LEVETIRACETAM - levetiracetam tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Levetiracetam (UNII: 44YRR34555) (Levetiracetam - UNII:44YRR34555)

Available from:

Methapharm, Inc.

INN (International Name):

Levetiracetam

Composition:

Levetiracetam 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. This product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in Levetiracetam tablets or oral solution. The abuse and dependence potential of Levetiracetam has not been evaluated in human studies.

Product summary:

Levetiracetam tablets are supplied as follows: Levetiracetam 250 mg tablets are blue, oblong-shaped, scored, film-coated tablets debossed with "OL" and "250" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-011-01). Levetiracetam 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "OL" and "500" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-012-01). Levetiracetam 750 mg tablets are dark pink, oblong-shaped, scored, film-coated tablets debossed with "OL" and "750" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 120 tablets (NDC 67850-013-01). Levetiracetam 1000 mg tablets are white, oblong-shaped, scored, film-coated tablets debossed with "OL" and "1000" on one side. They are supplied in white HDPE BOTTLE, PLASTICs containing 60 tablets (NDC 67850-014-02). Dispense in a tight, light-resistant container with a child-resistant closure. Provide Patient Information. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Methapharm, Inc.
----------
MEDICATION GUIDE
Levetiracetam Tablets
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 medicine taken by mouth that is used with other
medicines to treat:
•
partial onset seizures in patients 4 years of age and older with
epilepsy
•
myoclonic seiz

Summary of Product characteristics

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
METHAPHARM, INC.
----------
LEVETIRACETAM TABLETS
DESCRIPTION
Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500
mg (yellow), 750 mg (dark pink),
and 1000 mg (white) tablets for oral administration.
The chemical name of levetiracetam, 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 is
chemically unrelated to existing antiepileptic drugs (AEDs). It has
the following structural formula:
Levetiracetam is a white to off-white crystalline powder with a faint
odor and a bitter taste. It is very
soluble in water (104.0 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.
Inactive ingredients: copovidone,
croscarmellose sodium, magnesium stearate, polyethylene glycol 3350,
polysorbate 80, polyvinyl
alcohol, pregelatinized starch, talc, titanium dioxide, and additional
agents listed below:
250 mg tablets: FD&C Blue#2/Indigo Carmine Aluminum Lake
500 mg tablets: Iron Oxide Yellow
750 mg tablets: FD&C Red#40/Allura Red A C 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 electrical current or
different chemoconvulsants and showed only minimal activity in
submaximal stimulation and in threshold
tests. Protection was observed, however, against secondarily
generalized activity from focal seizures
induced by pilocarpine and kainic acid, two chemoconvulsants that
induce seizures that mimi