Olanzapine Tablets USP 5mg Technical Specification: 

Product Name:       Olanzapine Tablets USP 5mg
Brand Name:Generics
Strength:2.5mg, 5mg, 10mg
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, Antidepressants, Central Nervous System
Indication: Olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder)
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:

  • Olanzapine Tablets USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Olanzapine Tablets USP 5mg
    Each film coated tablet contains:
    Olanzapine USP………………….5mg
    Excipients………………………………. q.s.
    Colour: Yellow Iron Oxide

THERAPEUTIC INDICATIONS:

Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

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 county.

Why Taj Pharmaceuticals?

Experience the Taj Pharma Advantage when it comes to Olanzapine Tablets USP. Our dedication to pharmaceutical innovation and patient well-being sets us apart in the industry. At Taj Pharma, we prioritize quality control and rigorous testing throughout the manufacturing process. Our state-of-the-art facilities adhere to international standards, guaranteeing that each Olanzapine tablet meets or exceeds USP specifications. You can trust in the consistent potency and purity of our products, which are essential for managing mental health conditions effectively. Taj Pharma’s commitment to affordability ensures that you receive cost-effective solutions without compromising on quality. We understand the importance of access to medication, and we strive to make Olanzapine Tablets USP accessible to those who need them most.

In addition to our unwavering dedication to product quality and affordability, Taj Pharma values customer satisfaction and support. Our responsive customer service team is here to address your inquiries and concerns promptly, ensuring your confidence in every aspect of your Olanzapine treatment journey. Choose Taj Pharma for Olanzapine Tablets USP and experience pharmaceutical excellence, affordability, and unwavering support in your pursuit of mental health and well-being.

What is Olanzapine Tablets USP and its use?

Olanzapine Tablets USP, commonly referred to as Olanzapine, are a medication used to treat various mental health conditions, primarily schizophrenia and bipolar disorder. Here’s some key information about Olanzapine Tablets USP and their use:

  • Medication Type: Olanzapine belongs to a class of medications known as atypical antipsychotics. It is available in tablet form for oral administration.
  • Schizophrenia: Olanzapine is often prescribed to manage the symptoms of schizophrenia, which can include hallucinations, delusions, disorganized thinking, and difficulty in social interactions.
  • Bipolar Disorder: It is also used to treat bipolar disorder, specifically for the manic or mixed episodes associated with this condition. Olanzapine can help stabilize mood swings.
  • How It Works: Olanzapine works by affecting certain neurotransmitters in the brain, such as dopamine and serotonin. It helps to restore the balance of these neurotransmitters, which can be disrupted in conditions like schizophrenia and bipolar disorder.
  • Dosage: The dosage of Olanzapine varies depending on the individual’s condition and the severity of symptoms. It’s essential to follow your healthcare provider’s instructions carefully when taking this medication.
  • Possible Side Effects: Like all medications, Olanzapine may have side effects. Common side effects can include drowsiness, weight gain, increased appetite, and dry mouth. Some individuals may experience more severe side effects, so it’s crucial to report any unusual or severe reactions to your healthcare provider.
  • Monitoring: While taking Olanzapine, regular monitoring by a healthcare professional is often necessary to assess its effectiveness and monitor for any potential side effects.
  • Duration of Treatment: The duration of treatment with Olanzapine depends on the specific condition being treated and the individual’s response to the medication. It’s important not to discontinue or change the dosage without consulting a healthcare provider, as abruptly stopping the medication can lead to a recurrence of symptoms.
  • Cautions: Olanzapine may not be suitable for everyone, and its use should be discussed thoroughly with a healthcare provider. This includes consideration of potential drug interactions and any pre-existing medical conditions.

Olanzapine should only be used under the guidance and prescription of a qualified healthcare professional. This information is provided for general understanding, and individual circumstances may vary, so it’s essential to consult with a healthcare provider for personalized advice and treatment options.

How does Olanzapine Tablets USP Work?

