Rx Item-Haldol 5Mg/Ml Amp 10X1Ml By J O M Pharma

HALDOL- haloperidol lactate injection
Janssen Pharmaceuticals, Inc.

(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. HALDOL 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:

Chemical Structure
(click image for full-size original)
HALDOL (haloperidol) 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 � 3.6.

ACTIONS

The precise mechanism of action has not been clearly established.

INDICATIONS

HALDOL (haloperidol) is indicated for use in the treatment of schizophrenia.

HALDOL is indicated for the control of tics and vocal utterances of Tourette�s Disorder.

RX ITEM-Haldol 5Mg/Ml Amp 10X1Ml By J O
NDC 50458-0255-01 UPC/GTIN No.3-50458-25501-3 Mfg.Part No.25501

Haldol 5Mg/Ml Amp 10X1Ml By J O M Pharma
BRAND: HALDOL NDC: 50458-0255-01,50458025501 UPC: 3-50458-25501-3,350458255013 J/O/M Pharma Services

HALOPERIDOL LACTATE INJEC
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