GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Erlotinib Tablets BP 25mg
b) Erlotinib Tablets BP 100mg
c) Erlotinib Tablets BP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Erlotinib Tablets BP 25mg
Each film-coated tablet contains:
Erlotinib Hydrochloride BP Equivalent to
Erlotinib.………………………………….25mg
Excipients………………………………… q.s.
Colours: Titanium Dioxide BP

b) Erlotinib Tablets BP 100mg
Each film-coated tablet contains:
Erlotinib Hydrochloride BP Equivalent to
Erlotinib.………………………………….100mg
Excipients………………………………… q.s.
Colours: Iron Oxide Red

c) Erlotinib Tablets BP 150mg
Each film-coated tablet contains:
Erlotinib Hydrochloride BP Equivalent to
Erlotinib.………………………………….150mg
Excipients………………………………… q.s.
Colours: Iron Oxide Yellow


THERAPEUTIC INDICATIONS:

Erlotinib is a type of targeted cancer drug. It is a treatment for non-small cell lung cancer (NSCLC) that has spread and for advanced pancreatic cancer

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a Cancer Specialist.
Dispense in a tight, light resistant containers as defined in the USP.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Erlotinib Tablets BP 150mg (Melacyte) Technical Specification:

Product Name:Erlotinib Tablets BP 150mg
Brand Name:Melacyte
Strength:25mg, 100mg, 150mg
Dosage Form:Film-coated Tablet
Packing:10s, 30s
Route of Administration:For Oral Use only.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Erlotinib is a type of targeted cancer drug. It is a treatment for non-small cell lung cancer (NSCLC) that has spread and for advanced pancreatic cancer
Storage:Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Erlotinib Tablets BP 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Erlotinib Tablets BP 150mg
    Each film-coated tablet contains:

    Erlotinib Hydrochloride BP Equivalent to
    Erlotinib.………………………………….150mg
    Excipients………………………………… q.s.
    Colours: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Erlotinib is a type of targeted cancer drug. It is a treatment for non-small cell lung cancer (NSCLC) that has spread and for advanced pancreatic cancer

CAUTION & WARNING:

CAUTION: It is dangerous to take this preparation except under medical supervision.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.

WARNING: To be supplied against demand from Cancer Hospital, Institutions and against prescription of a Cancer Specialist.

Dispense in a tight, light resistant containers as defined in the USP.

Keep out of reach and sight of children.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

Erlotinib Tablets BP from Taj Pharma offer a superior path to effective cancer treatment. Our unwavering commitment to quality assurance ensures that every tablet is produced to the highest industry standards, guaranteeing the utmost safety and efficacy in your cancer therapy. At Taj Pharma, we understand the financial burden that often accompanies critical treatments. That’s why we offer Erlotinib Tablets BP at affordable prices, making advanced cancer care accessible to more individuals around the world. Your well-being is our top priority, and we aim to empower you on your journey to recovery. With a global reach, Taj Pharma ensures that patients everywhere can benefit from Erlotinib Tablets BP. Whether you require this essential medication at your local healthcare facility or in a distant corner of the world, Taj Pharma is here to support your health needs.

Choose Taj Pharma for Erlotinib Tablets BP – where excellence meets affordability for your cancer treatment needs.

What is Erlotinib Tablets BP and its use?

Erlotinib Tablets BP (British Pharmacopoeia) contain the active ingredient erlotinib, which is a medication used primarily in the treatment of certain types of cancer, particularly non-small cell lung cancer (NSCLC) and pancreatic cancer. Here’s an overview of Erlotinib Tablets BP and their uses:

Active Ingredient: Erlotinib hydrochloride is the active ingredient in Erlotinib Tablets BP.

Uses:

  • NonSmall Cell Lung Cancer (NSCLC): Erlotinib is often prescribed for patients with advanced or metastatic NSCLC, a common type of lung cancer. It is used in cases where the cancer has not responded well to previous treatments. Erlotinib works by targeting specific proteins (epidermal growth factor receptor or EGFR) involved in the growth and spread of cancer cells.
  • Pancreatic Cancer: Erlotinib is also used in combination with another medication called gemcitabine for the treatment of locally advanced, unresectable, or metastatic pancreatic cancer. This combination therapy can help slow the progression of the disease and improve survival rates.

How Erlotinib Works:

Erlotinib is a tyrosine kinase inhibitor (TKI), which means it blocks the activity of certain proteins (EGFR) involved in cell growth and division. By inhibiting EGFR, erlotinib helps slow down or stop the growth of cancer cells in the targeted areas, ultimately inhibiting the progression of the disease.

How does the Erlotinib Tablets BP work?

Erlotinib Tablets BP contain the active ingredient erlotinib, which is a targeted cancer therapy known as a tyrosine kinase inhibitor (TKI). Erlotinib works by specifically targeting and inhibiting a protein called the epidermal growth factor receptor (EGFR) that is found on the surface of cancer cells. Here’s how Erlotinib Tablets BP work:

  • EGFR Inhibition: In many cancer cells, particularly in non-small cell lung cancer (NSCLC) and pancreatic cancer, the EGFR protein is overactive. This overactivity stimulates cancer cell growth, division, and survival. Erlotinib specifically targets and binds to EGFR, blocking its activity.
  • Downstream Signaling Inhibition: When Erlotinib binds to EGFR, it disrupts the signalling pathways that are normally activated by EGFR. These signalling pathways are responsible for transmitting signals that promote cell growth and division. By inhibiting these pathways, Erlotinib hinders the cancer cell’s ability to proliferate.
  • Apoptosis Induction: Erlotinib also plays a role in inducing apoptosis, which is a natural process of programmed cell death. In cancer cells, the balance between cell growth and apoptosis is often disrupted, leading to uncontrolled cell growth. Erlotinib helps restore this balance by promoting apoptosis in cancer cells, causing them to self-destruct.
  • Anti-Angiogenic Effects: In addition to its direct effects on cancer cells, Erlotinib can also inhibit the formation of new blood vessels, a process known as angiogenesis. Tumours need a blood supply to grow and spread, and by blocking angiogenesis, Erlotinib can limit the tumour’s ability to access nutrients and oxygen.

