Quetiapine fumarate Tablets USP 25mg Technical Specification:

Product Name:                 Quetiapine fumarate Tablets USP 25mg
Brand Name:Generics
Strength:25mg, 50mg, 100mg, 150mg, 200mg, 300mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:60s, 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:Anticonvulsant, Antipsychotic
Indication: Quetiapine tablets may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children and teenagers.
Storage:Store below 25°C in a dry place. Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Quetiapine fumarate Tablets USP 25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Quetiapine fumarate Tablets USP 25mg
    Each film-coated tablet contains:
    Quetiapine fumarate USP
    Equivalent to Quetiapine………….25mg
    Excipients……………………………q.s.
    Colours: Iron Oxide Red

THERAPEUTIC INDICATIONS:

Quetiapine oral tablet is used to treat the symptoms of schizophrenia, bipolar disorder, or depression.

Quetiapine can be used to treat symptoms in adults who have depressive episodes or manic episodes caused by bipolar I disorder. For major depression, quetiapine is used as an add-on treatment for people already taking antidepressant drugs.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Avoid while taking quetiapine: Quetiapine Interactions with Food and Herbs

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

STORAGE & DOSAGE:

Storage:  Store below 25°C in a dry place. 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 Pharmaceuticals stands as a beacon of trust and excellence in the world of pharmaceuticals, offering Quetiapine Fumarate Tablets that epitomize quality, reliability, and innovation. Our unwavering commitment to ensuring the highest standards of quality is the cornerstone of our operations. Through rigorous quality control measures at every stage of manufacturing, we prioritize your safety and well-being. With a rich history in the pharmaceutical industry, Taj Pharmaceuticals brings extensive experience and proven expertise to the table, demonstrating the efficacy and safety of our Quetiapine tablets. In addition to our legacy, we offer a diverse portfolio of pharmaceutical products, catering to a wide spectrum of healthcare needs. From psychiatric medications like Quetiapine to treatments in various therapeutic areas, we provide comprehensive solutions. Taj Pharmaceuticals embraces a patient-centric approach, recognizing the significance of patient well-being. Our Quetiapine Fumarate Tablets are developed with a deep commitment to improving the quality of life for patients, offering effective treatment options. We prioritize regulatory compliance, adhering strictly to industry regulations and quality assurance protocols to ensure the highest level of product safety. With a global presence, Taj Pharmaceuticals possesses the reach and capability to supply Quetiapine Fumarate Tablets to patients and healthcare providers worldwide. We are dedicated to the mission of making quality healthcare accessible to all, underlining our commitment to your health and well-being. Choose Taj Pharmaceuticals for Quetiapine Fumarate Tablets, where quality, reliability, and a genuine focus on healthcare excellence converge.

What is Quetiapine Fumarate Tablets and its uses?

Quetiapine Fumarate Tablets: Regulating Mood and Behavior:

Quetiapine Fumarate Tablets contain quetiapine, a medication classified as an atypical antipsychotic. Quetiapine operates by influencing the activity of certain neurotransmitters in the brain, including dopamine and serotonin, with the primary aim of regulating mood and behavior.

Common Uses of Quetiapine Fumarate Tablets:

One of the prominent applications of Quetiapine is in the treatment of schizophrenia, a complex mental disorder characterized by distorted thinking, hallucinations, delusions, and emotional disturbances. It plays a pivotal role in reducing the severity of these symptoms and improving overall functioning in individuals grappling with schizophrenia. Quetiapine also extends its therapeutic reach to bipolar disorder, effectively managing both manic and depressive episodes. By stabilizing mood swings, it aids in preventing or mitigating the frequency of these mood fluctuations, offering relief to those with bipolar disorder. In cases of major depressive disorder (MDD), Quetiapine may be prescribed as an adjunctive treatment alongside antidepressant medications when standard treatments have proven insufficient. It enhances the effectiveness of antidepressants, offering a potential solution for individuals with treatment-resistant depression. Moreover, Quetiapine can address symptoms of generalized anxiety disorder (GAD), characterized by excessive worry and anxiety. It has the capacity to reduce anxiety levels in some individuals, contributing to an improved quality of life. While not officially approved for this purpose, Quetiapine is occasionally used off-label to manage insomnia, especially in individuals with co-existing mental health conditions where sleep disturbances are common. The prescription of Quetiapine should always be based on a comprehensive assessment by a healthcare provider, taking into account the specific diagnosis and individual response to the medication. The dosage and duration of treatment are determined accordingly, and adherence to the healthcare provider’s guidance is crucial. Any concerns or potential side effects should be promptly discussed with the healthcare provider to ensure proper management and optimal treatment outcomes.

