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Risperidone ER

Subcutaneous
Intramuscular
Class
Antipsychotics
Subclass
Atypical antipsychotics
Generic name
risperiDONE ER
Brand names
Perseris®
Common formulations
Kit
See also
Risperidone (Risperdal®)
Indications for use
Labeled indications
Adults
•
Treatment of schizophrenia
Safety risks
Boxed warnings
Increased risk of mortality
Contraindications
Hypersensitivity to risperidone or paliperidone, or to any of the excipients in the formulation
Warnings and precautions
Aspiration pneumonia
•
Use extreme caution in patients with advanced Alzheimer's dementia or with dysphagia or who are at risk for aspiration.
Ataxia
•
Use caution in patients with Parkinson's disease or dementia with Lewy Bodies.
Cardiovascular risk
•
Use caution in patients with pre-existing conditions such as obesity, pre-diabetes, established diabetes mellitus, or hyperlipidemia.
Cognitive difficulties, motor impairment
•
Use extreme caution in patients performing activities requiring mental alertness, such as driving or operating machinery.
Fever, neuroleptic malignant syndrome, ALF
•
Maintain a high level of suspicion, as risperidone has been associated with an increased risk for these adverse events.
Hyperprolactinemia
•
Use caution in patients taking the drug for a prolonged period.
Increased blood eosinophil count, increased blood glucose, increased serum cholesterol
•
Maintain a high level of suspicion, as risperidone has been associated with an increased risk for these adverse events.
Orthostatic hypotension
•
Use caution in patients with known CVD (history of myocardial infarction or ischemia, HF, or conduction abnormalities), cerebrovascular disease, and conditions which would predispose patients to hypotension, e.g., dehydration and hypovolemia, and in the elderly and patients with renal or hepatic impairment.
Priapism
•
Use caution in all patients, especially those with a history of sexual complications.
Prolonged QT interval
•
Maintain a high level of suspicion as risperidone is associated with an increased risk of the adverse event.
Seizure
•
Use caution in patients with a history of seizures or with conditions that lower the seizure threshold.
Tardive dyskinesia, falls, stroke
•
Maintain a high level of suspicion, as risperidone has been associated with an increased risk for these adverse events.
Specific populations
Renal impairment
CrCl ≥ 60 mL/min
•
Use acceptable. No dose adjustment required.
CrCl 20-50 mL/min
•
Use with extreme caution. Do not exceed frequency of q1 month. Titrate slowly. Monitor for QT prolongation.
CrCl 10-20 mL/min
•
Use with extreme caution. Do not exceed frequency of q1 month. Titrate slowly. Monitor for QT prolongation.
CrCl < 10 mL/min
•
Use with extreme caution. Do not exceed frequency of q1 month. Titrate slowly. Monitor for QT prolongation.
Renal replacement therapy
Continuous renal replacement
•
Do not use.
Intermittent hemodialysis
•
Do not use.
Peritoneal dialysis
•
Do not use.
Hepatic impairment
Any severity
•
Use with caution. Long-acting injectable riridn has not been studied in patients with liver cirrhosis; use with caution as pharmacokinetics may be unpredictable, especially in patients with concurrent kidney insufficiency or at risk of decompensation.
Pregnancy and breastfeeding
Pregnancy
Third trimester • Australia Category: C
•
Use only if benefits outweigh potential risks. Monitor neonates for extrapyramidal and/or withdrawal symptoms.
Second trimester • Australia Category: C
•
Use only if benefits outweigh potential risks. When considering the use of risperidone during pregnancy, the possibility of risperidone-related adverse outcomes in the fetus or neonate should be weighed against the risks of an untreated maternal psychiatric condition, which may include hospitalization, relapse, suicide, and increased adverse perinatal outcomes (e.g., pre-term birth).
•
Drug-induced hyperprolactinemia may impair reproductive function in both male and female patients. Hyperprolactinemia causes a reduction in the pituitary secretion of gonadotropin which, in turn, impairs gonadal steroidogenesis.
