Prescription Drug Information: Haloperidol (Page 3 of 3)

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/day
Nonpsychotic 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 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 69292-580-01

bottles of 100 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 69292-582-01

bottles of 100 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 69292-584-01

bottles of 100 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 69292-586-01

bottles of 100 tablets

NDC 69292-580-10

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 69292-588-01

bottles of 100 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 69292-590-01

bottles of 100 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:

Amici Pharmaceuticals, LLC

Melville, NY 11747

Rev. 04/2022

PRINCIPAL DISPLAY PANEL

NDC 69292-580-01

Haloperidol Tablets USP,

0.5 mg

100 Tablets

Rx Only

Amici Pharmaceuticals, LLC

label1
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69292-582-01

Haloperidol

Tablets USP,

1 mg

100 Tablets

Rx Only

Amici Pharmaceuticals, LLC

label2
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69292-584-01

Haloperidol

Tablets USP, 2 mg

100 Tablets

Rx Only

Amici Pharmaceuticals, LLC

label3
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69292-586-01

Haloperidol Tablets USP,

5 mg

100 Tablets

Amici Pharmaceuticals, LLC

label4
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69292-586-10

Haloperidol Tablets USP,

5 mg

1000 Tablets

Amici Pharmaceuticals, LLC

label5
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69292-588-01

Haloperidol Tablets USP, 10 mg

100 Tablets

Rx Only

Amici Pharmaceuticals, LLC

label6
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 69292-590-01

Haloperidol Tablets USP, 20 mg

100 Tablets

Rx Only

Amici Pharmaceuticals, LLC

label7
(click image for full-size original)

HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69292-580
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 0.5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69292-580-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 04/18/2022
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69292-582
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 1 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;151
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69292-582-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 04/18/2022
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69292-584
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 2 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;152
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69292-584-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 04/18/2022
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69292-586
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
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I;153
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69292-586-01 100 TABLET in 1 BOTTLE None
2 NDC:69292-586-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 04/18/2022
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69292-588
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 10 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
Product Characteristics
Color TURQUOISE (AQUA) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code I;154
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69292-588-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 04/18/2022
HALOPERIDOL
haloperidol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69292-590
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 20 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
FD&C RED NO. 40
Product Characteristics
Color PINK (SALMON) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code I;155
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69292-590-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071173 04/18/2022
Labeler — Amici Pharmaceuticals, LLC (079536824)
Establishment
Name Address ID/FEI Operations
Innogenix, LLC 044649124 ANALYSIS (69292-580), ANALYSIS (69292-582), ANALYSIS (69292-584), ANALYSIS (69292-586), ANALYSIS (69292-588), ANALYSIS (69292-590), LABEL (69292-580), LABEL (69292-582), LABEL (69292-584), LABEL (69292-586), LABEL (69292-588), LABEL (69292-590), MANUFACTURE (69292-580), MANUFACTURE (69292-582), MANUFACTURE (69292-584), MANUFACTURE (69292-586), MANUFACTURE (69292-588), MANUFACTURE (69292-590), PACK (69292-580), PACK (69292-582), PACK (69292-584), PACK (69292-586), PACK (69292-588), PACK (69292-590)

Revised: 05/2022 Amici Pharmaceuticals, LLC

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