Risperdal/Risperdal Consta

Risperidone

Risperdal Schizophrenia in adults & adolescents 13-17 yr. Monotherapy for acute manic or mixed episodes associated w/ bipolar I disorder in adults & childn/adolescents 10-17 yr. Adjunctive therapy w/ lithium or valproate for acute manic or mixed episodes associated w/ bipolar I disorder in adults. Irritability associated w/ autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, & quickly changing moods in childn/adolescents 5-17 yr. Risperdal Consta Schizophrenia. Monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.

Risperdal Schizophrenia Adult Initially 2 mg daily, may increase to recommended dose of 4-8 mg daily at ≥24-hr intervals in increments of 1-2 mg daily. Adolescent Initially 0.5 mg once daily as a single daily dose in the morning or evening, may be adjusted to recommended dose of 3 mg daily at ≥24-hr intervals in increments of 0.5-1 mg daily. Bipolar mania Adult Initially 2-3 mg daily, may be adjusted at ≥24-hr intervals in increments of 1 mg daily. Adolescent & childn Initially 0.5 mg once daily as a single daily dose in the morning or evening, may be adjusted to recommended dose of 1-2.5 mg daily at ≥24-hr intervals in increments of 0.5-1 mg daily. Irritability associated w/ autistic disorder Adolescent & childn Individualized dosage according to patient's response & tolerability. Weighing ≥20 kg Initially 0.5 mg daily, may be increased to recommended dose of 1 mg daily after min of 4 days. Maintain dose for min of 14 days. If not achieving sufficient clinical response, increase dose at ≥2-wk intervals in increments of 0.5 mg daily, <20 kg Initially 0.25 mg daily, may be increased to recommended dose of 0.5 mg daily after min of 4 days. Maintain dose for min of 14 days. If not achieving sufficient clinical response, increase dose at ≥2-wk intervals in increments of 0.25 mg daily. Risperdal Consta Adult Oral Risperdal (or another antipsychotic medication) should be given w/ the 1st inj & continued for 3 wk (then discontinued). Schizophrenia 25 mg IM every 2 wk. Max: 50 mg every 2 wk. Bipolar disorder 25 mg IM every 2 wk. Risperdal Patient w/ severe renal (CrCl <30 mL/min) or hepatic (Child-Pugh score 10-15) impairment Initially 0.5 mg bd, may be increased in increments of ≤0.5 mg bd. For doses >1.5 mg bd, increase in ≥1-wk intervals. Risperdal Consta Elderly 25 mg IM every 2 wk. Oral Risperdal (or another antipsychotic medication) should be given w/ the 1st inj & continued for 3 wk. Patient w/ renal or hepatic impairment 0.5 mg bd oral Risperdal during the 1st wk, can be increased to 1 mg bd or 2 mg once daily during the 2nd wk. If a total daily dose of at least 2 mg oral Risperdal is well tolerated, administer 25 mg inj every 2 wk. Oral supplementation should be continued for 3 wk after the 1st inj.

May be taken with or without food.

Hypersensitivity to risperidone or paliperidone.

Establish tolerability w/ oral Risperdal prior to initiating treatment w/ Risperdal Consta. Cerebrovascular adverse reactions (including stroke) & increased mortality in elderly patients w/ dementia-related psychosis. Not approved for the treatment of patients w/ dementia-related psychosis. Discontinue treatment if neuroleptic malignant syndrome &/or tardive dyskinesia occurs. Associated w/ metabolic changes eg, hyperglycemia & DM, dyslipidemia, body wt gain. Elevation of prolactin levels which persists during chronic administration. May induce orthostatic hypotension associated w/ dizziness, tachycardia, & in some patients, syncope, especially during the initial dose-titration period. Risk of somnolence, postural hypotension, motor & sensory instability. Use w/ caution in patients w/ a history of seizures; patients at risk for aspiration pneumonia. Reports of leukopenia, neutropenia & agranulocytosis; priapism; hyperthermia & hypothermia. Intraoperative floppy iris syndrome has been observed during cataract surgery in patients treated w/ medicines w/ α_1a-adrenergic antagonist effect. Increased sensitivity to antipsychotic medications in patients w/ Parkinson's disease or dementia w/ Lewy bodies. May impair ability to drive or operate machinery. Patients w/ renal &/or hepatic impairment. Pregnancy & lactation. Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal &/or w/drawal symptoms following delivery. Risperdal Consta Avoid inadvertent inj into a blood vessel. Possible antiemetic effect. Use w/ caution in patients w/ diseases or conditions that could affect metabolism or hemodynamic responses.

Risperdal Parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased wt, fatigue, rash, nasal congestion, upper resp tract infection, nasopharyngitis, & pharyngolaryngeal pain. Risperdal Consta Schizophrenia: Headache, parkinsonism, dizziness, akathisia, fatigue, constipation, dyspepsia, sedation, increased wt, pain in extremity, & dry mouth. Bipolar disorder: Increased wt (monotherapy); tremor & parkinsonism (adjunctive therapy).

Additive CNS effects w/ other centrally-acting drugs & alcohol. Enhanced hypotensive effects of other drugs w/ this potential. Antagonized effects of levodopa & dopamine agonists. Increased AUC of risperidone & 9‑hydroxyrisperidone w/ ranitidine. Decreased clearance w/ clozapine. Increased peak plasma conc of valproate. Increased plasma conc w/ CYP2D6 inhibitors eg, fluoxetine & paroxetine. Decreased steady-state plasma conc of risperidone & 9-hydroxyrisperidone w/ CYP3A4 inducers eg, carbamazepine, phenytoin, rifampin, & phenobarb.

Antipsychotics

N05AX08 - risperidone ; Belongs to the class of other antipsychotics.

P₁S₁S₃