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:

Hetero Drugs Ltd.,

INN (International Name):

LEVETIRACETAM

Composition:

LEVETIRACETAM 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levetiracetam Tablet 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. The abuse and dependence potential of levetiracetamhas not been evaluated in human studies.

Product summary:

Levetiracetam tablets, 250 mg are blue coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘87’ on other side. They are supplied in containers of  30 tablets (NDC 65977-5036-0)  60 tablets (NDC 65977-5036-1)  120 tablets (NDC 65977-5036-2)  500 tablets (NDC 65977-5036-3)  1000 tablets (NDC 65977-5036-4)  Levetiracetam tablets, 500 mg are yellow coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘88’ on other side. They are supplied in  containers of  30 tablets (NDC 65977-5037-0)  60 tablets (NDC 65977-5037-1)  120 tablets (NDC 65977-5037-2)  500 tablets (NDC 65977-5037-3)  1000 tablets (NDC 65977-5037-4) Levetiracetam tablets, 750 mg are orange coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘90’ on other side. They are supplied in containers of  30 tablets (NDC 65977-5038-0)  60 tablets (NDC 65977-5038-1) 120 tablets (NDC 65977-5038-2) 500 tablets (NDC 65977-5038-3) 30 tablets (NDC 65977-5039-0) 60 tablets (NDC 65977-5039-1) 120 tablets (NDC 65977-5039-2) 500 tablets (NDC 65977-5039-3) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.                                                                                                                                                                                                            

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Hetero Drugs Ltd.,
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SPL MEDGUIDE
MEDICATION GUIDE
Levetiracetam Tablets
Rx Only
Read this Medication Guidebefore you start taking levetiracetam and
each time you get a refill. There
may be new information. This informationdoes not take the place of
talkingto your healthcare provider
about your medical condition or treatment
What is the most important information I shouldknow about
levetiracetam?
Like other antiepileptic drugs, levetiracetam may cause suicidal
thoughts or actions in a very
smallnumber of people, about 1 in 500 people taking it.
Call a healthcareprovider 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 commitsuicide
• new or worsedepression
• new or worse anxiety
• feeling agitated orrestless
• panic attacks
• trouble sleeping(insomnia)
• new or worseirritability
• acting aggressive,being angry, or violent
• acting on dangerous impulses
• an extremeincrease in activity and talking (mania)
• other unusual changesin behavior or mood
Do not stop levetiracetam without first talking to a healthcare
provider.
• Stopping levetiracetamsuddenly can cause serious problems.
Stopping aseizure 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 checkfor other
causes.
How canI 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-upvisits with your healthcare provideras
scheduled.
• Call your healthcare providerbetween 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 4 years ofage and older with
epilepsy
• myocl

Summary of Product characteristics

LEVETIRACETAM - LEVETIRACETAM TABLET, FILM COATED
HETERO DRUGS LTD.,
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LEVETIRACETAM TABLETS
DESCRIPTION
Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500
mg (yellow),750 mg (orange), 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 (1040 mg/mL). It is freely soluble in chloroform (653
mg/mL) and in methanol (536
mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in
acetonitrile (57 mg/mL) and practically
insoluble in n-hexane. (Solubility limits are expressed as mg/mL
solvent.)
Levetiracetam tablets contain the labeled amount of levetiracetam.
Inactive ingredients: corn starch,
croscarmellose sodium, povidone, colloidal silicon dioxide, talc,
magnesium stearate and additional
agents listed below:
250 mg tablets: opadry II blue (polyvinyl alcohol, titanium dioxide,
polyethylene glycol 3350, talc,
FD&C blue #2/indigo carmine aluminum lake)
500 mg tablets: opadry II yellow (polyvinyl alcohol, titanium dioxide,
polyethylene glycol 3350, talc,
iron oxide yellow)
750 mg tablets: opadry II orange (polyvinyl alcohol, titanium dioxide,
polyethylene glycol 3350, talc,
FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red)
1000 mg tablets: opadry II white (polyvinyl alcohol, titanium dioxide,
polyethylene glycol 3350, talc)
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism(s) by which levetiracetamexerts its
antiepileptic effect is unknown. The
antiepileptic activity oflevetiracetam was assessed in a number of
animal models of epileptic
seizures.Levetiracetam did not inhibit single seizures induced by
maximal stimulationwith electrical
current or d