First trimester • Australia Category: C
•
Use only if benefits outweigh potential risks. When considering the use of risperidone during pregnancy, the possibility of risperidone-related adverse outcomes in the fetus or neonate should be weighed against the risks of an untreated maternal psychiatric condition, which may include hospitalization, relapse, suicide, and increased adverse perinatal outcomes (e.g., pre-term birth).
•
Drug-induced hyperprolactinemia may impair reproductive function in both male and female patients. Hyperprolactinemia causes a reduction in the pituitary secretion of gonadotropin which, in turn, impairs gonadal steroidogenesis.
Breastfeeding
Consider alternative agents that may be safer.
Unknown amount excreted in breastmilk.
Very low levels in breastfed infants (< 5%).
May potentially cause adverse effects in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Very common > 10%
•
Bowel obstruction, ↑ blood glucose, nasopharyngitis, parkinsonism, akathisia, cough, dizziness, drooling, dry mouth, headache, ↑ appetite, injection site reactions, nasal congestion, weight gain, weight gain, sedation, tremor
Common 1-10%
•
Acne, agitation, anemia, ↓ serum HDL, dry skin patches, dyskinesia, dystonia, extrapyramidal signs, hypertension, ↑ serum CK, ↑ serum cholesterol, ↑ serum prolactin, ↑ serum triglycerides, lethargy, orthostatic hypotension, peripheral edema, pharyngitis, abdominal discomfort, abdominal pain, akathisia, amenorrhea, anejaculation, anxiety, anxiety, arthralgia, asthenia, back pain, back pain, blurred vision, constipation, constipation, dental pain, diarrhea, dry mouth, dyspnea, erectile dysfunction, fever, gait disturbance, hypersalivation, ↑ appetite, ↑ thirst, indigestion, insomnia, leg pain, loss of appetite, muscle spasms, musculoskeletal pain, nausea, nosebleed, otalgia, pain in extremity, palpitations, paresthesia, skin rash, syncope, throat pain, urinary incontinence, vomiting, weight loss, rhinitis, sedation, short attention span, sinusitis, tachycardia, tardive dyskinesia, urinary tract infections, upper respiratory tract infections
Uncommon < 1%
•
Blepharospasm, congenital neutropenia, vertigo, seizure
Unknown frequency
•
AF, acute pancreatitis, agranulocytosis, allergic reactions, alopecia, anaphylaxis, angioedema, bradycardia, cardiac arrest, catatonia, cerebrovascular accident, chorea, ↓ WBC count, ↓ blood glucose, ↓ blood neutrophil count, ↓ body temperature, ↓ bone mineral density, ↓ platelet count, delirium, diabetes mellitus, diabetic ketoacidosis, drug withdrawal syndrome, drug-induced liver injury, dystonia, EEG abnormalities, extrapyramidal symptoms, gestational diabetes mellitus, gynecomastia, hemorrhagic cystitis, hip fracture, ileus, ↑ LFTs, ↑ body temperature, ↑ serum gamma-glutamyltransferase, intraoperative floppy iris syndrome, jaundice, metabolic syndrome, neuroleptic malignant syndrome, obsessive-compulsive disorder, pulmonary embolism, pituitary tumor, pneumonia, precocious puberty, ↑QT interval, change in taste, ejaculation difficulties, falls, mania, priapism, sexual dysfunction, somnolence, stuttering, urinary retention, visual disturbances, vomiting, amenorrhea, anorgasmia, arthralgia, ↑ blood glucose, breast enlargement, trismus, tremor, tongue movements, tardive dyskinesia, dysarthria after long period of speaking, parkinsonism, rhabdomyolysis, sudden cardiac death, syndrome of inappropriate antidiuretic hormone secretion, skin discoloration, sleep apnea, sleep-related eating disorder, Stevens-Johnson syndrome, thrombotic thrombocytopenic purpura, toxic epidermal necrolysis, venous thromboembolism, water intoxication
Interactions
Drug(s)
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