Haloperidol (Page 5 of 5)

Treatment

Since there is no specific antidote, treatment is primarily supportive. Dialysis is not recommended in the treatment of overdose because it removes only very small amounts of haloperidol. 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 must 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 QTc-interval prolongation or dysrhythmias and monitoring should continue until the ECG is normal.

Severe arrhythmias should be treated with appropriate anti-arrhythmic measures.

In case of an overdose, consult a Certified Poison Control Center (1-800-222-1222).

DOSAGE AND ADMINISTRATION

There is considerable variation from patient to patient in the amount of medication required for treatment. As with all drugs used to treat schizophrenia, 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. Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol injection. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels.

Parenteral medication, administered intramuscularly in doses of 2 to 5 mg, is utilized for prompt control of the acutely agitated schizophrenic 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. The maximum dose is 20 mg/day.

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

An 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 12-24 hours following the last parenteral dose.

HOW SUPPLIED:

Haloperidol Injection, USP is supplied as follows:

Product Code Unit of Sale Strength Each
437401 NDC 63323-474-01Unit of 25 5 mg per mL, 1 mL fill, in a 2 mL vial. NDC 63323-474-001 mL Single Dose Vial
437410 NDC 63323-474-10Individually packaged 50 mg per 10 mL (5 mg per mL) 10 mL Multiple Dose Vial

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

PROTECT FROM LIGHT.

The container closure is not made with natural rubber latex.

Fresenius Kabi Logo

Lake Zurich, IL 60047
www.fresenius-kabi.com/us

45850N
Revised: October 2021

PACKAGE LABEL — PRINCIPAL DISPLAY — Haloperidol Injection 1 mL Vial Label

NDC 63323-474-00 437401
Haloperidol
Injection, USP
(For Immediate Release)

5 mg per mL

For intramuscular use. Sterile. Protect from light.

1 mL Single Dose Vial Rx only

PACKAGE LABEL -- PRINCIPAL DISPLAY -- Haloperidol Injection 1 mL Vial Label
(click image for full-size original)


PACKAGE LABEL — PRINCIPAL DISPLAY — Haloperidol Injection 1 mL Vial Tray Label

NDC 63323-474-01 437401
Haloperidol
Injection, USP
(For Immediate Release)

5 mg per mL

For intramuscular use.

25 x 1 mL Single Dose Vials Rx only

PACKAGE LABEL -- PRINCIPAL DISPLAY -- Haloperidol Injection 1 mL Vial Tray Label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY – Haloperidol Injection, USP 10 mL Vial Label
NDC 63323-474-10 437410
Haloperidol

Injection, USP

(For Immediate Release)

50 mg per 10 mL

(5 mg per mL)For intramuscular use.

10 mL

Multiple Dose Vial Rx only

PACKAGE LABEL -- PRINCIPAL DISPLAY – Haloperidol Injection, USP 10 mL Vial Label
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY – Haloperidol Injection, USP 10 mL Carton Panel
NDC 63323-474-10 437410
Haloperidol

Injection, USP
(For Immediate Release)

50 mg per 10 mL

(5 mg per mL)
For intramuscular use.

10 mL Multiple Dose Vial

Rx only

PACKAGE LABEL -- PRINCIPAL DISPLAY – Haloperidol Injection, USP 10 mL Carton Panel
(click image for full-size original)
HALOPERIDOL haloperidol lactate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-474
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL LACTATE (HALOPERIDOL) HALOPERIDOL 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLPARABEN 0.2 mg in 1 mL
METHYLPARABEN 1.8 mg in 1 mL
LACTIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-474-01 25 VIAL in 1 TRAY contains a VIAL (63323-474-00)
1 NDC:63323-474-00 1 mL in 1 VIAL This package is contained within the TRAY (63323-474-01)
2 NDC:63323-474-10 1 VIAL, MULTI-DOSE in 1 BOX contains a VIAL, MULTI-DOSE
2 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the BOX (63323-474-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075689 10/20/2000
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 ANALYSIS (63323-474), MANUFACTURE (63323-474)

Revised: 01/2022 Fresenius Kabi USA, LLC

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