HALOPERIDOL DECANOATE injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D)

Предлага се от:

AGILA SPECIALTIES PRIVATE LIMITED

INN (Международно Name):

HALOPERIDOL DECANOATE

Композиция:

HALOPERIDOL 50 mg in 1 mL

Вид предписание :

PRESCRIPTION DRUG

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

HALOPERIDOL DECANOATE- HALOPERIDOL DECANOATE INJECTION
AGILA SPECIALTIES PRIVATE LIMITED
----------
HALOPERIDOL DECANOATE INJECTION 50 MG/ML
HALOPERIDOL DECANOATE INJECTION 100 MG/ML
FOR IM INJECTION ONLY RX ONLY
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH. ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED
TRIALS (MODAL DURATION OF
10 WEEKS), LARGELY IN PATIENTS TAKING ATYPICAL ANTIPSYCHOTIC DRUGS,
REVEALED A RISK OF DEATH IN
DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF DEATH IN
PLACEBO-TREATED
PATIENTS. OVER THE COURSE OF A TYPICAL 10-WEEK CONTROLLED TRIAL, THE
RATE OF DEATH IN DRUG-
TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN
THE PLACEBO GROUP.
ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED
TO BE EITHER
CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR INFECTIOUS
(E.G., PNEUMONIA) IN NATURE.
OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO ATYPICAL ANTIPSYCHOTIC
DRUGS, TREATMENT WITH
CONVENTIONAL ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE EXTENT TO
WHICH THE FINDINGS
OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE ATTRIBUTED TO
THE ANTIPSYCHOTIC DRUG
AS OPPOSED TO SOME CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR.
HALOPERIDOL DECANOATE
INJECTION IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS (SEE
WARNINGS).
DESCRIPTION
Haloperidol decanoate, USP is the decanoate ester of the
butyrophenone, haloperidol, USP. It has a
markedly extended duration of effect. It is available in sesame oil in
sterile form for intramuscular (IM)
injection. The structural formula of haloperidol decanoate, USP,
4-(4-chlorophenyl)-1-[4-(4-
fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:
Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL),
but is soluble in most organic
solvents.
Each mL of haloperidol decanoate, USP 50 mg/mL for IM injection
contains 50 mg haloperi