rment
In patients with hepatic impairment, carefully titrate with oral risperidone (up to at least 3 mg) before initiating treatment with PERSERIS at a dose of 90 mg [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].
PERSERIS was not studied in patients with hepatic impairment, however, such effect has been investigated with oral risperidone.
10 OVERDOSAGE
10.1 Human Experience
No cases of overdose were reported in premarketing studies with PERSERIS. Because PERSERIS is to be administered by healthcare professionals, the potential for overdosage by patients is low.
10.2 Management of Overdosage
In case of overdosage, consult a Poison Control Center at 1-800-222-1222.
In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of QT prolonging effects that might be additive to those of risperidone. Similarly, it is reasonable to expect that the alpha-blocking properties of bretylium might be additive to those of risperidone, resulting in problematic hypotension.
There is no specific antidote to risperidone. Appropriate supportive measures should be instituted. Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of risperidone-induced alpha blockade). In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision and monitoring should continue until the patient recovers.
Consider the long-acting nature of PERSERIS when assessing treatment needs and recovery.
11 DESCRIPTION
PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol.
The structural formula is:
Figure 14
Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl.
PERSERIS is available as a sterile two-syringe mixing system; a liquid syringe prefilled with the delivery system, a colorless to yellow solution. The delivery system provides the monthly extended-release delivery of risperidone in PERSERIS. It is comprised of poly (DL-lactide-co-glycolide) polymer and N-methyl-2-pyrrolidone. The powder syringe is prefilled with risperidone (white to yellow). Prior to use, the product is constituted by coupling the liquid and powder syringes and passing the contents back and forth between the syringes [see Dosage and Administration (2.4)]. On completion of the mixing cycles, the combined mixture resides in the liquid syringe. A sterile, safety needle is affixed to the liquid syringe and the expressible syringe contents are injected subcutaneously into the abdomen. The product should be prepared immediately prior to use for subcutaneous injection.
After mixing, PERSERIS is av
