Irinotecan Hydrochloride Injection USP 20mg/ml (100mg/5ml) Technical Specification:  

Product Name:Irinotecan Hydrochloride Injection USP 20mg/ml (100mg/5ml)
Brand Name:Irinotecan
Strength:20mg/ml (40mg/2ml, 100mg/5ml, 300mg/15ml, 500mg/25ml)
Dosage Form:Liquid Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.V. use only. Must be diluted before use.
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: Irinotecan is a medication used to treat colon cancer and small cell lung cancer.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Irinotecan Hydrochloride Injection USP 20mg/ml (100mg/5ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Irinotecan Hydrochloride Injection USP 20mg/ml (100mg/5ml)
    Each ml contains
    Irinotecan Hydrochloride trihydrate…….20mg
    Sorbitol………………………………………………..45mg
    Lactic acid…………………………………………….0.9mg
    Water for injection……………………………….q.s.
    When necessary, PH was adjusted with sodium hydroxide and/or hydrochloric acid.

THERAPEUTIC INDICATION:

Irinotecan is a medication used to treat colon cancer and small cell lung cancer.

PACKING:

20mg/ml

  • 40mg/2ml
  • 100mg/5ml
  • 300mg/15ml
  • 500mg/25ml

DIRECTION OF USE:

For Intravenous use only. Must be diluted before use.

For Intravenous use only must be diluted with 5% dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP before use.

Read accompanying package insert for detailed information of dosage, directions for use, Reconstitution, storage and precautions.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.

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

WARNING: For Intravenous use only. Must be diluted before use.

CONTRAINDICATIONS: Irinotecan Hydrochloride trihydrate for Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. *Antineoplastic Agent

WARNING: You will be closely monitored (e.g. – blood test) by your doctor while using this medication. Keep all medical and laboratory appointments. Irinotecan may cause severe diarrhea, which can occur during or right after you receive this medication and/or more than 24 hours afterwards. If the diarrhea starts immediately, you may also have other side effects such as runny nose, increased saliva, watery eyes, sweating, stomach cramps or flushing. If the diarrhea starts later, it could be a different type that may be persistent and can cause serious (possibly fatal) loss of too much body water (dehydration).

IF CONTENTS ARE DAMAGED AND/OR LEAKING INCINERATE ENTIRE PACKAGE.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of reach of children

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

Protect from light. Do not freeze.

Dosage: As directed by the Oncologist.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands out as a reputable choice for individuals seeking cancer treatment, particularly in the form of Irinotecan Hydrochloride Injection. With a distinguished history in the pharmaceutical industry, Taj Pharma has consistently upheld pharmaceutical excellence. Their commitment to producing top-tier medications extends to Irinotecan Hydrochloride Injection, reflecting their dedication to providing reliable and effective cancer treatment options. Specializing in oncology and cancer therapies, Taj Pharmaceuticals boasts a wealth of expertise in this field. This specialization underscores their unwavering commitment to enhancing the lives of cancer patients, as evidenced by the quality of Irinotecan Hydrochloride Injection. The medication adheres to stringent quality control measures to ensure its safety and efficacy, meeting the highest standards in the industry. At the heart of Taj Pharma’s mission is a patient-centered approach. Irinotecan Hydrochloride Injection is designed to offer not only effective cancer treatment but also compassionate care. The company prioritizes improved treatment outcomes and the overall quality of life for individuals grappling with cancer, emphasizing the human aspect of healthcare. Taj Pharmaceuticals’ global reach is a critical asset in the realm of cancer treatment. Their extensive distribution network ensures that medications like Irinotecan Hydrochloride Injection are readily accessible to patients and healthcare providers worldwide. This global presence plays a pivotal role in the fight against cancer, ensuring that life-saving treatments are available when and where they are needed most. The company’s commitment to ongoing research and innovation in oncology is another hallmark of Taj Pharma. Their dedication drives the development of new and improved cancer therapies, including Irinotecan Hydrochloride Injection, aimed at enhancing patient outcomes and pushing the boundaries of cancer care. Affordability is a key consideration for many patients facing cancer treatment. Taj Pharmaceuticals strives to provide cost-effective options, and Irinotecan Hydrochloride Injection is no exception. The medication strikes a balance between quality and affordability, supporting patients in their battle against cancer without compromising on the quality of care they receive. In summary, Taj Pharmaceuticals is a trusted and reputable choice for Irinotecan Hydrochloride Injection, backed by a legacy of pharmaceutical excellence, a focus on cancer treatment expertise, rigorous quality control, patient-centered care, global accessibility, a commitment to research, and affordability. In the realm of cancer care, Taj Pharma stands as a beacon of hope, delivering high-quality medications that contribute to improved patient well-being and treatment outcomes.

What is Irinotecan Hydrochloride Injection and its uses?

