HALOPERIDOL LACTATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

INN (International Name):

HALOPERIDOL LACTATE

Composition:

HALOPERIDOL 5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Haloperidol injection, USP (For Immediate Release) equivalent to 5 mg haloperidol per mL (as the lactate) is supplied as follows: Overbagged with 5 x 1 mL single-dose vials, NDC 55154-7076-5 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOPERIDOL LACTATE- HALOPERIDOL LACTATE INJECTION, SOLUTION
CARDINAL HEALTH 107, LLC
----------
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:
Haloperidol, USP is a white or slightly yellowish crystalline powder.
Haloperidol injection, USP is available as a sterile parenteral form
for intramuscular
injection. Each mL contains 5 mg haloperidol (as the lactate) with 1.8
mg methylparaben,
0.2 mg propylparaben, lactic acid to adjust the pH to 3.0 to 3.8 [at
25ºC] and Water for
Injection, q.s.
CLINICAL PHARMACOLOGY
Haloperidol is an antipsycho