Aripiprazole Tablets 2mg Technical Specification:

Product Name:       Aripiprazole Tablets 2mg
Brand Name:Aripiprazole
Strength:2mg, 5mg, 10mg, 15mg, 30mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 500s, 1000s
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 (SGA) or atypical antipsychotic, Central nervous system
Indication: Aripiprazole is a medication that works in the brain to treat schizophrenia. used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette’s syndrome, and irritability associated with autistic disorder).
Storage:Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Aripiprazole Tablets 2mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Aripiprazole Tablets 2mg
    Each film coated tablet contains:
    Aripiprazole………………2mg
    Excipients…………………. q.s.
    Colour: Yellow Oxide of Iron

THERAPEUTIC INDICATIONS:

Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
keep medicine out of reach of children.
swallow whole does not chew or crush
ANY UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage:  As directed by the Physician.

Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Taj Pharma is your trusted partner for Aripiprazole Tablets, offering pharmaceutical excellence that spans generations. Our commitment to quality ensures dependable treatment for various mental health conditions, from schizophrenia to bipolar disorder. We prioritize mental health care, and our Aripiprazole Tablets are a testament to our dedication to improving well-being. With a global reputation for reliability and patient-centered care, Taj Pharma is the choice you can trust for your mental health and healthcare needs.

Select Taj Pharma for Aripiprazole Tablets and experience the difference in quality, efficacy, and patient-centered care. Trust us for your mental health and well-being needs.

What is Aripiprazole Tablets and Its Use?

Aripiprazole Tablets are a medication that contains the active ingredient aripiprazole. Aripiprazole is classified as an atypical antipsychotic, and it is used to treat various mental health conditions and disorders. Here is an overview of its uses:

Uses of Aripiprazole Tablets:

  • Schizophrenia: Aripiprazole is prescribed to individuals with schizophrenia, a severe mental disorder characterized by disturbances in thought, emotions, and perceptions. It helps alleviate symptoms such as hallucinations, delusions, and disorganized thinking, and can improve overall functioning.
  • Bipolar Disorder: Aripiprazole is used as a mood stabilizer in the treatment of bipolar disorder, specifically for the manic or mixed episodes. It can help reduce the intensity and frequency of manic episodes and may also be used in combination with other medications.
  • Major Depressive Disorder (as an Adjunct): In some cases, aripiprazole is prescribed as an adjunct to antidepressant medications to enhance their effectiveness in the treatment of major depressive disorder (MDD).
  • Autism Spectrum Disorders: Aripiprazole may be used to manage irritability associated with autism spectrum disorders in children and adolescents.
  • Tourette’s Disorder: It can also be prescribed to manage the symptoms of Tourette’s disorder, which includes motor and vocal tics.

Aripiprazole works by modulating certain neurotransmitters in the brain, such as dopamine and serotonin, which play a crucial role in regulating mood, behavior, and thought processes. It helps to restore the balance of these neurotransmitters, leading to a reduction in symptoms associated with mental health conditions.

The use of Aripiprazole Tablets should be guided by a healthcare provider who will determine the appropriate dosage, treatment duration, and whether it should be used as monotherapy or in combination with other medications based on the specific diagnosis and individual patient needs. It’s important for patients to follow their healthcare provider’s instructions closely and attend regular check-ups to monitor their response to the medication.

How does Aripiprazole Tablets Work?

Aripiprazole Tablets work by affecting the activity of certain neurotransmitters in the brain, primarily dopamine and serotonin. These tablets are classified as atypical antipsychotics and have a unique mechanism of action compared to older antipsychotic medications. Here’s how Aripiprazole works:

  • Partial Agonism: Aripiprazole is often described as a partial agonist. This means that it can both stimulate and block the activity of dopamine and serotonin receptors in the brain, depending on the specific circumstances.
  • Dopamine Regulation: In conditions like schizophrenia and bipolar disorder, there can be an overactivity of dopamine in certain areas of the brain. Aripiprazole helps normalize dopamine activity. It acts as a partial agonist at dopamine D2 receptors, which means it can reduce excessive dopamine transmission when levels are too high and increase it when levels are too low. This balancing act is thought to help alleviate symptoms of psychosis and mood disturbances.
  • Serotonin Modulation: Aripiprazole also affects serotonin receptors, particularly 5-HT1A receptors. By acting as a partial agonist at these receptors, it can enhance serotonin transmission in certain brain regions, which may contribute to mood stabilization.
  • Stabilizing Effects: Overall, Aripiprazole’s unique mechanism of action is believed to provide mood-stabilizing and antipsychotic effects without causing excessive sedation or motor impairment, which can be common side effects of older antipsychotic medications.

The precise mechanisms of action of Aripiprazole are complex and not entirely understood. However, its ability to modulate both dopamine and serotonin systems in a balanced manner is thought to contribute to its effectiveness in managing a range of mental health conditions, including schizophrenia, bipolar disorder, and major depressive disorder. The specific effects may vary from person to person, and individual responses to the medication can differ. Treatment with Aripiprazole should be closely monitored by a healthcare provider to ensure the best possible outcomes.

Benefits of Aripiprazole Tablets:

  • Management of Schizophrenia: Aripiprazole is effective in treating the symptoms of schizophrenia, including hallucinations, delusions, thought disorders, and emotional disturbances. It can help individuals with schizophrenia regain stability and improve their quality of life.
  • Mood Stabilization in Bipolar Disorder: Aripiprazole is used to stabilize mood in individuals with bipolar disorder. It can reduce the frequency and intensity of manic episodes and may help prevent depressive episodes.
  • Adjunctive Treatment for Depression: When added to an antidepressant, Aripiprazole can enhance the treatment of major depressive disorder (MDD) that does not respond adequately to antidepressant therapy alone. It may help improve mood and energy levels.
  • Tourette’s Disorder Management: Aripiprazole is used to manage the motor and vocal tics associated with Tourette’s disorder, improving daily functioning and reducing the impact of tics.
  • Irritability in Autism Spectrum Disorders: In children and adolescents with autism spectrum disorders, Aripiprazole can help manage irritability, temper tantrums, and aggression, improving social interactions and communication skills.

