LEVETIRACETAM solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Alembic Pharmaceuticals Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.'s levetiracetam tablets and oral solution. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Levetiracetam Oral Solution, USP 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 Oral Solution, USP 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 is contraindicated in patients with a hypersensitivity to levetiracetam.

Ürün özeti:

Levetiracetam Oral Solution, USP 1 00 mg/ mL is a clea r, c ol o rle ss, gra p e -fla v o red li qu i d. It is su pplied in 16 fl. oz. ( 473 mL) w hite HDPE bottles (NDC 62332 -626 -16 ). St ore at 20° to 2 5°C (68° to 7 7°F) ; e x c ur si ons pe rmitted to 15° to 30°C (59° to 86°F ) [ see USP C ont rolled R oom Te mpe rat u re ]. Dispense in a tight, light-resistant container with a child-resistant closure. Di s pe n se acc ompa nyi ng Me d icati on G ui de to ea ch patie nt.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

LEVETIRACETAM - LEVETIRACETAM SOLUTION
Alembic Pharmaceuticals Inc.
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MEDICATION GUIDE
Levetiracetam Oral Solution, USP
Read t his Me dicati on G ui de be fore y ou sta rt ta ki ng
Levetiracetam Oral Solution, USP a nd ea ch ti
me you get a r e fill. The re m ay be new i nformati o n. This i n f
ormati on does not ta ke t he place of tal
k i ng to y our healt hca re pr o vi der a bout your me dical c o
nditi on or t reat me nt.
Wh at is the m o st imp or tant in form ati on I sh ould kn ow ab out
Levetiracetam Oral Solution, USP?
Like other an tiepilep tic dr u g s, Levetiracetam Oral Solution, USP
m ay c au se suicid al th ou g h ts or
ac ti ons in a very sm all number of pe ople, ab out 1 in 500 pe ople
taking i t.
C all a he al thc are pr ovider r i ght aw ay if you h ave any of the
se s ymp to m s, e speci ally if they are
new, w or se, or w or ry you:
• t houghts a b out s uici de or d yi ng
• atte mpts to c ommit s uici de
• new or w or se de pre ssi on
• new or w or se a nxiety
• feeli ng a gitated or re stle ss
• pa nic attac ks
• t rouble slee pi ng (i n s omnia)
• new or w or se i r rita bility
• acti ng a ggre ssi ve, be i ng a n g r y, or vi ole nt
• acti ng on da ng e rous i m p ul ses
• an e xt re me i n c rea se in acti v ity a nd tal ki ng (m a nia)
• ot her u nu s ual c h a nges in b e ha vi or or m o od
Do n ot s top Levetiracetam Oral Solution, USP wi th out fir st
talking to a he al thc are pr ovide r.
• St oppi ng Levetiracetam Oral Solution, USP s udde n ly can c a u
se se ri ous pr o ble m s. St oppi ng a
seiz ure me dici ne su dde n ly can c a u se seiz ures t hat will not
st op ( stat us e pile ptic u s ).
• S uici dal t hou g hts or acti ons can be ca u sed by t h i ngs ot
her t han me dici ne s. If y ou h a ve suici
dal t hou g hts or acti on s, y o ur healt hca re provi d er may c
heck for ot her ca u se s.
How c an I w atch for e arly symp toms of suic id al th ou gh ts and
ac ti on s?
• Pay atte nti on to a ny c h a nge s, e s pecially s udden c

Ürün özellikleri

LEVETIRACETAM - LEVETIRACETAM SOLUTION
ALEMBIC PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVETIRACETAM ORAL SOLUTION, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVETIRACETAM ORAL
SOLUTION, USP.
LEVETIRACETAM ORAL SOLUTION, USP
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
I n d ic a t io ns a nd Us a g e, P a r t i al O ns et S ei z u r es (
1 . 1) [ 1 2 / 20 11]
D os a ge a nd A d m i n is t r a t io n, P a r t i al O ns et S e i z
u r es ( 2 . 1, 2 . 2, 2 . 5) [1 2 /2 0 1 1]
W a r n in gs a nd Pr e c a u t i o ns ( 5 . 1, 5 . 3, 5 . 4, 5 . 5, 5
. 7, 5 . 8, 5 . 9) [ 1 2 / 20 1 1]
INDICATIONS AND USAGE
Levetiracetam Oral Solution, USP is an antiepileptic drug indicated
for adjunctive therapy in the treatment of:
• Partial onset seizures in patients 4 years 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)
(1)
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) (2)
_Partial Onset Seizures_
• _4 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 (2.2)
• _Adults 16 Years And Older:_ 500 mg twice daily, increase as
needed and tolerated in increments of 500 mg twice daily
every 2 weeks to a maximum recommended dose of 1500 mg twice daily
(2.2) (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) (2)
_Primary Generalized Tonic-Clonic Seizures