Infusion Bags (overwrapped), packaged in a Carton of 10                                                                                NDC 55150-248-47 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

LEVETIRACETAM - LEVETIRACETAM IN SODIUM CHLORIDE INJECTION, SOLUTION
EUGIA US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM IN
SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LEVETIRACETAM IN SODIUM CHLORIDE INJECTION.
LEVETIRACETAM IN SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levetiracetam in Sodium Chloride Injection is indicated for adjunct
therapy in adults (≥16 years of age)
with the following seizure types when oral administration is
temporarily not feasible:
Partial-onset seizures (1.1)
Myoclonic seizures in patients with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures (1.3)
DOSAGE AND ADMINISTRATION
For intravenous infusion only (2.1)
Do not dilute prior to its use (2.1)
Administer dose-specific bag intravenously over 15-minutes (2.1)
Initial Exposure to Levetiracetam
_Partial-Onset Seizures: _Initial dose is 500 mg twice daily. Increase
by 500 mg twice daily every 2 weeks
to a maximum recommended dose of 1,500 mg twice daily. (2.2).
_Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy:
_Initial dose is 500 mg twice daily.
Increase by 500 mg twice daily every 2 weeks to the recommended dose
of 1,500 mg twice daily. (2.2).
_Primary Generalized Tonic-Clonic Seizures: _Initial dose is 500 mg
twice daily. Increase by 500 mg twice
daily every 2 weeks to the recommended dose of 1,500 mg twice daily.
(2.2).
Switching from or to oral Levetiracetam: The total daily
dosage/frequency of levetiracetam injection should
be equivalent to those of oral levetiracetam (2.3, 2.4).
Renal Impairment: Dose adjustment necessary based on creatinine
clearance (2.5).
DOSAGE FORMS AND STRENGTHS
Levetiracetam in Sodium Chloride Injection in single-dose bags:
Levetiracetam in 0.82% sodium chloride injection (500 mg/100 mL) (5
mg/mL) (3)
Levetiracetam in 0.75% sodium chloride injection (1,000 mg/100 mL) (10
mg/mL) (