Haloperidol (Page 4 of 4)

Treatment

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 QT 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 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.

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 to 24 hours following the last parenteral dose.

HOW SUPPLIED

Product

No.

NDC

No.

437401

63323-474-01

Haloperidol Injection, USP, 5 mg/mL, 2 mL vial, packaged in trays of 25.

437410

63323-474-10

Haloperidol Injection, USP, 5 mg/mL, 10 mL multiple dose vial, packaged individually.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

PROTECT FROM LIGHT.

Vial stoppers do not contain natural rubber latex.

address_band

45850G

Revised: January 2011

PACKAGE LABEL — PRINCIPAL DISPLAY — Haloperidol 1 mL Vial Label

NDC 63323-474-01

437401

HALOPERIDOL INJECTION, USP

(For Immediate Release)

5 mg/mL

For Intramuscular Use

1 mL Vial

Rx only

Sterile

PROTECT FROM LIGHT.

437401_vlbl

PACKAGE LABEL — PRINCIPAL DISPLAY — Haloperidol 1 mL Vial Carton Panel

NDC 63323-474-01

437401

HALOPERIDOL INJECTION, USP

(For Immediate Release)

5 mg/mL

For Intramuscular Use

Sterile

1 mL Vial

Rx only

437401_tray437401_vlbl437401_tray
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 LACTATE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN 1.8 mg in 1 mL
PROPYLPARABEN 0.2 mg in 1 mL
LACTIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-474-01 25 VIAL (25 VIAL) in 1 TRAY contains a VIAL
1 1 mL in 1 VIAL This package is contained within the TRAY (63323-474-01)
2 NDC:63323-474-10 1 VIAL, MULTI-DOSE (1 VIAL) 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 03/28/2011
Labeler — APP Pharmaceuticals, LLC (608775388)
Establishment
Name Address ID/FEI Operations
APP Pharmaceuticals, LLC 023648251 MANUFACTURE

Revised: 03/2011 APP Pharmaceuticals, LLC

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.