HALOPERIDOL- haloperidol lactate injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

HALOPERIDOL LACTATE (UNII: 6387S86PK3) (HALOPERIDOL - UNII:J6292F8L3D)

Disponible depuis:

Cardinal Health 107, LLC

DCI (Dénomination commune internationale):

HALOPERIDOL LACTATE

Composition:

HALOPERIDOL 5 mg in 1 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Haloperidol injection is indicated for the treatment of patients with schizophrenia. Haloperidol injection is contraindicated in patients with:

Descriptif du produit:

Haloperidol Injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. PROTECT FROM LIGHT. The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 45850N Distributed By: Cardinal Health Dublin, OH 43017 L36082620124 Revised: October 2021

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

HALOPERIDOL- HALOPERIDOL LACTATE INJECTION, SOLUTION
CARDINAL HEALTH 107, LLC
----------
HALOPERIDOL INJECTION, USP
Rx only
(FOR IMMEDIATE RELEASE)
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 INJECTION,
USP IS
NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (SEE WARNINGS).
DESCRIPTION
Haloperidol is the first of the butyrophenone series of major
antipsychotics. The
chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-
4'-
fluorobutyrophenone and it has the following structural formula:
Haloperidol Injection, USP is available as a sterile parenteral form
for intramuscular
injection. The injection provides 5 mg haloperidol (as the lactate)
with 1.8 mg
methylparaben and 0.2 mg propylparaben per mL, and lactic acid for pH
adjustment
between 3.0 to 3.8.
CLINICAL PHARMACOLOGY
Haloperidol is an antipsychotic. The mechanism of action of
haloperidol for the treatment
of schizophrenia is uncl