GENERIC NAME OF THE MEDICINAL PRODUCT:

Cytarabine Injection USP 1gm/10ml
Cytarabine Injection USP 2gm/20ml
Cytarabine Injection USP 500mg/5ml
Cytarabine Injection USP 100mg/1ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Cytarabine Injection USP 1gm/10ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
B) Cytarabine Injection USP 2gm/20ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
C) Cytarabine Injection USP 500mg/5ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.
D) Cytarabine Injection USP 100mg/1ml
Each ml Contains:
Cytarabine HIS Sodium…………………….100mg
Hydroxide USP Hydrochloride……………..q.s.
Acid USP…………………………………….q.s.
Water for Injection USP………………….q.s.

THERAPEUTIC INDICATIONS:

Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute non-lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.

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
CAUTION: Cytotoxic agent – Special Handling
CAUTION: This is a potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against prescription of a Cancer Specialist only.
Cytotoxic Agent: Wear gloves at all times when handling containers.
OVERDOSAGE: There is no antidote for overdosage of Cytarabine Injection. Doses of 4.5 g/m2 by intravenous infusion over 1 hour every 12 hours for 12 doses have caused an unacceptable increase in irreversible CNS toxicity and death. Single doses as high as 3 g/m2 have been administered by rapid intravenous infusion without apparent toxicity.
NOTE: Only physicians experienced in cancer chemotherapy should use Cytarabine Injection.
IMPORTANT WARNING:
For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine injection is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Contains no antibacterial preservatives.
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].
Dosage: As directed by the Oncologist.

Cytarabine Injection USP 500mg/5ml Technical Specification: 

Product Name:Cytarabine Injection USP
Brand Name:Cyotaj
Strength:1gm/10ml, 2gm/20ml, 500mg/5ml, 100mg/1ml
Dosage Form:Liquid Injection
Packing:Single-use vial
Route of Administration:For I.V. 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: Cytarabine Injection in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute non-lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative-free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.
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].

Cytarabine Injection USP 500mg Manufacturers, Suppliers in India:

Taj Pharmaceuticals is of the prominent Cytarabine Injection USP 500mg Manufacturers in India that brings the best quality products. Our company Taj Pharma carries a rich experience in the niche manufacturing of Cytarabine Injection.

Taj Pharmaceuticals is a reputed manufacturer and Cytarabine Injection USP 500mg Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.

Taj Pharma is a well-known Cytarabine Injection USP 500mg Manufacturer in India that gives the assurance of high- quality and high standard. Strict quality control ensures that every batch of medicine brings a harmonious standard.

Cytarabine Injection USP 500mg manufactured at Taj Pharma follows USP (United States Pharmacopeia); i.e. the product is manufactured to comply with USP quality standards which are considered the Best in the world. Further, Taj Pharma uses Cytarabine Injection USP grade best active ingredient to manufacture its Injections to comply with international standards of European products.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cytarabine Injection USP 1gm/10ml
    Each ml Contains:
    Cytarabine HIS Sodium…………………….100mg
    Hydroxide USP Hydrochloride……………..q.s.
    Acid USP…………………………………….q.s.
    Water for Injection USP………………….q.s.
  • Cytarabine Injection USP 2gm/20ml
    Each ml Contains:
    Cytarabine HIS Sodium…………………….100mg
    Hydroxide USP Hydrochloride……………..q.s.
    Acid USP…………………………………….q.s.
    Water for Injection USP………………….q.s.
  • Cytarabine Injection USP 500mg/5ml
    Each ml Contains:
    Cytarabine HIS Sodium…………………….100mg
    Hydroxide USP Hydrochloride……………..q.s.
    Acid USP…………………………………….q.s.
    Water for Injection USP………………….q.s.
  • Cytarabine Injection USP 100mg/1ml
    Each ml Contains:
    Cytarabine HIS Sodium…………………….100mg
    Hydroxide USP Hydrochloride……………..q.s.
    Acid USP…………………………………….q.s.
    Water for Injection USP………………….q.s.

