LEVETIRACETAM tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Kup teraz

Ulotka dla pacjenta Ulotka dla pacjenta (PIL)
30-09-2010

Składnik aktywny:

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

Dostępny od:

Rebel Distributors Corp

INN (International Nazwa):

LEVETIRACETAM

Skład:

LEVETIRACETAM 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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. The abuse and dependence potential of levetiracetam has not been evaluated in human studies.

Podsumowanie produktu:

Levetiracetam 250 mg tablets are blue colored, oval shaped, film-coated tablets debossed with breakline separating ‘250’ and ‘MG’ on one side and ‘1014’ on other side. They are supplied as:                                                                 Bottle of 60                                    NDC -21695-071-60 Levetiracetam 500 mg tablets are yellow colored, oval shaped, film-coated tablets debossed with breakline separating ‘500’ and ‘MG’ on one side and ‘1015’ on other side. They are supplied as:                                                                 Bottle of 60                                    NDC -21695-006-60                                                               Levetiracetam 750 mg tablets are orange colored, oval shaped, film-coated tablets debossed with breakline separating ‘750’ and ‘MG’ on one side and ‘1016’ on other side. They are supplied as:                                                                Bottle of 60                                NDC -21695-136-60 Levetiracetam 1000 mg tablets are white to off white, oval shaped, film-coated tablets debossed with breakline separating ‘1000’ and ‘MG’ on one side and ‘1017’ on other side. They are supplied as:                                                                 Bottle of 60                                    NDC -21695-016-60                                                                 Storage Store at 20o - 25o C (68o - 77o F); excursions permitted to 15o - 30o C (59o - 86o F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

                                Rebel Distributors Corp
----------
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
e
                                
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Charakterystyka produktu

                                LEVETIRACETAM- LEVETIRACETAM TABLET
REBEL DISTRIBUTORS CORP
----------
LEVETIRACETAM
RX ONLY
DESCRIPTION
Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500
mg (yellow), 750 mg (orange),
and 1000 mg (white) tablets.
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 (104.0 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,
USP. Inactive ingredients: colloidal
silicon dioxide, corn starch, hypromellose, magnesium stearate,
polyethylene glycol 400, povidone,
sodium starch glycolate, talc, titanium dioxide, and additional agents
listed below:
250 mg tablets: FD&C Blue # 2 Lake of indigo carmine
500 mg tablets: Ferric oxide yellow
750 mg tablets: Ferric oxide red and FD&C # 6 lake of sunset yellow
CLINICALS 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
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