LEVETIRACETAM- levetiracetam tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

REMEDYREPACK INC.

INN (International ime):

LEVETIRACETAM

Sastav:

LEVETIRACETAM 500 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Levetiracetam Tablet 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 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. Levetiracetam Tablet 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.

Proizvod sažetak:

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 31722-536-30) 60 tablets (NDC 31722-536-60) 120 tablets (NDC 31722-536-12) 500 tablets (NDC 31722-536-05) 1000 tablets (NDC 31722-536-10) 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 31722-537-30) 60 tablets (NDC 31722-537-60) 120 tablets (NDC 31722-537-12) 500 tablets (NDC 31722-537-05) 1000 tablets (NDC 31722-537-10) 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 31722-538-30) 60 tablets (NDC 31722-538-60) 120 tablets (NDC 31722-538-12) 500 tablets (NDC 31722-538-05) Levetiracetam tablets, 1000 mg are white coloured, oblong shaped, scored, film coated tablets debossed with ‘H’ on one side and ‘91’ on other side. They are supplied in containers of 30 tablets (NDC 31722-539-30) 60 tablets (NDC 31722-539-60) 120 tablets (NDC 31722-539-12) 500 tablets (NDC 31722-539-05) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured for: Camber Pharmaceuticals, Inc.                                    2007436-00 Piscataway, NJ 08854 By: Hetero Drugs Limited Jeedimetla, Hyderabad – 500 055, India.

Status autorizacije:

Abbreviated New Drug Application

Uputa o lijeku

REMEDYREPACK INC.
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MEDICATION GUIDE
Levetiracetam Tablets
Rx Only
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 prescription medicine taken by mouth that is used
with other medicines to treat:
•
partial onset seizures in people 4 years of age and older with
epileps

Svojstava lijeka

LEVETIRACETAM- LEVETIRACETAM TABLET, FILM COATED
REMEDYREPACK INC.
----------
LEVETIRACETAM TABLETS
RX ONLY
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 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 c