Risperidone tablet is indicated for the treatment of:

• Acute and chronic psychoses
• Mania
• Schizophrenia

Risperidone is a selective monoaminergic antagonist with high affinity for serotonin (5-HT2) and dopamine (D2) receptors. It also binds to alpha-adrenergic receptors and, with lower affinity, to histamine (H1) and other alpha-adrenergic receptors. It has no significant affinity for cholinergic receptors. As a potent D2 receptor antagonist, risperidone improves the positive symptoms of schizophrenia while causing less suppression of motor activity. The balanced central antagonism of serotonin and dopamine may reduce the risk of extrapyramidal side effects and may also improve negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1–2 divided doses on day 1 then 4 mg in 1–2 divided doses on day 2 (slower titration appropriate in some patients);
• Usual dose range 4–6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (maximum 16 mg daily).
• Elderly (or in hepatic or renal impairment): initially 1 mg daily in two divided doses, increased in steps of 1–2 mg twice daily.
• Child under 15 years: not recommended.

Mania:

• Initially, 2 mg once daily, increased if necessary in steps of 1 mg daily; usual dose range 1–6 mg daily.
• Elderly (or in hepatic or renal impairment): initially 1 mg daily in two divided doses, increased in steps of 1–2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg twice daily initially, with increases in increments of 1 mg twice daily on the second and third day, as tolerated, to a target dose of 3 mg twice daily by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1–2 mg are recommended.

Risperidone may reduce the effects of levodopa and dopamine agonists. Long-term use with carbamazepine may decrease the plasma concentration of risperidone by increasing its clearance. Chronic co-administration with clozapine may also reduce risperidone clearance. Risperidone may enhance the hypotensive effects of certain antihypertensive drugs.

Risperidone is contraindicated in patients with known hypersensitivity to risperidone or any of its components.

Reported side effects include insomnia, agitation, anxiety, headache, and less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea, vomiting, dyspepsia, abdominal pain, hyperprolactinemia, urinary incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neutropenia, and thrombocytopenia.

Animal studies did not show direct reproductive toxicity, although some indirect prolactin and CNS-mediated effects were observed. No teratogenic effects have been reported. The safety of risperidone in human pregnancy has not been established. Risperidone and its active metabolite (9-hydroxyrisperidone) are excreted in animal milk as well as human breast milk. Therefore, breastfeeding is not recommended during treatment with risperidone.

Use with caution in patients with cardiovascular disease. Discontinue if signs of tardive dyskinesia appear. Caution is required in renal or hepatic impairment, elderly patients, epilepsy, Parkinson’s disease, and during pregnancy.

Atypical antipsychotic (neuroleptic) drugs

Do not store above 30°C. Protect from light. Keep out of reach of children.