THERAPEUTIC INDICATIONS:

Cytarabine Injection in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute non-lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative-free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.

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

CAUTION: Cytotoxic agent – Special Handling

CAUTION: This is a potent cytotoxic agent. Use only after reading the directions on the pack insert.

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

WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institu   tions & against the prescription of a Cancer Specialist only.

Cytotoxic Agent: Wear gloves at all times when handling containers.

OVERDOSAGE: There is no antidote for overdosage of Cytarabine Injection. Doses of 4.5 g/m2 by intravenous infusion over 1 hour every 12 hours for 12 doses have caused an unacceptable increase in irreversible CNS toxicity and death. Single doses as high as 3 g/m2 have been administered by rapid intravenous infusion without apparent toxicity.

NOTE: Only physicians experienced in cancer chemotherapy should use Cytarabine Injection.

IMPORTANT WARNING:
For induction therapy, patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine injection is bone marrow suppression with leukopenia, thrombocytopenia, and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Contains no antibacterial preservatives.
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].

Dosage: As directed by the Oncologist.

Why Taj Pharmaceuticals?

Discover Enhanced Cancer Care with Taj Pharmaceuticals: Cytarabine Injection USP

Taj Pharmaceuticals brings a wealth of experience to the forefront of cancer treatment, offering Cytarabine Injection USP as a critical tool in combating cancer. Backed by a legacy of pharmaceutical expertise, our Cytarabine Injection USP is the result of meticulous research and stringent quality control measures. This assures patients of a treatment that meets the highest standards of safety and efficacy.

At the heart of our approach is a commitment to effective cancer management. Cytarabine, a potent chemotherapy agent, forms the cornerstone of our Cytarabine Injection USP, demonstrating its capability to hinder cancer cell growth and division. This offers patients facing leukemia and lymphoma a dependable option in their battle against cancer. Taj Pharmaceuticals places patients first by ensuring accessibility to quality treatments. Our Cytarabine Injection USP underscores this commitment, striving to provide effective care without compromise. Collaborating closely with medical professionals, we ensure that our medication aligns with the latest advancements in cancer treatment.

A holistic view of cancer care guides our approach. The Cytarabine Injection USP is designed to integrate seamlessly into comprehensive treatment strategies, enhancing overall outcomes and quality of life. With a global presence, Taj Pharmaceuticals ensures that this vital treatment reaches patients and healthcare providers worldwide. Taj Pharmaceuticals’ dedication to pharmaceutical excellence shines through our Cytarabine Injection USP. By choosing us, patients gain a steadfast ally in the fight against cancer, fortified by a legacy of quality, a patient-centric ethos, and a shared commitment to advancing cancer care.

What is Cytarabine Injection USP and its uses:

Cytarabine Injection USP, is a medication used in the treatment of various types of cancer, particularly leukemia and lymphoma. It is a chemotherapy drug that works by interfering with the growth and replication of cancer cells. Here’s an overview of cytarabine and its uses:

Cytarabine (Cytarabine Injection USP):
Cytarabine is a synthetic nucleoside analog of cytidine, a building block of DNA. It is incorporated into the DNA of rapidly dividing cells, including cancer cells, which disrupts the normal DNA replication process and ultimately leads to cell death. Cytarabine primarily targets cells in the S-phase of the cell cycle, where DNA replication is actively taking place.

Uses: Cytarabine Injection USP is used in the treatment of several types of cancer, with the most common indications being:

  • Acute Myeloid Leukemia (AML): Cytarabine is a cornerstone of chemotherapy regimens for AML. It’s often used in combination with other chemotherapy drugs to induce remission by suppressing the abnormal growth of leukemia cells.
  • Acute Lymphoblastic Leukemia (ALL): Cytarabine can also be part of chemotherapy protocols for ALL, a type of leukemia that primarily affects lymphocytes.
  • Non-Hodgkin Lymphoma: Cytarabine is used in combination with other drugs to treat certain types of non-Hodgkin lymphoma, a cancer that starts in lymphocytes (white blood cells).
  • Hodgkin Lymphoma: In some cases, cytarabine is used in combination with other chemotherapy agents for the treatment of Hodgkin lymphoma.
  • Meningeal Leukemia: Cytarabine can also be administered directly into the cerebrospinal fluid (intrathecal administration) to treat leukemia that has spread to the central nervous system, a condition known as meningeal leukemia.