How does Quetiapine Fumarate Tablets work?

Quetiapine Fumarate Tablets, categorized as atypical antipsychotics, exert their therapeutic effects by intricately influencing the brain’s neurotransmitter activity, particularly dopamine and serotonin. These neurotransmitters hold pivotal roles in regulating mood, emotions, and behavior. Quetiapine operates primarily as an antagonist, targeting specific dopamine and serotonin receptors in the brain. Notably, it displays a higher affinity for serotonin receptors (5-HT2A) than for dopamine receptors (D2). One of Quetiapine’s fundamental actions is the restoration of neurotransmitter balance, a key aspect in conditions like schizophrenia and bipolar disorder, where this equilibrium is disrupted. By binding to receptors and modulating the activity of dopamine and serotonin, Quetiapine reduces excessive dopamine activity in specific brain regions while enhancing serotonin function. This fine-tuned regulation contributes to mood stabilization and the alleviation of distressing symptoms. In addition to its effects on dopamine and serotonin, Quetiapine also interacts with other neurotransmitter receptors, such as histamine (H1) and alpha-adrenergic receptors. These interactions not only contribute to its antipsychotic effects but also induce sedation, potentially benefiting individuals with sleep disturbances and anxiety-related symptoms. It is important to note that the onset of action for Quetiapine is typically gradual, requiring several weeks for individuals to experience its full therapeutic benefits. This delay is attributed to the complex nature of the changes in neurotransmitter activity and receptor regulation initiated by the medication. Individuals prescribed Quetiapine should adhere to their healthcare provider’s guidance, attending regular follow-up appointments for proper monitoring and adjustments to ensure optimal treatment outcomes.

Benefits of Quetiapine Fumarate Tablets:

Quetiapine Fumarate Tablets offer a range of therapeutic benefits across various mental health conditions. First and foremost, they are highly effective in the management of schizophrenia, providing relief from symptoms like hallucinations, delusions, and thought disturbances. This can significantly enhance the quality of life for individuals living with schizophrenia. Additionally, Quetiapine plays a crucial role in the treatment of bipolar disorder, effectively stabilizing mood swings and managing both manic and depressive episodes. This stability allows individuals with bipolar disorder to lead more balanced lives.

In cases of major depressive disorder (MDD), particularly when standard antidepressant treatments prove insufficient, Quetiapine may be prescribed as an adjunctive therapy. Its use alongside antidepressants enhances their effectiveness, offering hope to those struggling with treatment-resistant depression. Quetiapine also extends its therapeutic reach to the realm of generalized anxiety disorder (GAD), where it helps reduce excessive worry and anxiety levels, promoting a greater sense of calm.

While not officially approved for this purpose, Quetiapine is occasionally employed off-label to manage insomnia, especially in individuals contending with co-occurring mental health conditions that disrupt sleep patterns. Its sedative effects can significantly improve sleep quality.

Side Effects of Quetiapine Fumarate Tablets:

As with many medications, Quetiapine Fumarate Tablets can be associated with certain side effects. Common side effects include sedation and drowsiness, which can affect alertness and concentration. Individuals should exercise caution when engaging in activities requiring focus, such as driving.

Another potential side effect is weight gain, which can occur in some individuals. Regular weight monitoring and the adoption of a healthy lifestyle can help mitigate this side effect. Quetiapine can also influence metabolic parameters, potentially leading to elevated cholesterol levels, changes in blood sugar, and an increased risk of diabetes. Monitoring metabolic health is advisable.

Extrapyramidal symptoms such as tremors, restlessness, and muscle stiffness may occur but are generally less severe than those associated with typical antipsychotics. Some individuals may experience orthostatic hypotension, which can lead to dizziness upon standing. Additionally, Quetiapine may cause elevated levels of prolactin, resulting in side effects like breast enlargement and milk production.

In rare cases, more serious side effects such as neuroleptic malignant syndrome (NMS), tardive dyskinesia, and an increased risk of suicidal thoughts (especially in young adults) have been reported. It’s imperative for individuals taking Quetiapine to maintain a close relationship with their healthcare provider, remain vigilant for potential side effects, attend regular check-ups, and promptly report any unusual symptoms for appropriate management and assessment of the medication’s benefits against potential risks.

