Temozolomide Capsules 100mg Technical Specification:

Product Name:Temozolomide Capsules 100mg
Brand Name:Temozolomide
Strength:5mg, 20mg, 100mg, 140mg, 180mg, 250mg
Dosage Form:Hard-Gelatin Capsules
Packing:5s, 14s
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: Temozolomide is used to treat specific types of brain cancer (eg – glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed.
Storage:Store at 20°C to 25°C (68° to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Temozolomide Capsules 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Temozolomide Capsules 100mg
    Each hard-gelatin capsule contains:
    Temozolomide……………….100mg
    Excipients……………………………..q.s.
    Colours: Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Temozolomide is used to treat specific types of brain cancer (eg – glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed.

CAUTION & WARNING:

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

Caution: Cytotoxic: Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.

Caution: Cytotoxic Agent – Special Handling.

Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals/ Institutions and against prescription from a Cancer Specialist.

Attention Pharmacist: Special dispensing information included. Please review carefully.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

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

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

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

Why Taj Pharmaceuticals?

At Taj Pharma, we take pride in being a reliable partner in the fight against cancer, offering Temozolomide Capsules of the highest quality. Our pharmaceutical expertise is underscored by state-of-the-art manufacturing facilities and stringent quality control processes, ensuring that every capsule meets the most stringent industry standards. We prioritize patients’ well-being, striving to provide accessible and effective cancer treatments that make a positive difference in the lives of individuals and their families.

Our commitment to healthcare extends beyond delivering medications. We understand the urgency and sensitivity of cancer treatment, and our well-established supply chain ensures that Temozolomide Capsules are readily available when and where they are needed most. With Taj Pharma, you’re not just choosing a medication; you’re choosing a trusted partner dedicated to your health and hope. Count on us for unparalleled quality, reliability, and accessibility in the world of pharmaceuticals.

What is Temozolomide Capsules and its use?

Temozolomide Capsules are a medication used in the treatment of certain types of brain tumors. Temozolomide is the active ingredient, and it is typically administered orally in capsule form. Here’s an overview of Temozolomide Capsules and their uses:

Temozolomide:

Temozolomide is an oral chemotherapy drug classified as an alkylating agent. It works by damaging the DNA inside cancer cells, preventing them from dividing and growing. This is particularly effective against rapidly dividing cancer cells.

Uses:

  • Glioblastoma Multiforme: Temozolomide is commonly prescribed for patients with glioblastoma multiforme, which is a highly aggressive form of brain cancer. It is often used in combination with radiation therapy.
  • Anaplastic Astrocytoma: Temozolomide may also be used to treat anaplastic astrocytoma, another type of malignant brain tumor.
  • Other Brain Tumors: In some cases, Temozolomide may be considered for other types of brain tumors that are unresponsive to other treatments or have recurred.

Treatment Regimen:

The dosing and treatment schedule for Temozolomide Capsules depend on the type and stage of brain cancer being treated. Typically, the medication is taken daily for a specific number of days in a treatment cycle, followed by a rest period. This cycle may be repeated several times as part of the overall treatment plan.

How does Temozolomide Capsules Work?

Temozolomide Capsules work by damaging the DNA inside cancer cells, particularly those in the brain, which interferes with their ability to replicate and grow. This mechanism of action makes Temozolomide an effective chemotherapy drug for the treatment of certain types of brain tumors. Here’s a more detailed explanation of how Temozolomide works:

  • DNA Alkylating Agent: Temozolomide is classified as an alkylating agent. Alkylating agents are a group of chemotherapy drugs that attach chemical groups called alkyl groups to DNA molecules within the nucleus of a cell.
  • Formation of DNA Adducts: When Temozolomide is metabolized in the body, it produces a reactive compound called methyl-triazen-1-yl imidazole-4-carboxamide (MTIC). MTIC is responsible for the alkylating activity of Temozolomide.
  • DNA Modification: MTIC and its breakdown products can transfer alkyl groups to DNA strands. Specifically, they add alkyl groups to the DNA bases (guanine, in particular), forming abnormal chemical structures called DNA adducts.
  • DNA Damage: The formation of these DNA adducts disrupts the normal structure and function of DNA. The abnormal DNA adducts create kinks or breaks in the DNA strands, preventing the DNA from accurately replicating itself during cell division.
  • Cell Cycle Arrest and Cell Death: Cells with damaged DNA cannot successfully complete the cell cycle and divide. As a result, they may undergo cell cycle arrest, preventing them from proliferating further. Additionally, some of these cells may undergo programmed cell death, known as apoptosis.
  • Selective Action: Temozolomide’s effectiveness is particularly pronounced in rapidly dividing cancer cells, which are more susceptible to DNA damage because they are actively replicating. Healthy cells, which typically divide at a slower rate, are less affected by Temozolomide.
  • Targeting Brain Tumors: Temozolomide has the ability to penetrate the blood-brain barrier, which is a protective barrier around the brain. This allows it to reach brain tumors directly and exert its cytotoxic (cell-killing) effects in the brain tissue.

Benefits of Temozolomide:

  • Effective Against Brain Tumors: Temozolomide is often used as part of the standard treatment regimen for specific types of brain tumors. It can help slow the growth of cancer cells and shrink tumors in some cases.
  • Oral Administration: Temozolomide is available in oral capsule form, making it more convenient for patients to take compared to intravenous chemotherapy.
  • Adjunct to Radiation Therapy: It is sometimes used in combination with radiation therapy to enhance the treatment’s effectiveness.

