Fluphenazine Decanoate

• Patients requiring prolonged parenteral neuroleptic therapy (eg, chronic schizophrenics).¹³

Initiation Regimen Required for Schizophrenia

No¹³

Oral Supplementation Required During Initiation for Schizophrenia

No¹³

Initiation Regimen for Schizophrenia

12.5 mg (0.5 mL) to 25 mg (1 mL)

The onset of action generally appears between 24-72 hours after injection and the effects of the drug on psychotic symptoms becomes significant within 48-96 hours. Subsequent injections and the dosage interval are determined in accordance with the patient's response.¹³

Disease States

• Patients requiring prolonged parenteral neuroleptic therapy (eg, chronic schizophrenics).¹³

Reconstitution Required

No¹³

How Supplied

5-mL multiple-dose vials containing a clear, pale yellow solution of fluphenazine decanoate in a sesame oil vehicle with benzyl alcohol as a preservative.¹³

Preparation Instructions

A dry syringe and needle of at least 21 gauge should be used. Use of a wet needle or syringe may cause the solution to become cloudy.¹³

Requirements Once Prepared or Reconstituted

Retain vial in carton until ready for use.¹³ Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Number of Dosing Options Available

8¹³

Preparation Kits Available

• 5-mL multiple-dose vials¹³

Dose Strengths

After the initial dose of 12.5 mg to 25 mg (0.5 mL to 1 mL), the optimal amount of drug and frequency of administration must be determined for each patient. Dosage should not exceed 100 mg. If doses greater than 50 mg are deemed necessary, the next dose and succeeding doses should be increased cautiously in increments of 12.5 mg.

• 12.5 mg (0.5 mL)
• 25 mg (1 mL)
• 37.5 mg (1.5 mL)
• 50 mg (2.0 mL)
• 62.5 mg (2.5 mL)
• 75 mg (3.0 mL)
• 87.5 mg (3.5 mL)
• 100 mg (4.0 mL)¹³

Equivalencies

12.5 mg (0.5 mL) fluphenazine decanoate (Q3W) = 10 mg fluphenazine hydrochloride (PO, QD)

No precise formula can be given to convert from oral fluphenazine hydrochloride to fluphenazine decanoate injection. However, in a controlled, multicentered study, 20 mg fluphenazine hydrochloride administered orally once per day was equivalent to 25 mg (1 mL) fluphenazine decanoate injection administered once every 3 weeks. This represents an approximate conversion ratio of 12.5 mg (0.5 mL) of fluphenazine decanoate every three weeks for every 10 mg of fluphenazine hydrochloride daily.¹³

Maintenance Dose for Schizophrenia

The optimal amount of the drug and frequency of administration must be determined for each patient, since dosage requirements have been found to vary with clinical circumstances as well as with individual responses to the drug.

Dosage should not exceed 100 mg. If doses greater than 50 mg are deemed necessary, the next dose and succeeding doses should be increased cautiously in increments of 12.5 mg.

When administered as maintenance therapy, a single injection may be effective in controlling schizophrenic symptoms up to 4 weeks or longer. The response to a single dose has been found to last as long as 6 weeks in a few patients on maintenance therapy.¹³

Q1M¹³

When administered as maintenance therapy, a single injection may be effective in controlling schizophrenic symptoms up to 4 weeks or longer. The response to a single dose has been found to last as long as 6 weeks in a few patients on maintenance therapy.

0.5 mL - 4 mL:¹³

• 0.5 mL (12.5 mg dose)
• 1 mL (25 mg dose)
• 1.5 mL (37.5 mg dose)
• 2.0 mL (50 mg dose)
• 2.5 mL (62.5 mg dose)
• 3.0 mL (75 mg dose)
• 3.5 mL (87.5 mg dose)
• 4.0 mL (100 mg dose)¹³

Needle Lengths

Not stated in the PI

Needle Gauges

A dry syringe and needle of at least 21 gauge should be used¹³

Injection Site(s)

IM or SC¹³

Deltoid Administration (Needle Gauge & Length)

A dry syringe and needle of at least 21 gauge should be used¹³

Gluteal Administration (Needle Gauge & Length)

A dry syringe and needle of at least 21 gauge should be used¹³

Subcutaneous Administration (Needle Gauge & Length)

A dry syringe and needle of at least 21 gauge should be used¹³

How Supplied

5-mL multiple-dose vials containing a clear, pale yellow solution of fluphenazine decanoate in a sesame oil vehicle with benzyl alcohol as a preservative.¹³

Preparation Kits Available

5-mL multiple-dose vials¹³

Kit Contents

5-mL multiple-dose vial containing fluphenazine decanoate in a concentration of 25 mg/mL¹³

Kit Storage (Refrigeration Required)

No¹³

Kit Storage (Specific Temperature Requirements)

Store at 20° to 25°C (68° to 77°F)¹³

Kit Storage (Excursions Permitted)

n/a

Kit Storage (Protect from Light)

Yes¹³

Kit Storage (Other Requirements)

Retain vial in carton until ready for use.¹³ Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Temperature Requirements for Drug Preparation

Not stated in PI

Preparation Instructions

A dry syringe and needle of at least 21 gauge should be used. Use of a wet needle or syringe may cause the solution to become cloudy.¹³

Requirements Once Prepared or Reconstituted

Retain vial in carton until ready for use.¹³ Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.