Haldol (Page 5 of 5)

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.

INSTRUCTIONS FOR OPENING AMPULE

	Step 1
1. Medication often rests in the top part of the ampule. Before breaking the ampule, lightly tap the top of the ampule with your finger until all fluid moves to the bottom portion of the ampule. The ampule has a colored ring(s) and colored point which aids in the placement of fingers while breaking the ampule.
	Step 2
2. Hold the ampule between thumb and index finger with the colored point facing you.
	Step 3
3. Position the index finger of the other hand to support the neck of the ampule. Position the thumb so that it covers the colored point and is parallel to the colored ring(s).
	Step 4
4. Keeping the thumb on the colored point and with the index fingers close together, apply firm pressure on the colored point in the direction of the arrow to snap the ampule open.

HOW SUPPLIED

HALDOL brand of haloperidol Injection (For Immediate Release) 5 mg per mL (as the lactate) – NDC 50458-255-01, units of 10 × 1 mL ampules.

Store HALDOL (haloperidol) Injection at controlled room temperature (15°–30°C, 59°–86°F). Protect from light. Do not freeze.

Keep out of reach of children.

Product of Belgium

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560

Revised November 2020

© 2005 Janssen Pharmaceuticals Companies

PRINCIPAL DISPLAY PANEL- 5 mg ampule box

NSN 6505-00-268-8530
NDC 50458-255-01

Usual Dosage
For dosage and
other prescribing
information, see
accompanying
product literature.

Dispense in a light-
resistant container
as defined in the
official compendium.

Store at controlled
room temperature
(15°-30°C, 59°-86°F).
Protect from light.
Do not freeze.

Haldol^®
BRAND OF

HALOPERIDOL
INJECTION
For Itramuscular Use
For Immediate Release

5 mg per mL

10 x 1-mL
STERILE AMPULES

Rx only.

Each mL contains:
Haloperidol 5 mg
(as the lactate) and
lactic acid for pH
adjustment to 3.0-3.6

For Intramuscular Use

Product of Belgium
Mfg by: GlaxoSmithKline
Manufacturing S.p.A.
Parma, Italy

Mfg for: Janssen
Pharmaceuticals, Inc.Titusville, NJ 08560

62000000040377

© 2005 Janssen

Janssen

HALDOL haloperidol injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-255 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 LACTIC ACID, UNSPECIFIED FORM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50458-255-01 10 AMPULE in 1 BOX contains a AMPULE 1 1 mL in 1 AMPULE This package is contained within the BOX (50458-255-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA015923 05/18/1971 08/02/2050

Labeler — Janssen Pharmaceuticals, Inc. (063137772)

Establishment
Name	Address	ID/FEI	Operations
Janssen Pharmaceutica N.V.		400345889	API MANUFACTURE (50458-255)

Establishment
Name	Address	ID/FEI	Operations
GlaxoSmithKline		338471078	MANUFACTURE (50458-255), ANALYSIS (50458-255)

Revised: 08/2021 Janssen Pharmaceuticals, Inc.