APO-RISPERIDONE risperidone 1mg tablets bottle

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

risperidone, Quantity: 1 mg

から入手可能:

Arrotex Pharmaceuticals Pty Ltd

INN（国際名）:

Risperidone

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: microcrystalline cellulose; hyprolose; titanium dioxide; maize starch; magnesium stearate; hypromellose; lactose monohydrate; macrogol 8000

投与経路:

Oral

パッケージ内のユニット:

60 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Treatment of schizophrenia and related psychoses. Short-term treatment of acute mania associated with bipolar I disorder. Treatment of behavioural disturbances in dementia. Treatment of conduct and other disruptive 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. Treatment of behavioural disorders associated with autism in children and adolescents.

製品概要:

Visual Identification: White, capsule-shaped, biconvex, film-coated tablets. Engraved "APO" on one side, "RI" score "1" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Registered

承認日:

2007-08-03

製品の特徴

Product Information – Australia
APO-Risperidone Tablets
Page 1
APO-RISPERIDONE TABLETS
NAME OF THE MEDICINE
Risperidone.
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.
Structural Formula:
Molecular Formula:
C
23
H
27
FN
4
O
2
Molecular Weight:
410.5
CAS Registry Number:
106266-06-2
DESCRIPTION
Risperidone is a novel antipsychotic belonging to a new class of
antipsychotic agents, the benzisoxazole
derivatives.
Risperidone 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. It shows polymorphism.
Each tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone
as the active ingredient.
In addition, each tablet contains the following inactive ingredients:
lactose, cellulose microcrystalline,
maize starch, magnesium stearate, hypromellose,
hydroxypropylcellulose, macrogol 8000, titanium
dioxide, iron oxide red (0.5 mg), sunset yellow FCF aluminium lake (2
mg), iron oxide yellow (3 mg and 4
mg) and indigo carmine aluminium lake (4 mg).
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 α
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.
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