Risomax4 mg

Schizophrenia (Established)

Risomax is FDA-approved for the treatment of schizophrenia in adults and in adolescents aged 13 to 17 years.

Bipolar I Disorder – Acute Manic or Mixed Episodes (Established)

Risomax is approved as monotherapy for acute manic or mixed episodes of Bipolar I Disorder in adults and in children and adolescents aged 10 to 17 years. Risomax is also approved as adjunctive therapy with lithium or valproate for acute manic or mixed episodes of Bipolar I Disorder in adults (Adjunct use).

Irritability Associated with Autistic Disorder (Established)

Risomax is approved for the treatment of irritability associated with autistic disorder (including symptoms such as aggression, self-injury, and severe tantrums) in children and adolescents aged 5 to 16 years.

Other Psychotic and Behavioral Disorders (Off-label)

Risomax is sometimes used off-label, under specialist supervision, for other psychotic disorders and severe behavioral disturbances based on clinical judgement; such use of Risomax is not an FDA-approved indication.

Each tablet of Risperidone contains Risperidone INN 1 mg, 2 mg, 3 mg, or 4 mg. Risperidone is also available as an oral solution containing Risperidone 1 mg/mL.

Risomax is an atypical (second-generation) antipsychotic medicine used to help manage symptoms of certain mental health conditions. Risomax works by helping to rebalance certain chemical messengers in the brain, particularly dopamine and serotonin, which are thought to be involved in symptoms such as hallucinations, delusions, and severe mood disturbances. Risomax is prescribed for adults and, in specific approved age groups, for children and adolescents with schizophrenia, bipolar mania, or irritability associated with autistic disorder. Risomax should only be used under the guidance of a qualified healthcare professional, who will determine the right dose and monitor for effectiveness and side effects. Risomax is not a cure, but when taken as prescribed, Risomax can help reduce symptoms and improve day-to-day functioning.

Antipsychotic (Atypical/Second-Generation)

Risperidone acts as a potent antagonist at central dopamine D2 receptors and serotonin 5-HT2A receptors, a combined action thought to underlie the antipsychotic and mood-stabilizing effects of Risperidone with a comparatively lower risk of extrapyramidal symptoms than older antipsychotics at usual doses. Risperidone also has affinity for alpha1- and alpha2-adrenergic receptors and histamine H1 receptors, which contributes to effects such as orthostatic hypotension and sedation seen with Risperidone. Risperidone is extensively metabolized in the liver, primarily via the CYP2D6 enzyme pathway, to an active metabolite (9-hydroxyrisperidone/paliperidone) that contributes to the overall clinical effect of Risperidone; because of this pathway, drugs that inhibit or induce CYP2D6 can significantly change blood levels of Risperidone.

• Take Risomax exactly as prescribed by a healthcare professional; do not change the dose of Risomax or stop Risomax without medical advice.
• Risomax tablets can be taken with or without food, at approximately the same time each day.
• Risomax orally disintegrating tablets should be placed on the tongue immediately after opening the blister and allowed to dissolve; Risomax orally disintegrating tablets can be taken with or without water.
• Risomax oral solution can be taken directly or mixed with water, coffee, orange juice, or low-fat milk; do not mix Risomax oral solution with cola or tea.
• Use the calibrated dosing device supplied with Risomax oral solution for accurate measurement; do not use a household spoon to measure Risomax.
• If a dose of Risomax is missed, take the missed dose of Risomax as soon as remembered unless it is close to the time for the next scheduled dose; do not double the next dose of Risomax.
• Do not stop Risomax suddenly without consulting a healthcare professional, as abrupt discontinuation of Risomax may cause symptoms to return.

• CNS depressants (e.g., benzodiazepines, opioids, sedating antihistamines, alcohol): Combining these with Risomax can increase sedation and the risk of respiratory depression.
• Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): These drugs can raise blood levels of Risomax; the dose of Risomax may need to be reduced when used together.
• Enzyme inducers (e.g., carbamazepine, phenytoin, rifampin): These drugs can lower blood levels of Risomax; a higher dose of Risomax may be needed when co-administered.
• Antihypertensive medicines: Risomax can cause additive blood-pressure-lowering and orthostatic hypotension when combined with antihypertensive medicines, due to the alpha-adrenergic blocking activity of Risomax.
• Levodopa and dopamine agonists: Risomax may antagonize the effects of levodopa and other dopamine agonists because of the dopamine-receptor blocking action of Risomax.
• Other centrally-acting dopamine antagonists (e.g., other antipsychotics, metoclopramide): Combining these with Risomax may increase the risk of extrapyramidal symptoms.
• QT-prolonging medicines: Using QT-prolonging medicines together with Risomax may increase the risk of cardiac arrhythmia; caution and monitoring are advised.

