Haloperidol

Haloperidol

Haloperidol Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

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. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).

Cardiovascular Effects

Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients receiving haloperidol. Higher than recommended doses of any formulation of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome).

Tardive Dyskinesia

A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential  to cause tardive dyskinesia is unknown.

Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome. (For further information about the description of tardive dyskinesia and its clinical detection, please refer to ADVERSE REACTIONS.)

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs) and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

Hyperpyrexia and heat stroke, not associated with the above symptom complex, have also been reported with haloperidol.

Usage in Pregnancy
Pregnancy
Nonteratogenic Effects

Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Haloperidol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Rodents given 2 to 20 times the usual maximum human dose of haloperidol by oral or parenteral routes showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality. No teratogenic effect has been reported in rats, rabbits or dogs at dosages within this range, but cleft palate has been observed in mice given 15 times the usual maximum human does. Cleft palate in mice appears to be a nonspecific response to stress or nutritional imbalance as well as to a variety of drugs, and there is no evidence to relate this phenomenon to predictable human risk for most of these agents.

There are no well controlled studies with haloperidol in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of haloperidol along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships were not established in these cases. Since such experience does not exclude the possibility of fetal damage due to haloperidol, this drug should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus. Infants should not be nursed during drug treatment.

Combined Use of Haloperidol and Lithium

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.

General

A number of cases of bronchopneumonia, some fatal, have followed the use of antipsychotic drugs, including haloperidol. It has been postulated that lethargy and decreased sensation of thirst due to central inhibition may lead to dehydration, hemoconcentration and reduced pulmonary ventilation. Therefore, if the above signs and symptoms appear, especially in the elderly, the physician should institute remedial therapy promptly.

Although not reported with haloperidol, decreased serum cholesterol and/or cutaneous and ocular changes have been reported in patients receiving chemically-related drugs.

Haloperidol may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be warned accordingly.

The use of alcohol with this drug should be avoided due to possible additive effects and hypotension.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.

History

There is currently no drug history available for this drug.

Other Information

Haloperidol 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:

Structural Formula

C21H23ClFNO2 375.87

C21H23ClFNO2 375.87

Haloperidol is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. In addition, the 10 mg and 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake.

Haloperidol Manufacturers


  • Cardinal Health
    Haloperidol Tablet [Cardinal Health]
  • Lake Erie Medical Dba Quality Care Products Llc
    Haloperidol Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Direct Rx
    Haloperidol Tablet [Direct Rx]
  • State Of Florida Doh Central Pharmacy
    Haloperidol Tablet [State Of Florida Doh Central Pharmacy]
  • Contract Pharmacy Services-pa
    Haloperidol Tablet [Contract Pharmacy Services-pa]
  • State Of Florida Doh Central Pharmacy
    Haloperidol Tablet [State Of Florida Doh Central Pharmacy]
  • Rebel Distributors Corp
    Haloperidol Tablet [Rebel Distributors Corp]
  • Cadila Healthcare Limited
    Haloperidol Tablet [Cadila Healthcare Limited]
  • Cardinal Health
    Haloperidol Injection [Cardinal Health]
  • Remedyrepack Inc.
    Haloperidol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Haloperidol Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Haloperidol Tablet [Remedyrepack Inc. ]
  • Dispensing Solutions, Inc.
    Haloperidol Tablet [Dispensing Solutions, Inc.]
  • Sandoz Inc
    Haloperidol Tablet [Sandoz Inc]
  • Remedyrepack Inc.
    Haloperidol Tablet [Remedyrepack Inc. ]
  • Cardinal Health
    Haloperidol Tablet [Cardinal Health]
  • Major Pharmaceuticals
    Haloperidol Tablet [Major Pharmaceuticals]
  • Cardinal Health
    Haloperidol (Haloperidol Lactate) Injection [Cardinal Health]
  • Physicians Total Care, Inc.
    Haloperidol Tablet [Physicians Total Care, Inc.]
  • Mylan Institutional Inc.
    Haloperidol Tablet [Mylan Institutional Inc.]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Haloperidol Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Remedyrepack Inc.
    Haloperidol Tablet [Remedyrepack Inc. ]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Haloperidol Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Mckesson Contract Packaging
    Haloperidol Tablet [Mckesson Contract Packaging]
  • Remedyrepack Inc.
    Haloperidol Injection [Remedyrepack Inc. ]
  • Teva Pharmaceuticals Usa Inc
    Haloperidol (Haloperidol Lactate) Solution, Concentrate [Teva Pharmaceuticals Usa Inc]
  • Patriot Pharmaceuticals Llc
    Haloperidol Injection [Patriot Pharmaceuticals Llc]
  • Zydus Pharmaceuticals (Usa) Inc.
    Haloperidol Tablet [Zydus Pharmaceuticals (Usa) Inc.]
  • Remedyrepack Inc.
    Haloperidol (Haloperidol Lactate) Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Haloperidol Tablet [Remedyrepack Inc. ]
  • Pfizer Laboratories Div Pfizer Inc
    Haloperidol (Haloperidol Lactate) Injection, Solution [Pfizer Laboratories Div Pfizer Inc]
  • Remedyrepack Inc.
    Haloperidol Tablet [Remedyrepack Inc. ]
  • Teva Parenteral Medicines, Inc.
    Haloperidol Injection [Teva Parenteral Medicines, Inc.]
  • Remedyrepack Inc.
    Haloperidol (Haloperidol Lactate) Injection, Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Haloperidol (Haloperidol Lactate) Injection, Solution [Remedyrepack Inc. ]
  • American Health Packaging
    Haloperidol Tablet [American Health Packaging]
  • Cardinal Health
    Haloperidol (Haloperidol Lactate) Injection, Solution [Cardinal Health]
  • State Of Florida Doh Central Pharmacy
    Haloperidol Tablet [State Of Florida Doh Central Pharmacy]
  • Remedyrepack Inc.
    Haloperidol Tablet [Remedyrepack Inc. ]
  • Mylan Pharmaceuticals Inc.
    Haloperidol Tablet [Mylan Pharmaceuticals Inc.]
  • Cardinal Health
    Haloperidol Tablet [Cardinal Health]
  • Clinical Solutions Wholesale
    Haloperidol Tablet [Clinical Solutions Wholesale]
  • Fresenius Kabi Usa, Llc
    Haloperidol (Haloperidol Lactate) Injection, Solution [Fresenius Kabi Usa, Llc]
  • Tya Pharmaceuticals
    Haloperidol Tablet [Tya Pharmaceuticals]
  • Cardinal Health
    Haloperidol (Haloperidol Lactate) Injection, Solution [Cardinal Health]
  • Tya Pharmaceuticals
    Haloperidol Injection [Tya Pharmaceuticals]
  • Tya Pharmaceuticals
    Haloperidol Tablet [Tya Pharmaceuticals]
  • General Injectables And Vaccines, Inc
    Haloperidol (Haloperidol Lactate) Injection [General Injectables And Vaccines, Inc]

Login To Your Free Account