LEVITAM 1000 levetiracetam 1000 mg tablet blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

levetiracetam

Prieinama:

Arrow Pharma Pty Ltd

INN (Tarptautinis Pavadinimas):

Levetiracetam

Autorizacija statusas:

Registered

Pakuotės lapelis

LEVITAM- Consumer Medicine Information
Page 1 of 4
LEVITAM
levetiracetam
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LEVITAM. It does
not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking LEVITAM against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT LEVITAM IS USED
FOR
LEVITAM is used to control
epilepsy.
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different types of
seizures, ranging from mild to
severe.
LEVITAM belongs to a group of
medicines called antiepileptics.
These medicines are thought to
work by controlling brain chemicals
which send signals to nerves so that
seizures do not happen.
LEVITAM may be used alone, or in
combination with other medicines,
to treat your condition. Your doctor
may prescribe this medicine in
addition to your current therapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS
BEEN PRESCRIBED FOR YOU.
LEVITAM is not recommended for
use in children under the age of 4,
as there have been no studies of its
effects in children of this age group.
This medicine is available only with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE LEVITAM IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
LEVETIRACETAM OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itching or hives, swelling of
the face, lips or tongue which may
cause difficulty in swallowing or
breathing, wheezing or shortness of
breath.
DO NOT TAKE LEVITAM IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT, WITHOUT TALKING TO
YOUR DOCTOR FIRST.
Like most antiepileptic medicines

Prekės savybės

LEVITAM- Product Information
Page 1 of 19
Levitam
PRODUCT INFORMATION
NAME OF THE MEDICINE
Levetiracetam. The chemical name for levetiracetam is (
S
)-

-ethyl-2-oxo-1-pyrrolidine acetamide.
Its structural formula is:
C
8
H
14
N
2
O
2
Molecular weight: 170.21
CAS No.: 102767-28-2
DESCRIPTION
Levetiracetam is a white to off-white powder with a faint odour and a
bitter taste. It is very soluble
in water (104 g/100 mL), freely soluble in chloroform (65.3 mg/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.
Levitam tablets come in four strengths and contain either 250 mg, 500
mg, 750 mg or 1000 mg of
levetiracetam. The tablets also contain the following excipients:
maize starch, povidone, purified
talc, colloidal anhydrous silica, magnesium stearate, Opadry II
85F60833 Blue (250 mg tablets),
Opadry II 85F62663 Yellow (500 mg tablets), Opadry II 85F63149 Orange
(750mg tablets) and
Opadry II 85F18378 White (1000 mg tablets). The tablets are gluten
free.
PHARMACOLOGY
Mechanism of action
The precise mechanism of action by which levetiracetam induces seizure
protection still remains to
be fully elucidated, but appears to be unrelated to the mechanisms of
current antiepileptic drugs.
In vitro
and
in vivo
experiments suggest that levetiracetam does not alter basic cell
characteristics
and normal neurotransmission.
In vitro
studies show that levetiracetam affects intraneuronal Ca
2+
levels by partial inhibition of N
type Ca
2+
currents and by reducing the release of Ca
2+
from intraneuronal stores. In addition, it
partially reverses the reductions in GABA (gamma-aminobutyric acid)
and glycine gated currents
induced by zinc and

-carbolines. Furthermore, levetiracetam has been shown in
in vitro
studies to
bind to a specific site in rodent brain tissue. This binding site is
the synaptic vesicle protein 2A,
believed to be involved in vesicle fusion and neurotransmitter
exocytosis. Levetiracetam and
related an