LEVETIRACETAM - levetiracetam tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Karalex Pharma LLC

INN（国际名称）:

LEVETIRACETAM

组成:

LEVETIRACETAM 250 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with 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. 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. This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam tablets. The abuse and dependence potential of levetiracetam has not been evaluated in human studies.

產品總結:

Levetiracetam tablets, 250 mg are yellow colored, film coated, oblong, biconvex, debossed with "L" breakline and "250" on one side and plain on the other side. They are supplied in white HDPE bottles containing 120 tablets (NDC 42043-190-04), with a child-resistant closure and 500 tablets (NDC 42043-190-05). Levetiracetam tablets, 500 mg are orange colored, film coated, oblong, biconvex, debossed with "L" breakline and "500" on one side and plain on the other side. They are supplied in white HDPE bottles containing 120 tablets (NDC 42043-191-04), with a child-resistant closure and 500 tablets (NDC 42043-191-05). Levetiracetam tablets, 750 mg are blue colored, film coated, oblong, biconvex, debossed with "L" breakline and "750" on one side and plain on the other side. They are supplied in white HDPE bottles containing 120 tablets (NDC 42043-192-04), with a child-resistant closure and 500 tablets (NDC 42043-192-05).

授权状态:

Abbreviated New Drug Application

资料单张

Karalex Pharma LLC
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MEDICATION GUIDE
Levetiracetam Tablets
250 mg, 500 mg and 750 mg
Read this Medication Guide before you start taking levetiracetam
tablets 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 tablets?
Like other antiepileptic drugs, levetiracetam tablets 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 tablets without first talking to a
healthcare provider.
•
Stopping levetiracetam tablets 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:
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产品特点

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
KARALEX PHARMA LLC
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DESCRIPTION
Levetiracetam USP is an antiepileptic drug available as 250 mg
(yellow), 500 mg (orange), and 750 mg
(blue) tablets for oral administration.
The chemical name of levetiracetam USP, a single enantiomer, is
(-)-(S)-α-ethyl-2-oxo-1-pyrrolidine
acetamide, its molecular formula is C H N O and its molecular weight
is 170.21. Levetiracetam USP
is chemically unrelated to existing antiepileptic drugs (AEDs). It has
the following structural formula:
Levetiracetam USP is a white to off-white crystalline powder with a
faint odor and a bitter taste. It is
very soluble in water (104 g/100 mL). It is freely soluble in
chloroform (65.3 g/100 mL) and in
methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL),
sparingly soluble in acetonitrile (5.7
g/100 mL) and practically insoluble in n-hexane. (Solubility limits
are expressed as g/100 mL solvent.)
Levetiracetam tablets contain the labeled amount of levetiracetam USP.
Inactive ingredients: colloidal
silicon dioxide, corn starch, croscarmellose sodium, magnesium
stearate, povidone and additional
agents listed below:
250 mg tablets: Opadry Yellow (hypromellose 3cP, hypromellose 6cP,
titanium dioxide, polyethylene
glycol 4000, iron oxide yellow and FD&C Blue #2/indigo carmine
aluminum lake).
500 mg tablets: Opadry Orange (hypromellose 3cP, hypromellose 6cP,
titanium dioxide, polyethylene
glycol 4000, iron oxide red, FD&C Yellow #6/sunset yellow FCF aluminum
lake and FD&C Blue
#2/indigo carmine aluminum lake).
750 mg tablets: Opadry Blue (hypromellose 3cP, hypromellose 6cP,
titanium dioxide, polyethylene
glycol 4000 and FD&C Blue #2/indigo carmine aluminum lake).
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism(s) by which levetiracetam exerts its
antiepileptic effect is unknown. The
antiepileptic activity of levetiracetam was assessed in a number of
animal models of epileptic seizures.
Levetiracetam did not inhibit single seizures induced by maximal
stimulation with elec