Risperdal Consta®
(risperidone) long-acting injection
The information contained in this learning resource contains a portion of the product information. For full details see the product information by each product owner. A full list can be found in the References tab.
Disease States
- Schizophrenia in adults8
- Monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder8
Initiation Regimen
Initiation Regimen Required for Schizophrenia
Yes8
Oral Supplementation Required During Initiation for Schizophrenia
Yes8
Initiation Regimen for Schizophrenia
25 mg - 50 mg Q2WK8+
PO RISPERDAL x 3 weeks past 1st injection8
A lower initial dose of 12.5 mg may be appropriate in the presence of certain clinical factors (hepatic impairment, renal impairment, or for certain drug interactions that increase risperidone plasma concentrations). However, the efficacy of the 12.5 mg dose has not been evaluated in clinical trials.8
Disease States
- Schizophrenia in adults8
- Monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder8
Reconstitution
Reconstitution Required
Yes8
How Supplied
Powder for reconstitution (white to off-white, free-flowing powder; risperidone microspheres encapsulated in 7525 polyactide-co-glycolide [PLG] at a concentration of 381 mg risperidone per gram of microspheres)8+
Diluent (clear, colorless solution)8
Preparation Instructions
Attach vial adapter to vial containing the microsphere powder.8
Connect the prefilled syringe containing the diluent to vial adapter and transfer entire amount of diluent into the vial.8
Suspend the microspheres in the diluent by shaking the vial vigorously for at least 10 seconds. When properly mixed, the suspension appears uniform, thick, and milky.8
Once properly mixed, immediately transfer the entire contents of the vial back up into the syringe.8
Attach appropriate needle to syringe.8
Requirements Once Prepared or Reconstituted
Administer the dose as soon as possible after reconstitution to avoid settling of the suspension.8
Just before injection, shake the syringe vigorously again, as some settling will have occurred.8
Do not store suspension after reconstitution.8
Dosing Strengths
Number of Dosing Options Available
48
Preparation Kits Available
Single-dose pack
- 12.5 mg
- 25 mg
- 37.5 mg
- 50 mg8
Dose Strengths
- 12.5 mg
- 25 mg
- 37.5 mg
- 50 mg8
Equivalencies
RISPERDAL CONSTA is supplied as white to off-white powder of risperidone microspheres for reconstitution, which is equivalent to the following doses of risperidone:
- 41 mg risperidone microsphere powder = 12.5 mg risperidone
- 78 mg risperidone microsphere powder = 25 mg risperidone
- 116 mg risperidone microsphere powder = 37.5 mg risperidone
- 152 mg risperidone microsphere powder = 50 mg risperidone8
Maintenance Dose for Schizophrenia
25 mg - 50 mg Q2WK8
In patients with clinical factors such as hepatic impairment, renal impairment, or certain drug interactions that increase risperidone plasma concentrations, dose reduction as low as 12.5 mg may be appropriate. However, the efficacy of the 12.5 mg dose has not been investigated in clinical trials.8
Dosing Frequency
Q2WK8
Injection Volumes
- 2 mL8
Needle Size
Needle Lengths
1, 28
Needle Gauges
20, 218
Injection Route
Injection Site(s)
IM (deltoid or gluteal)8
Deltoid Administration (Needle Gauge & Length)
21 gauge, 1-inch needle8
Gluteal Administration (Needle Gauge & Length)
20 gauge, 2-inch needle8
Subcutaneous Administration (Needle Gauge & Length)
n/a
How Supplied
How Supplied
Powder for reconstitution (white to off-white, free-flowing powder; risperidone microspheres encapsulated in 7525 polyactide-co-glycolide [PLG] at a concentration of 381 mg risperidone per gram of microspheres)8+
Diluent (clear, colorless solution)8
Preparation Kits Available
Single-dose pack
- 12.5 mg
- 25 mg
- 37.5 mg
- 50 mg8
Kit Contents
1 vial of risperidone microsphere powder
+
1 prefilled syringe containing the diluent (2 mL)
+
2 ultra thin-walled safety needles to choose from for drug administration8
Storage
Kit Storage (Refrigeration Required)
Yes8
Kit Storage (Specific Temperature Requirements)
Store dose pack in the refrigerator (36°F-46°F; 2°C-8°C).8
Kit Storage (Excursions Permitted)
If refrigeration is unavailable, can be stored at temperatures not exceeding 77°F (25°C) for no more than 7 days prior to administration. Do not expose unrefrigerated product to temperatures above 77°C (25°C).8
Kit Storage (Protect from Light)
Yes8
Kit Storage (Other Requirements)
Not stated in PI
Temperature Requirements for Drug Preparation
Remove the dose pack from the refrigerator and allow to sit at room temperature for at least 30 minutes before reconstituting.8
Preparation Instructions
Attach vial adapter to vial containing the microsphere powder.8
Connect the prefilled syringe containing the diluent to vial adapter and transfer entire amount of diluent into the vial.8
Suspend the microspheres in the diluent by shaking the vial vigorously for at least 10 seconds. When properly mixed, the suspension appears uniform, thick, and milky.8
Once properly mixed, immediately transfer the entire contents of the vial back up into the syringe.8
Attach appropriate needle to syringe.8
Requirements Once Prepared or Reconstituted
Administer the dose as soon as possible after reconstitution to avoid settling of the suspension.8
Just before injection, shake the syringe vigorously again, as some settling will have occurred.8
Do not store suspension after reconstitution.8
tv46-US-NP-00158 November 2024
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