post-title portfolio-title Hydroxycarbamide (Hydroxyurea) Tablets 100mg 2023-02-24 06:27:36 no no

Hydroxycarbamide (Hydroxyurea) Tablets 100mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Hydroxycarbamide (Hydroxyurea) Tablets 100mg [THAROLAX]
B) Hydroxycarbamide (Hydroxyurea) Tablets 500mg [THAROLAX]
C) Hydroxycarbamide (Hydroxyurea) Tablets 1000mg [THAROLAX]

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Hydroxycarbamide (Hydroxyurea) Tablets 100mg
Each film-coated tablet contains:
Hydroxyurea USP
Hydroxycarbamide………….100mg
Excipients…………………….….q.s.
Colour: Titanium Dioxide USP

B) Hydroxycarbamide (Hydroxyurea) Tablets 500mg
Each film-coated tablet contains:
Hydroxyurea USP
Hydroxycarbamide………….500mg
Excipients…………………….….q.s.
Colour: Titanium Dioxide USP

C) Hydroxycarbamide (Hydroxyurea) Tablets 1000mg
Each film-coated tablet contains:
Hydroxyurea USP
Hydroxycarbamide………….1000mg
Excipients…………………….….q.s.
Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Hydroxyurea Tablets is used to treat cancer of the white blood cells called chronic myeloid leukemia (CML). It may also be given together with radiation treatment for head and neck cancer (advanced squamous cell cancer). Hydroxyurea interferes with the growth of cancer cells, which are eventually destroyed by the body. This medication is also used for sickle cell anaemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions in adults and children, 2 years of age and older.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: Cytotoxic Agent: To be supplied on demand from Cancer Hospitals, Institutions & on prescription of an Oncologist only
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Broken tablets must be stored in a bottle and must be used within three months.
Dosage: As directed by the Physician.
Take tablets 1 time a day at the same time each day.
Attach dispensing label as per end country.

Hydroxycarbamide (Hydroxyurea) Tablets 100mg Technical Specification:

Product Name:Hydroxycarbamide (Hydroxyurea) Tablets
Brand Name:THAROLAX
Strength:100mg, 500mg, 1000mg
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 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:Anti-anaemic, Sickle cell anaemia
Indication: Hydroxyurea Tablets is used to treat cancer of the white blood cells called chronic myeloid leukemia (CML). It may also be given together with radiation treatment for head and neck cancer (advanced squamous cell cancer). Hydroxyurea interferes with the growth of cancer cells, which are eventually destroyed by the body. This medication is also used for sickle cell anaemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions in adults and children, 2 years of age and older.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Hydroxycarbamide (Hydroxyurea) Tablets 100mg 
  • Hydroxycarbamide (Hydroxyurea) Tablets 500mg
  • Hydroxycarbamide (Hydroxyurea) Tablets 1000mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Hydroxycarbamide (Hydroxyurea) Tablets 100mg
    Each film-coated tablet contains:
    Hydroxyurea USP
    Hydroxycarbamide………….100mg
    Excipients…………………….….q.s.
    Colour: Titanium Dioxide USP
  • Hydroxycarbamide (Hydroxyurea) Tablets 500mg
    Each film-coated tablet contains:
    Hydroxyurea USP
    Hydroxycarbamide………….500mg
    Excipients…………………….….q.s.
    Colour: Titanium Dioxide USP
  • Hydroxycarbamide (Hydroxyurea) Tablets 1000mg
    Each film-coated tablet contains:
    Hydroxyurea USP
    Hydroxycarbamide………….1000mg
    Excipients…………………….….q.s.
    Colour: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Hydroxyurea Tablets is used to treat cancer of the white blood cells called chronic myeloid leukemia (CML). It may also be given together with radiation treatment for head and neck cancer (advanced squamous cell cancer). Hydroxyurea interferes with the growth of cancer cells, which are eventually destroyed by the body. This medication is also used for sickle cell anaemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions in adults and children, 2 years of age and older.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.