Frequently Asked Questions About Quetiapine Fumarate Tablets:

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

  1. What is Quetiapine Fumarate, and how does it work?

Quetiapine Fumarate is a medication classified as an atypical antipsychotic. It works by affecting the activity of neurotransmitters in the brain, such as dopamine and serotonin, to help regulate mood and behavior.

  1. What medical conditions are treated with Quetiapine Fumarate Tablets?

Quetiapine Fumarate Tablets are primarily used to treat schizophrenia and bipolar disorder. They may also be used as an adjunctive treatment for major depressive disorder (MDD) and to manage symptoms of generalized anxiety disorder (GAD).

  1. How long does it take for Quetiapine to start working for mood disorders?

The onset of action can vary from person to person, but it typically takes several weeks for individuals to experience the full therapeutic effects of Quetiapine. It’s essential to continue taking the medication as prescribed, even if improvements are not immediately noticeable.

  1. What are the common side effects of Quetiapine Fumarate Tablets?

Common side effects may include sedation, drowsiness, weight gain, changes in metabolic parameters, extrapyramidal symptoms (tremors, restlessness), orthostatic hypotension, and increased prolactin levels. Regular monitoring and communication with a healthcare provider are important to manage side effects.

  1. Can Quetiapine be used in children or adolescents?

Quetiapine may be prescribed to children and adolescents for certain conditions, but its use in pediatric populations should be closely monitored by a healthcare provider, and the potential risks and benefits should be carefully considered.

  1. Is Quetiapine safe during pregnancy or while breastfeeding?

The use of Quetiapine during pregnancy or breastfeeding should be discussed with a healthcare provider. The potential risks and benefits must be evaluated on an individual basis.

  1. Are there interactions with other medications or substances?

Quetiapine may interact with certain medications, including other psychiatric drugs, so it’s crucial to inform your healthcare provider about all the medications, including over-the-counter drugs and supplements, that you are taking to avoid potential interactions.

  1. Can Quetiapine Fumarate Tablets be abruptly stopped?

Abruptly discontinuing Quetiapine can lead to withdrawal symptoms. It’s important to follow your healthcare provider’s guidance and taper the dosage gradually if you decide to stop taking the medication.

  1. How often should I have follow-up appointments while taking Quetiapine?

Regular follow-up appointments with your healthcare provider are important to monitor your progress, assess the effectiveness of the medication, and address any side effects or concerns.

  1. What should I do if I experience serious side effects or worsening of symptoms while taking Quetiapine Fumarate Tablets?

If you experience serious side effects or a worsening of your symptoms, contact your healthcare provider promptly. It’s crucial to report any adverse reactions for proper evaluation and management.

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

Quetiapine Fumarate 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 Quetiapine Fumarate 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. Quetiapine fumarate Tablets USP 25mg
B. Quetiapine fumarate Tablets USP 50mg
C. Quetiapine fumarate Tablets USP 100mg
D. Quetiapine fumarate Tablets USP 150mg
E. Quetiapine fumarate Tablets USP 200mg
F. Quetiapine fumarate Tablets USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Quetiapine fumarate Tablets USP 25mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….25mg
Excipients……………………………q.s.
Colours: Iron Oxide Red


B. Quetiapine fumarate Tablets USP 50mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….50mg
Excipients……………………………q.s.
Colours: Quinoline Yellow

C. Quetiapine fumarate Tablets USP 100mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….100mg
Excipients……………………………q.s.
Colours: D&C Orange 4

D. Quetiapine fumarate Tablets USP 150mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….150mg
Excipients……………………………q.s.
Colours: Erythrosine Lake

E. Quetiapine fumarate Tablets USP 200mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….200mg
Excipients……………………………q.s.
Colours: Yellow Iron Oxide

F. Quetiapine fumarate Tablets USP 300mg
Each film-coated tablet contains:
Quetiapine fumarate USP
Equivalent to Quetiapine………….300mg
Excipients……………………………q.s.
Colours: Iron oxide Red

THERAPEUTIC INDICATIONS:

Quetiapine oral tablet is used to treat the symptoms of schizophrenia, bipolar disorder, or depression.
Quetiapine can be used to treat symptoms in adults who have depressive episodes or manic episodes caused by bipolar I disorder. For major depression, quetiapine is used as an add-on treatment for people already taking antidepressant drugs.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Avoid while taking quetiapine: Quetiapine Interactions with Food and Herbs
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C in a dry place. 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.