Olanzapine Tablets USP, like other atypical antipsychotic medications, work by affecting neurotransmitters in the brain, specifically dopamine and serotonin. Here’s how Olanzapine works:

  • Dopamine Regulation: One of the primary mechanisms of action of Olanzapine is its effect on the neurotransmitter dopamine. Dopamine is a chemical messenger in the brain that plays a crucial role in various functions, including mood, motivation, and the regulation of pleasure and reward.
  • Dopamine Blockade: Olanzapine is classified as an antagonist of dopamine receptors, particularly the D2-type receptors. By binding to these receptors and blocking their activation, Olanzapine reduces the activity of dopamine in certain brain pathways.
  • Serotonin Regulation: Olanzapine also affects serotonin receptors, particularly 5-HT2A receptors. It has a higher affinity for these receptors compared to its affinity for dopamine receptors. By modulating serotonin activity, Olanzapine helps to restore the balance of neurotransmitters in the brain.
  • Restoring Neurotransmitter Balance: In conditions like schizophrenia and bipolar disorder, there is often an imbalance in the activity of these neurotransmitters. Excess dopamine activity, in particular, is associated with symptoms like hallucinations, delusions, and disorganized thinking. By blocking some of the dopamine receptors and affecting serotonin receptors, Olanzapine helps to normalize the neurotransmitter balance.
  • Stabilizing Mood: In the treatment of bipolar disorder, Olanzapine’s ability to stabilize mood swings is attributed to its modulation of neurotransmitters. It can help reduce the severity and frequency of manic or mixed episodes.
  • Reduction of Psychotic Symptoms: For individuals with schizophrenia, Olanzapine’s action on dopamine and serotonin receptors can lead to a reduction in the severity of psychotic symptoms, such as hallucinations and delusions.

It’s important to note that the exact mechanism of action of Olanzapine is complex and not fully understood. Moreover, individual responses to the medication can vary, so healthcare providers carefully monitor patients to assess the effectiveness and manage any potential side effects. Olanzapine is typically prescribed as part of a comprehensive treatment plan that may include therapy and other interventions to address the underlying mental health condition. Patients should follow their healthcare provider’s guidance and communicate any concerns or side effects during the course of treatment.

Benefits and Side effects of Olanzapine Tablets USP?

Olanzapine Tablets USP are a medication used to treat mental health conditions like schizophrenia and bipolar disorder. Like any medication, they come with both benefits and potential side effects. It’s important to note that individual responses to Olanzapine can vary, so not everyone will experience the same effects. Below, I’ll outline the benefits and common side effects associated with Olanzapine:

Benefits:

  • Symptom Management: Olanzapine is effective in managing the symptoms of schizophrenia. It can help reduce or eliminate hallucinations, delusions, disorganized thinking, and emotional withdrawal.
  • Mood Stabilization: In bipolar disorder, Olanzapine can help stabilize mood swings. It is particularly useful in managing manic or mixed episodes, which are characterized by high energy, impulsivity, and irritability.
  • Reduction of Agitation: Olanzapine can help reduce agitation and aggressive behavior in some individuals with mental health conditions.
  • Improved Quality of Life: By controlling symptoms and stabilizing mood, Olanzapine can contribute to an improved overall quality of life for individuals living with schizophrenia or bipolar disorder.

Common Side Effects:

  • Drowsiness: One of the most common side effects of Olanzapine is drowsiness or sedation. This can affect alertness and concentration.
  • Weight Gain: Many people experience weight gain while taking Olanzapine. This can be significant and may lead to obesity in some cases.
  • Increased Appetite: Olanzapine can stimulate appetite, contributing to weight gain.
  • Dry Mouth: Some individuals may experience dry mouth, which can be uncomfortable.
  • Dizziness: Olanzapine can cause dizziness, particularly when standing up quickly. This may increase the risk of falls.
  • Constipation: Constipation is another possible side effect of Olanzapine.
  • Blurred Vision: Some people may experience blurred vision while taking this medication.
  • Restlessness or Akathisia: Restlessness, an inner sense of restlessness, or akathisia (a movement disorder) can occur as side effects in some individuals.
  • Increased Blood Sugar and Lipid Levels: Olanzapine can lead to increased blood sugar levels and lipid (fat) levels, which can increase the risk of diabetes and cardiovascular issues.
  • Extrapyramidal Symptoms (EPS): EPS can include involuntary movements, muscle stiffness, and tremors. These side effects are less common with atypical antipsychotics like Olanzapine compared to older antipsychotic medications.

