Risperidone LAI

RISPERDAL CONSTA

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What it isLong-acting injectable D2 and serotonin-receptor antagonist; maintenance treatment of schizophrenia and bipolar disorder.

Why this oneThe microspheres release almost nothing for the first three weeks, so it needs three weeks of oral risperidone overlap, unlike newer depots.

What limits itEvery-two-week injections require refrigeration; prolactin elevation, weight gain, and EPS persist.

FDA label

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BOXED WARNING Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death; not approved for dementia-related psychosis.

FDA dosing	Population	Start	Target	Max
Schizophrenia	Adult	25 mg IM every 2 weeks	25–50 mg IM every 2 weeks	50 mg every 2 weeks
Bipolar I disorder, maintenance (monotherapy or adjunct to lithium/valproate)	Adult	25 mg IM every 2 weeks	25–50 mg IM every 2 weeks	50 mg every 2 weeks

Titration Do not adjust dose upward more frequently than every 4 weeks

Renal Titrate carefully with oral risperidone before initiating; reduced elimination in renal impairment (a lower Consta starting dose of 12.5 mg may be appropriate)

Hepatic Titrate carefully with oral risperidone before initiating; a lower Consta starting dose of 12.5 mg may be appropriate

Administered every 2 weeks; upward dose adjustments no more often than every 4 weeks.

Instructions

Establish tolerability with oral risperidone before initiating
Deep IM deltoid (1-inch needle, alternate arms) or gluteal (2-inch needle, alternate buttocks) injection by a healthcare professional; do not give IV
Give oral risperidone (or another antipsychotic) with the first injection and continue for 3 weeks, then discontinue

Contraindications

Known hypersensitivity to risperidone or paliperidone, or to any excipients in the formulation (anaphylactic reactions and angioedema reported).

Cautions

Increased mortality in elderly patients with dementia-related psychosis (boxed; not approved for this use)
Cerebrovascular adverse events, including stroke, in elderly dementia patients
Neuroleptic malignant syndrome
Tardive dyskinesia
Metabolic changes (hyperglycemia/diabetes, dyslipidemia, weight gain)
Hyperprolactinemia
Orthostatic hypotension and syncope
Falls
Leukopenia/neutropenia; seizures; potential for cognitive/motor impairment; dysphagia; priapism; disruption of body temperature regulation

Adverse reactions

headache
parkinsonism
dizziness
akathisia
fatigue
constipation
dyspepsia
sedation
weight increased
pain in extremity
dry mouth

Pregnancy Neonates exposed to antipsychotics in the third trimester are at risk for extrapyramidal and/or withdrawal symptoms after delivery. Pregnancy registry available.

Lactation Risperidone and 9-hydroxyrisperidone present in human milk (relative infant dose 2.3–4.7% of maternal); reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms in breastfed infants.

⚠ BOXED WARNING