Common Side Effects

• Somnolence/sedation with Risomax
• Dizziness
• Headache
• Akathisia (restlessness) and other extrapyramidal symptoms (tremor, stiffness)
• Increased appetite and weight gain
• Nausea, vomiting, constipation, or dry mouth
• Fatigue
• Anxiety or insomnia
• Nasal congestion or upper respiratory symptoms

Serious Side Effects – Seek Medical Attention

• Signs of Neuroleptic Malignant Syndrome (high fever, severe muscle stiffness, confusion, irregular heartbeat) associated with Risomax – see Precautions and Warnings.
• Uncontrollable, repetitive movements of the face, tongue, or body suggestive of tardive dyskinesia associated with Risomax – see Precautions and Warnings.
• Symptoms of high blood sugar (excessive thirst, frequent urination, unexplained fatigue) during Risomax treatment – see Precautions and Warnings.
• Fainting, severe dizziness, or a fast/irregular heartbeat.
• Signs of a severe allergic reaction to Risomax (rash, swelling of the face/throat, difficulty breathing).
• Seizures.
• Painful or prolonged erection (priapism).
• Difficulty swallowing.
• Unusual bruising, bleeding, or signs of infection.

Pregnancy

Risomax should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as data on Risomax in human pregnancy are limited. Neonates exposed to Risomax and other antipsychotic medicines during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms after delivery, which may include agitation, abnormal muscle tone, tremor, somnolence, respiratory distress, or feeding difficulty; these symptoms have varied in severity and duration, and some newborns exposed to Risomax have required extended hospital monitoring. Any decision to continue or stop Risomax during pregnancy should be made together with a healthcare professional.

Breastfeeding

Risomax passes into breast milk. Breastfeeding is generally not recommended during treatment with Risomax unless a healthcare professional determines the benefit outweighs the risk; if Risomax is used while breastfeeding, the infant should be monitored for excess sedation, feeding difficulty, and extrapyramidal symptoms.

• Increased mortality in elderly patients with dementia-related psychosis (Boxed Warning): Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including Risomax, are at an increased risk of death compared with placebo, largely from cardiovascular events (such as heart failure or sudden death) or infections (such as pneumonia). Risomax is not approved for the treatment of patients with dementia-related psychosis.
• Cerebrovascular adverse events in elderly patients with dementia-related psychosis: In placebo-controlled trials of elderly patients with dementia, Risomax was associated with a higher incidence of cerebrovascular adverse events, including stroke and transient ischemic attack, some of which were fatal.
• Neuroleptic Malignant Syndrome (NMS): Risomax, like other antipsychotics, can cause NMS, a rare but potentially fatal reaction marked by high fever, severe muscle rigidity, altered mental status, and autonomic instability (irregular pulse or blood pressure, tachycardia, sweating). If NMS is suspected, Risomax should be discontinued immediately and supportive medical care given.
• Tardive Dyskinesia: Risomax may cause tardive dyskinesia, a syndrome of potentially irreversible, involuntary, repetitive movements that can develop even after relatively brief treatment with Risomax; the risk increases with total cumulative dose and duration of treatment with Risomax. Discontinuation of Risomax should be considered if clinically appropriate should signs and symptoms appear.
• Metabolic changes – weight gain, hyperglycemia, and dyslipidemia: Risomax can cause weight gain, elevated blood glucose (including new-onset diabetes and, rarely, diabetic ketoacidosis), and unfavorable changes in cholesterol and triglycerides. Weight, blood glucose, and lipid profile should be monitored periodically during treatment with Risomax.
• Hyperprolactinemia: Risomax elevates prolactin levels, which may persist during long-term use of Risomax and can cause galactorrhea, gynecomastia, menstrual irregularities/amenorrhea, and sexual dysfunction; the long-term effects of Risomax on bone density and, in children, on growth and sexual maturation are not fully known.
• Orthostatic hypotension: Risomax can cause orthostatic hypotension, dizziness, and, rarely, syncope, particularly during initial dose titration of Risomax, related to its alpha-adrenergic blocking activity; caution is advised in patients with cardiovascular disease or dehydration.
• QT interval and cardiac conduction: Risomax should be used with caution in patients with known cardiovascular disease, a history of QT prolongation, electrolyte disturbances, or concomitant use of other QT-prolonging medicines.
• Blood cell changes: Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents, including Risomax; patients with a history of low white cell count should have blood counts monitored during treatment with Risomax.
• Seizures: Risomax should be used cautiously in patients with a history of seizures or conditions that lower the seizure threshold.
• Cognitive and motor impairment: Risomax may impair judgment, thinking, or motor skills; patients should avoid driving or operating hazardous machinery until they know how Risomax affects them.
• Body temperature regulation: Risomax may impair the body's ability to regulate core temperature; caution is advised with strenuous exercise, heat exposure, dehydration, or concomitant medicines with anticholinergic activity while taking Risomax.
• Priapism: Rarely, Risomax has been associated with priapism due to its alpha-adrenergic blocking effects; this requires urgent medical attention.
• Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic use, including Risomax, and should be considered particularly in elderly patients with dementia (see Boxed Warning above).