It’s important to note that cytarabine is typically administered by healthcare professionals in a controlled clinical setting, as it can have significant side effects and requires careful monitoring. The specific regimen and dosage of cytarabine will depend on the type of cancer being treated, the patient’s overall health, and the treatment plan determined by the medical team. Like many chemotherapy drugs, cytarabine affects both cancer cells and normal cells that divide rapidly, which can lead to side effects. These side effects may include nausea, vomiting, fatigue, decreased blood cell counts, mouth sores, and hair loss. Close communication with the healthcare provider is essential to manage these side effects and ensure the best possible treatment outcome.

How does Cytarabine Injection USP work?

Cytarabine Injection USP works by disrupting the process of DNA synthesis and replication in rapidly dividing cells, particularly cancer cells. Here’s how it works:

  • Nucleoside Analog: Cytarabine is a synthetic analog of cytidine, which is one of the building blocks of DNA. It resembles cytidine in structure but has a slightly altered configuration.
  • Incorporation into DNA: During DNA replication, cells use cytidine to build new DNA strands. Cytarabine is taken up by the cancer cells and incorporated into their DNA during the replication process.
  • DNA Chain Termination: Once incorporated into the DNA strand, cytarabine lacks a 3′-hydroxyl group, which is necessary for the addition of the next nucleotide. This halts the elongation of the DNA chain, preventing further replication.
  • Disruption of DNA Synthesis: The incorporation of cytarabine into the DNA disrupts the normal base pairing between nucleotides, causing structural abnormalities in the DNA strand. As a result, the DNA cannot be accurately replicated or repaired.
  • Cell Death: The disruption of DNA synthesis and replication leads to the activation of cell death pathways. The cancer cell recognizes the damaged DNA and undergoes programmed cell death, known as apoptosis. This prevents the cancer cell from dividing and proliferating.
  • Selectivity for Rapidly Dividing Cells: Cytarabine’s mechanism of action targets rapidly dividing cells, which includes cancer cells. Cancer cells often divide more rapidly than normal cells, making them more susceptible to the effects of cytarabine. However, because some normal cells also divide rapidly, cytarabine can lead to side effects affecting healthy tissues, such as bone marrow cells responsible for blood cell production, cells lining the gastrointestinal tract, and hair follicles. The goal of cytarabine treatment is to preferentially target and destroy cancer cells while minimizing damage to normal cells. This is achieved by carefully controlling the dosage, and administration schedule, and monitoring the patient’s response to treatment.

Benefits of Cytarabine Injection USP:

  • Effective Cancer Treatment: Cytarabine is a potent chemotherapy drug used to treat various types of cancer, particularly leukemia and lymphoma. Its mechanism of action disrupts DNA synthesis and replication in rapidly dividing cells, including cancer cells, leading to their death.
  • Induction of Remission: Cytarabine is often a key component of chemotherapy regimens for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). It helps induce remission by suppressing the abnormal growth of leukemia cells, allowing the patient’s bone marrow to produce healthy blood cells.
  • Combination Therapy: Cytarabine is frequently used in combination with other chemotherapy agents to enhance treatment effectiveness and reduce the risk of drug resistance. This combination approach can lead to improved outcomes.
  • Treatment of Meningeal Leukemia: Cytarabine can be administered directly into the cerebrospinal fluid to treat leukemia that has spread to the central nervous system, helping to target cancer cells in the brain and spinal cord.

