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Uses

Psychotic Disorders

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Symptomatic management of psychotic disorders (i.e., schizophrenia).

The long-acting decanoate ester is used principally in patients requiring prolonged antipsychotic therapy (e.g., patients with chronic schizophrenic disorder).

Tourette’s Syndrome

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Control of tics and vocal utterances of Tourette’s syndrome (Gilles de la Tourette’s syndrome).

May be used concomitantly with a stimulant for tic disorders (e.g., Tourette’s syndrome) and comorbid attention deficit hyperactivity disorder† (ADHD) in children in whom stimulants alone cannot control tics.

Disruptive Behavior Disorder and Attention Deficit Hyperactivity Disorder (ADHD)

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Treatment of severe behavioral problems in children marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations).

Short-term treatment of hyperactive children who exhibit excessive motor activity with accompanying conduct disorders that are manifested as impulsive behavior, difficulty sustaining attention, aggression, mood lability, and/or poor frustration tolerance.

Manufacturers recommend to reserve for use in children with severe behavioral problems or ADHD only after failure to respond to psychotherapy or drug therapy other than antipsychotics. Some experts currently recommend use only for the treatment of comorbid tics in children with ADHD.

Delirium

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Management of delirium†.

Although other drugs (e.g., phenothiazines, droperidol) have been used, haloperidol generally is considered the antipsychotic of choice for most patients with delirium† because of its relatively low risk of anticholinergic activity and of sedative and hypotensive effects.

Nausea and Vomiting

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Has been used in the prevention and control of severe nausea and vomiting† (e.g., cancer chemotherapy-induced emesis). Based on limited data, appears to be as effective as phenothiazines in prevention of cancer chemotherapy-induced emesis; additional studies required.

Dosage and Administration

Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Administer haloperidol orally as tablets.

Administer haloperidol lactate orally as solution concentrate or IM; also has been administered by IV injection† or infusion†.

Administer haloperidol decanoate IM; do not administer IV.

Avoid skin contact with haloperidol lactate oral solution and injection, since contact dermatitis has occurred rarely.

Oral Administration

Haloperidol or haloperidol lactate: Administer orally 2 or 3 times daily.

IM Administration

Haloperidol decanoate: Administer by deep IM injection into the gluteal region using a 21-gauge needle, usually at monthly intervals; maximum volume should not exceed 3 mL per IM injection site..

Haloperidol lactate: Administer IM at intervals based on patient response; may administer as often as every hour, although 4–8 hour intervals may be satisfactory.

IM administration of haloperidol lactate or decanoate in children is not recommended by the manufacturers.

IV Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Haloperidol lactate: Has been administered by IV injection† or infusion†.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Available as the base, decanoate (decanoic acid ester), and lactate salt; dosage is expressed in terms of haloperidol.

There is considerable interindividual variation in optimum dosage requirements; carefully adjust dosage according to individual requirements and response, using the lowest possible effective dosage.

Because of risk of adverse reactions associated with cumulative effects of butyrophenones, periodically evaluate patients with a history of long-term therapy with haloperidol and/or other antipsychotic agents to determine whether maintenance dosage can be decreased or drug therapy discontinued.

Pediatric Patients

Psychotic Disorders

Oral

Children 3–12 years of age (weighing 15–40 kg): Initially, 0.5 mg daily given in 2 or 3 divided doses. Subsequent dosage may be increased by 0.5 mg daily at 5- to 7-day intervals, depending on the patient’s tolerance and therapeutic response; usual dosage range is 0.05–0.15 mg/kg daily given in 2 or 3 divided doses.

Severely disturbed psychotic children may require higher dosages.

During prolonged maintenance therapy, keep dosage at the lowest possible effective level; once an adequate response has been achieved, gradually reduce dosage and make subsequent adjustments according to patient response and tolerance.

Tourette’s Disorder

Oral

Children 3–12 years of age (weighing 15–40 kg): Initially, 0.5 mg daily given in 2 or 3 divided doses. Subsequent dosage may be increased by 0.5 mg daily at 5- to 7-day intervals, depending on the patient’s tolerance and therapeutic response; usual dosage range is 0.05–0.075 mg/kg daily given in 2 or 3 divided doses.

Once an adequate response is achieved, gradually reduce dosage and make subsequent adjustments according to patient response and tolerance.

Disruptive Behavior Disorder and ADHD

Oral

Children 3–12 years of age (weighing 15–40 kg): Initially, 0.5 mg daily given in 2 or 3 divided doses. Subsequent dosage may be increased by 0.5 mg daily at 5- to 7-day intervals, depending on the patient’s tolerance and therapeutic response; usual dosage range is 0.05–0.075 mg/kg daily given in 2 or 3 divided doses.

Non-psychotic or hyperactive behavioral problems in children may be acute, and short-term administration may be adequate.

Maximum effective dosage for management of behavioral problems in children not established, but there is little evidence that improvement in behavior is further enhanced at dosages >6 mg daily.

Adults

Psychotic Disorders

Moderate Symptomatology

Oral

Initially, 0.5–2 mg 2 or 3 times daily. Carefully adjust subsequent dosage according to the patient’s tolerance and therapeutic response. During prolonged maintenance therapy, keep dosage at lowest effective level.

Severe Symptomatology

Oral

Initially, 3–5 mg 2 or 3 times daily.

To achieve prompt control, higher dosages may be required in some patients. Patients who remain severely disturbed or inadequately controlled may require dosage adjustment.

Dosages up to 100 mg daily may be required in some severely psychotic patients. Occasionally, dosages >100 mg daily have been used for the management of severely resistant disorders in adults; however, safety of prolonged administration of such dosages has not been demonstrated.