Common Side Effects of Aripiprazole Tablets:

  • Nausea: Nausea is a common side effect when starting Aripiprazole, but it often improves with time. Taking the medication with food may help reduce nausea.
  • Headache: Some individuals may experience headaches while taking Aripiprazole.
  • Insomnia: Difficulty falling asleep or staying asleep can occur. Adjusting the timing of the medication may help.
  • Restlessness (Akathisia): Akathisia is a sensation of inner restlessness and a compelling need to move. It can be managed by adjusting the dose or using other medications.
  • Dizziness: Dizziness or lightheadedness may occur, especially when standing up quickly. Be cautious when changing positions.
  • Weight Gain: Some people may experience weight gain while taking Aripiprazole. Maintaining a healthy diet and exercise routine can help manage this side effect.
  • Extrapyramidal Symptoms (EPS): EPS include symptoms like tremors, muscle stiffness, and restlessness. These can be minimized with dose adjustments or other medications.
  • Increased Blood Sugar and Lipid Levels: Aripiprazole may lead to elevated blood sugar and lipid levels, so regular monitoring is important, especially in individuals with a predisposition to diabetes.
  • Metabolic Changes: Some individuals may experience changes in metabolism, leading to weight gain, increased cholesterol levels, and altered glucose metabolism.
  • Tardive Dyskinesia (Rare): In rare cases, Aripiprazole may lead to tardive dyskinesia, which is characterized by involuntary repetitive movements, particularly of the face and tongue.

It’s crucial to discuss the benefits and potential side effects of Aripiprazole with a healthcare provider. They can provide guidance on managing side effects and ensure that the medication’s benefits outweigh the risks for your specific condition. Patients should never stop or adjust the dosage of Aripiprazole without consulting their healthcare provider, as abrupt changes can lead to withdrawal symptoms or a recurrence of symptoms.

Frequently asked questions (FAQs) about Aripiprazole Tablets:

  1. What is Aripiprazole used to treat?

Aripiprazole is used to treat a range of mental health conditions, including schizophrenia, bipolar disorder (manic or mixed episodes), major depressive disorder (as an adjunct to antidepressants), irritability associated with autism spectrum disorders, and Tourette’s disorder.

  1. How does Aripiprazole work in managing mental health conditions?

Aripiprazole modulates the activity of dopamine and serotonin neurotransmitters in the brain, helping to stabilize mood, reduce hallucinations and delusions, and manage symptoms associated with various mental health disorders.

  1. Is Aripiprazole habitforming or addictive?

Aripiprazole is not habitforming or addictive. It does not lead to physical dependence when taken as prescribed.

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

The use of Aripiprazole during pregnancy or breastfeeding should be discussed with a healthcare provider. The potential risks and benefits must be carefully considered in each individual case.

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

The time it takes for Aripiprazole to show noticeable effects can vary among individuals and depends on the specific mental health condition being treated. Some individuals may experience improvements within a few weeks, while others may require a longer duration.

  1. Are there any specific dietary restrictions while taking Aripiprazole?

Aripiprazole does not typically require specific dietary restrictions. However, it’s essential to maintain a balanced diet and exercise regularly to manage potential weight gain, a common side effect of the medication.

  1. Can I drink alcohol while taking Aripiprazole?

It’s generally recommended to avoid alcohol while taking Aripiprazole, as it may interact with the medication and increase the risk of side effects or affect the medication’s efficacy.

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

If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next scheduled dose. Do not double up on doses. Consult your healthcare provider for guidance on missed doses.

  1. Can Aripiprazole interact with other medications I’m taking?

Aripiprazole can interact with certain medications, including other antipsychotics and drugs that affect dopamine receptors. It’s crucial to inform your healthcare provider about all medications and supplements you are taking to prevent potential interactions.

  1. Can Aripiprazole be used in children and adolescents?

Aripiprazole is approved for use in certain mental health conditions in pediatric patients. The specific indications and dosages for children and adolescents should be determined by a healthcare provider.

As Aripiprazole Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Aripiprazole 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

Aripiprazole 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 Aripiprazole 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

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Aripiprazole Tablets 2mg
B. Aripiprazole Tablets 5mg
C. Aripiprazole Tablets 10mg
D. Aripiprazole Tablets 15mg
E. Aripiprazole Tablets 30mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Aripiprazole Tablets 2mg
Each film coated tablet contains:
Aripiprazole………………2mg
Excipients…………………. q.s.
Colour: Yellow Oxide of Iron


B. Aripiprazole Tablets 5mg
Each film coated tablet contains:
Aripiprazole………………5mg
Excipients……………………q.s.
Colour: Quinoline Yellow Lake

C. Aripiprazole Tablets 10mg
Each film coated tablet contains:
Aripiprazole….………….10mg
Excipients…………………...q.s.
Colour: D&C Orange 4

D. Aripiprazole Tablets 15mg
Each film coated tablet contains:
Aripiprazole……………...15mg
Excipients…………………………q.s.
Colour: Carmoisine Lake

E. Aripiprazole Tablets 30mg
Each film coated tablet contains:
Aripiprazole……………….30mg
Excipients…………………………q.s.
Colour: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
keep medicine out of reach of children.
swallow whole does not chew or crush
ANY UNUSED MEDICINAL PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.