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:

Breckenridge Pharmaceutical, Inc.

INN (International Name):

Haloperidol Lactate

Composition:

Haloperidol 5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Haloperidol is indicated for use in the treatment of schizophrenia. Haloperidol is indicated for the control of tics and vocal utterances of Tourette's Disorder. Haloperidol is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.

Product summary:

Haloperidol Injection, USP equivalent to 5 mg/mL haloperidol (as the lactate) is supplied as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. DO NOT FREEZE. Preservative Free.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOPERIDOL- HALOPERIDOL LACTATE INJECTION
BRECKENRIDGE PHARMACEUTICAL, INC.
----------
HALOPERIDOL INJECTION USP
(FOR IMMEDIATE RELEASE)
PRESERVATIVE FREE
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:
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), Water for Injection USP q.s.
and lactic acid USP for pH adjustment between 3.0 to 3.6.
CLINICAL PHARMACOLOGY
The precise mechanism of action has not been clearly established.
INDICATIONS AND USAGE
Haloperidol is indi