LEVETIRACETAM tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

REMEDYREPACK INC.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Levetiracetam tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. Levetiracetam tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Levetiracetam tablet is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Levetiracetam tablets are contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [ see Warnings and Precautions ( 5.4) ]. Levetiracetam blood levels may decrease during pregnancy [ see Warnings and Precautions ( 5.10)]. Pregnancy Category C There are no adequate and controlled studies in pregnant women. In animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. Levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (equivalent to the maximum recommended human dose of 3,000 mg [MRHD] on a mg/m 2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1,800 mg/kg/day (6 times the MRHD on a mg/m 2 basis). The developmental no effect dose was 70 mg/kg/day (0.2 times the MRHD on a mg/m 2 basis). There was no overt maternal toxicity at the doses used in this study. Oral administration of levetiracetam to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and increased incidences of minor fetal skeletal abnormalities at doses ≥600 mg/kg/day (4 times MRHD on a mg/m 2 basis) and in decreased fetal weights and increased incidences of fetal malformations at a dose of 1,800 mg/kg/day (12 times the MRHD on a mg/m 2 basis). The developmental no effect dose was 200 mg/kg/day (equivalent to the MRHD on a mg/m 2 basis). Maternal toxicity was also observed at 1,800 mg/kg/day. When levetiracetam was administered orally to pregnant rats during the period of organogenesis, fetal weights were decreased and the incidence of fetal skeletal variations was increased at a dose of 3,600 mg/kg/day (12 times the MRHD). 1,200 mg/kg/day (4 times the MRHD) was a developmental no effect dose. There was no evidence of maternal toxicity in this study. Treatment of rats with levetiracetam during the last third 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/m 2 basis). Pregnancy Registry To provide information regarding the effects of in utero exposure to levetiracetam, physicians are advised to recommend that pregnant patients taking levetiracetam enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by the patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. The effect of levetiracetam on labor and delivery in humans is unknown. Levetiracetam is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from levetiracetam, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of levetiracetam in the adjunctive treatment of partial onset seizures in pediatric patients age 1 month to 16 years old with epilepsy have been established [ see Clinical Studies ( 14.1) ]. The dosing recommendation in these pediatric patients varies according to age group and is weight-based [ see Dosage and Administration ( 2.2) ]. The safety and effectiveness of levetiracetam as adjunctive treatment of myoclonic seizures in adolescents 12 years of age and older with juvenile myoclonic epilepsy have been established [ see Clinical Studies ( 14.2) ]. The safety and effectiveness of levetiracetam as adjunctive therapy in the treatment of primary generalized tonic­clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established [ see Clinical Studies ( 14.3) ]. A 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in 98 (levetiracetam N=64, placebo N=34) pediatric patients, ages 4 to 16 years old, with partial seizures that were inadequately controlled. The target dose was 60 mg/kg/day. Neurocognitive effects were measured by the Leiter-R Attention and Memory (AM) Battery, which measures various aspects of a child's memory and attention. Although no substantive differences were observed between the placebo and drug treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority of the drug and placebo. The Achenbach Child Behavior Checklist (CBCL/6 to 18), a standardized validated tool used to assess a child's competencies and behavioral/emotional problems, was also assessed in this study. An analysis of the CBCL/6 to 18 indicated on average a worsening in levetiracetam-treated patients in aggressive behavior, one of the eight syndrome scores [ see Warnings and Precautions ( 5.1) ]. Studies of levetiracetam in juvenile rats (dosing from day 4 through day 52 of age) and dogs (dosing from week 3 through week 7 of age) at doses of up to 1,800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m 2 basis) did not indicate a potential for age-specific toxicity. There were 347 subjects in clinical studies of levetiracetam that were 65 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) ]. Dose 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) ].

Resumo do produto:

Levetiracetam tablets USP, 750 mg are orange coloured, oblong shaped, scored, film coated tablets debossed with 'H' on one side and '90' on other side. They are supplied in containers of NDC: 70518-2230-00 PACKAGING: 30 in 1 BLISTER PACK Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

REMEDYREPACK INC.
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MEDICATION GUIDE
MEDICATION GUIDE
LEVETIRACETAM (lee-vah-tih-RACE-ah-tam)
Tablets, USP Read this Medication Guide before you start taking
levetiracetam and each time you get a
refill. There may be new information. This information does not take
the place of talking to your
healthcare provider about your medical condition or treatment.
What is the most important information I should know about
levetiracetam?
Like other antiepileptic drugs, levetiracetam may cause suicidal
thoughts or actions in a very small
number of people, about 1 in 500 people taking it.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse, or worry you:
• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood
Do not stop levetiracetam without first talking to a healthcare
provider.
• Stopping levetiracetam suddenly can cause serious problems.
Stopping a seizure medicine suddenly can
cause seizures that will not stop (status epilepticus).
• Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal thoughts
or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
• Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as
scheduled.
• Call your healthcare provider between visits as needed, especially
if you are worried about symptoms.
What is levetiracetam tablet?
Levetiracetam tablet is a prescription medicine taken by mouth that is
used with other medicines to treat:
• partial onset se

Características técnicas

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVETIRACETAM TABLETS.
LEVETIRACETAM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Contraindications (4) 4/2017
Warnings and Precautions, Anaphylaxis and 4/2017
Angioedema (5.4)
Warnings and Precautions, Hematologic Abnormalities (5.8)10/2017
INDICATIONS AND USAGE
Levetiracetam tablet is indicated for adjunctive therapy in the
treatment of:
• Partial onset seizures in patients one month of age and older with
epilepsy (1.1)
• Myoclonic seizures in patients 12 years of age and older with
juvenile myoclonic epilepsy (1.2)
• Primary generalized tonic-clonic seizures in patients 6 years of
age and older with idiopathic generalized
epilepsy (1.3)
DOSAGE AND ADMINISTRATION
• Use the oral solution for pediatric patients with body weight ≤
20 kg ( 2.1).
• For pediatric patients, use weight-based dosing for the oral
solution with a calibrated measuring device
(not a household teaspoon or tablespoon) ( 2.1)
Partial Onset Seizures
• 1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg
twice daily every 2 weeks to
recommended dose of 21 mg/kg twice daily ( 2.2)
• 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg
twice daily every 2 weeks to
recommended dose of 25 mg/kg twice daily ( 2.2)
• 4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg
twice daily every 2 weeks to
recommended dose of 30 mg/kg twice daily ( 2.2)
• Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg
twice daily every 2 weeks to a
recommended dose of 1,500 mg twice daily ( 2.2)
Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older
• 500 mg twice daily; increase by 500 mg twice daily every 2 weeks
to recommended dose of 1,500 mg
twice daily ( 2