Psychodal 1mg Drops

Risperidone 1mg

Black Box Warnings
Not approved for dementia-related psychosis; patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

Documented hypersensitivity

Increased incidence of cerebrovascular disease reported; may alter cardiac conduction; life threatening arrhythmias reported with therapeutic doses of antipsychotics
May cause anicholinergic effects including blurred vision, urinary retention, agitation, confusion, blurred vision, and xerostomia
Use with caution in patients with history of seizures, Parkinson disease, Lewy body dementia, cardiovascular disease, hypovolemia, dehydration
Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia
If patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recovery
May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy
Use caution in patients at risk of pneumonia; esophageal dysmotility and aspiration reported with antipsychotic use
May cause extrapyramidal symptoms including acute dystonic reactions, akathisia, pseudoparkinsonism, and tardive dyskinesia
Intraoperative floppy iris syndrome reported in patients receiving risperidone therapy
Monitor for fever, mental status changes, muscle regidity and or autonomic instability; neuroleptic malignant syndrome associated with resperidone use
Use with caution in children <15 kg
Cases of priapism reported with therapy
Prolactin elevations occur and persist during chronic administration
Use caution when operating heavy machinery
FDA warning regarding off-label use for dementia in elderly
Metabolic changes
  • Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular or cerebrovascular risk (eg, hyperglycemia, dyslipidemia, and body weight gain)
  • In some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Psychodal 1mg Drops only for the indication prescribed.