SPRITAM- levetiracetam tablet, for suspension

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Aprecia Pharmaceuticals, LLC

SNN (starptautisko nepatentēto nosaukumu):

LEVETIRACETAM

Kompozīcija:

LEVETIRACETAM 250 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg. SPRITAM is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. SPRITAM is indicated as adjunctive therapy for the treatment of primary generalized tonic‑clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. SPRITAM is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including SPRITAM, during pregnancy. Encourage women who are taking SPRITAM 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 2-4% and 15-20%, 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/m2 ) basis. Oral administration of levetiracetam (0, 200, 600, or 1800 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 1800 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 1800 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 developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SPRITAM and any potential adverse effects on the breastfed infant from SPRITAM or from the underlying maternal condition. SPRITAM is not recommended for pediatric patients that weigh 20 kg or less. The following sections describe age appropriate indications. Partial-Onset Seizures The safety and effectiveness of SPRITAM have been established for the treatment of partial-onset seizures in pediatric patients 4 years of age and older. Use is based on controlled studies in adult patients and efficacy data in 198 pediatric patients 4 to 16 years of age treated with levetiracetam with partial-onset seizures [see Clinical Pharmacology (12.3) and Clinical Studies (14.1)]. Safety and effectiveness for the treatment of partial-onset seizures in pediatric patients below the age of 4 years have not been established. A 3-month, randomized, double-blind, placebo-controlled study was conducted to assess the neurocognitive and behavioral effects of levetiracetam as adjunctive therapy in 98 (levetiracetam N=64, placebo N=34) pediatric patients, 4 to 16 years of age, 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/6-18), 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/6-18 indicated on average a worsening in levetiracetam-treated patients in aggressive behavior, one of the eight syndrome scores [see Warnings and Precautions (5.1)] . Myoclonic Seizures The safety and effectiveness of SPRITAM have been established as adjunctive treatment of myoclonic seizures in pediatric patients 12 years of age and older with juvenile myoclonic epilepsy. Use is based on one controlled study that included 113 adult and pediatric patients as young as 12 years of age treated with levetiracetam with juvenile myoclonic epilepsy [see Clinical Studies (14.2)] . Safety and effectiveness as adjunctive therapy for the treatment of myoclonic seizures in pediatric patients below the age of 12 years have not been established. Primary Generalized Tonic-Clonic Seizures The safety and effectiveness of SPRITAM have been established as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy. Use is based on one controlled study that included 164 adult and pediatric patients treated with levetiracetam with generalized tonic-clonic seizures [see Clinical Studies (14.3)] . Safety and effectiveness as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in pediatric patients below the age of 6 years have not been established. Juvenile Animal Toxicity Data Studies of levetiracetam in juvenile rats (dosed on postnatal days 4 through 52) and dogs (dosed from postnatal weeks 3 through 7) at doses of up to 1800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m2 basis) did not demonstrate adverse effects on postnatal development. 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 renal impairment. 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 renal impairment and supplemental doses should be given to patients after dialysis [see Dosage and Administration (2.5)] .

Produktu pārskats:

SPRITAM (levetiracetam) tablet(s) for oral suspension are supplied in child-resistant blisters as follows: 250 mg: round, white to off‑white, spearmint‑flavored tablets, marked with "" on one side, 60 tablets per carton containing 6 blisters per card x 10 cards (NDC 43485-101-60); and an Institutional Use Carton of 6 unit dose Tablets x 1 Blister card (NDC 43485-101-03) 500 mg: round, white to off‑white, spearmint‑flavored tablets, marked with "" on one side, 60 tablets per carton containing 6 blisters per card x 10 cards (NDC 43485-102-60); and an Institutional Use Carton of 6 unit dose Tablets x 1 Blister card (NDC 43485-102-03) 750 mg: round, white to off‑white, spearmint‑flavored tablets, marked with "" on one side, 60 tablets per carton containing 6 blisters per card x 10 cards (NDC 43485-103-60); and an Institutional Use Carton of 6 unit dose Tablets x 1 Blister card (NDC 43485-103-03) 1000 mg: round, white to off‑white, spearmint‑flavored tablets, marked with "" on one side, 60 tablets per carton containing 6 blisters per card x 10 cards (NDC 43485-104-60); and an Institutional Use Carton of 6 unit dose Tablets x 1 Blister card (NDC 43485-104-03) Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

New Drug Application

Lietošanas instrukcija

Aprecia Pharmaceuticals, LLC
----------
MEDICATION GUIDE
SPRITAM® (SPREE-tam)
(levetiracetam)
tablets for oral suspension
What is the most important information I should know about SPRITAM?
Like other antiepileptic drugs, SPRITAM 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
•
new or worse depression
•
feeling agitated or restless
•
trouble sleeping (insomnia)
•
acting aggressive, being angry, or violent
•
an extreme increase in activity or talking (mania)
•
attempts to commit suicide
•
new or worse anxiety
•
panic attacks
•
new or worse irritability
•
acting on dangerous impulses
•
other unusual changes in behavior or mood
Do not stop SPRITAM without first talking to a healthcare provider.
•
Stopping SPRITAM 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 SPRITAM?
SPRITAM is a prescription medicine taken by mouth that used to treat
partial-onset seizures in people 4
years of age and older weighing more than 20 kg (44 pounds).
SPRITAM is a prescription medicine taken by mouth that is used with
other medicines to treat:
•
myoclonic seizures in people 12 years of age and older with juvenile
myoclonic epilepsy.
•
primary generalized tonic-clonic seizures in people

Produkta apraksts

SPRITAM- LEVETIRACETAM TABLET, FOR SUSPENSION
APRECIA PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPRITAM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SPRITAM.
SPRITAM (LEVETIRACETAM) TABLETS, FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
SPRITAM is indicated for the treatment of partial-onset seizures in
patients 4 years of age and older
weighing more than 20 kg (1.1)
SPRITAM is indicated for adjunctive therapy for the treatment of:
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
SPRITAM is intended to disintegrate in the mouth when taken with a sip
of liquid. Swallow only after the
tablet disintegrates. Do not swallow tablet(s) intact. Partial
tablet(s) should not be administered (2.1)
Alternately, add whole SPRITAM tablet(s) to a small volume of liquid
in a cup (one tablespoon or enough
to cover the medicine). Allow the tablet(s) to disperse prior to
consuming entire contents immediately
(2.1)
Partial-Onset Seizures (monotherapy or adjunctive therapy)
Adults/pediatric patients 4 years and older weighing over 40 kg: 500
mg twice daily; increase as
needed/tolerated by 500 mg twice daily every 2 weeks to a maximum
recommended dose of 1500 mg
twice daily (2.2)
Pediatric patients 4 years and older weighing 20 to 40 kg: 250 mg
twice daily; increase by 250 mg twice
daily every two weeks to a maximum of 750 mg twice daily (2.2)
Myoclonic Seizures in Adults and Pediatric Patients 12 Years of Age
and Older
500 mg twice daily; increase by 500 mg twice daily every 2 weeks to
recommended dose of 1500 mg
twice daily (2.3)
Primary Generalized Tonic-Clonic Seizures in Patients 6 Years of Age
and Older
Adults/pediatric patients 6 years and older weighing over 40 kg: 500
mg twice daily; increase as
needed/