risperidone (Rx) - Risperdal, Risperdal Consta, more..Risperdal M-Tab

Dosing Forms & Strengths

Schizophrenia

2 mg/day PO intially; may increase at q24hr interval by 1-2 mg/d

Recommended target dose: 4-8 mg/day PO qDay or divided BID

Efficacy follows bell-shaped curve, 4-8 mg/day more effective than 12-16 mg/day

Bipolar Mania

2-3 mg PO qDay initially, may increase to 6 mg PO qDay

Delusional Parasitosis (Off-label)

1-2 mg PO qDay initially

Riperdal Consta

12.5-50 mg IM in deltoid/gluteal muscle q2week

Recommended to establish tolerability with oral risperidone prior to initiating treatment with risperidone injection

Use only supplied diluent for resuspension

Administer within 2 min of resuspension, if not, shake vigorously to resuspend

Geriatric Dosing

Not approved for dementia-related psychosis because of increased risk of cardiovascular or infectious related deaths (see Black Box Warnings)

Risk of orthostatic hypotension higher in elderly

Renal/Hepatic Impairment, Hypotensive

PO: initiate with 0.5 mg PO BID, consider longer titration intervals

IM: may start with 12.5 mg

Other Information

Efficacy follows bell-shaped curve, 4-8 mg/d more effective than 12-16 mg/d

Other Indications & Uses

Schizophrenia, bipolar mania, autism-associated irritability

Off-label: delusional parasitosis, stuttering, dementia-related psychotic symptoms

Dosing Forms & Strengths

Schizophrenia (13-17 Years Old)

Initiate: 0.5 mg PO qDay in the morning or evening

May increase by 0.5-1 mg/d at intervals not less than 24 hr to recommended dose of 3 mg/d

Dosage range: 1-6 mg/day

Persistent somnolence: may divide daily dose BID

Bipolar Mania (10-17 Years Old)

Initiate: 0.5 mg PO qDay in the morning or evening

May increase by 0.5-1 mg/d at intervals not less than 24 hr to recommended dose of 2.5 mg/d

Dosage range: 0.5-6 mg/day

Persistent somnolence: may divide daily dose BID

Autism

Indicated for treatment of irritability associated with autistic disorder in children aged 5-16 years

<5 years: Safety and efficacy not established

5-16 years (<20 kg): start 0.25 mg/d PO, may increase after at least 4 days to 0.5 mg/d (recommended dose)

5-16 years (20 kg or more): start 0.5 mg/d PO, may increase after at least 4 days to 1 mg/d (recommended dose)

>10%

Somnolence (40-45%)

Insomnia (26-30%)

Agitation (20-25%)

Anxiety (10-15%)

Headache (10-15%)

Rhinitis (10-15%)

Hyperprolactinemia in peds

1-10%

Constipation (5-10%)

Dyspepsia (5-10%)

Nausea (5-10%)

Vomiting (5-10%)

Abdominal pain (1-5%)

Aggressive reaction (1-5%)

Dizziness (1-5%)

Extrapyramidal symptoms (1-5%)

Gynecomastia in peds (1-5%)

Rash (1-5%)

Tachycardia (1-5%)

<1%

Nausea

Orthostatic hypotension

Seizures

Frequency Not Defined

Hyperthermia

Hypothermia

Myelosuppression

Neuroleptic malignant syndrome

Priapism

Prolonged QT interval

Tardive dyskinesia

TTP

Sleep apnea syndrome

Urinary retention

Diabetes mellitus

Hypoglycemia

Black Box Warnings

Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials. The deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.

This drug is not approved for the treatment of patients with dementia-related psychosis.

Contraindications

Documented hypersensitivity

Cautions

Cardiovascular disease, cerebrovascular disease, dehydration, hypovolemia, history of seizures, Parkinson's, Lewy body dementia, current/history of leukopenia/neutropenia (monitor CBC of such patients during initial period of treatment)

Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia (if history of clinically significant low WBC or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of a clinically significant decline <1000/mm3 in WBC in absence of other causative factors and continue monitoring WBC until recovery)

Children <15 kg

Risk of orthostatic hypotension

Not approved for use in patients with dementia-related psychosis

FDA Warning regarding off-label use for dementia in elderly

Mechanism of Action

Binds to dopamine D2-receptor with 20 times lower affinity than for 5-HT2-receptor affinity. Improves negative symptoms of psychoses and reduces incidence of extrapyramidal side effects.