WARNING: Cytotoxic Agent: To be supplied on demand from Cancer Hospitals, Institutions & on prescription of an Oncologist only.

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

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Broken tablets must be stored in a bottle and must be used within three months.
Dosage: As directed by the Physician.
Take tablets 1 time a day at the same time each day.
Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands as a highly appealing choice for Hydroxycarbamide Tablets, offering a range of compelling reasons to instill confidence in patients and healthcare professionals alike. At the heart of their reputation is a steadfast commitment to quality assurance and safety. Taj Pharmaceuticals rigorously adheres to stringent quality control measures, ensuring that Hydroxycarbamide Tablets meet the highest industry standards. Patients can rely on the safety and effectiveness of their medications, placing their health at the forefront of every prescription.

With a rich history in the pharmaceutical industry, Taj Pharmaceuticals boasts a depth of experience and expertise that inspires trust. Over the years, they have consistently delivered reliable and effective medications, earning the confidence of healthcare providers and patients worldwide. This track record speaks to their unwavering dedication to excellence in healthcare. Taj Pharmaceuticals goes beyond past achievements through its commitment to research and development. Their ongoing efforts in this realm are geared towards optimizing their medications for therapeutic efficacy. This ensures that treatments like Hydroxycarbamide Tablets not only meet current healthcare needs but also evolve to address emerging challenges.

Global accessibility is a key strength of Taj Pharmaceuticals. Their extensive distribution network extends across borders, ensuring that essential medications reach patients wherever they may reside. This global reach is pivotal in providing healthcare solutions on a worldwide scale. Affordability is another pillar of Taj Pharmaceuticals’ approach. They understand the importance of making healthcare accessible and strive to offer cost-effective solutions. This commitment ensures that crucial medications like Hydroxycarbamide Tablets remain within reach for individuals, irrespective of economic constraints. In addition to their quality, accessibility, and affordability, Taj Pharmaceuticals places a strong emphasis on a customer-centric approach. Patient satisfaction is a top priority, and they are dedicated to providing exceptional service and support. This fosters a positive healthcare experience, where patient needs and concerns are addressed with utmost care.

Environmental responsibility is also woven into Taj Pharmaceuticals’ ethos. They actively pursue environmentally responsible manufacturing practices, striving to minimize their ecological footprint and contribute to overall sustainability. In sum, Taj Pharmaceuticals emerges as a trusted healthcare partner for Hydroxycarbamide Tablets. Their unwavering commitment to quality, safety, affordability, and customer satisfaction underscores their mission to prioritize the health and well-being of patients. By choosing Taj Pharmaceuticals, individuals and healthcare providers are selecting a reliable partner with a global presence and a legacy of excellence in healthcare.

What is Hydroxycarbamide Tablets and its uses:

Hydroxycarbamide Tablets, also known by the trade name Hydroxyurea, are a medication that contains the active ingredient hydroxycarbamide. These tablets are used to treat various medical conditions and are particularly known for their effectiveness in certain blood disorders. Here are its primary uses:

  • Blood Disorders: Sickle Cell Disease: Hydroxycarbamide is commonly prescribed to manage sickle cell disease, a genetic blood disorder. It helps reduce the frequency and severity of pain crises and other complications associated with this condition. Increasing the production of fetal hemoglobin (HbF) can inhibit the formation of abnormal hemoglobin (HbS) which leads to the sickling of red blood cells.
    Polycythemia Vera: Hydroxycarbamide is also used in the treatment of polycythemia vera, a rare blood disorder characterized by the overproduction of red blood cells. It helps lower the elevated red blood cell count, reducing the risk of complications like blood clots.
    Essential Thrombocythemia: In cases of essential thrombocythemia, where there is an excessive production of platelets, Hydroxycarbamide can be prescribed to lower platelet counts and reduce the risk of thrombotic events
  • Cancer Treatment: Hydroxycarbamide has applications in cancer treatment. It is sometimes used in combination with other medications or therapies to treat certain types of cancer, such as chronic myeloid leukemia (CML) and some forms of head and neck cancer.
  • Psoriasis and HIV Infection: Hydroxycarbamide may be considered in the treatment of psoriasis, a skin condition, and as part of therapy for some patients with HIV infection
  • Other Uses: In some cases, healthcare providers may prescribe Hydroxycarbamide for off-label uses, depending on the patient’s specific medical condition and needs. Always follow your healthcare provider’s recommendations regarding the use of this medication.

