HALDOL DECANOAS

Država: Indonezija

Jezik: indonezijski

Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivni sastojci:

HALOPERIDOL DECANOATE

Dostupno od:

SOHO INDUSTRI PHARMASI - Indonesia

INN (International ime):

HALOPERIDOL DECANOATE

Doziranje:

50 MG/ML

Farmaceutski oblik:

CAIRAN INJEKSI

Jedinice u paketu:

DUS, 5 AMPUL @ 1 ML

Proizveden od:

JANSSEN - Belgia

Datum autorizacije:

2019-02-07

Svojstava lijeka

proposed package insert_haldol deca_
(anno
)_komnas22dec21_clean.docxMar 2018.docx
Page 1
HALDOL
® DECANOAS
_haloperidol decanoate_
COMPOSITION
Each ml of Haldol Decanoas 50 mg/ml is expressed in terms of the
haloperidol content and is equivalent to
70.52 mg haloperidol decanoate.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: antipsychotics, ATC Code N05AD01
MECHANISM OF ACTION
Haloperidol decanoate is an ester of haloperidol and decanoic acid,
and as such, a depot antipsychotic
belonging to the butyrophenones group. After intramuscular injection,
haloperidol decanoate is gradually
released from muscle tissue and hydrolyzed slowly into free
haloperidol which enters the systemic
circulation.
Haloperidol is a potent central dopamine type 2 receptor antagonist,
and at recommended dosages, has low
alpha 1 antiadrenergic activity and no antihistaminergic or
anticholinergic activity.
PHARMACODYNAMIC EFFECTS
Haloperidol suppresses delusions and hallucinations as a direct
consequence of blocking dopaminergic
signaling in the mesolimbic pathway. The central dopamine blocking
effect has activity on the basal ganglia
(nigrostriatal bundles). Haloperidol causes effective psychomotor
sedation, which explains the favourable
effect on manias.
The activity on the basal ganglia probably underlies the undesirable
extrapyramidal motor effects (dystonia,
akathisia and parkinsonism).
The antidopaminergic effects of haloperidol on lactotropes in the
anterior pituitary explain hyperprolactinemia
due to inhibition of dopamine mediated tonic inhibition of prolactin
secretion.
CLINICAL STUDIES
In clinical studies, patients were mostly reported to have received
prior treatment with orally administered
haloperidol before converting to haloperidol decanoate. Occasionally,
patients had previously been treated
orally with another antipsychotic medicinal product.
PHARMACOKINETIC PROPERTIES
ABSORPTION
Administration of haloperidol decanoate as a depot intramuscular
injection results in a slow and sustained
rel