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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Risperdal M-tab
Generic Name
Risperidone
Active Ingredient
RisperidoneCategory
Atypical Antipsychotic [EPC]
Variants
5
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Risperdal M-tab, you must consult a qualified healthcare professional.
| 3 mg/1 | TABLET, ORALLY DISINTEGRATING | ORAL | 50458-335 |
| .5 mg/1 | TABLET, ORALLY DISINTEGRATING | ORAL | 50458-395 |
Detailed information about Risperdal M-tab
Risperidone is a second-generation (atypical) antipsychotic medication primarily used to treat schizophrenia, bipolar mania, and irritability associated with autism. It works by modulating dopamine and serotonin activity in the brain to help manage mood and behavior.
Dosage of Risperidone must be carefully individualized by a healthcare professional. For Schizophrenia, the typical starting dose for adults is 2 mg per day, administered in one or two doses. Your doctor may increase the dose in increments of 1 mg to 2 mg per day at intervals of at least 24 hours. Most patients find an optimal dose between 4 mg and 6 mg per day. Doses above 6 mg per day have not been shown to be more effective and are associated with a higher risk of side effects.
For Bipolar Mania, the recommended starting dose is 2 mg to 3 mg once daily. If adjustments are needed, they should occur at intervals of no less than 24 hours in increments of 1 mg per day. The typical effective range is 1 mg to 6 mg per day.
In Pediatric Schizophrenia (ages 13-17), the starting dose is usually 0.5 mg once daily in the morning or evening. Adjustments should happen in 0.5 mg to 1 mg increments. The target dose is typically 3 mg per day.
For Pediatric Bipolar Mania (ages 10-17), the starting dose is 0.5 mg once daily, with a target dose of 2.5 mg per day.
For Irritability in Autism (ages 5-16), dosing is often weight-based. For children weighing less than 20 kg, the starting dose is 0.25 mg per day. For those weighing 20 kg or more, the starting dose is 0.5 mg per day. Dose increases should occur no more frequently than every two weeks.
In patients with significant kidney disease, the clearance of the active therapeutic moiety is reduced by 60%. Healthcare providers typically recommend a starting dose of 0.5 mg twice daily, with very slow titration to the target dose.
While the pharmacokinetics in patients with liver disease are similar to healthy individuals, the free fraction of risperidone in the blood may increase. Therefore, a cautious starting dose of 0.5 mg twice daily is recommended for those with severe hepatic impairment.
Older adults often have reduced renal function and increased sensitivity to the sedative and orthostatic effects of Risperidone. A starting dose of 0.5 mg twice daily is standard, with increases occurring in 0.5 mg increments to minimize the risk of falls and cardiovascular events.
Risperidone can be taken with or without food. If you are using the Orally Disintegrating Tablet, do not open the blister pack until you are ready to take the dose. With dry hands, peel back the foil, place the tablet on your tongue, and allow it to dissolve. Do not chew or crush the tablet. For the Oral Solution, use the provided calibrated pipette to measure the exact dose. You may mix the solution with water, coffee, orange juice, or low-fat milk, but do NOT mix it with cola or tea, as the medication may precipitate (clump together).
Store all forms at room temperature, away from excess heat and moisture. Keep the medication in its original container to protect it from light.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular routine. Do not 'double up' or take two doses at once to make up for a missed one, as this increases the risk of serious side effects.
Signs of a Risperidone overdose may include severe drowsiness, rapid heart rate (tachycardia), low blood pressure (hypotension), and abnormal muscle movements (extrapyramidal symptoms). In some cases, seizures or heart rhythm abnormalities (QT prolongation) may occur. If an overdose is suspected, contact emergency medical services or a poison control center immediately. Emergency treatment often involves gastric lavage, administration of activated charcoal, and cardiovascular monitoring.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without direct medical guidance, as this can lead to a relapse of symptoms.
Many patients taking Risperidone experience mild to moderate side effects as their bodies adjust to the medication. The most frequently reported include:
Risperidone is a powerful psychiatric medication that requires careful medical supervision. It can significantly impair your physical and mental reactions, especially when you first start the medication or when the dose is increased. You must inform your doctor of your complete medical history, particularly any history of heart disease, seizures, diabetes, or kidney/liver impairment.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Risperidone is associated with an increased risk of death when used in elderly patients with dementia. Analyses of seventeen placebo-controlled trials in these patients revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Risperidone is not FDA-approved for this use, and healthcare providers must weigh the risks heavily if considering off-label use in this population.
