RESPAZ risperidone 0.5mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

risperidone, Quantity: 0.5 mg

Sẵn có từ:

Dr Reddys Laboratories Australia Pty Ltd

INN (Tên quốc tế):

Risperidone

Dạng dược phẩm:

Tablet, film coated

Thành phần:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate; colloidal anhydrous silica; pregelatinised maize starch; sodium lauryl sulfate; purified talc; titanium dioxide; hypromellose; iron oxide red; macrogol 400

Tuyến hành chính:

Oral

Các đơn vị trong gói:

20, 60 tablet

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

Treatment of schizophrenia and related psychoses. Short-term treatment of acute mania associated with bipolar I disorder. Treatment (up to 12 weeks) of psychotic symptoms, or persistent agitations or aggression unresponsive to non-pharmacological approaches, in patients with moderate to severe dementia of the Alzheimer type. Treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with subaverage intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials for maintenance data). Treatment of behavioural disorders associated with autism in children and adolescents (see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).

Tóm tắt sản phẩm:

Visual Identification: Brown, capsule shaped, biconvex film coated tablets embossed with '0.5' on one side and 'RSP' on the other side with a scoreline separating 'R' and 'SP'; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Tình trạng ủy quyền:

Licence status A

Ngày ủy quyền:

2010-05-12

Đặc tính sản phẩm

Page 1 of 34
RESPAZ
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active:
Risperidone
DESCRIPTION
Chemical Name:
3-[2-[4-(6-fluoro –1,2-benzisoxazol –3-yl) –1-piperidinyl]
ethyl] –6,7,8,9-
tetrahydro –2-methyl-4H-pyrido [1,2-a] pyrimidin-4-one.
Molecular formula:
C
23
H
27
FN
4
O
2
Molecular Weight:
410.49
CAS:
106266-06-2
Excipients:
Lactose,
pregelatinised
maize
starch,
microcrystalline
cellulose,
sodium
lauryl
sulfate, colloidal anhydrous silica, purified talc, magnesium
stearate. In addition, the 0.5 mg
tablet contains Opadry complete film coating system 03B56980j Brown;
the 1 mg tablet contains
Opadry complete film coating system OY-58900 White; the 2 mg tablet
contains Opadry
complete film coating system 03B53509 Orange; the 3 mg tablet contains
Opadry complete film
coating system 03B52209 Yellow; and the 4 mg tablet contains Opadry
complete film coating
system 03B51293 Green.
PHARMACOLOGY
Risperidone is a novel antipsychotic belonging to a new class of
antipsychotic agents, the
benzisoxazole derivatives.
PHARMACODYNAMICS
Risperidone is a selective monoaminergic antagonist with a high
affinity for serotoninergic
5HT2- 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 its active
metabolite 9-hydroxy risperidone.
_Product Information _
_Respaz (risperidone tablets) _
_Dr Reddy’s Laboratories (Australia) Pty Ltd _
_Version 2 09May11 _
Page 2 of 34
Central dopamine D
2
-receptor antagonism is considered to be the mechanism of action by
which conventional neuroleptics improve the positive symptoms of
schizophrenia, but also
induce extrapyramidal symptoms and release of prolactin.
Although risperidone antagonises dopamine D
2
-receptors and causes release of prolactin, it is
less potent than classical neuroleptics for depress