Chronic/Resistant Disorders

Oral

Initially, 3–5 mg 2 or 3 times daily.

Patients who remain severely disturbed or inadequately controlled may require dosage adjustment.

Dosages up to 100 mg daily may be required in some severely psychotic patients. Occasionally, dosages >100 mg daily have been used for the management of severely resistant disorders in adults; however, safety of prolonged administration of such dosages has not been demonstrated.

IM

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Haloperidol decanoate (extended-duration of effect): May consider for patients requiring prolonged antipsychotic therapy (e.g., patients with chronic schizophrenic disorder).

Initially, stabilize patient’s condition with an antipsychotic agent prior to attempting conversion to haloperidol decanoate. If patient is receiving an antipsychotic agent other than haloperidol, initial conversion to oral haloperidol is recommended to minimize risk of an unexpected adverse reaction that might not be readily reversible following use of the decanoate.

Base initial IM decanoate dose on patient’s clinical history, physical condition, and response to previous antipsychotic therapy.

A precise formula for converting oral haloperidol dosage to IM haloperidol decanoate not established, but an initial IM dose 10–20 times the previous daily oral haloperidol dose, not >100 mg (regardless of previous antipsychotic dosage requirements) is suggested, although limited clinical experience suggests that a lower initial dosage of the decanoate may be adequate. (See Table: Haloperidol Decanoate Dosage Recommendations under Dosage and Administration.)

If conversion requires an initial haloperidol decanoate dosage >100 mg, administer in 2 injections (i.e., administering a maximum initial dosage of 100 mg followed by the balance in 3–7 days); however, some clinicians have converted therapy to decanoate using a higher initial dose.

Usually, administer at monthly intervals (i.e., every 4 weeks), but individual response may dictate need for adjusting dosing interval as well as the dose.

Observe closely during dosage titration to minimize risk of overdosage or emergence of psychotic manifestations prior to next dose; if supplemental antipsychotic therapy is necessary during periods of dosage titration or for control of acute exacerbations of psychotic manifestations, use a short-acting haloperidol preparation.

Experience with haloperidol decanoate dosages >450 mg monthly is limited.

Acute Agitation

IM

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Haloperidol lactate: Initially, 2–5 mg as a single dose for prompt control in patients with moderately severe to very severe symptoms. Depending on patient response, may repeat dose as often as every hour; however, administration every 4–8 hours may be adequate to control symptoms in some patients.

Conversion from IM to Oral Therapy

Replace short-acting parenteral therapy with haloperidol lactate with oral therapy as soon as possible; depending on patient’s clinical status, give first oral dose within 12–24 hours after administration of last parenteral dose.

Use total parenteral dosage during preceding 24 hours for initial approximation of total daily oral dosage required; since this dosage is only an initial estimate, closely monitor patients being switched to oral therapy, particularly for symptoms of efficacy, sedation, and adverse effects, for first several days following initiation of oral therapy.

Increase or decrease subsequent oral dosage according to patient tolerance and therapeutic response, using lowest possible effective dosage.

Tourette’s Disorder

Moderate Symptomatology

Oral

Initially, 0.5–2 mg 2 or 3 times daily. Carefully adjust subsequent dosage according to patient’s tolerance and therapeutic response.

During prolonged maintenance therapy, keep dosage at lowest effective level.

Severe Symptomatology and/or Chronic/Resistant Patients

Oral

Initially, 3–5 mg 2 or 3 times daily.

Patients who remain inadequately controlled may require dosage adjustment.

Dosages up to 100 mg daily may be required in some patients to achieve optimal response. Occasionally, dosages >100 mg daily have been used for management of severely resistant disorders in adults; however, safety of prolonged administration of such dosages has not been demonstrated.

Delirium

IV

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.†

Optimum dosage not established. However, initiation of IV† haloperidol (as the lactate) with dosages of 1–2 mg every 2–4 hours has been suggested; severely agitated adults may require titration to higher dosages.†

Although single IV doses up to 50 mg or total daily dosages of 500 mg have been reported, must consider risk of adverse effects, particularly torsades de pointes.†

Some evidence suggests that risk of torsades de pointes increases at total daily dosages ≥35–50 mg.†

In patients requiring multiple IV injections of the drug to control delirium (e.g., >8 [10-mg] doses in 24 hours or >10 mg/hour for >5 consecutive hours), may consider continuous IV infusion†; in such patients, an initial 10-mg dose followed by an infusion of 5–10 mg/hour has been suggested. If agitation persists, can consider repeating 10-mg IV doses at 30-minute intervals, accompanied by a 5 mg/hour increase in the infusion rate.†

Determine ECG at baseline and periodically thereafter, with special attention paid to possible prolongation of the QT interval, and reduce dosage or discontinue if clinically important QT prolongation (e.g., 15–25% or more over baseline) occurs or the QT_c exceeds 450 msec.†

Prescribing Limits

Pediatric Patients

Oral

Maximum effective dosage not established, but there is little evidence that improvement in behavior is further enhanced at dosages >6 mg daily.

IM

Safety and efficacy not established in children.

Adults

Oral

Safety of prolonged administration of dosages >100 mg not demonstrated.

IM

Experience with haloperidol decanoate dosages >450 mg monthly is limited.

Special Populations

Geriatric/Debilitated Patients

In geriatric or debilitated patients, lower dosages may be required than those in younger adults; optimal response is usually obtained with more gradual dosage adjustments.

Initially, 0.5–2 mg orally 2 or 3 times daily; increase dosage more gradually in debilitated, emaciated, or geriatric patients than in younger adults.

Lower IV† dosages (e.g., 0.25–0.5 mg every 4 hours as haloperidol lactate) have been suggested for geriatric patients with delirium.