GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Hydroxyurea Capsules USP 200mg
b) Hydroxyurea Capsules USP 300mg
c) Hydroxyurea Capsules USP 400mg
d) Hydroxyurea Capsules USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Hydroxyurea Capsules USP 200mg
Each hard gelatin capsule contains:
Hydroxyurea USP………………200mg
Excipients………………………….q.s.
Colours: Approved colours used in capsule shell

b) Hydroxyurea Capsules USP 300mg
Each hard gelatin capsule contains:
Hydroxyurea USP……………….300mg
Excipients…………………………..q.s.
Colours: Approved colours used in capsule shell

c) Hydroxyurea Capsules USP 400mg
Each hard gelatin capsule contains:
Hydroxyurea USP………………..400mg
Excipients……………………………q.s.
Colours: Approved colours used in capsule shell

d) Hydroxyurea Capsules USP 500mg
Each hard gelatin capsule contains:
Hydroxyurea USP……………….500mg
Excipients…………………………..q.s.
Colours: Approved colours used in capsule shell


THERAPEUTIC INDICATION:

Hydroxyurea 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.

CAUTION & WARNING:

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.
CAUTION: It is dangerous to take this preparation except under medical supervision.
Swallow capsules whole. Do not chew, dissolve or open the capsules.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F).
Do not refrigerate.
Dosage: As directed by an Oncologist.

Hydroxyurea Capsules USP 500mg Technical Specification:

Product Name:Hydroxyurea Capsules USP 500mg
Brand Name:Tharolax
Strength:200mg, 300mg, 400mg, 500mg
Dosage Form:Hard – Gelatin capsule
Packing:10s, 50s, 60s, 100s
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: Hydroxyurea 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.
Storage:Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F). Do not refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Hydroxyurea Capsules USP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Hydroxyurea Capsules USP 500mg
    Each hard gelatin capsule contains:
    Hydroxyurea USP………………500mg
    Excipients………………………….q.s.
    Colours: Approved colours used in capsule shell

THERAPEUTIC INDICATION:

Hydroxyurea 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.

CAUTION & WARNING:

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.
CAUTION: It is dangerous to take this preparation except under medical supervision.
Swallow capsules whole. Do not chew, dissolve or open the capsules.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F).
Do not refrigerate.
Dosage: As directed by an Oncologist.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a renowned pharmaceutical company known for its commitment to quality and effectiveness in providing Hydroxyurea Capsules. With a strong emphasis on quality assurance, they manufacture these capsules in state-of-the-art facilities while adhering to strict quality standards and Good Manufacturing Practices (GMP). This ensures that patients receive consistent and high-quality medication that meets the highest industry standards. With years of experience in the pharmaceutical industry, Taj Pharmaceuticals has earned a reputation as a reliable and knowledgeable provider of pharmaceutical products. Their expertise extends to the production of Hydroxyurea Capsules, which are used in the treatment of various medical conditions. Patients can trust in the company’s extensive experience and dedication to improving healthcare. Taj Pharmaceuticals is deeply committed to the health and well-being of patients. They understand the critical importance of providing safe and effective medications like Hydroxyurea Capsules to individuals who rely on them for the management of their medical conditions. This commitment to patient health is at the core of their mission. Investing in research and development is another hallmark of Taj Pharmaceuticals. This commitment to innovation ensures that their Hydroxyurea Capsules are up-to-date with the latest advancements in medical science. Patients can benefit from cutting-edge treatments that result from ongoing research efforts. Compliance with regulatory standards is a top priority for Taj Pharmaceuticals. They adhere to stringent national and international regulatory standards, ensuring that their Hydroxyurea Capsules meet all necessary safety and efficacy requirements. Patients and healthcare providers can have confidence in the quality and reliability of Taj Pharmaceuticals’ products. Taj Pharmaceuticals’ wide availability and distribution network make it convenient for patients and healthcare providers to access Hydroxyurea Capsules. Their patient-centric approach includes providing clear information, educational resources, and support to both patients and healthcare professionals, further enhancing the overall patient experience. Taj Pharmaceuticals stands out as a trusted provider of Hydroxyurea Capsules due to its unwavering commitment to quality, patient health, and regulatory compliance. With a wealth of experience, dedication to innovation, and a patient-centric approach, they continue to make significant contributions to the pharmaceutical industry and the well-being of patients worldwide.