Hydroxycarbamide works by inhibiting the growth and division of rapidly multiplying cells, including abnormal blood cells or cancer cells. This helps regulate the production of blood components, such as red blood cells, white blood cells, and platelets and can be particularly beneficial in conditions where there is an overproduction of these blood elements.

How do Hydroxycarbamide Tablets Work?

Hydroxycarbamide Tablets work by inhibiting the growth and replication of rapidly dividing cells in the body, including abnormal blood cells. The primary mechanism of action involves interfering with the synthesis of DNA, the genetic material in cells, which is necessary for cell division and growth. Here’s how Hydroxycarbamide Tablets work:

  • Inhibition of DNA Synthesis: Hydroxycarbamide, the active ingredient in the tablets, exerts its effect by inhibiting an enzyme called ribonucleotide reductase. This enzyme is crucial for the production of deoxyribonucleotides, the building blocks of DNA.
  • Depletion of Nucleotide Pools: By inhibiting ribonucleotide reductase, Hydroxycarbamide reduces the availability of deoxyribonucleotides. This depletion of nucleotide pools interferes with the synthesis of DNA strands during cell replication.
  • Interference with Cell Division: Without sufficient DNA building blocks, cells cannot replicate their genetic material accurately. This interference disrupts the normal cell division process, leading to cell cycle arrest, or cells becoming unable to progress through the cell division phases.
  • Inhibition of Rapidly Dividing Cells: Hydroxycarbamide has a greater impact on rapidly dividing cells, such as cancer cells and certain abnormal blood cells seen in conditions like sickle cell disease, polycythemia vera, and essential thrombocythemia. These cells rely heavily on DNA synthesis and cell division for their rapid proliferation.

In specific blood disorders, Hydroxycarbamide can increase the production of fetal hemoglobin (HbF), a type of hemoglobin typically found in newborns. This is particularly beneficial in sickle cell disease because HbF inhibits the formation of abnormal hemoglobin (HbS), which causes red blood cells to become misshapen and leads to sickling.

Hydroxycarbamide Tablets offer several benefits in the treatment of various medical conditions, but they can also be associated with potential side effects. Here’s an overview of the benefits and common side effects:

Benefits of Hydroxycarbamide Tablets:

  • Management of Sickle Cell Disease: One of the primary uses of Hydroxycarbamide is in the management of sickle cell disease. It helps reduce the frequency and severity of pain crises (sickle cell crises) by increasing the production of fetal hemoglobin (HbF) and inhibiting the formation of abnormal hemoglobin (HbS), which causes the sickling of red blood cells.
  • Polycythemia Vera: Hydroxycarbamide is effective in the treatment of polycythemia vera, a condition characterized by the overproduction of red blood cells. It helps lower elevated red blood cell counts, reducing the risk of complications like blood clots.
  • Essential Thrombocythemia: In cases of essential thrombocythemia, where there is an excessive production of platelets, Hydroxycarbamide can be prescribed to lower platelet counts and reduce the risk of thrombotic events.
  • Cancer Treatment: Hydroxycarbamide is used in cancer treatment, particularly for conditions like chronic myeloid leukemia (CML) and some forms of head and neck cancer. It helps slow down the growth of cancer cells.

