Overview
DESCRIPTION Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-( p -chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula: Haloperidol, USP is supplied as tablets for oral administration containing 0.
Mechanism of Action
CLINICAL PHARMACOLOGY The precise mechanism of action has not been clearly established.
Indications
- INDICATIONS AND USAGE Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation).
Common Doses
- 0.5 mg
- 2 mg
- 3 mg
- 5 mg
Dosage
DOSAGE AND ADMINISTRATION There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control. To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state.
Black Box Warning
BOXED WARNING 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.
Contraindications
- CONTRAINDICATIONS Haloperidol tablets are 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.
Side Effects
- ADVERSE REACTIONS Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of Torsades de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS). Cases of sudden and unexpected death have been reported in association with the administration of haloperidol.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.