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Haldol Decanoate

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Haldol Decanoate

HALDOL® Decanoate 50
(haloperidol decanoate)

HALDOL® Decanoate 100
(haloperidol decanoate)

Haldol Decanoate

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 Decanoate (haloperidol decanoate) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

DRUG DESCRIPTION

Haloperidol decanoate is the decanoate ester of the butyrophenone, HALDOL (haloperidol). It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is:

HALDOL® (Haloperidol decanoate) Structural Formula Illustration

Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents.

Each mL of HALDOL Decanoate (haloperidol decanoate) 50 for IM injection contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.

Each mL of HALDOL Decanoate (haloperidol decanoate) 100 for IM injection contains 100 mg haloperidol (present as haloperidol decanoate 141.04 mg) in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.

What are the precautions when taking haloperidol decanoate (Haldol Decanoate)?

Before using haloperidol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain severe nervous system problem (severe CNS depression), Parkinson's disease.

This medication should not be given to a patient who is unconscious.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bipolar disorder, difficulty urinating (e.g., due to prostate problems), glaucoma, heart...

Read All Potential Precautions of Haldol Decanoate »

Last reviewed on RxList: 10/17/2008
This monograph has been modified to include the generic and brand name in many instances.

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