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:

State of Florida DOH Central Pharmacy

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with 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 available containing 250 mg, 500 mg, 750 mg or 1000 mg of levetiracetam. The 250 mg tablets are white, film-coated, round tablets debossed with M above the score and 613 below the score on one side of the tablet and blank on the other side. The 500 mg tablets are white, film-coated, modified capsule-shaped tablets debossed with M to the left of the score and 615 to the right of the score on one side of the tablet and blank on the other side. The 750 mg tablets are white, film-coated, modified capsule-shaped tablets debossed with M to the left of the score and 617 to the right of the score on one side of the tablet and blank on the other side. The 1000 mg tablets are white, film-coated, modified capsule-shaped tablets debossed with M to the left of the score and 619 to the right of the score on one side of the tablet and blank on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. FOR MEDICAL INFORMATION Toll free 1-877-446-3679 (1-877-4-INFO-RX)

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
State of Florida DOH Central Pharmacy
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MEDICATION GUIDE
LEVETIRACETAM TABLETS
250 mg, 500 mg, 750 mg and 1000 mg
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 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 ARE LEVETIRACETAM TABLETS?
Levetiracetam tablets are a prescrip

Summary of Product characteristics

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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DESCRIPTION
Levetiracetam is an antiepileptic drug available as 250 mg, 500 mg,
750 mg or 1000 mg 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 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: colloidal silicon
dioxide, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate,
titanium dioxide and triacetin.
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 mimic some
features of human complex partial seizures with secondary
generalization. Levetiracetam also displayed
inhibitory properties in the kindling model in rats, another model