Haloperidol Decanoate (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reactions, antiparkinson medication should be administered, and should be continued for several weeks, and then withdrawn gradually as extrapyramidal symptoms may emerge. 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

Haloperidol decanoate injection should be administered by deep intramuscular injection. A 21 gauge needle is recommended. The maximum volume per injection site should not exceed 3 mL. DO NOT ADMINISTER INTRAVENOUSLY.

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

Haloperidol decanoate injection is intended for use in schizophrenic patients who require prolonged parenteral antipsychotic therapy. These patients must be previously stabilized on antipsychotic medication before considering a conversion to haloperidol decanoate. Furthermore, it is recommended that patients being considered for haloperidol decanoate therapy have been treated with, and tolerate well, short-acting haloperidol in order to reduce the possibility of an unexpected adverse sensitivity to haloperidol. Close clinical supervision is required during the initial period of dose adjustment in order to minimize the risk of overdosage or reappearance of psychotic symptoms before the next injection. During dose adjustment or episodes of exacerbation of symptoms of schizophrenia, haloperidol decanoate therapy can be supplemented with short-acting forms of haloperidol.

The dose of haloperidol decanoate should be expressed in terms of its haloperidol content. The starting dose of haloperidol decanoate should be based on the patient’s age, clinical history, physical condition, and response to previous antipsychotic therapy. The preferred approach to determining the minimum effective dose is to begin with lower initial doses and to adjust the dose upward as needed. For patients previously maintained on low doses of antipsychotics (e.g. up to the equivalent of 10 mg/day oral haloperidol), it is recommended that the initial dose of haloperidol decanoate be 10-15 times the previous daily dose in oral haloperidol equivalents; limited clinical experience suggests that lower initial doses may be adequate.

Initial Therapy

Conversion from oral haloperidol to haloperidol decanoate can be achieved by using an initial dose of haloperidol decanoate that is 10 to 20 times the previous daily dose in oral haloperidol equivalents.

In patients who are elderly, debilitated, or stable on low doses of oral haloperidol (e.g. up to the equivalent of 10 mg/day oral haloperidol), a range of 10 to 15 times the previous daily dose in oral haloperidol equivalents is appropriate for initial conversion.

In patients previously maintained on higher doses of antipsychotics for whom a low dose approach risks recurrence of psychiatric decompensation and in patients whose long-term use of haloperidol has resulted in a tolerance to the drug, 20 times the previous daily dose in oral haloperidol equivalents should be considered for initial conversion, with downward titration on succeeding injections.

The initial dose of haloperidol decanoate should not exceed 100 mg regardless of previous antipsychotic dose requirements. If, therefore, conversion requires more than 100 mg of haloperidol decanoate as an initial dose, that dose should be administered in two injections, i.e. a maximum of 100 mg initially followed by the balance in 3 to 7 days.

Maintenance Therapy

The maintenance dosage of haloperidol decanoate must be individualized with titration upward or downward based on therapeutic response. The usual maintenance range is 10 to 15 times the previous daily dose in oral haloperidol equivalents dependent on the clinical response of the patient.

HALOPERIDOL DECANOATE DOSING RECOMMENDATIONS
Patients Monthly
1 st Month
Maintenance
Stabilized on low daily oral doses (up to 10 mg/day) 10-15 x Daily
Oral Dose
10-15 x Previous Daily
Oral Dose
Elderly or Debilitated
High dose 20 x Daily
Oral Dose
10-15 x Previous Daily
Oral Dose
Risk of relapse
Tolerant to oral haloperidol

Close clinical supervision is required during initiation and stabilization of haloperidol decanoate therapy. Haloperidol decanoate is usually administered monthly or every 4 weeks. However, variation in patient response may dictate a need for adjustment of the dosing interval as well as the dose (see CLINICAL PHARMACOLOGY).

Clinical experience with haloperidol decanoate at doses greater than 450 mg per month has been limited.

HOW SUPPLIED:

Haloperidol decanoate injection is supplied as:

*as haloperidol

Product Code Unit of Sale Strength
PRX437101 NDC 63323-471-41
One l mL fill in a
2 mL flip-top vial
100 mg* per mL

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

Protect from light.

Keep out of reach of children.

Keep in carton until empty.

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

Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047

www.fresenius-kabi.com/us

451603A

Revised: September 2021

PREMIER ProRx®

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

NDC 63323-471-41 PRX437101

Haloperidol
Decanoate
Injection

100 mg* per mL

Intramuscular Use Only

1 mL Rx only

vial
vial

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

NDC 63323-471-41 PRX437101

Haloperidol
Decanoate
Injection

100 mg* per mL

*as haloperidol

Intramuscular Use Only

1 mL

Rx only

Sterile

Keep in carton until empty.

pbox
(click image for full-size original)
HALOPERIDOL DECANOATE
haloperidol decanoate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-471
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HALOPERIDOL DECANOATE (HALOPERIDOL) HALOPERIDOL 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SESAME OIL
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-471-41 1 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (63323-471-41)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074893 07/12/2000
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 ANALYSIS (63323-471), MANUFACTURE (63323-471)

Revised: 11/2021 Fresenius Kabi USA, LLC

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