What is Hydroxyurea Capsules and its uses:

Hydroxyurea Capsules are a medication that contains the active ingredient hydroxyurea, a cytotoxic (cell-killing) agent. They are prescribed for various medical conditions and have several important uses:

  • Treatment of Sickle Cell Disease (SCD): Hydroxyurea Capsules are commonly used to manage sickle cell disease, a genetic blood disorder. Sickle cell disease causes red blood cells to become misshapen and less flexible, leading to pain, anemia, and other complications. Hydroxyurea helps by increasing the production of fetal hemoglobin, which is a type of hemoglobin that reduces the formation of sickle-shaped cells. This can reduce the frequency and severity of pain crises and other complications associated with SCD.
  • Treatment of Myeloproliferative Disorders: Hydroxyurea is also used in the treatment of certain myeloproliferative disorders, such as essential thrombocythemia, polycythemia vera, and chronic myelogenous leukemia (CML). It helps to lower the abnormally high number of blood cells in these conditions, reducing the risk of blood clots and other complications.
  • Treatment of Solid Tumors: In some cases, Hydroxyurea Capsules may be prescribed for the treatment of solid tumors, such as melanoma, ovarian cancer, and head and neck cancers. It works by inhibiting the growth of cancer cells and preventing them from multiplying.
  • HIV Infection Management: Hydroxyurea is sometimes used as part of combination therapy for managing HIV infection. It can help lower viral load and boost the immune system’s response to the virus.
  • Psoriasis Treatment: Hydroxyurea has been used off-label for the treatment of severe psoriasis, a chronic skin condition characterized by thick, scaly patches of skin. It may help reduce the symptoms and severity of psoriasis flares.

It’s important to note that Hydroxyurea Capsules should only be used under the supervision of a healthcare professional, as they can have potential side effects and should be tailored to the specific condition and needs of the patient. The appropriate dosage and duration of treatment will be determined by a healthcare provider based on the individual’s medical history and condition. Patients should always follow their healthcare provider’s instructions when taking Hydroxyurea Capsules.

How Does Hydroxyurea Capsules Work?

Hydroxyurea Capsules work primarily by interfering with the growth and replication of cells, particularly rapidly dividing cells. This mechanism of action makes them useful in the treatment of various medical conditions, including sickle cell disease, myeloproliferative disorders, and certain types of cancer. Here’s how Hydroxyurea works:

  • Inhibition of DNA Synthesis: Hydroxyurea inhibits the enzyme ribonucleotide reductase, which is essential for the production of deoxyribonucleotides, the building blocks of DNA. By reducing the availability of deoxyribonucleotides, the medication interferes with the synthesis of DNA. This disrupts the ability of cells, especially rapidly dividing ones like cancer cells, to replicate their DNA and divide. As a result, the growth and proliferation of these cells are slowed or halted.
  • Induction of Fetal Hemoglobin (HbF) Production: In the treatment of sickle cell disease, Hydroxyurea is known to stimulate the production of fetal hemoglobin (HbF). Fetal hemoglobin is a type of hemoglobin that is present in newborns and has a different structure from adult hemoglobin (HbA). HbF is less prone to forming the characteristic sickle-shaped red blood cells seen in sickle cell disease. By increasing HbF levels, Hydroxyurea helps to improve the overall quality of red blood cells and reduce the frequency of painful vaso-occlusive crises in patients with sickle cell disease.
  • Reducing Blood Cell Counts: In myeloproliferative disorders, Hydroxyurea can reduce the abnormally high number of blood cells, such as red blood cells, white blood cells, and platelets, that are produced by the bone marrow. This helps to alleviate symptoms and reduce the risk of complications associated with these disorders, such as blood clot formation.
  • Inhibition of Cancer Cell Growth: Hydroxyurea’s ability to interfere with DNA synthesis and cell division is also valuable in cancer treatment. It disrupts the growth and replication of cancer cells, slowing down or stopping the progression of solid tumors and certain types of blood cancers.

It’s important to note that Hydroxyurea should be used under the supervision and guidance of a healthcare professional, as it can have potential side effects and requires careful monitoring to ensure its effectiveness and safety. The dosage and duration of treatment will be determined by a healthcare provider based on the specific medical condition and needs of the patient. Patients should follow their healthcare provider’s instructions and report any side effects or concerns while taking Hydroxyurea Capsules.

Benefits of Hydroxyurea Capsules:

  • Sickle Cell Disease Management: One of the primary benefits of Hydroxyurea Capsules is their effectiveness in managing sickle cell disease (SCD). They can reduce the frequency and severity of painful vaso-occlusive crises, which are common in SCD. By increasing the production of fetal hemoglobin (HbF), Hydroxyurea improves the quality of red blood cells and helps prevent them from assuming the characteristic sickle shape.
  • Myeloproliferative Disorder Treatment: Hydroxyurea is used to treat myeloproliferative disorders such as essential thrombocythemia, polycythemia vera, and chronic myelogenous leukemia (CML). It helps normalize blood cell counts, reducing the risk of blood clots and other complications associated with these disorders.
  • Cancer Treatment: Hydroxyurea Capsules are used in the treatment of various cancers, including melanoma, ovarian cancer, and head and neck cancers. They inhibit the growth of cancer cells and prevent them from multiplying, which can slow down or halt tumor progression.
  • HIV Infection Management: In HIV-infected individuals, Hydroxyurea can be part of combination therapy to lower viral load and enhance the immune system’s response to the virus.

