levoleucovorin calcium
levoleucovorin calcium is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Levoleucovorin. Available dosage forms: injection, powder, lyophilized, for solution, injection, solution.
Drug Details
- Generic Name
- levoleucovorin calcium
- Brand Names
- Levoleucovorin
- Application Number
- ANDA211003
- Sponsor
- Meitheal Pharmaceuticals Inc
- NDC Codes
- 2
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION, SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- LEVOLEUCOVORIN CALCIUM
Indications and Usage
1 INDICATIONS AND USAGE Levoleucovorin Injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use Levoleucovorin Injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. Levoleucovorin Injection is a folate analog indicated for: Rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. ( 1 ) Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. ( 1 ) Treatment of adults with metastatic colorectal cancer in combination with fluorouracil. ( 1 ) Limitations of Use Levoleucovorin Injection is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. ( 1 )