Risperstad 1

Rx

Indications:

• Treatment of schizophrenia and other psychoses.
• Short-term treatment of acute manic or mixed episodes associated with bipolar disorder.
• Treatment of irritability associated with autistic disorder in children.

Dosage:

Adults:

Schizophrenia: Initial dose is 2 mg daily; this may be increased to 4 mg daily on the second day, and subsequently adjusted as required in steps of 1 or 2 mg according to tolerance, at intervals of not less than 24 hours. The maximum dose is 16 mg daily.

Mania in bipolar disorder: Initial dose is 2 to 3 mg once daily. Dosage adjustments of 1 mg daily up to a total of 6 mg daily may be made at intervals of not less than 24 hours.

Children:

For schizophrenia in adolescents aged 13 to 17 years or acute manic or mixed episodes associated with bipolar disorder in children and adolescents aged 10 to 17 years: Initial dose of 0.5 mg once daily in the morning or in the evening. This may be increased in steps of 0.5 or 1 mg to a dose of 3 mg daily for schizophrenia or 2.5 mg daily for mania, at intervals of not less than 24 hours. The maximum dose is 6 mg daily.

For the treatment of irritability associated with autistic disorder in those aged 5 to 16 years:

• < 20 kg: The initial dose is 0.25 mg daily; increased to 0.5 mg daily after at least 4 days and subsequently adjusted as required in steps of 0.25 mg, at intervals of no less than 2 weeks. The maximum dose is 1 mg daily. Caution should be exercised with dosage for children < 15 kg.
• ≥ 20 kg: The initial dose is 0.5 mg daily; this may be increased to 1 mg daily after at least 4 days and subsequently adjusted as required in steps of 0.5 mg, at intervals of no less than 2 weeks. The maximum dose is 2.5 mg daily in those weighing over 20 kg and 3 mg daily in those > 45 kg.
• For those who experience persistent somnolence, the total daily dose may be given as a single dose at bedtime, or in 2 divided doses, or in a reduced dose.

Elderly or debilitated patients: An initial dose of 0.5 mg twice daily slowly increased in steps of 0.5 mg twice daily, to a dose of 1 to 2 mg twice daily. Above doses of 1.5 mg twice daily, increases should be made at intervals of at least 1 week.

Hepatic or renal impairment: The initial dose is 0.5 mg twice daily; slowly increased in steps of 0.5 mg twice daily, to a dose of 1 to 2 mg twice daily. Above doses of 1.5 mg twice daily, increases should be made at intervals of at least 1 week.

Usage:

Risperstad 1 is administered orally without regarding to meals; either in once-daily dose or in 2 equally divided doses daily.

Hypersensitivity to risperidone or any drug component.

Sedation or extrapyramidal effects, agitation; insomnia, anxiety, and headache.

Dyspepsia, nausea and vomiting, abdominal pain, constipation, blurred vision, sexual dysfunction including priapism, urinary incontinence, rash and other allergic reactions, drowsiness, concentration difficulties, dizziness, fatigue, and rhinitis. Orthostatic hypotension, hypertension.

Cerebrovascular accidents, tachycardia, weight gain, oedema, increased liver enzyme values, and decreases in neutrophil or thrombocyte counts. Hyperglycaemia. Dose-dependent increases in prolactin levels.

Caution should be observed when use Risperstad 1 in:

• Geriatric patients;
• Patient with known cardiovascular disease (e.g. history of myocardial infarction or ischemia, heart failure, conduction abnormalities), cerebrovascular disease, conditions that would predispose patients to hypotension (e.g. dehydration, hypovolemia), conditions associated with QT prolongation and patients receiving antihypertensive agents;
• Patients with parkinsonian syndrome, dementia with Lewy bodies; Patients with Parkinson’s disease or epilepsy;
• Patients with hepatic or renal impairment;
• Patients with preexisting diabetes mellitus (in whom therapy with atypical antipsychotic is initiated should be closely monitored for glucose control); those with risk factors for diabetes (e;g; obesity, family history of diabetes, should undergo fasting blood glucose testing upon therapy initiation and periodically throughout treatment)

Risperstad 1 is not approved for the treatment of dementia related psychosis.

Gradual withdrawal of Risperstad 1 is recommended because of the risk of withdrawal symptoms, including sweating, nausea and vomiting, and rebound psychosis, with abrupt cessation.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take Risperstad 1.

Risperstad 1 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Therefore, women receiving risperidone should not breast-feed.

Patients should be aware of how they react to drug before driving or operating machinery. Because Risperstad 1 has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about driving or operating hazardous machinery.