GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Risperidone Tablets USP 0.25mg
B. Risperidone Tablets USP 0.5mg
C. Risperidone Tablets USP 1mg
D. Risperidone Tablets USP 2mg
E. Risperidone Tablets USP 3mg
F. Risperidone Tablets USP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Risperidone Tablets USP 0.25mg
Each film-coated Tablet Contains:
Risperidone USP…………….0.25mg
Excipients……………………q.s.
Colures: F&D Yellow 5

B. Risperidone Tablets USP 0.5mg
Each film-coated Tablet Contains:
Risperidone USP…………….0.5mg
Excipients……………………q.s.
Colures: Indigo Carmine

C. Risperidone Tablets USP 1mg
Each film-coated Tablet Contains:
Risperidone USP…………….1mg
Excipients……………………q.s.
Colures: Brilliant Blue

D. Risperidone Tablets USP 2mg
Each film-coated Tablet Contains:
Risperidone USP…………….2mg
Excipients……………………q.s.
Colures: Sunset Yellow

E. Risperidone Tablets USP 3mg
Each film-coated Tablet Contains:
Risperidone USP…………….3mg
Excipients……………………q.s.
Colures: Iron Oxide Yellow


F. Risperidone Tablets USP 4mg
Each film-coated Tablet Contains:
Risperidone USP………………4mg
Excipients……………………q.s.
Colures: Quinoline Yellow

THERAPEUTIC INDICATIONS:

It is indicated for the treatment of schizophrenia, moderate to severe manic episodes associated with bipolar disorders, and short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.

CAUTION & WARNING:

CAUTION: Read the enclosed leaflet before use.
Keep medicine out of reach of children.
Swallow whole does not chew or crush.
*Not suitable for children under 10 years.
*Treatment of moderate to severe manic episodes associated with bipolar disorders.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
If you are using risperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

STORAGE & DOSAGE:

Storage: Protect from moisture at a temperature not exceeding 30˚C. Do not freeze.
Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.
NOTE: Risperidone is an atypical antipsychotic agent indicated for: Treatment of schizophrenia in adults & adolescents aged 13-17 years.
Attach dispensing label as per end country.

Risperidone Tablets USP 3mg Technical Specification:

Product Name:
Risperidone Tablets USP 3mg
Brand Name:RESPERITAJ
Strength:0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antipsychotic, Central Nervous System
Indication: It is indicated for the treatment of schizophrenia, moderate to severe manic episodes associated with bipolar disorders, and short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.
Storage:Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Risperidone Tablets USP 0.25mg
  • Risperidone Tablets USP 0.5mg
  • Risperidone Tablets USP 1mg
  • Risperidone Tablets USP 2mg
  • Risperidone Tablets USP 3mg
  • Risperidone Tablets USP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Risperidone Tablets USP 0.25mg
    Each film-coated Tablet Contains
    Risperidone…………….0.25mg
    Excipients……………………q.s.
    Colures: F&D Yellow 5
  • Risperidone Tablets USP 0.5mg
    Each film-coated Tablet Contains:
    Risperidone…………….0.5mg
    Excipients……………………q.s.
    Colures: Indigo Carmine
  • Risperidone Tablets USP 1mg
    Each film-coated Tablet Contains:
    Risperidone…………….1mg
    Excipients……………………q.s.
    Colures: Brilliant Blue
  • Risperidone Tablets USP 2mg
    Each film-coated Tablet Contains:
    Risperidone…………….2mg
    Excipients……………………q.s.
    Colures: Sunset Yellow
  • Risperidone Tablets USP 3mg
    Each film-coated Tablet Contains:
    Risperidone…………….3mg
    Excipients……………………q.s.
    Colures: Iron Oxide Yellow
  • Risperidone Tablets USP 4mg
    Each film-coated Tablet Contains:
    Risperidone………………4mg
    Excipients……………………q.s.
    Colures: Quinoline Yellow

THERAPEUTIC INDICATIONS:

It is indicated for the treatment of schizophrenia, moderate to severe manic episodes associated with bipolar disorders, and short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.