Side Effects of Hydroxyurea Capsules:

While Hydroxyurea can offer significant benefits, it also has potential side effects, and not everyone may experience them. Common side effects may include:

  • Bone Marrow Suppression: Hydroxyurea can suppress the bone marrow’s ability to produce blood cells, leading to anemia (low red blood cell count), leukopenia (low white blood cell count), and thrombocytopenia (low platelet count). This can increase the risk of infections, bleeding, and fatigue.
  • Gastrointestinal Issues: Some individuals may experience gastrointestinal side effects, such as nausea, vomiting, diarrhea, or constipation.
  • Skin Changes: Skin reactions like rash, itching, and changes in skin pigmentation can occur with Hydroxyurea use.
  • Oral Ulcers: Mouth sores or ulcers can develop in some individuals.
  • Elevated Liver Enzymes: Increased levels of liver enzymes may occur in some patients, which should be monitored by healthcare providers.
  • Fertility and Pregnancy: Hydroxyurea may affect fertility and should be used with caution in individuals planning to conceive. It is contraindicated during pregnancy due to potential harm to the developing fetus.
  • Secondary Leukemia: In rare cases, long-term use of Hydroxyurea has been associated with the development of secondary leukemia.

It’s essential for individuals taking Hydroxyurea to have regular check-ups and blood tests to monitor blood cell counts and liver function. Any unusual symptoms or side effects should be reported to a healthcare provider promptly. The benefits and risks of Hydroxyurea treatment should be carefully considered by both the patient and healthcare provider to determine the most appropriate treatment plan for a specific medical condition.

Frequently Asked Questions About Hydroxyurea Capsules:

  1. What is Hydroxyurea Capsules, and how does it work?

Hydroxyurea is a medication that interferes with the growth and replication of cells, primarily by inhibiting DNA synthesis. It is used to treat various medical conditions, including sickle cell disease, myeloproliferative disorders, and certain types of cancer.

  1. How does Hydroxyurea help in sickle cell disease management?

Hydroxyurea increases the production of fetal hemoglobin (HbF), which is less prone to forming the characteristic sickle-shaped red blood cells seen in sickle cell disease. This helps reduce the frequency and severity of painful vaso-occlusive crises in individuals with SCD.

  1. What are the common side effects of Hydroxyurea?

Common side effects may include bone marrow suppression (anemia, leukopenia, thrombocytopenia), gastrointestinal symptoms (nausea, vomiting, diarrhea), skin changes, oral ulcers, elevated liver enzymes, and skin pigmentation changes. It’s important to discuss potential side effects with your healthcare provider.

  1. How is the dosage of Hydroxyurea determined?

The dosage of Hydroxyurea is determined by a healthcare provider based on the specific medical condition being treated, the patient’s age, weight, and overall health. It may require adjustments over time based on the individual’s response to treatment.

  1. Can Hydroxyurea be used during pregnancy?

Hydroxyurea is contraindicated during pregnancy due to the potential risk of harm to the developing fetus. Women of childbearing age should use effective contraception while taking this medication.

  1. Is Hydroxyurea safe for long-term use?

Hydroxyurea can be used for extended periods, but its safety and effectiveness require careful monitoring by a healthcare provider. Regular blood tests to assess blood cell counts and liver function are essential during long-term use.

  1. Can Hydroxyurea be used in children?

Hydroxyurea can be prescribed for pediatric patients, particularly for the treatment of sickle cell disease. The dosage and monitoring will be tailored to the child’s specific needs.

  1. Are there any drug interactions with Hydroxyurea?

Hydroxyurea may interact with other medications or treatments. It’s important to inform your healthcare provider about all the medications, supplements, and treatments you are currently using to avoid potential interactions.

  1. What precautions should be taken while on Hydroxyurea therapy?

Patients taking Hydroxyurea should avoid exposure to infectious agents, stay hydrated, and follow their healthcare provider’s recommendations for blood tests and monitoring. They should also report any unusual symptoms or side effects promptly.

  1. Can Hydroxyurea cure sickle cell disease or cancer?

Hydroxyurea is not a cure for sickle cell disease or cancer but is used to manage symptoms and slow down disease progression. It can significantly improve the quality of life for individuals with these conditions and may help control cancer growth in certain cases.

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

Hydroxyurea 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 Hydroxyurea 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