Likely effects of a Risomax overdose include drowsiness, sedation, tachycardia (fast heart rate), low blood pressure, and extrapyramidal symptoms (tremor, stiffness, abnormal movements). More severe overdose of Risomax may cause QT-interval prolongation, irregular heart rhythm, seizures, respiratory depression, and coma; the safety of doses of Risomax above 16 mg/day has not been evaluated in clinical trials. There is no specific antidote for Risomax overdose; management is supportive and symptomatic, with cardiac (ECG) monitoring, maintenance of the airway, oxygenation and ventilation as needed, and treatment of hypotension and other symptoms. Do not induce vomiting unless specifically directed to do so by a doctor or poison control center. If an overdose of Risomax is suspected, contact emergency medical services or a poison control center immediately.

Store Risomax according to the instructions on the product label/pack. Keep Risomax in its original container, protected from light and moisture, and out of the sight and reach of children. Do not use Risomax after the expiry date printed on the pack.

Children

Risomax is approved for use in children and adolescents only for specific indications and age ranges: schizophrenia (13-17 years), Bipolar I mania monotherapy (10-17 years), and irritability associated with autistic disorder (5-16 years). Safety and effectiveness of Risomax are not established in children outside these approved ages and indications.

Elderly

Elderly patients with dementia-related psychosis face an increased risk of death and cerebrovascular events when treated with antipsychotic drugs, including Risomax; Risomax is not approved for this population (see Precautions and Warnings – Boxed Warning). In elderly patients without dementia, Risomax is generally started at a lower dose (0.5 mg twice daily) with slower titration due to greater sensitivity to sedation and orthostatic hypotension.

Renal Impairment

Patients with renal impairment should be started on a lower dose of Risomax (0.5 mg twice daily) with slower, more gradual titration, as clearance of Risomax and its active metabolite is reduced.

Hepatic Impairment

Patients with hepatic impairment should be started on a lower dose of Risomax (0.5 mg twice daily) with slower, more gradual titration, as the free fraction of Risomax is increased in this population.

Other Populations

Risomax should be used with caution in patients with cardiovascular disease, a history of seizures, Parkinson's disease or Lewy body dementia (increased sensitivity to the effects of Risomax), and in patients at risk of aspiration.

Schizophrenia

Risomax is typically used as long-term maintenance therapy for schizophrenia; the need for continued treatment with Risomax should be periodically reassessed by a healthcare professional.

Bipolar I Mania

The efficacy of Risomax for acute mania has been established in short-term trials (approximately 3 weeks); a healthcare professional will decide whether continued treatment with Risomax is appropriate based on ongoing evaluation.

Irritability Associated with Autistic Disorder

The efficacy of Risomax for this indication has been demonstrated in short-term trials (up to 8 weeks); if Risomax is continued longer-term, a healthcare professional should periodically reassess the ongoing need for and benefit of Risomax.

Atypical (second-generation) antipsychotic; benzisoxazole derivative; serotonin-dopamine antagonist

Risperidone exerts its effects mainly through antagonism of central dopamine D2 receptors and serotonin 5-HT2A receptors. Risperidone also has antagonist activity at alpha1- and alpha2-adrenergic receptors and H1-histaminergic receptors, but Risperidone has no appreciable affinity for cholinergic muscarinic receptors.

Risomax has specific, age-defined pediatric approvals and is not approved for use in all children. The current approved pediatric uses of Risomax are: schizophrenia in adolescents aged 13 to 17 years; Bipolar I Disorder (acute manic or mixed episodes), as monotherapy, in children and adolescents aged 10 to 17 years; and irritability associated with autistic disorder in children and adolescents aged 5 to 16 years. Safety and effectiveness of Risomax have not been established for schizophrenia below 13 years of age, for bipolar mania below 10 years of age, or for autistic disorder-related irritability below 5 years of age. Use of Risomax in children requires careful age- and weight-based dosing and close monitoring for weight gain, metabolic changes, sedation, and elevated prolactin, which have been reported at higher rates in pediatric patients treated with Risomax.