Haloperidol Decanoate

• Patients with schizophrenia who require prolonged parenteral antipsychotic therapy¹²

Initiation Regimen Required for Schizophrenia

No¹²

Oral Supplementation Required During Initiation for Schizophrenia

No¹²

Initiation Regimen for Schizophrenia

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.¹²

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, ie, a maximum of 100 mg initially followed by the balance in 3 to 7 days.

Disease States

• Patients with schizophrenia who require prolonged parenteral antipsychotic therapy¹²

Reconstitution Required

No¹²

How Supplied

1-mL ampules containing a solution of haloperidol decanoate in a sesame oil vehicle.¹²

Preparation Instructions

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.

Hold the ampule between thumb and index finger with the colored point facing you.

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).

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.¹²

Requirements Once Prepared or Reconstituted

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.¹²

Number of Dosing Options Available

Dosing will vary depending on patient's age, clinical history, physical condition, and response to previous antipsychotic therapy

Preparation Kits Available

• 3 x 1-mL ampules (each containing 50 mg haloperidol)
• 5 x 1-mL ampules (each containing 100 mg haloperidol)¹²

Dose Strengths

• 50 mg haloperidol (present as 70.52 mg haloperidol decanoate in 1 mL solution)
• 100 mg haloperidol (present as 141.04 mg haloperidol decanoate in 1 mL solution)¹²

Equivalencies

• "Haloperidol Decanoate 50" ampules: 70.52 mg haloperidol decanoate / 1 mL = 50 mg haloperidol
• "Haloperidol Decanoate 100" ampules: 141.04 mg haloperidol decanoate / 1 mL = 100 mg haloperidol¹²

Maintenance Dose for Schizophrenia

Usual maintenance range is 10-15 times the previous daily dose in oral haloperidol equivalents dependent on the clinical response of the patient.¹²

Q1M or Q4W¹²

Volume will vary depending on patient's dosage¹²

Needle Lengths

Not stated in the PI

Needle Gauges

A 21 gauge needle is recommended¹²

Injection Site(s)

Deep IM¹²

Needle Gauges Available (gauge)

A 21 gauge needle is recommended¹²

Needle Lengths Available (inches)

Not stated in the PI

Deltoid Administration (Needle Gauge & Length)

A 21 gauge needle is recommended¹²

Gluteal Administration (Needle Gauge & Length)

A 21 gauge needle is recommended¹²

Subcutaneous Administration (Needle Gauge & Length)

n/a

How Supplied

1-mL ampules containing a solution of haloperidol decanoate in a sesame oil vehicle.¹²

Preparation Kits Available

• 3 x 1-mL ampules (each containing 50 mg haloperidol)
• 5 x 1-mL ampules (each containing 100 mg haloperidol)¹²

Kit Contents

• 3 x 1-mL ampules (each containing 50 mg haloperidol)
• 5 x 1-mL ampules (each containing 100 mg haloperidol)¹²

Kit Storage (Refrigeration Required)

No¹²

Kit Storage (Specific Temperature Requirements)

Store at controlled room temperature (15°-30° C, 59°-86° F).¹² Do not refrigerate or freeze.

Kit Storage (Excursions Permitted)

Not stated in PI

Kit Storage (Protect from Light)

Yes¹²

Kit Storage (Other Requirements)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.¹²

Temperature Requirements for Drug Preparation

Not stated in PI

Preparation Instructions

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.

Hold the ampule between thumb and index finger with the colored point facing you.

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).

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.¹²

Requirements Once Prepared or Reconstituted

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.¹²