Latuda Film-Coated Tablets 20mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Lurasidone Hydrochloride

Boleh didapati daripada:

SUMITOMO PHARMA MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Lurasidone Hydrochloride

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Bushu Pharmaceuticals Ltd

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LATUDA FILM-COATED TABLETS
Lurasidone hydrochloride (20mg, 40mg & 80mg)
1
What is in this leaflet
1.
What Latuda is used for
2.
How Latuda works
3.
Before you use Latuda
4.
How to use Latuda
5.
While you are using Latuda
6.
Side effects
7.
Storage and Disposal of Latuda
8.
Product Description
9.
Manufacturer
and
Product Registration
Holder
10.
Date of Revision
11.
Serial Number
WHAT LATUDA IS USED FOR
LATUDA is a prescription medicine
used:
•
To treat adult and adolescent patients
13 to 17 years of age and older with
schizophrenia.
•
Alone to treat adult and adolescent
patients 13 to 17 years of age and
older with major depressive episodes
associated
with
Bipolar
I
Disorder
(bipolar depression).
•
With
the
medicine
lithium
or
valproate to treat adults with major
depressive episodes associated with
Bipolar
I
Disorder
(bipolar
depression).
HOW LATUDA WORKS
LATUDA
works
by
adjusting
the
levels
of
certain
chemical
messengers, called neurotransmitters,
in the brain.
BEFORE YOU USE LATUDA
_- When you must not use it _
Do not take Latuda if you are:
•
allergic to lurasidone hydrochloride
or
any
of
the
ingredients
in
LATUDA.
See
the
end
of
this
Medication Guide for a complete
list of ingredients in LATUDA.
•
taking
certain
other
medicines
called
CYP3A4
inhibitors
or
inducers
including
ketoconazole,
clarithromycin,
ritonavir,
voriconazole, mibefradil, rifampin,
avasimibe,
St.
John’s
wort,
phenytoin, or carbamazepine. Ask
your doctor or pharmacist if you are
not sure if you are taking any of
these medicines.
_Children and adolescents _
It is not known if LATUDA is safe
and effective in children:
•
less than 13 years of age
with schizophrenia.
•
less than 13 years of age with
bipolar
depression.
•
for
the
treatment
of
irritability
associated with autistic disorder.
-
_Before you start to use it _
Tell your doctor or pharmacist about all
of your medical conditions, including if
you:
•
have or have had heart problems or
stroke
•
have or have had low or h

Ciri produk

1
PRODUCT NAME
LATUDA 20MG FILM-COATED TABLETS
LATUDA 40MG FILM-COATED TABLETS
LATUDA 80MG FILM-COATED TABLETS
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
LURASIDONE HYDROCHLORIDE 20MG
LURASIDONE HYDROCHLORIDE 40MG
LURASIDONE HYDROCHLORIDE 80MG
PRODUCT DESCRIPTION
LATUDA is an atypical antipsychotic belonging to the chemical class of
benzisothiazol derivatives.
Its
chemical
name
is
(3a
_R_
,4
_S_
,7
_R_
,7a
_S_
)-2-{(1
_R_
,2
_R_
)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]
cyclohexylmethyl}hexahydro-4,7-methano-2
_H_
-isoindole-1,3-dione hydrochloride. Its molecular formula
is C
28
H
36
N
4
O
2
S·HCl and its molecular weight is 529.14.
The chemical structure is:
Lurasidone hydrochloride is a white to off-white powder. It is very
slightly soluble in water, practically
insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol,
sparingly soluble in methanol, practically
insoluble or insoluble in toluene and very slightly soluble in
acetone.
LATUDA film-coated tablets are intended for oral administration only.
Each tablet contains 20 mg, 40 mg,
or 80 mg of lurasidone hydrochloride.
Inactive ingredients are mannitol, pregelatinized starch,
croscarmellose sodium, hypromellose, magnesium
stearate, Opadry
®
and carnauba wax. Additionally, the 80 mg tablet contains yellow
ferric oxide and FD&C
Blue No. 2 Aluminum Lake.
PHARMACOLOGY
MECHANISM OF ACTION
The mechanism of action of lurasidone in the treatment of
schizophrenia and bipolar depression is
unclear. However, its efficacy in schizophrenia and bipolar depression
could be mediated through a
combination of central dopamine D
2
and serotonin Type 2 (5HT
2A
) receptor antagonism.
PHARMACODYNAMIC
Lurasidone is an antagonist with high affinity binding at the dopamine
D
2
receptors (Ki of 1 nM) and the
serotonin 5-HT
2A
(Ki of 0.5 nM) and 5-HT
7
(Ki of 0.5 nM) receptors. It also binds with moderate affinity
to the human α
2C
adrenergic receptors (Ki of 11 nM), is a partial agonist at serotonin
5-HT
1A
(Ki of 6.4
2
nM) receptors, and is an antagonist at the