Haloperidol (Page 3 of 4)

OVERDOSAGE

Manifestations

In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: 1) severe extrapyramidal reactions, 2) hypotension, or 3) sedation. The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. The extrapyramidal reaction would be manifest by muscular weakness or rigidity and a generalized or localized tremor as demonstrated by the akinetic or agitans types respectively. With accidental overdosage, hypertension rather than hypotension occurred in a 2 year old child. The risk of ECG changes associated with Torsades de pointes should be considered. (For further information regarding Torsades de pointes, please refer to ADVERSE REACTIONS.)

Treatment

Gastric lavage or induction of emesis should be carried out immediately followed by administration of activated charcoal. Since there is no specific antidote, treatment is primarily supportive. A patent airway must be established by use of an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy. Respiratory depression may be counteracted by artificial respiration and mechanical respirators. Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine. Epinephrine should not be used. In case of severe extrapyramidal reactions, antiparkinson medication should be administered. ECG and vital signs should be monitored especially for signs of Q-T prolongation or dysrhythmias and monitoring should continue until the ECG is normal. Severe arrhythmias should be treated with appropriate antiarrhythmic measures.

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. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below.

Clinical experience suggests the following recommendations:

Oral Administration

Initial Dosage Range

Adults

Moderate Symptomatology — 0.5 mg to 2 mg b.i.d. or t.i.d.Severe Symptomatology — 3 mg to 5 mg b.i.d. or t.i.d.

To achieve prompt control, higher doses may be required in some cases.

Geriatric or Debilitated Patients — 0.5 mg to 2 mg b.i.d. or t.i.d.Chronic or Resistant Patients — 3 mg to 5 mg b.i.d. or t.i.d.Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Children

The following recommendations apply to children between the ages of 3 and 12 years (weight range 15 kg to 40 kg). Haloperidol is not intended for children under 3 years old. Therapy should begin at the lowest dose possible (0.5 mg per day). If required, the dose should be increased by an increment of 0.5 mg at 5 to 7 day intervals until the desired therapeutic effect is obtained. (See chart below.) The total dose may be divided, to be given b.i.d. or t.i.d.

Psychotic Disorders — 0.05 mg/kg/day to 0.15 mg/kg/dayNonpsychotic Behavior Disorders and Tourette’s Disorder — 0.05 mg/kg/day to 0.075 mg/kg/daySeverely disturbed psychotic children may require higher doses. In severely disturbed, non-psychotic children or in hyperactive children with accompanying conduct disorders, who have failed to respond to psychotherapy or medications other than antipsychotics, it should be noted that since these behaviors may be short lived, short term administration of haloperidol may suffice. There is no evidence establishing a maximum effective dosage. There is little evidence that behavior improvement is further enhanced in dosages beyond 6 mg per day.

Maintenance Dosage

Upon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the lowest effective maintenance level.

Switchover Procedure

The oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient’s clinical status, the first oral dose should be given within 12 to 24 hours following the last parenteral dose.

HOW SUPPLIED

Haloperidol Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP.

The 0.5 mg tablets are white color, round, flat tablets with bevel edge, debossed “150” on one side and “I” on the other side. They are available as follows:

NDC 71247-150-01

bottles of 100 tablets

NDC 71247-150-10

bottles of 1000 tablets

The 1 mg tablets are yellow color, round, flat tablets with bevel edge, debossed “151” on one side and “I” on the other side. They are available as follows:

NDC 71247-151-01

bottles of 100 tablets

NDC 71247-151-10

bottles of 1000 tablets

The 2 mg tablets are white color, round, flat tablets with bevel edge, debossed “152” on one side and “I” on the other side. They are available as follows:

NDC 71247-152-01

bottles of 100 tablets

NDC 71247-152-10

bottles of 1000 tablets

The 5 mg tablets are green color, round, flat tablets with bevel edge, debossed “153” on one side and “I” on the other side. They are available as follows:

NDC 71247-153-01

bottles of 100 tablets

NDC 71247-153-10

bottles of 1000 tablets

The 10 mg tablets are aqua color, round, flat tablets with bevel edge, debossed “154” on one side and “I” on the other side. They are available as follows:

NDC 71247-154-01

bottles of 100 tablets

NDC 71247-154-10

bottles of 1000 tablets

The 20 mg tablets are salmon color, round, flat tablets with bevel edge, debossed “155” on one side and “I” on the other side. They are available as follows:

NDC 71247-155-01

bottles of 100 tablets

NDC 71247-155-10

bottles of 1000 tablets

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Distributed by:

Innogenix, LLC.

Amityville, NY 11701

Rev. 12/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-150-01

Haloperidol Tablets USP, 0.5 mg

100 Tablets

Rx Only

Innogenix, LLC.

Label1
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71247-151-01

Haloperidol Tablets USP, 1 mg

100 Tablets

Rx Only

Innogenix, LLC.

Label2
(click image for full-size original)

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