Doxorubicin Hydrochloride for Injection USP 10mg (Humadrain)

Doxorubicin Hydrochloride for Injection USP 10mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Doxorubicin Hydrochloride for Injection USP 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Doxorubicin Hydrochloride for Injection USP 10mg
  Each sterile lyophilized vial contains:
  Doxorubicin Hydrochloride USP……10mg
  Mannitol USP……………………………….60mg
  Lactose Monohydrate USNF…………50mg
  Methyl Paraben USNF………………….2mg
  Sodium Hydroxide USNF………………q.s.
  Hydrochloric Acid USNF………………q.s.

THERAPEUTIC INDICATION:

Doxorubicin Hydrochloride is used in treatment of acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma.

DIRECTION OF USE:

For Intravenous use only.
Reconstitution for 10mg: Reconstitute with 5ml 0.9% sodium chloride injection. After reconstitution the   solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C. Discard unused portion.
Read accompanying leaflet for detailed dosage, directions of use and precautions.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution. Fatal if given intrathecally for Intravenous use only.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of Cancer Specialist only.
CAUTION: Cytotoxic agent – Special Handling.
This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
Use immediately after preparation.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store between 2°C to 8°C in a refrigerator. Do not freeze. Protect from light.
Dosage: As directed by the physician.

Why Taj Pharceuticals?

Taj Pharmaceuticals is your premier source for Doxorubicin Hydrochloride for Injection, an essential component in cancer treatment. Our unwavering dedication to pharmaceutical excellence ensures that every vial meets stringent global standards for safety and efficacy. At Taj Pharmaceuticals, we understand the significance of providing access to high-quality chemotherapy medications. Our commitment to affordability ensures that patients can receive this vital treatment without unnecessary financial burden. Innovation is at the core of our mission. We continually strive to advance drug formulations, improve treatment outcomes, and minimize side effects. Our research and development efforts focus on enhancing the efficacy and safety of Doxorubicin Hydrochloride for Injection. Choose Taj Pharmaceuticals for Doxorubicin Hydrochloride for Injection, and experience pharmaceutical excellence that places your health and well-being at the forefront. We are here to support you in your battle against cancer, offering the quality and affordability you deserve.

What is Doxorubicin Hydrochloride for Injection and its uses:

Doxorubicin Hydrochloride for Injection is a chemotherapy medication used in the treatment of various types of cancer. It belongs to a class of drugs known as anthracyclines and is often marketed under brand names like Adriamycin. Here’s an overview of Doxorubicin Hydrochloride for Injection and its primary uses:

• Composition: Doxorubicin Hydrochloride is the active ingredient in this medication.
• Primary Uses: Cancer Treatment: Doxorubicin Hydrochloride is primarily used in the treatment of various types of cancer, including:
  Breast cancer
  Ovarian cancer
  Lung cancer
  Bladder cancer
  Soft tissue sarcomas
  Hodgkin’s lymphoma
  Non-Hodgkin’s lymphoma
  Leukemia
  Wilms’ tumor (a type of kidney cancer in children)
• Mechanism of Action:
  Doxorubicin works by interfering with the replication and growth of cancer cells. It exerts its anticancer effects through multiple mechanisms, including:
  Inhibition of DNA and RNA synthesis, which disrupts the genetic material required for cell division.
  Generation of free radicals that cause damage to cellular structures, leading to cell death.
  Inhibition of topoisomerase II enzyme activity, which is essential for DNA replication and repair.
• Administration:
  Doxorubicin Hydrochloride is typically administered as an intravenous (IV) injection or infusion in a clinical setting under the supervision of a healthcare provider.
• Combination Therapy:
  It is often used in combination with other chemotherapy drugs to enhance its effectiveness in treating cancer.
• Off-Label Uses:
  In some cases, healthcare providers may prescribe Doxorubicin Hydrochloride for off-label uses, which are uses not approved by regulatory authorities but based on clinical judgment and research.

It’s important to note that Doxorubicin Hydrochloride for Injection is a potent chemotherapy drug with the potential for serious side effects. Treatment with this medication requires close monitoring by healthcare professionals. The specific dosing regimen and combination of drugs used in cancer treatment may vary depending on the type and stage of cancer, as well as the individual patient’s health and treatment goals. Patients receiving Doxorubicin should discuss potential risks and benefits with their healthcare provider.

How does Doxorubicin Hydrochloride for Injection work?

Doxorubicin Hydrochloride for Injection, commonly known as Doxorubicin, is a chemotherapy medication used to treat various types of cancer. It works by interfering with the growth and replication of cancer cells through multiple mechanisms:

• Inhibition of DNA and RNA Synthesis:
  Doxorubicin disrupts the synthesis of DNA and RNA, the genetic material necessary for the division and growth of cells, including cancer cells.
  It inserts itself into the DNA strands, preventing the normal separation of the double helix during replication. This interference inhibits the ability of cancer cells to make new DNA and RNA molecules, hindering their ability to divide and multiply.
• Generation of Free Radicals:
  Doxorubicin generates free radicals, which are highly reactive molecules that can cause damage to cellular structures, including DNA, proteins, and lipids.
  These free radicals induce oxidative stress within cancer cells, leading to cell damage and eventually cell death.
• Inhibition of Topoisomerase II Enzyme:
  Doxorubicin inhibits the activity of an enzyme called topoisomerase II, which plays a crucial role in DNA replication and repair.
  By interfering with topoisomerase II, Doxorubicin prevents the enzyme from unwinding and rewinding DNA strands properly. This results in the accumulation of DNA breaks within cancer cells, leading to their death.
• Disruption of Cell Cycle:
  Cancer cells typically undergo a cycle of growth and division. Doxorubicin disrupts this cycle by arresting cancer cells at various stages of the cell cycle, preventing them from progressing to the next phase.
  This cell cycle arrest further inhibits the ability of cancer cells to divide and multiply.

