HALOPERIDOL- haloperidol lactate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Haloperidol Lactate (UNII: 6387S86PK3) (Haloperidol - UNII:J6292F8L3D)

Available from:

Akorn

INN (International Name):

Haloperidol Lactate

Composition:

Haloperidol 5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Haloperidol Injection, USP is indicated for use in 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).

Product summary:

Haloperidol Injection, USP (For Immediate Release) 5 mg per mL (as the lactate) NDC 17478-110-01, units of 10 x 1 mL vials Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. Keep out of reach of children. AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 HL00N Rev. 05/21

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOPERIDOL- HALOPERIDOL LACTATE INJECTION
AKORN
----------
HALOPERIDOL INJECTION, USP
(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
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)
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 unclear. However, its efficacy could be mediated
through its activity
as an antagonist at central dopamine