Irinotecan Hydrochloride Injection is a medication used in cancer therapy, specifically in the treatment of certain types of cancer. It contains the active ingredient Irinotecan hydrochloride, which is a cytotoxic chemotherapy drug. Here are its primary uses:

  • Colorectal Cancer: Irinotecan Hydrochloride Injection is commonly employed in the treatment of colorectal cancer, particularly when the disease has advanced or metastasized to other parts of the body. It is often used in combination with other chemotherapy drugs.
  • Small Cell Lung Cancer: It may also be prescribed for small cell lung cancer, a type of lung cancer that tends to grow and spread rapidly. Irinotecan is often used in combination with other chemotherapy agents in this context.
  • Other Cancers: In addition to colorectal cancer and small cell lung cancer, Irinotecan Hydrochloride Injection is sometimes used off-label for the treatment of various other cancers, including gastric (stomach) cancer and pancreatic cancer.

Irinotecan works by inhibiting the growth and replication of cancer cells. It interferes with DNA synthesis and repair processes within cancer cells, preventing them from multiplying and ultimately leading to their death. It’s important to note that Irinotecan Hydrochloride Injection is administered under the supervision of a healthcare professional, typically in a clinical setting such as a hospital or cancer treatment center. The dosage and treatment regimen are determined by an oncologist based on the type and stage of cancer, as well as the patient’s overall health and individual response to the medication. Irinotecan is often used in combination with other chemotherapy drugs or as part of a comprehensive cancer treatment plan, which may also include surgery and radiation therapy, depending on the specific cancer diagnosis. The goal of treatment is to shrink tumors, slow the progression of the disease, and improve the patient’s quality of life.

Benefits of Irinotecan Hydrochloride Injection:

  • Effective Cancer Treatment: Irinotecan Hydrochloride Injection is an effective chemotherapy drug used to treat colorectal cancer and small cell lung cancer, among other cancer types. It plays a crucial role in slowing down or halting the growth of cancer cells, helping to manage the disease.
  • Combination Therapy: Irinotecan is often used in combination with other chemotherapy agents, which can enhance its effectiveness in treating cancer. Combination therapy is especially important in addressing advanced or metastatic cancers.
  • Extended Survival: In many cases, Irinotecan treatment can extend the survival of cancer patients, providing them with valuable additional time and improving their overall quality of life.
  • Palliative Care: Irinotecan is used not only with curative intent but also for palliative care. It can help alleviate cancer-related symptoms, such as pain and discomfort, even in cases where a cure is not possible.

Side Effects of Irinotecan Hydrochloride Injection:

  • Gastrointestinal Side Effects: Irinotecan is associated with gastrointestinal side effects, including nausea, vomiting, diarrhea, and abdominal cramps. These symptoms can range from mild to severe and may require additional medications to manage.
  • Myelosuppression: Irinotecan can lead to myelosuppression, a condition in which the bone marrow’s ability to produce blood cells is suppressed. This can result in anemia, increased susceptibility to infections, and a reduced ability to form blood clots.
  • Fatigue: Cancer patients undergoing treatment with Irinotecan may experience fatigue, which can significantly impact their daily activities. Rest and proper nutrition are important for managing this side effect.
  • Neutropenia: Neutropenia, a reduction in the number of white blood cells called neutrophils, can occur with Irinotecan use. This can increase the risk of infections. Patients are closely monitored for this side effect, and in some cases, treatment may be adjusted.
  • Hair Loss: Irinotecan can cause hair loss, which is often temporary. Not all patients experience hair loss, and for some, it may be partial rather than complete.
  • Irinotecan-Induced Diarrhea (IID): IID is a specific type of diarrhea associated with Irinotecan. It can be severe and may require immediate treatment with medications such as loperamide.
  • Hypersensitivity Reactions: In rare cases, hypersensitivity reactions, including rash, itching, swelling, and difficulty breathing, can occur. These reactions require immediate medical attention.
  • Liver Toxicity: Irinotecan can affect liver function, leading to elevated liver enzymes. Monitoring of liver function is important during treatment.
  • Blood Clots: In some instances, Irinotecan can increase the risk of blood clots, which can be a serious complication. Patients should report any signs of blood clots, such as swelling, pain, or redness in the limbs

It’s important to note that not all patients will experience these side effects, and their severity can vary from person to person. Healthcare providers closely monitor patients undergoing Irinotecan treatment and take steps to manage and mitigate side effects as needed to ensure the best possible treatment outcome. Patients should communicate openly with their healthcare team about any side effects they experience during treatment.

Frequently Asked Questions About Irinotecan Hydrochloride Injection:

Certainly, here are some frequently asked questions (FAQs) about Irinotecan Hydrochloride Injection:

  1. What is Irinotecan Hydrochloride Injection used for?

Irinotecan Hydrochloride Injection is used primarily in the treatment of colorectal cancer and small cell lung cancer. It may also be used off label for other cancer types under the guidance of an oncologist.

