Prescription Drug Information: Haloperidol (Page 3 of 3)

Endocrine Disorders

Lactation, breast engorgement, mastalgia, menstrual irregularities, gynecomastia, impotence, increased libido, hyperglycemia, hypoglycemia and hyponatremia.

Gastrointestinal Effects

Anorexia, constipation, diarrhea, hypersalivation, dyspepsia, nausea and vomiting.

Autonomic Reactions

Dry mouth, blurred vision, urinary retention, diaphoresis and priapism.

Respiratory Effects

Laryngospasm, bronchospasm and increased depth of respiration.

Special Senses

Cataracts, retinopathy and visual disturbances.

Other

Cases of sudden and unexpected death have been reported in association with the administration of haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases. The possibility that haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs.

Postmarketing Events

Hyperammonemia has been reported in a 5 1⁄2 year old child with citrullinemia, an inherited disorder of ammonia excretion, following treatment with haloperidol.

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 manifested 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 two-year old child. The risk of ECG changes associated with torsade de pointes should be considered. (For further information regarding torsade 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 anti-arrhythmic 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:

Maintenance Dosage

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

Intramuscular Administration

Adults

Parenteral medication, administered intramuscularly in doses of 2 to 5 mg, is utilized for prompt control of acutely agitated patient with moderately severe to very severe symptoms. Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4 to 8 hour intervals may be satisfactory.

Controlled trials to establish the safety and effectiveness of intramuscular administration in children have not been conducted.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Switchover Procedure (From Intramuscular Administration)

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 oral solution USP (concentrate), 2 mg per mL (as the lactate), is a colorless, odorless, tasteless solution is available in the following oral dosage forms:

NDC 0121-0581-15: 15 mL Bottle with an accompanying dropper calibrated at 0.5 mg and 1.0 mg.

NDC 0121-0581-04: 4 fl oz (120 mL) Bottle:with an accompanying dropper calibrated at 1.0 mg, 1.5 mg, 2.0 mg, 3.0 mg, 4.0 mg and 5.0 mg

NDC 0121-0581-05: 5 mL unit dose cup, case contains 100 unit dose cups of 5 mL

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

Dispense in a tight, light-resistant container as described in the USP.

MANUFACTURED BY

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R03/20

PRINCIPAL DISPLAY PANEL — 15 mL Carton

NDC 0121-0581-15

Haloperidol Oral Solution, USP

(Concentrate)

2 mg/mL

Rx Only

15 mL

Pharmaceutical Associates, Inc.

image description
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mL Bottle

NDC 0121-0581-15

Haloperidol Oral Solution, USP

(Concentrate)

2 mg/mL

Rx Only

15 mL

Pharmaceutical Associates, Inc.

image description
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4 fl oz (120 mL) Carton

NDC 0121-0581-04

Haloperidol Oral Solution, USP

(Concentrate)

2 mg/mL

Rx Only

4 fl oz (120 mL)

Pharmaceutical Associates, Inc.

PRINCIPAL DISPLAY PANEL -- 4 fl oz (120 mL) Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4 fl oz (120 mL) Bottle

NDC 0121-0581-04

Haloperidol Oral Solution, USP

(Concentrate)

2 mg/mL

Rx Only

4 fl oz (120 mL)

Pharmaceutical Associates, Inc.

image description
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Unit Dose Cup Lid

Delivers 5 mL
NDC 0121-0581-05
H ALOPERIDOL
O RAL S OLUTION USP
(Concentrate)

Haloperidol USP (present as the lactate)
10 mg/5 mL
Usual Dosage: See Insert

FOR INSTITUTIONAL USE ONLY Rx ONLY
PHARMACEUTICALS ASSOCIATES, INC.
GREENVILLE, SC 29605

A05810500

PRINCIPAL DISPLAY PANEL -- 5 mL Unit Dose Cup Lid
(click image for full-size original)
HALOPERIDOL
haloperidol solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0581
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL (HALOPERIDOL) HALOPERIDOL 2 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0121-0581-05 10 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-0581-05) and contains a CUP, UNIT-DOSE
1 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0581-05)
2 NDC:0121-0581-15 15 mL in 1 BOTTLE None
3 NDC:0121-0581-04 120 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073037 11/10/2009
Labeler — Pharmaceutical Associates, Inc. (044940096)
Establishment
Name Address ID/FEI Operations
Pharmaceutical Associates, Inc. 097630693 manufacture (0121-0581)

Revised: 06/2020 Pharmaceutical Associates, Inc.

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