Side Effects of Temozolomide:

  • Nausea and Vomiting: Nausea and vomiting are common side effects. Your healthcare provider may prescribe anti-nausea medications to help manage these symptoms.
  • Fatigue: Temozolomide can lead to fatigue or tiredness, which may affect your daily activities.
  • Low Blood Cell Counts: Temozolomide can suppress the bone marrow’s ability to produce blood cells, which can result in low levels of white blood cells (increasing the risk of infection), red blood cells (causing anemia), and platelets (raising the risk of bleeding). Blood tests will be done regularly to monitor these counts.
  • Hair Loss: Some people may experience hair loss while taking temozolomide.
  • Headache: Headaches can occur as a side effect.
  • Skin Rash: Skin rashes or allergic reactions are possible but less common.
  • Liver and Kidney Function: Temozolomide can affect liver and kidney function, so regular blood tests may be necessary to monitor these organs.
  • Digestive Issues: Diarrhea and constipation can occur in some cases.
  • Increased Risk of Blood Clots: Temozolomide may increase the risk of blood clots, which can be serious. Inform your healthcare provider if you experience symptoms like swelling, pain, or redness in the legs.
  • Other Side Effects: Less common side effects can include dizziness, confusion, and changes in blood pressure.

Frequently asked questions (FAQs) about Temozolomide Capsules:

  1. What is Temozolomide?

Temozolomide is a chemotherapy drug used to treat certain types of brain tumors, such as glioblastoma multiforme and anaplastic astrocytoma.

  1. How does Temozolomide work?

Temozolomide works by damaging the DNA in cancer cells, preventing them from growing and dividing. It is an oral alkylating agent.

  1. How is Temozolomide administered?

Temozolomide is usually taken orally in the form of capsules. Your healthcare provider will prescribe a specific dosing schedule.

  1. What are the common side effects of Temozolomide?

Common side effects include nausea, vomiting, fatigue, low blood cell counts, hair loss, headache, and digestive issues. However, side effects can vary from person to person.

  1. How can I manage nausea and vomiting caused by Temozolomide?

Your healthcare provider may prescribe antinausea medications to help manage these side effects. Eating small, frequent meals and staying hydrated may also help.

  1. Will I lose my hair while taking Temozolomide?

Some people may experience hair loss while on Temozolomide, but not everyone does. Hair loss can be temporary and typically grows back after treatment ends.

  1. How often will I need blood tests while on Temozolomide?

Regular blood tests will be required to monitor your blood cell counts and assess liver and kidney function. Your healthcare team will determine the frequency of these tests.

  1. Can Temozolomide affect my liver and kidneys?

Yes, Temozolomide can affect liver and kidney function. Monitoring these organ functions is essential during treatment.

  1. Are there any drug interactions with Temozolomide?

Temozolomide may interact with other medications you are taking, so it’s crucial to inform your healthcare provider about all your medications, including overthecounter drugs and supplements.

  1. Can I drink alcohol while on Temozolomide?

It is generally advisable to avoid alcohol while taking Temozolomide, as it can interact with the medication and may increase the risk of side effects.

  1. Is Temozolomide safe during pregnancy or breastfeeding?

Temozolomide can harm an unborn baby, so it should not be used during pregnancy. If you are breastfeeding or planning to become pregnant, discuss the risks and benefits with your healthcare provider.

  1. How long will I need to take Temozolomide?

The duration of Temozolomide treatment varies depending on your specific medical condition and treatment plan. Your healthcare provider will determine the appropriate treatment duration.

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

If you miss a dose, consult your healthcare provider or pharmacist for guidance. It’s essential to follow the prescribed dosing schedule as closely as possible.

As Temozolomide Capsules Exporters; We can cater to export business queries from the following geographies. We are exporting our Temozolomide Capsules 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

Temozolomide Capsules 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 Temozolomide Capsules, 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) Temozolomide Capsules 5mg
b) Temozolomide Capsules 20mg
c) Temozolomide Capsules 100mg
d) Temozolomide Capsules 140mg
e) Temozolomide Capsules 180mg
f) Temozolomide Capsules 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Temozolomide Capsules 5mg
Each hard-gelatin capsule contains:
Temozolomide ……………….5mg
Excipients……………………………..q.s.
Colours: Approved colours used in capsule shell.

b) Temozolomide Capsules USP 20mg
Each hard-gelatin capsule contains:
Temozolomide………………20mg
Excipients…………………………….q.s.
Colours: Approved colours used in capsule shell.

c) Temozolomide Capsules 100mg
Each hard-gelatin capsule contains:
Temozolomide……………100mg
Excipients…………………………..q.s.
Colours: Approved colours used in capsule shell.


d) Temozolomide Capsules 140mg
Each hard-gelatin capsule contains:
Temozolomide……………140mg
Excipients…………………………..q.s.
Colours: Approved colours used in capsule shell.

e) Temozolomide Capsules 180mg
Each hard-gelatin capsule contains:
Temozolomide…………….180mg
Excipients……………………………q.s.
Colours: Approved colours used in capsule shell.

f) Temozolomide Capsules 250mg
Each hard-gelatin capsule contains:
Temozolomide……………250mg
Excipients………………………….q.s.
Colours: Approved colours used in capsule shell.

THERAPEUTIC INDICATIONS:

Temozolomide is used to treat specific types of brain cancer (eg - glioblastoma multiforme, anaplastic astrocytoma) in patients whose tumors have returned or whose tumors have just been diagnosed.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Caution: Cytotoxic: Do not open the capsules. Swallow whole. If a capsule is damaged, avoid contact with your skin, eyes or nose.
Caution: Cytotoxic Agent – Special Handling.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals/ Institutions and against prescription from a Cancer Specialist.
Attention Pharmacist: Special dispensing information included. Please review carefully.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dispense in tight container, light-resistant containers as defined in the USP.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.