While there are few absolute contraindications for combinations, Risperidone should never be used with other drugs that significantly prolong the QT interval in a way that creates an immediate life-threatening risk, such as certain anti-arrhythmics (e.g., Sparfloxacin). Additionally, using Risperidone with other potent Dopamine antagonists may lead to severe movement disorders and should be avoided unless specifically managed by a specialist.
Risperidone is strictly contraindicated in individuals with a known hypersensitivity to risperidone, paliperidone (its active metabolite), or any of the excipients (inactive ingredients) found in the various formulations. An allergic reaction may manifest as skin rash, pruritus (itching), angioedema (swelling under the skin), or anaphylaxis. Because paliperidone is the primary active metabolite of risperidone, a patient who has had a severe reaction to Invega (paliperidone) must not take Risperidone.
Relative contraindications require a careful risk-benefit analysis by a healthcare provider:
Risperidone is classified under the older FDA Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. However, neonates (newborns) exposed to antipsychotic drugs like Risperidone during the third trimester are at risk for Extrapyramidal Symptoms (EPS) and withdrawal symptoms after delivery. These symptoms can include agitation, hypertonia (increased muscle tone), hypotonia (decreased muscle tone), tremor, somnolence, and respiratory distress. Risperidone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women who become pregnant while on Risperidone are encouraged to enroll in the National Pregnancy Registry for Atypical Antipsychotics.
Risperidone and its active metabolite, 9-hydroxyrisperidone, are excreted in human breast milk. Studies have shown that the milk-to-plasma ratio is approximately 0.42. While the amount of drug the infant receives is relatively low, there are concerns regarding potential effects on the developing nervous system. A risk-benefit assessment is necessary; some providers may recommend monitoring the infant for excessive sedation, poor feeding, or developmental milestones, while others may suggest formula feeding.
Risperidone is a selective monoaminergic antagonist with a high affinity for the Serotonin Type 2 (5-HT2A) and Dopamine Type 2 (D2) receptors. Its efficacy in schizophrenia is mediated through a combination of D2 and 5-HT2A receptor antagonism. It also acts as an antagonist at Alpha-1 and Alpha-2 adrenergic receptors and H1 histamine receptors. Crucially, Risperidone has no affinity for cholinergic muscarinic receptors, which explains why it does not cause typical anticholinergic side effects like dry mouth or blurred vision as frequently as older drugs.
The 'atypical' nature of Risperidone comes from its higher affinity for 5-HT2A receptors than for D2 receptors. This ratio is thought to reduce the incidence of extrapyramidal symptoms (EPS) compared to typical antipsychotics. The onset of action for acute psychosis or mania is usually within 1 to 2 weeks, though the full therapeutic effect may take 4 to 6 weeks to manifest. Tolerance to the sedative and orthostatic effects often develops within the first few weeks of treatment.
Common questions about Risperdal M-tab
Risperidone is primarily used to treat several psychiatric conditions including schizophrenia, bipolar I disorder, and irritability associated with autism. In schizophrenia, it helps manage symptoms like hallucinations and social withdrawal in both adults and teenagers. For bipolar disorder, it is used to treat acute manic or mixed episodes, either alone or with other medications. In children with autism, it targets specific behaviors like aggression and self-injury. It is also occasionally used off-label for other conditions like Tourette syndrome, though this must be managed strictly by a doctor.
The most common side effects include drowsiness, increased appetite, weight gain, and feeling restless or dizzy. Many patients also report upper respiratory symptoms like a cough or sore throat. Because it affects dopamine, some people may experience tremors or muscle stiffness, known as parkinsonism. In children, sleepiness and fatigue are particularly common. Most of these effects are dose-dependent, meaning they may improve if your healthcare provider adjusts your dosage.
No, you should avoid drinking alcohol while taking Risperidone. Alcohol can significantly increase the sedative effects of the medication, leading to extreme drowsiness and impaired coordination. This combination increases the risk of accidents, falls, and respiratory issues. Furthermore, alcohol can worsen the symptoms of the underlying psychiatric condition being treated. Always consult your doctor before consuming any substance that affects the central nervous system.
