HALOPERIDOL- haloperidol lactate injection HALOPERIDOL- haloperidol lactate injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Hikma Pharmaceuticals USA Inc.

INN (International namn):

HALOPERIDOL LACTATE

Sammansättning:

HALOPERIDOL 5 mg in 1 mL

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Haloperidol is indicated for the treatment of patients with schizophrenia. Haloperidol Injection is contraindicated in patients with: - Severe toxic central nervous system depression or comatose states from any cause. - Hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see WARNINGS, Hypersensitivity Reactions and ADVERSE REACTIONS ). - Parkinson’s disease (see WARNINGS, Neurological Adverse Reactions in Patients with Parkinson’s Disease or Dementia with Lewy Bodies ). - Dementia with Lewy bodies (see WARNINGS, Neurological Adverse Reactions in Patients with Parkinson’s Disease or Dementia with Lewy Bodies ).

Produktsammanfattning:

Haloperidol Injection, USP, equivalent to 5 mg/mL haloperidol (as the lactate), is supplied as follows: NDC 0143-9501-25 - 1 mL Single-dose vial in carton of 25. NDC 0143-9502-01 - 10 mL Multiple-dose vial individually boxed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light . Do not freeze . To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença 2705-906 Terrugem SNT, PORTUGAL Distributed by Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised July 2023 PIN425-WES/11

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

HALOPERIDOL- HALOPERIDOL LACTATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
HALOPERIDOL INJECTION USP
(FOR IMMEDIATE RELEASE)
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 INJECTION
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:
M.F. = C
H
ClFNO
M.W. = 375.86
21
23
2
Haloperidol Injection, USP is available as a sterile parenteral form
for intramuscular
injection. Each mL of Haloperidol Injection, USP contains 5 mg
haloperidol (as the lactate)
with 1.8 mg methylparaben, 0.2 mg propylparaben and lactic acid for pH
adjustment
between 3.0 to 3.8.
CLINICAL PHARMACOLOGY
Haloperidol is an antipsychotic. The mechanism of action of
haloper