Common Side Effects of Cytarabine Injection USP:

  • Bone Marrow Suppression: Cytarabine can suppress the bone marrow’s ability to produce blood cells, leading to low red blood cell counts (anemia), low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). This can increase the risk of infection, anemia-related fatigue, and bleeding tendencies.
  • Nausea and Vomiting: Gastrointestinal side effects, including nausea and vomiting, are common during cytarabine treatment. Medications to manage these side effects can be prescribed.
  • Mouth Sores: Cytarabine can cause sores in the mouth and throat, making eating and drinking uncomfortable. Good oral hygiene and supportive care measures can help alleviate this side effect.
  • Hair Loss: Hair loss (alopecia) is a potential side effect of cytarabine treatment, though it’s usually temporary and hair regrowth typically occurs after treatment.
  • Fatigue: Cytarabine treatment can lead to fatigue and general weakness. Rest, proper nutrition, and staying hydrated can help manage this side effect.
  • Liver and Kidney Effects: Cytarabine can affect liver and kidney function, leading to changes in laboratory test results. Regular monitoring is essential.

Serious but Rare Side Effects:

  • Bone Marrow Failure: In some cases, cytarabine can lead to severe bone marrow suppression, necessitating close monitoring and possible dose adjustments.
  • Neurological Effects: High doses of cytarabine can cause neurological symptoms such as confusion, hallucinations, and difficulty with coordination.
  • Allergic Reactions: While rare, allergic reactions to cytarabine can occur and may manifest as skin rashes, difficulty breathing, or swelling of the face and throat.
  • Organ Toxicity: Cytarabine can affect the liver, kidneys, and other organs. Close medical supervision and monitoring are crucial.

Frequently asked questions about Cytarabine Injection:

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

What is Cytarabine Injection used for?

Cytarabine Injection is a chemotherapy medication used to treat various types of cancer, including leukemia and lymphoma. It works by disrupting DNA synthesis and replication in rapidly dividing cells, such as cancer cells.

How is Cytarabine Injection administered?

Cytarabine Injection is typically administered by healthcare professionals as an intravenous (IV) infusion. In some cases, it may also be administered intrathecally (into the cerebrospinal fluid) for the treatment of meningeal leukemia.

What types of cancer does Cytarabine Injection treat?

Cytarabine is commonly used to treat acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). It can also be used in the treatment of other types of leukemia and certain forms of non-Hodgkin lymphoma.

What are the common side effects of Cytarabine Injection?

Common side effects of Cytarabine Injection include bone marrow suppression (low blood cell counts), nausea, vomiting, mouth sores, hair loss, and fatigue. These side effects are usually managed with supportive care measures and medications.

How often will I receive Cytarabine Injection?

The frequency of Cytarabine Injection depends on the specific treatment plan prescribed by your healthcare provider. Treatment schedules can vary and may involve cycles of treatment followed by periods of rest.

Can Cytarabine Injection cure cancer?

Cytarabine is not typically used as a standalone treatment for cancer cure. It is often used in combination with other chemotherapy agents as part of a comprehensive treatment approach to achieve remission and manage cancer.

How can I manage the side effects of Cytarabine Injection?

Managing side effects involves communication with your healthcare provider. They can prescribe medications to alleviate nausea, provide recommendations for managing mouth sores, and offer guidance on maintaining overall well-being during treatment.

Is hair loss permanent with Cytarabine Injection?

Hair loss caused by Cytarabine Injection is usually temporary, and hair typically starts to grow back after treatment is completed.

Can I continue working during Cytarabine Injection treatment?

The ability to work during Cytarabine Injection treatment depends on your individual response to treatment and the severity of side effects. It’s important to discuss your situation with your healthcare provider and make decisions based on your health needs.

Are there any long-term effects of Cytarabine Injection?

Long-term effects can vary, but potential effects on fertility, the risk of secondary cancers, and organ function may be considered. It’s important to have open discussions with your healthcare provider about potential long-term effects based on your treatment plan.

As Cytarabine Injection USP 500mg Exporters; We can cater to export business queries from the following geographies. We are exporting our Cytarabine Injection USP 500mg product in 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, 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

Cytarabine Injection USP 500mg 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 Cytarabine Injection USP 100mg, 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