Risperidone should only be used during pregnancy if the potential benefits outweigh the risks to the fetus. While there is no definitive evidence of birth defects, babies exposed to the drug in the third trimester may experience withdrawal symptoms or movement disorders after birth. These symptoms can include difficulty breathing, tremors, or feeding problems. If you are pregnant or planning to become pregnant, discuss your treatment options with your doctor immediately. You may also consider joining a pregnancy registry to help researchers monitor the drug's effects.
While some patients may notice a slight improvement in agitation or sleep within the first few days, the full antipsychotic effects usually take longer. It typically takes 1 to 2 weeks for symptoms like hallucinations or mania to begin fading significantly. The maximum therapeutic benefit for schizophrenia or bipolar disorder is often not reached until 4 to 6 weeks of consistent use. It is important to continue taking the medication exactly as prescribed, even if you do not feel better immediately. Do not stop the medication without consulting your doctor.
Stopping Risperidone suddenly is not recommended as it can lead to a rapid return of psychiatric symptoms or 'withdrawal psychosis.' You may also experience physical symptoms like nausea, sweating, or insomnia if the drug is stopped abruptly. If you and your doctor decide to discontinue the medication, they will provide a tapering schedule to slowly lower the dose over several weeks. This gradual reduction helps your brain chemistry adjust and minimizes the risk of a relapse. Always follow your provider's specific instructions for stopping any antipsychotic.
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed one and continue with your regular dosing schedule. Never take two doses at the same time to make up for a missed one, as this significantly increases the risk of side effects like extreme drowsiness or low blood pressure. If you find yourself frequently forgetting doses, consider using a pill organizer or setting a daily alarm. Consistent blood levels are key to the medication's effectiveness.
Yes, weight gain is a very common side effect of Risperidone and other atypical antipsychotics. The medication can increase appetite and cause metabolic changes that make it easier to gain weight and harder to lose it. Some patients may gain a significant amount of weight within the first few months of treatment. It is important to monitor your weight regularly and discuss a healthy diet and exercise plan with your healthcare provider. Your doctor will also likely monitor your blood sugar and cholesterol levels to watch for signs of metabolic syndrome.
Risperidone can interact with many other drugs, so it is vital to inform your doctor of everything you are taking. It can have serious interactions with certain antidepressants like fluoxetine or paroxetine, which can raise Risperidone levels in your blood. It may also interact with blood pressure medications, seizure drugs, and Parkinson's medications. Combining it with other sedatives or opioids can be dangerous. Your doctor will review your current medications to ensure there are no harmful interactions and may adjust your doses accordingly.
Yes, Risperidone is available as a generic medication in several forms, including oral tablets, orally disintegrating tablets, and oral solutions. Generic versions are typically much more affordable than the brand-name version, Risperdal, and are required by the FDA to have the same active ingredient, strength, and effectiveness. The long-acting injectable forms may also have generic or biosimilar versions depending on your region. Choosing the generic version is a common way to manage healthcare costs while receiving the same clinical benefits.
Other drugs with the same active ingredient (Risperidone)
> Warning: Stop taking Risperidone and call your doctor or emergency services immediately if you experience any of the following:
Prolonged use of Risperidone requires ongoing monitoring for metabolic syndrome. This includes the development of Type 2 diabetes, high cholesterol (dyslipidemia), and hypertension. Because Risperidone can cause long-term elevations in prolactin, there are concerns regarding bone mineral density loss (osteoporosis) over many years, although more research is needed in this area. Additionally, the risk of Tardive Dyskinesia increases with the total duration of exposure to antipsychotic drugs.
Elderly Patients with Dementia-Related Psychosis: The FDA has issued a Black Box Warning for Risperidone. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Most deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Risperidone is NOT approved for the treatment of patients with dementia-related psychosis.
Report any unusual symptoms or changes in your health to your healthcare provider immediately to ensure your treatment remains safe and effective.
Patients on Risperidone should undergo regular clinical monitoring, including:
Risperidone can cause significant somnolence (sleepiness) and blurred vision. Do not drive, operate heavy machinery, or engage in dangerous activities until you know how this medication affects you. The sedative effects are often potentiated by alcohol.