  1. How does Irinotecan Hydrochloride Injection work in cancer treatment?

Irinotecan works by inhibiting the growth and replication of cancer cells. It interferes with DNA synthesis and repair processes within cancer cells, preventing them from multiplying and ultimately leading to their death.

  1. Is Irinotecan Hydrochloride Injection a curative treatment for cancer?

Irinotecan is often used in combination with other cancer treatments and is intended to slow down or stop the growth of cancer cells. While it can lead to remission in some cases, its primary goal is to manage the disease and extend survival.

  1. What are the common side effects of Irinotecan Hydrochloride Injection?

Common side effects include gastrointestinal symptoms like nausea, vomiting, and diarrhea. Other potential side effects include myelosuppression (reduced blood cell counts), fatigue, hair loss, and hypersensitivity reactions.

  1. How is Irinotecan Hydrochloride Injection administered?

Irinotecan is typically administered as an intravenous (IV) infusion by a healthcare professional in a clinical setting, such as a hospital or cancer treatment center. The dosage and schedule are determined by an oncologist.

  1. Is Irinotecan Hydrochloride Injection safe during pregnancy or breastfeeding?

Irinotecan is known to cause harm to a developing fetus, so it is generally avoided during pregnancy. It is also excreted in breast milk, so breastfeeding is typically not recommended while undergoing Irinotecan treatment.

  1. Can Irinotecan Hydrochloride Injection be used for other types of cancer not listed in the official indications?

In some cases, oncologists may use Irinotecan off label for cancer types other than colorectal cancer and small cell lung cancer when they believe it may be beneficial. This decision is made on a case-by-case basis.

  1. How often is Irinotecan Hydrochloride Injection administered, and for how long?

The frequency and duration of Irinotecan treatment vary depending on the specific cancer diagnosis and stage, as well as the treatment plan outlined by the oncologist. Treatment can range from several weeks to several months.

  1. What precautions should patients take during Irinotecan treatment?

Patients should closely follow their healthcare provider’s instructions, attend regular check-ups, and report any side effects or concerns promptly. They should also discuss potential drug interactions and any changes in their health status with their medical team.

  1. Can Irinotecan Hydrochloride Injection cure cancer?

While Irinotecan can lead to remission in some cases, its primary goal is to manage cancer by slowing down or halting the growth of cancer cells and improving the patient’s quality of life. It may be used as part of a comprehensive cancer treatment plan.

Patients should consult with their oncologist for personalized information and guidance regarding Irinotecan Hydrochloride Injection and its role in their cancer treatment.

As Irinotecan Hydrochloride Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Irinotecan Hydrochloride Injection 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

Irinotecan Hydrochloride Injection 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 Irinotecan Hydrochloride Injection, 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:

Irinotecan Hydrochloride Injection USP 20mg/ml (40mg/2ml, 100mg/5ml, 300mg/15ml, 500mg/25ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Irinotecan Hydrochloride Injection USP 20mg/ml (40mg/2ml, 100mg/5ml, 300mg/15ml, 500mg/25ml)
Each ml contains
Irinotecan Hydrochloride trihydrate…….20mg
Sorbitol………………………………………………..45mg
Lactic acid…………………………………………….0.9mg
Water for injection……………………………….q.s.
When necessary, PH was adjusted with sodium hydroxide and/or hydrochloric acid

THERAPEUTIC INDICATION:

Irinotecan is a medication used to treat colon cancer and small cell lung cancer.

PACKING:

20mg/ml
1) 40mg/2ml
2) 100mg/5ml
3) 300mg/15ml
4) 500mg/25ml

DIRECTION OF USE:

For Intravenous use only. Must be diluted before use.
For Intravenous use only must be diluted with 5% dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP before use.
Read accompanying package insert for detailed information of dosage, directions for use, Reconstitution, storage and precautions.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: For Intravenous use only. Must be diluted before use.
CONTRAINDICATIONS: Irinotecan Hydrochloride trihydrate for Injection is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. *Antineoplastic Agent
WARNING: You will be closely monitored (e.g. – blood test) by your doctor while using this medication. Keep all medical and laboratory appointments. Irinotecan may cause severe diarrhea, which can occur during or right after you receive this medication and/or more than 24 hours afterwards. If the diarrhea starts immediately, you may also have other side effects such as runny nose, increased saliva, watery eyes, sweating, stomach cramps or flushing. If the diarrhea starts later, it could be a different type that may be persistent and can cause serious (possibly fatal) loss of too much body water (dehydration).
IF CONTENTS ARE DAMAGED AND/OR LEAKING INCINERATE ENTIRE PACKAGE.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Protect from light. Do not freeze.
Dosage: As directed by the Oncologist.