CAUTION & WARNING:

CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Swallow whole does not chew or crush.
*Not suitable for children under 10 years.
*Treatment of moderate to severe manic episodes associated with bipolar disorders. <br>
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only. <br>
If you are using risperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

STORAGE & DOSAGE:

Storage: Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture.
Dosage:  As directed by the Physician.
NOTE: Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults & adolescents aged 13-17 years.
Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

When considering a pharmaceutical company for Risperidone Tablets, it’s essential to assess various critical factors to ensure the safe and effective management of conditions like schizophrenia and bipolar disorder. Taj Pharmaceuticals, a pharmaceutical company based in India, is one option to consider, but the choice should be made based on a thorough evaluation of several key considerations. First and foremost, the quality and regulatory compliance of the pharmaceutical company must be of the highest standard. The quality and safety of the medication are paramount, and it’s crucial to confirm that Taj Pharmaceuticals maintains rigorous manufacturing standards and adheres to regulatory guidelines. Risperidone is a medication primarily prescribed for the treatment of serious mental health conditions, such as schizophrenia and bipolar disorder. Therefore, the choice of manufacturer should align with the recommendations and prescription of your healthcare provider, who plays a pivotal role in determining the most suitable brand or manufacturer for your mental health management. Affordability and accessibility are also important considerations. Medication costs can vary, and evaluating your budget and insurance coverage can help you make an informed decision regarding Risperidone Tablets.

Consistency in medication supply is vital for individuals managing mental health conditions. It’s important to ensure that the chosen pharmaceutical company, such as Taj Pharmaceuticals, has a reliable supply chain, providing ongoing access to Risperidone Tablets when needed. Patient reviews and feedback can offer valuable insights into the experiences of individuals who have used a specific brand of Risperidone Tablets. These insights can provide information about what you can expect from Taj Pharmaceuticals’ products. Ultimately, the decision regarding which pharmaceutical company to choose for Risperidone Tablets should be made in consultation with your healthcare provider. They can take into account your unique medical history, the specific mental health condition you are managing, and your response to the medication when recommending a particular brand or manufacturer. In conclusion, when selecting a pharmaceutical company for Risperidone Tablets, it’s essential to consider factors such as quality, prescription guidance, cost, availability, patient feedback, and consultation with healthcare providers. This comprehensive approach ensures that you receive the most appropriate and effective treatment for your mental health condition.

What is Risperidone Tablets and its uses:

Risperidone Tablets are a medication used to treat various mental health conditions, primarily those characterized by disturbances in thought, mood, and behavior. Here’s an overview of Risperidone Tablets and their uses:

Risperidone Tablets: Risperidone is the active ingredient in Risperidone Tablets. It belongs to a class of drugs known as atypical antipsychotics.

Uses of Risperidone Tablets:

  • Schizophrenia: Risperidone is commonly prescribed for the treatment of schizophrenia, a severe mental disorder characterized by distorted thinking, hallucinations, delusions, and impaired social functioning. It helps alleviate symptoms and improve cognitive and emotional well-being.
  • Bipolar Disorder: Risperidone is used in the management of bipolar disorder, particularly in the treatment of manic episodes. It helps stabilize mood, reduce irritability, and prevent the recurrence of manic episodes.
  • Irritability Associated with Autism: Risperidone may be prescribed for children and adolescents with autism who exhibit severe irritability, including aggressive behavior and temper tantrums. It can help manage these symptoms and improve overall functioning.
  • Behavioral Disorders in Dementia: In some cases, Risperidone is used to manage behavioral disturbances in individuals with dementia, such as Alzheimer’s disease. It can help reduce agitation, aggression, and psychotic symptoms.
  • Tourette Syndrome: Risperidone may be considered for individuals with Tourette syndrome when tics and associated behavioral issues significantly impact their daily life. It can help manage tics and related symptoms.

