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Admatex 50/500 Liquid Injection

Generic Name- Methotrexate
Drug Class– Antineoplastic agent
Methotrexate is an antimetabolite and antifolate agent which exhibits antineoplastic and immunosuppressant activities. It is widely used in the therapy of leukemia, lymphoma and solid tumors. It acts by blocking enzyme dihydrofolate reductase, resulting in inhibition of purine nucleotide and thymidylate synthesis. These series of events results in disruption of DNA and RNA synthesis, ultimately leading to cell cycle arrest and apoptosis.

Category

Product Description

Admatex 50/500 (Methotrexate for injection) is a single use vial containing aqueous drug concentrate for intramuscular, intravenous or intra-arterial administration.

Indications and Usage

Methotrexate is indicated for treatment of:
• Gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole
• Acute lymphocytic leukemia (ALL) in combination with other chemotherapeutic agents.
• Meningeal leukemia
• Solid tumors including breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types
• Advanced stage non-Hodgkin’s lymphomas, in combination with other chemotherapy drugs
• Non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor

Limitations of Use
• This formulation of methotrexate in not indicated for treatment of treatment of psoriasis and rheumatoid arthritis

Dosage and Administration

• Recommended dose in choriocarcinoma and similar trophoblastic diseases: 15 to 30 mg IM, daily for a five-day course
• Recommended dose in ALL: 3.3 mg/m2 IM followed by 60 mg/m2 of prednisone, given daily, within a period of 4 to 6 weeks for induction regimen and 30 mg/m2 IM or 2.5 mg/kg IV every 14 days for maintenance regimen
• Recommended dose in meningeal leukemia: 12 mg/m2 for 2 to 5 days
• Recommended dose in lymphoma: 10 to 25 mg/day orally for 4 to 8 days
• Recommended dose in mycosis fungoides: 5 to 50 mg once weekly in early therapy, then increased dose of 15 to 37.5 mg in patients who have responded poorly to weekly therapy
• Recommended dose in osteosarcoma: 12 g/m2 IV as 4 hour infusion (starting dose), then increased to 15 grams/m2 in subsequent treatments

Dosage Form and Strengths
• Supplied as a single use vial with aqueous drug concentrate for intravenous infusion
• Available as 50 mg and 500 mg for injection

Clinical Efficacy

• Increases survival in 70-80% of children diagnosed with acute lymphocytic leukemia (ALL)
• Effective treatment for the induction of remission after meningeal relapse in acute lymphoblastic leukemia
• Improves quality of life and provide durable remissions for leptomeningeal disease in breast cancer
• Achieves a complete remission (CR) rate in patients with non-Hodgkin’s lymphomas either as a single agent in those patients who had previously failed to respond to conventional chemotherapy or in previously untreated patients in combination with other chemotherapeutic agents
• Shows significantly better event‐free and overall survival outcomes in patients with osteosarcoma

Adverse Reactions
• The most common adverse events reported after administration of methotrexate are nausea, vomiting, abdominal pain, ulcerative stomatitis, bronchitis, leukopenia, thrombocytopenia, pancytopenia, alopecia, malaise, undue fatigue, chills and fever, headache, dizziness and decreased resistance to infection

Contraindications
• It is contraindicated in patients with a known hypersensitivity to methotrexate
• It is contraindicated in pregnant and breast feeding mothers

Special Precautions

• Methotrexate can lead to serious toxicity, therefore dose and frequency of administration should be determined carefully
• Monitor complete blood counts, renal function and liver function tests to determine potential risk of bone marrow, kidney, liver, lung, and skin toxicities
• Consider dose reduction in patients with renal impairment, ascites, or pleural effusions
• It may cause interstitial pneumonitis during therapy at low doses. If pulmonary
symptoms (especially a dry, nonproductive cough) occur, interrupt treatment.
• Monitor patients for the risk of diarrhea, ulcerative stomatitis, hemorrhagic enteritis, and intestinal perforation and treat accordingly
• Advise patients to avoid activities such as driving or operating machine, as methotrexate induces dizziness and fatigue
• It can cause impairment of fertility, oligospermia and menstrual dysfunction
• Advise males to avoid pregnancy for a minimum of three months after therapy and females to avoid pregnancy for at least one ovulatory cycle after therapy
• Do not administer methotrexate in combination with non steroidal anti-inflammatory drugs as it can cause unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity
• Use caution while administering high-dose methotrexate to patients receiving proton pump inhibitor (PPI) therapy

Admatex 50/500 Liquid Injection - ADMAC Life Science