It’s crucial to discuss both the benefits and potential side effects of Olanzapine with a healthcare provider. The decision to use Olanzapine should be made on an individual basis, weighing the potential benefits against the risks and side effects. Additionally, regular monitoring and follow-up with a healthcare provider are important during Olanzapine treatment to manage side effects and assess its effectiveness in managing the underlying mental health condition.

Frequently asked questions (FAQs) about Olanzapine Tablets USP:

  1. What is Olanzapine Tablets USP, and what is it used for?

Olanzapine Tablets USP is a medication used to treat mental health conditions such as schizophrenia and bipolar disorder. It helps manage symptoms like hallucinations, delusions, mood swings, and agitation.

  1. How does Olanzapine work?

Olanzapine works by affecting neurotransmitters in the brain, particularly dopamine and serotonin, to restore the balance of these chemicals and reduce symptoms.

  1. What should I discuss with my healthcare provider before taking Olanzapine?

You should inform your healthcare provider about your medical history, current medications, allergies, and any existing health conditions. This information helps determine if Olanzapine is safe and appropriate for you.

  1. How should I take Olanzapine Tablets USP?

Olanzapine is usually taken orally, as directed by your healthcare provider. The dosage and timing will depend on your specific condition.

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

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 one and continue with your regular schedule. Do not take extra doses to make up for missed ones.

  1. Are there any potential side effects of Olanzapine?

Yes, Olanzapine can have side effects. Common ones include drowsiness, weight gain, increased appetite, dry mouth, and dizziness. It’s important to discuss potential side effects with your healthcare provider.

  1. Can Olanzapine interact with other medications or substances?

Yes, Olanzapine can interact with certain medications, including other antipsychotics, antidepressants, and drugs that affect the central nervous system. Be sure to inform your healthcare provider of all medications and substances you are taking.

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

The time it takes for Olanzapine to take effect can vary from person to person. Some individuals may experience improvements in symptoms within a few days, while for others, it may take several weeks.

  1. Can I drink alcohol while taking Olanzapine?

It’s generally advisable to avoid alcohol while taking Olanzapine, as it can increase the risk of side effects and interactions with the medication.

  1. Can I stop taking Olanzapine if I feel better?

No, you should not stop taking Olanzapine without consulting your healthcare provider. Abruptly discontinuing the medication can lead to a recurrence of symptoms. Any changes to your treatment plan should be discussed with your healthcare provider.

  1. Is it safe to drive or operate heavy machinery while on Olanzapine?

Olanzapine can cause drowsiness and affect alertness. It’s essential to be cautious when driving or operating machinery, especially when you first start taking the medication.

  1. How often should I see my healthcare provider while taking Olanzapine?

Your healthcare provider will determine the appropriate frequency of followup appointments to monitor your progress, manage side effects, and adjust your treatment plan as needed.

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

Olanzapine Tablets USP 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 Olanzapine Tablets USP, 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:

Olanzapine Tablets USP 2.5mg
Olanzapine Tablets USP 5mg
Olanzapine Tablets USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Olanzapine Tablets USP 2.5mg
Each film coated tablet contains:
Olanzapine USP…………………...2.5mg
Excipients………………………………. q.s.
Colour: Red Oxide of Iron

b) Olanzapine Tablets USP 5mg
Each film coated tablet contains:
Olanzapine USP………………….5mg
Excipients………………………………. q.s.
Colour: Yellow Iron Oxide


c) Olanzapine Tablets USP 10mg
Each film coated tablet contains:
Olanzapine USP………………….10mg
Excipients………………………………. q.s.
Colour: Orange 5

THERAPEUTIC INDICATIONS:

Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
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 county.