* Prolonged release suspension for intramuscular injection:
– Vial with risperidone, powder for suspension for injection.
– Pre-filled syringe containing 2mL of diluent for reconstitution.
– Needle-free vial access device for reconstitution.
– Safety needle for administration.
* Vial with risperidone, powder for suspension for injection: Formula: Risperidone 25 mg,
7525 DL JN1 [poly-(d, l-lactide-co-glycolide)] polymer.
* Pre-filled syringe containing 2ml of diluent for reconstitution: Formula: polysorbate 20, carmellose sodium 40 mPa.s,
sodium hydrogen phosphate dihydrate, citric acid anhydrous, sodium chloride, sodium hydroxide and water for injections.
* INDICATIONS AND USAGE: RISPERDAL® CONSTA® (risperidone) is indicated for the treatment of schizophrenia.
– RISPERDAL® CONSTA® should be administered every 2 weeks by deep intramuscular (IM) gluteal injection.
– Each injection should be administered by a health care professional using the enclosed safety needle.
– Injections should alternate between the two buttocks. Do not administer intravenously.
– The recommended dose is 25 mg IM every 2 weeks.
– The maximum dose should not exceed 50 mg RISPERDAL® CONSTA® every 2 weeks.
– A lower initial dose of 12.5 mg may be appropriate when clinical factors warrant dose adjustment, such as in patients
with hepatic or renal impairment, for certain drug interactions that increase risperidone plasma concentrations,
or in patients who have a history of poor tolerability to psychotropic medications.
– Oral RISPERDAL® (or another antipsychotic medication) should be given with the first injection of RISPERDAL® CONSTA®
and continued for 3 weeks (and then discontinued) to ensure that adequate therapeutic plasma concentrations
are maintained prior to the main release phase of risperidone from the injection site.
– RISPERDAL® CONSTA® has not been studied in children younger than 18 years old.
* For immediate intramuscular (IM) use after reconstitution with diluent.
* Store at 2 degrees – 8 degrees C. Keep container in the outer carton.


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