It’s important to note that Risperidone Tablets are typically used as part of a comprehensive treatment plan for these conditions, which may include psychotherapy, counseling, and other interventions. The specific dosage and duration of Risperidone treatment will be determined by a healthcare provider based on an individual’s diagnosis, symptoms, and response to the medication. Risperidone works by affecting certain neurotransmitters in the brain, particularly dopamine and serotonin, to help regulate mood and reduce symptoms associated with mental health disorders. It’s important to take this medication as prescribed and attend regular follow-up appointments to monitor its effectiveness and any potential side effects. The use of Risperidone should always be under the supervision and guidance of a healthcare provider, as it can have potential side effects and requires careful monitoring, especially when used long-term.

How do Risperidone Tablets work?

Risperidone Tablets work by affecting certain neurotransmitters in the brain, primarily dopamine and serotonin, to help regulate mood and reduce the symptoms associated with mental health disorders. Here’s how Risperidone works:

  • Dopamine Receptor Blockade: Risperidone belongs to a class of medications known as atypical antipsychotics. One of its primary mechanisms of action is to block specific dopamine receptors in the brain. Dopamine is a neurotransmitter that plays a key role in regulating mood, behavior, and perception. By blocking dopamine receptors, Risperidone helps modulate the activity of dopamine in certain brain pathways.
  • Balancing Dopamine Levels: In conditions like schizophrenia and bipolar disorder, there is often an imbalance of dopamine activity in the brain. Excessive dopamine signaling can contribute to symptoms such as hallucinations, delusions, and mood instability. Risperidone helps restore a more balanced dopamine activity, reducing the severity of these symptoms.
  • Serotonin Receptor Modulation: Risperidone also affects serotonin receptors in the brain. Serotonin is another neurotransmitter involved in regulating mood and behavior. By modulating serotonin receptors, Risperidone can help improve mood and reduce irritability in conditions like bipolar disorder and autism spectrum disorders.
  • Stabilizing Mood: Risperidone’s actions on dopamine and serotonin receptors help stabilize mood and reduce symptoms associated with mental health disorders. It can be particularly effective in managing manic episodes in bipolar disorder and alleviating the positive symptoms of schizophrenia, such as hallucinations and delusions.
  • Reducing Aggression and Irritability: In children and adolescents with autism spectrum disorders, Risperidone may help reduce severe irritability, aggression, and temper tantrums. Its calming effects can improve daily functioning and quality of life for individuals with these behavioral issues.

It’s important to note that the precise mechanism of action of Risperidone may vary from person to person, and the medication’s effects are influenced by individual brain chemistry and the specific mental health condition being treated. Risperidone is typically prescribed as part of a comprehensive treatment plan that may include psychotherapy, counseling, and other interventions tailored to the individual’s needs. While Risperidone can be highly effective in managing symptoms, it should be used under the supervision and guidance of a healthcare provider, and the dosage should be carefully monitored to achieve the desired therapeutic effects while minimizing potential side effects.

Benefits and side effects of Risperidone Tablets?

Risperidone Tablets offer benefits in managing various mental health conditions, particularly schizophrenia, bipolar disorder, and certain behavioral symptoms associated with autism spectrum disorders. However, like all medications, they can be associated with potential side effects. Here’s an overview of the benefits and common side effects of Risperidone Tablets:

Benefits:

  • Treatment of Schizophrenia: Risperidone is effective in reducing the positive symptoms of schizophrenia, such as hallucinations and delusions. It also helps improve negative symptoms, including social withdrawal and lack of motivation.
  • Management of Bipolar Disorder: Risperidone is used to stabilize mood and manage manic episodes in bipolar disorder. It can help reduce irritability, impulsivity, and symptoms of mania.
  • Behavioral Symptom Control in Autism: In children and adolescents with autism spectrum disorders, Risperidone may effectively reduce severe behavioral symptoms, including aggression, temper tantrums, and self-injurious behavior. This can improve daily functioning and enhance the quality of life for both individuals and their caregivers.
  • Tourette Syndrome: Risperidone may be considered for individuals with Tourette syndrome to manage tics and associated behavioral issues, helping them lead more functional lives.
  • Psychosis in Dementia: In some cases, Risperidone is used to manage behavioral disturbances in individuals with dementia, such as Alzheimer’s disease. It can help reduce agitation and aggression.

