RISPERIDONE SG risperidone 3 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone, Quantity: 3 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Risperidone

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; hypromellose; quinoline yellow aluminium lake; macrogol 400

Administration route:

Oral

Units in package:

60 tablets / carton

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of schizophrenia and related psychoses.,Short term treatment of acute mania associated with bipolar 1 disorder (See DOSAGE AND ADMINISTRATION: Bipolar mania).,Treatment of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe demetia of the Alzheimer type). *(See DOSAGE AND ADMINISTRATION: Behavioural Disturbances in Dementia),Risperidone is indicated for the treatment *(up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type. *(See DOSAGE AND ADMINISTRATION: Behavioural Disturbances in Dementia),Treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (see CLINICAL TRIALS for maintenance data).,Treatment of behavioural disorders associated with autism in children and adolescents (see CLINICAL TRIALS).

Product summary:

Visual Identification: Yellow coloured film coated biconvex capsule shaped, debossed on one side with "A" and on the other side with "53", score line between "5" and "3"; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-09-11

Summary of Product characteristics

_Risperidone SG Product Information _
_ _
_ _
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_ Amneal Pharma Australia Pty Ltd _
Doc ID:107.SG.P.1.2
Page 1
RISPERIDONE SG
_(RISPERIDONE TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is Risperidone
CHEMICAL
NAME:
3-[2-[4-(6-Fluoro
-
1,2-benzisoxazol
-3-yl)-piperidin-1-yl]
ethyl]
-2-methyl-
6,7,8,9-tetrahydro -4H-pyrido [1,2-a] pyrimidin-4-one.
MOLECULAR FORMULA:
C
23
H
27
FN
4
O
2
MOLECULAR WEIGHT:
410.5
CAS NO:. _106266-06-2_.
DESCRIPTION
Risperidone SG is a white or almost white powder, practically
insoluble in water, freely soluble in
methylene chloride, sparingly soluble in alcohol. It dissolves in
dilute acid solutions.
Risperidone
is
a
novel
antipsychotic
belonging
to
a
new
class
of
antipsychotic
agents,
the
benzisoxazole derivatives.
Risperidone SG tablets are available as 0.5, 1, 2, 3 and 4 mg oral
film-coated tablets.
Each tablet contains lactose, microcrystalline cellulose, colloidal
anhydrous silica and magnesium
stearate.
Additionally for coating the different strengths of the tablets also
contains
_ _
_0.5 mg tablets:_
Opadry complete film coating system 03B51373 green, PI No.: 12533
_ _
_1 mg tablet : _
Opadry White Y-1-7000, PI No.: 2731
_2 mg tablets:_
Opadry complete film coating system 03B53576 orange, PI No.: 12528.
_ _
_3 mg tablets:_
Opadry complete film coating system 03B52852 yellow, PI No.: 12527
_ _
_4 mg tablets:_
Opadry complete film coating system 03B51373 green, PI No.: 12533
_Risperidone SG Product Information _
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_ Amneal Pharma Australia Pty Ltd _
Doc ID:107.SG.P.1.2
Page 2
PHARMACOLOGY
PHARMACODYNAMICS
Risperidone is a selective monoaminergic antagonist with a high
affinity for serotoninergic 5HT
2
-
receptors and dopaminergic D
2
receptors. Risperidone binds also to alpha
1
-adrenergic receptors,
and with lower affinity, to H
1
-histaminergic and alpha
2
-adrenergic receptors. Risperidone has no
affinity for cholinergic receptors. The antipsychotic activity of
risperidone is considered to be
attributable to both risperidone and i