Alcohol should be avoided while taking Risperidone. Combining the two can lead to extreme drowsiness, respiratory depression, and an increased risk of accidental injury or falls.
Do not stop taking Risperidone abruptly. Sudden discontinuation can lead to 'withdrawal psychosis' or a rapid return of symptoms. If the medication needs to be stopped, your healthcare provider will provide a tapering schedule to gradually reduce the dose over several weeks.
> Important: Discuss all your medical conditions and concerns with your healthcare provider before starting Risperidone to ensure a safe treatment plan.
Risperidone is generally not affected by food. However, as mentioned previously, the Oral Solution should not be mixed with tea or cola, as the chemical components in these drinks can cause the medication to clump and not be absorbed properly. While grapefruit juice affects many drugs via CYP3A4, its effect on Risperidone is typically considered minimal, though patients should still exercise caution.
Risperidone does not typically interfere with standard laboratory tests. However, it can cause a false-positive result on some urine drug screens for amphetamines or LSD depending on the specific assay used. If you are undergoing a drug test, inform the laboratory that you are taking Risperidone.
For each major interaction, the mechanism usually involves either the competition for metabolic enzymes (CYP2D6/3A4) or additive pharmacodynamic effects (such as increased sedation or blood pressure drops). Management strategies typically involve frequent clinical monitoring and proactive dose adjustments.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter drugs.
There is a high degree of cross-sensitivity between Risperidone and Paliperidone. Patients who have experienced severe side effects or allergic reactions to one should generally avoid the other. There is no known cross-sensitivity between Risperidone and chemically unrelated antipsychotics like Clozapine or Olanzapine, though similar side-effect profiles (like metabolic syndrome) may occur.
> Important: Your healthcare provider will evaluate your complete medical history and current health status before determining if Risperidone is a safe option for you.
Risperidone is FDA-approved for specific uses in children: Schizophrenia (13-17 years), Bipolar Mania (10-17 years), and Autism-related irritability (5-16 years). Safety and efficacy have not been established for children under 5 for autism or under 10 for other indications. Long-term effects on growth and sexual maturation are a concern due to chronic hyperprolactinemia. Pediatric patients should have their height, weight, and pubertal development monitored regularly.
Clinical studies did not include enough subjects aged 65 and over to determine if they respond differently than younger subjects. However, geriatric patients are known to have slower renal clearance and a higher risk of orthostatic hypotension. The 'start low and go slow' approach is vital. Geriatric patients also have a significantly higher risk of Tardive Dyskinesia and are subject to the Black Box Warning regarding increased mortality in dementia-related psychosis.
In patients with moderate to severe renal disease (Creatinine Clearance < 30 mL/min), the clearance of the active moiety is reduced by approximately 60%. These patients must start at a lower dose (0.5 mg twice daily) and have their dose increased more slowly than patients with normal kidney function.
While the liver's ability to metabolize the drug remains relatively intact in mild to moderate hepatic impairment, the amount of 'free' (unbound) drug in the blood can increase because of lower protein levels (albumin). Patients with severe hepatic impairment should be monitored closely for increased side effects and should follow the same cautious dosing as renal patients.
> Important: Special populations require individualized medical assessment and frequent follow-up to ensure safety.
|---|---|
| Bioavailability | 70% (Oral Tablet) |
| Protein Binding | 90% (Risperidone), 77% (9-hydroxyrisperidone) |
| Half-life | 3 hours (Risperidone), 24 hours (Active Metabolite) |
| Tmax | 1 hour (Tablet), 3-17 hours (M-Tab) |
| Metabolism | Hepatic (Primary: CYP2D6; Secondary: CYP3A4) |
| Excretion | Renal 70%, Fecal 14% |
Risperidone has the molecular formula C23H27FN4O2 and a molecular weight of 410.48 g/mol. It is a benzisoxazole derivative. Structurally, it consists of a piperidine ring and a functionalized benzisoxazole moiety. It is practically insoluble in water but soluble in methylene chloride and methanol.
Risperidone is classified as an Atypical Antipsychotic (Second-Generation Antipsychotic). It belongs to the benzisoxazole class. Related medications include Paliperidone (the active metabolite), Ziprasidone, and Lurasidone. These drugs are distinguished from first-generation antipsychotics (like Haloperidol) by their lower risk of movement disorders at therapeutic doses.