Common Side Effects of Hydroxycarbamide Tablets:

  • Gastrointestinal Symptoms: Common side effects may include nausea, vomiting, diarrhea, and abdominal discomfort. These symptoms can often be managed with supportive care.
  • Bone Marrow Suppression: Hydroxycarbamide can lead to bone marrow suppression, resulting in decreased production of blood cells (red blood cells, white blood cells, and platelets). This may lead to anemia, increased susceptibility to infections, and an increased risk of bleeding.
  • Skin Changes: Some patients may experience skin changes, such as skin darkening or skin ulcers, especially if they have been taking the medication for an extended period.
  • Headache and Fatigue: Headache and fatigue are among the side effects reported by some individuals while taking Hydroxycarbamide.
  • Mild Hair Loss: Some patients may experience mild hair loss during treatment.
  • Oral Ulcers: The development of oral ulcers is a less common side effect but should be reported to a healthcare provider if they occur.
  • Reversible Male Infertility: In some cases, Hydroxycarbamide can lead to reversible male infertility. Patients concerned about fertility should discuss this with their healthcare provider.
  • Other Side Effects: Less common side effects may include respiratory symptoms, fever, and gastrointestinal bleeding.

Frequently Asked Questions About Hydroxycarbamide Tablets:

Certainly, here are some frequently asked questions (FAQs) about Hydroxycarbamide Tablets:

  • What are Hydroxycarbamide Tablets?

Hydroxycarbamide Tablets are a prescription medication that contains the active ingredient hydroxycarbamide. They are used to treat various medical conditions, including sickle cell disease, polycythemia vera, and certain types of cancer.

  • How do Hydroxycarbamide Tablets work?

Hydroxycarbamide inhibits the growth and replication of rapidly dividing cells, including abnormal blood cells and cancer cells, by interfering with DNA synthesis. This helps regulate blood cell production and control the growth of cancer cells.

  • What medical conditions are treated with Hydroxycarbamide Tablets?

Hydroxycarbamide is primarily used to manage sickle cell disease, polycythemia vera, and essential thrombocythemia. It is also employed in cancer treatment for conditions like chronic myeloid leukemia (CML).

  • How is Hydroxycarbamide administered?

Hydroxycarbamide Tablets are usually taken orally with water, as directed by a healthcare provider. The dosage and frequency of administration depend on the specific medical condition and the patient’s individual needs.

  • What are the common side effects of Hydroxycarbamide Tablets?

Common side effects may include nausea, vomiting, diarrhea, abdominal discomfort, bone marrow suppression (leading to anemia, increased infection risk, and bleeding risk), skin changes, headache, fatigue, and mild hair loss.

  • How long does it take for Hydroxycarbamide to show results in treating sickle cell disease?

The time it takes for Hydroxycarbamide to show noticeable improvement in sickle cell disease varies from patient to patient. Some individuals may experience benefits within a few weeks, while for others, it may take several months.

  • Are there any precautions or monitoring required during Hydroxycarbamide treatment?

Patients receiving Hydroxycarbamide typically require regular monitoring of blood counts to ensure that the medication is effective and safe. Healthcare providers may adjust the dosage based on these results.

  • Can Hydroxycarbamide be used during pregnancy or breastfeeding?

The use of Hydroxycarbamide during pregnancy or while breastfeeding should be carefully considered, and the potential benefits should outweigh the risks. Pregnant or breastfeeding individuals should discuss this with their healthcare provider.

  • Is it safe to drink alcohol while taking Hydroxycarbamide Tablets?

It’s advisable to consult with a healthcare provider regarding alcohol consumption while taking Hydroxycarbamide, as it may interact with the medication.

  • Can Hydroxycarbamide cause longterm side effects?

Long-term use of Hydroxycarbamide may be associated with certain side effects, such as skin changes. Patients should have regular follow-up appointments with their healthcare provider to monitor any potential long-term effects.

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

Hydroxycarbamide Tablets 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 Hydroxycarbamide Tablets, 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

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