LATUDA lurasidone hydrochloride 40 mg film-coated tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

lurasidone hydrochloride, Quantity: 40 mg

Fáanlegur frá:

Servier Laboratories (Aust) Pty Ltd

INN (Alþjóðlegt nafn):

lurasidone hydrochloride

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: hypromellose; Carnauba Wax; magnesium stearate; mannitol; pregelatinised maize starch; croscarmellose sodium; titanium dioxide; macrogol 6000

Stjórnsýsluleið:

Oral

Einingar í pakka:

28 Tablets, 56 Tablets, 98 Tablets, 90 Tablets, 30 Tablets, 60 Tablets, 100 Tablets, 14 Tablets, 7 Tablets, 10 Tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

LATUDA is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

Vörulýsing:

Visual Identification: 40 mg: White to off-white, round film-coated tablet, debossed with L 40; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Registered

Leyfisdagur:

2014-04-16

Upplýsingar fylgiseðill

LATUDA
®
_Lurasidone Hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LATUDA.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking LATUDA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LATUDA IS USED
FOR
LATUDA is used to treat adults with
schizophrenia. Schizophrenia is a
mental illness with disturbances in
thinking, feelings and behaviour.
Your doctor may have prescribed
LATUDA for another reason. Ask
your doctor if you have any questions
about why LATUDA has been
prescribed for you.
LATUDA belongs to a group of
medicines called atypical
antipsychotics. It helps to correct
chemical imbalances in the brain,
which may cause mental illness.
There is no evidence that LATUDA
is addictive or habit forming.
This medicine is available only with
a doctor's prescription.
LATUDA is not recommended for
use in children or adolescents under
18 years of age, as safety and
effectiveness have not been
established in this age group.
BEFORE YOU TAKE
LATUDA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE LATUDA IF:
•
YOU HAVE AN ALLERGY TO
LURASIDONE HYDROCHLORIDE (THE
ACTIVE INGREDIENT IN LATUDA)
OR ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
•
YOU ARE TAKING MEDICINES THAT
CAN AFFECT HOW YOUR BODY
PROCESSES LATUDA SUCH AS:
-
KETOCONAZOLE OR VORICONAZOLE,
USED TO TREAT CERTAIN FUNGAL
INFECTIONS
-
RITONAVIR, USED TO TREAT HIV
INFECTION
-
CARBAMAZEPINE, USED TO TREAT
CONVULSIONS (FITS)
-
PHENYTOIN, USED TO TREAT
CONVULSIONS (FITS) AND SOME
HEART CONDITIONS
-
RIFAMPICIN OR CLARITHROMYCIN,
USED TO TREAT BACTERIAL
INFECTIONS
-
HERBAL MEDICINES DERIVED FROM
ST. JOHN'S WORT, USED TO TREAT
DEPRESSION.
DO NOT TAKE LATUDA AFTER THE
EXPIRY DATE PRINT

Vara einkenni

LATUDA
®
_ _(LURASIDONE) – PRODUCT INFORMATION
1 (20)
Version 6
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
LATUDA
®
Lurasidone hydrochloride
Lurasidone hydrochloride (HCl) is chemically identified as
(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 and has the following structural formula.
_Molecular formula:_ C
28
H
36
N
4
O
2
S·HCl
_Molecular weight:_ 529.14
_CAS number:_ 367514-88-3
DESCRIPTION
Lurasidone is an atypical antipsychotic belonging to the chemical
class of benzisothiazol
derivatives. It has antagonist activity on the dopamine 2 (D2) and
serotonin (5-HT)-2A receptors.
LATUDA film-coated tablets are intended for oral administration only.
LATUDA tablets contain 20
mg lurasidone hydrochloride (equivalent to 18.62 mg of lurasidone), 40
mg (equivalent to 37.24 mg
lurasidone), or 80 mg (equivalent to 74.49 mg lurasidone).
Lurasidone HCl (active entity) 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 very slightly
soluble in acetone and has a
pKa of 7.6.
LATUDA tablets also contains the following inactive ingredients:
carnauba wax, croscarmellose
sodium, hypromellose, magnesium stearate, mannitol, Opadry complete
film coating system
03F48969 white, pregelatinised maize starch; the 80 mg tablet also
contains: indigo carmine and
iron oxide yellow.

H
C l
H
N
N
N
S
H
N
O
O
H
H
H
H
LATUDA
®
_ _(LURASIDONE) – PRODUCT INFORMATION
2 (20)
Version 6
_ _
PHARMACOLOGY
PHARMACODYNAMICS
The mechanism of action of lurasidone, as with other medicines having
efficacy in schizophrenia,
is not fully understood. However, based on its receptor pharmacology,
it is believed that the
efficacy of LATUDA is mediated mainly through antagonist activity at
dopamine D
2
and 5-
hydroxytryptamine (5-HT, serotonin) 5-HT
2A
receptors