Zuvitrex
Methotrexate Injection
Strength
✓50✓500 mg
Pack Size
Vial
Drug Class
Antineoplastic Drug, Antimetabolite
Specification
USP/BP/IH Specs offered for exports
Storage
Store at 25°C to 30°C.
Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division.
Because of these effects, Methotrexate is often used to treat inflammation caused by arthritis or to control cell division in neoplastic diseases such as breast cancer and non-Hodgkin's lymphoma.
Methotrexate Injection is a folate analog metabolic inhibitor indicated for the treatment of:
- Adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen.
- Adult and pediatric patients with non-Hodgkin lymphoma.
- Adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen.
- Limitations of Use:
Methotrexate Injection is not indicated for non-oncology diseases.
In a Canadian double-blind randomized trial, 18 patients with active rheumatoid arthritis (RA) were treated with 12.5 mg oral Methotrexate and 17 patients with 50 mg parenteral gold for 6 months.
The patients improved significantly but there was no major advantage observed for gold therapy.
In another Canadian trial, 20 patients were treated with 10 mg oral Methotrexate and 50 mg aurothiomalate respectively, demonstrating significant clinical improvement.
Pregnancy
Methotrexate should be avoided during pregnancy, especially during the first trimester. Adequate contraceptive measures should be advised if either partner is undergoing Methotrexate treatment.
Breastfeeding
Mothers receiving Methotrexate should refrain from breastfeeding due to potential harm to the nursing infant.
Fertility
Methotrexate may lead to suppression of ovarian function, with reports of amenorrhea following therapy. In males, azoospermia has been observed after receiving Methotrexate, typically after cumulative doses exceeding a certain threshold. Some recovery of spermatogenesis has been noted in patients post-treatment.
Teratogenicity
Similar to other cytotoxic agents, Methotrexate carries a potential risk of teratogenic effects.
- For intravenous use only. Not for intrathecal use.
- Verify the concentration prior to preparation and administration to avoid overdosage.
- Verify pregnancy status in females of reproductive potential before starting Methotrexate Injection.
- See full prescribing information about monitoring and concomitant therapies for intermediate- and high-dose regimens.
- Acute Lymphoblastic Leukemia:
The recommended dosage of Methotrexate Injection varies from 10 mg/m² to 5000 mg/m² intravenously as part of a combination chemotherapy regimen.
- Non-Hodgkin Lymphoma:
The recommended dosage of Methotrexate Injection varies from 1000 mg/m² to 8000 mg/m² intravenously.
- Osteosarcoma:
The recommended dosage of Methotrexate Injection is typically 12 grams/m² (maximum: 20 grams per dose) as an intravenous infusion over 4 hours followed by leucovorin rescue in accordance with high-dose therapy protocols.