Haloperidol (Page 4 of 4)

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 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/day
Non-Psychotic Behavior Disorders and Tourette’s Disorder 0.05 mg/kg/day to 0.075 mg/kg/day
Severely 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 dos ages 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 for oral administration is available as:

0.5 mg: white to off-white, round, flat beveled edge, scored, uncoated tablets, debossed with “AC” and “151” separated by a break line and plain on the reverse side.

1 mg: white to off-white, round, flat beveled edge, scored, uncoated tablets, debossed with “AC” and “152” separated by a break line and plain on the reverse side.

2 mg: pale pink, round, flat beveled edge, scored, uncoated tablets, debossed with “AC” and “153” separated by break line and plain on the reverse side.

5 mg: pale orange, round, flat beveled edge, scored, uncoated tablets, debossed with “AC” and “154” separated by a break line and plain on the reverse side and supplied as:

NDC 0615-8355-39 blistercards of 30

10 mg: pale orange, round, flat beveled edge, scored, uncoated tablets, debossed with “AC” and “155” separated by a break line and plain on the reverse side.

20 mg: pale orange, round, flat beveled edge, scored, uncoated tablets, debossed with “AC” and “156” separated by a break line and plain on the reverse side.

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

Dispense in a tight, light-resistant container.

Distributed by:
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369.

Revised 06/2019

PRINCIPAL DISPLAY PANEL — 5 mg

Haloperidol 5mg tab bingo label
(click image for full-size original)
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8355(NDC:0832-1540)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
haloperidol (haloperidol) haloperidol 5 mg
Inactive Ingredients
Ingredient Name Strength
D&C red no. 27 aluminum lake
D&C yellow no. 10
hypromellose, unspecified
lactose monohydrate
magnesium stearate
microcrystalline cellulose
silicon dioxide
sodium starch glycolate type a corn
Product Characteristics
Color ORANGE (pale orange) Score 2 pieces
Shape ROUND (round flat beveled edge) Size 7mm
Flavor Imprint Code AC;154
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8355-39 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211061 01/09/2020
Labeler — NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK (0615-8355)

Revised: 11/2020 NCS HealthCare of KY, Inc dba Vangard Labs

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