Haloperidol (Page 4 of 4)

Postmarketing Experience

The following adverse reactions relating to the active moiety haloperidol have been identified during postapproval use of haloperidol or haloperidol decanoate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Pancytopenia, Agranulocytosis, Thrombocytopenia, Leukopenia, Neutropenia

Cardiac Disorders: Ventricular fibrillation, Torsade de pointes, Ventricular tachycardia, Extrasystoles

Endocrine Disorders: Inappropriate antidiuretic hormone secretion

Gastrointestinal Disorders: Vomiting, Nausea

General Disorders and Administration Site Conditions: Sudden death, Face edema, Edema, Hyperthermia, Hypothermia

Hepatobiliary Disorders: Acute hepatic failure, Hepatitis, Cholestasis, Jaundice, Liver function test abnormal

Immune System Disorders: Anaphylactic reaction, Hypersensitivity Investigations: Electrocardiogram QT prolonged, Weight decreased

Metabolic and Nutritional Disorders: Hypoglycemia

Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis

Nervous System Disorders: Convulsion, Headache, Opisthotonus, Tardive dystonia

Pregnancy, Puerperium and Perinatal Conditions: Drug withdrawal syndrome neonatal

Psychiatric Disorders: Agitation, Confusional state, Depression, Insomnia

Renal and Urinary Disorders: Urinary retention

Reproductive System and Breast Disorders: Priapism, Gynecomastia

Respiratory, Thoracic and Mediastinal Disorders: Laryngeal edema, Bronchospasm, Laryngospasm, Dyspnea

Skin and Subcutaneous Tissue Disorders: Angioedema, Dermatitis exfoliative, Hypersensitivity vasculitis, Photosensitivity reaction, Urticaria, Pruritus, Rash, Hyperhidrosis

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 reactions 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

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 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 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. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels.

Parenteral medication, administered intramuscularIy 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 to 24 hours following the last parenteral dose.

HOW SUPPLIED

Haloperidol Injection, USP, equivalent to 5 mg/mL haloperidol (as the lactate), is supplied as follows:

NDC 0143-9319-25 — 1 mL Single-dose vial in carton of 25.

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

Keep out of reach of children.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

PREMIER ProRx®

Manufactured by:

HIKMA FARMACÊUTICA (PORTUGAL), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL

Distributed by:

West-Ward Pharmaceuticals

Eatontown, NJ 07724 USA

PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Revised May 2019

PIN493-PRE/2

VIAL LABEL

Haloperidol Injection, USP 5 mg/mL vial label Premier ProRx

Haloperidol Injection, USP 5 mg/mL vial label Premier ProRx

NDC 0143-9319-01 Rx only

Haloperidol Injection, USP

(For Immediate Release)

5 mg/mL

FOR INTRAMUSCULAR

USE ONLY

CARTON LABEL

Haloperidol Injection, USP 5 mg/mL Premier Label Carton

Haloperidol Injection, USP 5 mg/mL Premier Label Carton

NDC 0143-9319-25 Rx only

Haloperidol Injection, USP

(For Immediate Release)

5 mg/mL

FOR INTRAMUSCULAR

USE ONLY

25 x 1 mL Single-dose Vials

SERIALIZATION IMAGE

Representative Carton Serialization Image

Representative Carton Serialization Image

HALOPERIDOL
haloperidol lactate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9319
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
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:0143-9319-25 25 VIAL in 1 BOX contains a VIAL
1 1 mL in 1 VIAL This package is contained within the BOX (0143-9319-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075858 09/14/2018
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)
Registrant — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 07/2019 Hikma Pharmaceuticals USA Inc.

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.