Overall, Doxorubicin’s multiple mechanisms of action make it a potent chemotherapy drug that targets rapidly dividing cancer cells. However, it can also affect normal, healthy cells, leading to potential side effects. The therapeutic benefit of Doxorubicin in treating cancer must be carefully balanced with the risk of adverse effects, and its use is typically determined by healthcare providers based on the specific type and stage of cancer being treated.

Benefits of Doxorubicin Hydrochloride for Injection:

• Effective Cancer Treatment: Doxorubicin is a potent chemotherapy drug that is highly effective in treating various types of cancer, including breast cancer, ovarian cancer, lung cancer, and lymphomas, among others.
• Widely Used: It has been used for many years and is considered a standard treatment for certain cancers, making it a well-established and trusted option in oncology.
• Combination Therapy: Doxorubicin is often used in combination with other chemotherapy drugs to enhance its effectiveness in cancer treatment. This combination approach can improve treatment outcomes.
• Treatment of Childhood Cancers: Doxorubicin is used to treat certain childhood cancers, such as Wilms’ tumor and certain types of leukemia, helping improve survival rates in pediatric oncology.
• Post-Surgery or Pre-Radiation: It may be used as adjuvant therapy after surgery to reduce the risk of cancer recurrence or as neoadjuvant therapy before surgery or radiation to shrink tumors and make them easier to remove.

Side Effects of Doxorubicin Hydrochloride for Injection:

• Cardiotoxicity: One of the most significant concerns with Doxorubicin is its potential to cause heart problems, including cardiomyopathy and congestive heart failure. Monitoring heart function during treatment is essential.
• Nausea and Vomiting: Doxorubicin can cause nausea and vomiting, which can be severe. Medications to prevent or manage these side effects are often prescribed.
• Myelosuppression: This drug can suppress bone marrow function, leading to a decrease in white blood cells, red blood cells, and platelets. This can result in an increased risk of infections, anemia, and bleeding.
• Hair Loss: Many individuals experience hair loss or thinning while receiving Doxorubicin chemotherapy.
• Mucositis: Inflammation and sores in the mouth and throat, known as mucositis, can occur as a side effect of Doxorubicin.
• Gastrointestinal Issues: Diarrhea and stomach pain are possible side effects of this medication.
• Fatigue: Many people receiving Doxorubicin experience fatigue, which can sometimes be severe and affect daily activities.
• Skin and Nail Changes: Skin may become more sensitive to sunlight, and nails may become brittle or discolored.
• Secondary Cancers: There is a small risk of developing secondary cancers, such as leukemia, after treatment with Doxorubicin, although the benefits of treatment typically outweigh this risk.
• Injection Site Reactions: Pain, redness, and swelling at the injection site can occur.

It’s important to note that the benefits and risks of Doxorubicin treatment vary depending on the specific type and stage of cancer, as well as individual patient factors. Healthcare providers carefully consider these factors when prescribing and monitoring Doxorubicin therapy. Close communication with the medical team is essential to manage side effects and ensure the best possible treatment outcome.

Frequently Asked Questions About Doxorubicin Hydrochloride for Injection:

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

1. What is Doxorubicin Hydrochloride for Injection used for?

Doxorubicin is a chemotherapy medication used to treat various types of cancer, including breast cancer, ovarian cancer, lung cancer, lymphomas, and childhood cancers, among others.

2. How is Doxorubicin administered?

Doxorubicin is typically administered as an intravenous (IV) injection or infusion in a clinical setting under the supervision of a healthcare provider.

3. What is the mechanism of action of Doxorubicin?

Doxorubicin interferes with the growth and replication of cancer cells by inhibiting DNA and RNA synthesis, generating free radicals that damage cellular structures, and inhibiting the topoisomerase II enzyme.

4. What are the potential side effects of Doxorubicin?

Common side effects may include nausea, vomiting, cardiotoxicity (heart problems), myelosuppression (bone marrow suppression), hair loss, fatigue, and mucositis (mouth and throat sores), among others.

5. Is Doxorubicin safe during pregnancy or breastfeeding?

Doxorubicin is generally not recommended during pregnancy as it can harm the developing fetus. It may also be excreted in breast milk, so breastfeeding is usually discouraged during treatment.

6. How is cardiotoxicity monitored during Doxorubicin treatment?

Cardiotoxicity is monitored through regular heart function assessments, including echocardiograms or MUGA scans, to detect any signs of heart damage.

7. Can Doxorubicin cause longterm side effects?

Long-term side effects may include an increased risk of secondary cancers, such as leukemia, although the benefits of treatment often outweigh this risk.

8. Are there any drug interactions with Doxorubicin?

Some medications may interact with Doxorubicin, potentially affecting its effectiveness or increasing the risk of side effects. It’s essential to inform your healthcare provider about all medications and supplements you are taking.

9. Can I drink alcohol while receiving Doxorubicin treatment?

Alcohol consumption should be limited during Doxorubicin treatment, as it may exacerbate certain side effects and affect liver function.

10. How often will I receive Doxorubicin injections?

The frequency of Doxorubicin injections depends on the specific cancer type, stage, and treatment plan prescribed by your healthcare provider. Treatment schedules can vary widely.

Always consult with your healthcare provider for personalized information and guidance regarding Doxorubicin Hydrochloride for Injection, including its use, potential side effects, and interactions.

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

Doxorubicin Hydrochloride for 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 Doxorubicin Hydrochloride for 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