Common Side Effects:

  • Sedation: Drowsiness and sedation are common side effects of Risperidone, particularly when the medication is first initiated or when the dosage is increased. It can impact alertness and concentration.
  • Weight Gain: Many individuals experience weight gain while taking Risperidone. This side effect can contribute to metabolic changes and potentially increase the risk of obesity and related health issues.
  • Increased Appetite: Some people may experience an increased appetite, which can contribute to weight gain.
  • Extrapyramidal Symptoms (EPS): EPS include side effects such as tremors, muscle stiffness, restlessness (akathisia), and tardive dyskinesia (involuntary movements of the face and body). These symptoms can vary in intensity and are more likely to occur at higher doses.
  • Elevated Prolactin Levels: Risperidone can increase prolactin levels, which may lead to side effects like breast enlargement and lactation (even in males), menstrual irregularities, and sexual dysfunction.
  • Orthostatic Hypotension: Some individuals may experience a drop in blood pressure when standing up, leading to dizziness or fainting, especially during the initial phase of treatment.
  • Metabolic Changes: Risperidone can lead to metabolic changes, including elevated blood sugar levels and lipid abnormalities, which may increase the risk of diabetes and cardiovascular problems.

It’s important to note that the severity and prevalence of side effects can vary among individuals. Additionally, healthcare providers carefully monitor individuals prescribed Risperidone to minimize side effects and ensure its safe and effective use. Before starting Risperidone or any medication, it’s essential to have a comprehensive discussion with a healthcare provider to assess the potential benefits and risks in your specific situation and explore alternative treatments or interventions if appropriate. Regular follow-up appointments are crucial to monitor treatment progress and address any side effects promptly.

Frequently Asked Questions About Risperidone Tablets:

Certainly, here are some frequently asked questions (FAQs) about Risperidone Tablets:

  1. What are Risperidone Tablets, and what are they used for?

Risperidone Tablets contain the active ingredient risperidone and are used to treat various mental health conditions, including schizophrenia, bipolar disorder, and behavioural symptoms associated with autism.

  1. How does Risperidone work?

Risperidone affects neurotransmitters in the brain, primarily dopamine and serotonin, to help regulate mood and reduce symptoms of mental health disorders.

  1. Is Risperidone safe for long-term use?

Long-term use of Risperidone should be carefully monitored by a healthcare provider due to potential side effects and risks. The decision to continue treatment is based on individual needs and ongoing assessment.

  1. What should I do if I miss a dose of Risperidone?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses to make up for a missed one.

  1. Are there any dietary restrictions while taking Risperidone?

While there are no specific dietary restrictions, it’s advisable to maintain a balanced diet and discuss any dietary considerations with your healthcare provider.

  1. Can Risperidone be taken during pregnancy or while breastfeeding?

The use of Risperidone during pregnancy and breastfeeding should be discussed with a healthcare provider. The benefits and risks need to be carefully evaluated for each individual.

  1. What are common side effects of Risperidone Tablets?

Common side effects may include sedation, weight gain, increased appetite, extrapyramidal symptoms (tremors, stiffness), elevated prolactin levels, orthostatic hypotension, and metabolic changes.

  1. Is Risperidone addictive?

No, Risperidone is not considered addictive. It is not a controlled substance.

  1. Can Risperidone interact with other medications?

Risperidone may interact with certain medications, including other antipsychotics, antidepressants, and drugs that affect dopamine or serotonin levels. Inform your healthcare provider about all medications and supplements you are taking.

  1. How long does it take for Risperidone to start working?

The onset of action can vary, but some individuals may start to experience symptom relief within a few days to a few weeks. Full therapeutic effects may take longer.

  1. Can Risperidone be used in children?

Risperidone is sometimes prescribed to children and adolescents for specific indications, such as autism related irritability. Its use in this population should be carefully evaluated and monitored.

These FAQs provide general information about Risperidone Tablets. However, individual responses to the medication can vary, and it’s important to consult with your healthcare provider for personalized guidance and information based on your specific medical condition and treatment plan.

As Risperidone Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Risperidone Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Risperidone Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Risperidone Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274