Overall, Erlotinib Tablets BP works by targeting the molecular mechanisms that drive the growth and survival of cancer cells, thereby slowing down or stopping the progression of the disease. This targeted approach is designed to minimize damage to healthy cells and tissues, resulting in fewer side effects compared to traditional chemotherapy.

Benefits and Side Effects of Erlotinib Tablets BP

Benefits:

  • Effective Cancer Treatment: Erlotinib is effective in the treatment of NSCLC, particularly in patients with specific mutations in the epidermal growth factor receptor (EGFR) gene. It can also be used in combination therapy for pancreatic cancer.
  • Tumour Growth Inhibition: Erlotinib targets and inhibits EGFR, a protein often overexpressed or mutated in cancer cells. By blocking EGFR, it can slow down or stop the growth and spread of cancer cells.
  • Increased Survival: In some cases, Erlotinib has been shown to improve survival rates and prolong the time until disease progression in patients with advanced NSCLC or pancreatic cancer.
  • Symptom Relief: Erlotinib treatment can help alleviate symptoms associated with cancer, such as pain, shortness of breath, and weight loss.

Common Side Effects:

  • Skin Rash: A common side effect of Erlotinib is a skin rash, which can range from mild to severe. It may be accompanied by dryness, itching, or redness. Proper skincare and medications can help manage this rash.
  • Diarrhea: Diarrhea is another frequent side effect of Erlotinib. It can range from mild to severe, and patients are advised to stay hydrated and report severe diarrhea to their healthcare provider.
  • Fatigue: Many individuals experience fatigue or weakness during treatment with Erlotinib.
  • Loss of Appetite: A reduced appetite and weight loss can occur.
  • Nausea and Vomiting: Some patients may experience nausea and vomiting, which can often be managed with medications.
  • Mouth Sores: Mouth sores or ulcers are less common but can occur.
  • Eye Irritation: Erlotinib can cause eye irritation, including dryness, redness, and blurred vision.
  • Liver Enzyme Changes: Changes in liver enzyme levels may occur, and regular monitoring of liver function is essential during treatment.
  • Respiratory Symptoms: Coughing, shortness of breath, and chest discomfort are possible but less common side effects.
  • Infection Risk: Erlotinib can lower the body’s ability to fight infections, increasing the risk of bacterial or viral infections.

Frequently asked questions about Erlotinib Tablets BP

  • What is Erlotinib Tablets BP used for?

Erlotinib Tablets BP are primarily used in the treatment of nonsmall cell lung cancer (NSCLC), particularly in patients with specific EGFR mutations, and in combination therapy for pancreatic cancer.

  • How does Erlotinib work in the treatment of cancer?

Erlotinib is a targeted therapy that inhibits the activity of the epidermal growth factor receptor (EGFR), a protein often overactive in cancer cells. By blocking EGFR, Erlotinib helps slow down or stop cancer cell growth.

  • What are the common side effects of Erlotinib Tablets BP?

Common side effects include skin rash, diarrhoea, fatigue, loss of appetite, nausea, vomiting, mouth sores, and eye irritation. However, side effects can vary from person to person.

  • How can I manage the skin rash associated with Erlotinib treatment?

Proper skincare and the use of prescribed creams or ointments can help manage the skin rash. It’s important to report any severe or worsening rash to your healthcare provider.

  • Is Erlotinib Tablets BP a cure for cancer?

Erlotinib can be effective in slowing down or controlling cancer growth, but it may not be a cure on its own. It is often used as part of a comprehensive treatment plan, and its effectiveness varies depending on the individual and the specific cancer type.

  • Can Erlotinib be used in combination with other cancer treatments?

Yes, Erlotinib is often used in combination with other chemotherapy medications or targeted therapies to enhance its effectiveness in treating cancer.

  • How is Erlotinib taken?

Erlotinib Tablets BP are taken orally, typically once a day. It’s essential to follow the prescribed dosage and administration instructions provided by your healthcare provider.

  • What should I do if I miss a dose of Erlotinib?

If you miss a dose, follow your healthcare provider’s instructions. In general, you may be advised to take the missed dose if it is within 12 hours of the scheduled time. If more than 12 hours have passed, you may need to skip the missed dose and resume your regular dosing schedule.

  • Is Erlotinib covered by insurance?

Coverage for Erlotinib may vary depending on your insurance plan and individual circumstances. It’s essential to check with your insurance provider for information on coverage and financial assistance programs.

  • Can I continue taking Erlotinib if I experience side effects?

Your healthcare provider will assess the severity of side effects and may adjust your treatment plan, including dose modifications or temporary interruptions, to manage side effects while continuing treatment.

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

Erlotinib Tablets BP 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 Erlotinib Tablets BP, 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