LEVETIRACETAM tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

RedPharm Drug, Inc.

INN (Kansainvälinen yleisnimi):

LEVETIRACETAM

Koostumus:

LEVETIRACETAM 1000 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

1.1 Partial Onset Seizures Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam 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. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam 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. None 8.1 Pregnancy Levetiracetam blood levels may decrease during pregnancy [see WARNINGS AND PRECAUTIONS (5.9)]. 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 therape

Tuoteyhteenveto:

16.1 How Supplied Levetiracetam tablets, USP, 250 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "SLC" and "221" on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 43547-221-15). Levetiracetam tablets, USP, 500 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "SLC" and"222" on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 43547-222-15), and 1,000 tablets (NDC 43547-222-11). Levetiracetam tablets, USP, 750 mg are pink, oblong-shaped, bi-convex, scored film coated tablets, debossed "SLC" and"223" on either side of the score and plain on the other side. They are supplied in containers of 120 tablets (NDC 43547-223-15). Levetiracetam tablets, USP, 1000 mg are white to off-white, modified capsules shaped, bi-convex, scored film-coated tablets, debossed "SLC" and"224" on either side of the score and plain on the other side. They are supplied in containers of 60 tablets (NDC 43547-224-06). 16.2 Storage Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

LEVETIRACETAM- levetiracetam tablet, film coated
RedPharm Drug, Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Levetiracetam (lee” ve tye ra’ se 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?
Levetiracetam is a prescription medicine taken by mouth that is used
with other medicines to treat:
partial onset seizures in people 1 month of age

Valmisteyhteenveto

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
REDPHARM DRUG, INC.
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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
Warnings and Precautions, (5.1, 5.3, 5.7, 5.8) 03/2015
INDICATIONS AND USAGE
Levetiracetam 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 1500 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 1500 mg twice daily (2.3)
Primary Generalized Tonic-Clonic Seizures
6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of
10 mg/kg twice
daily every 2 weeks to recommended dose of 30 mg/kg twice daily (