LEUCOVORIN CALCIUM 15 mg/1
LEUCOVORIN CALCIUM · TABLET · Leading Pharma, LLC
LEUCOVORIN CALCIUM is a tablet containing leucovorin calcium at 15 mg/1, taken oral. Manufactured by Leading Pharma, LLC.
Key Facts
- Brand Name
- LEUCOVORIN CALCIUM
- Generic Name
- LEUCOVORIN CALCIUM
- NDC Code (Product)
69315-186- Manufacturer
- Leading Pharma, LLC
- Strength
- 15 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA213929
- Marketing Start
- 11/16/2020
Recall History
Ben Venue Laboratories Inc
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
South Coast Specialty Compounding, Inc.
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Ingenus Pharmaceuticals Llc
Crystallization: Presence of particulate matter identified as API crystallization
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
West-Ward Columbus Inc
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Teva Pharmaceuticals USA
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent over dosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.
Dosage & Administration
DOSAGE AND ADMINISTRATION Advanced Colorectal Cancer Either of the following two regimens is recommended: 1. Leucovorin is administered at 200 mg/m 2 by slow intravenous injection over a minimum of 3 minutes, followed by 5-fluorouracil at 370 mg/m 2 by intravenous injection. 2. Leucovorin is administered at 20 mg/m 2 by intravenous injection followed by 5-fluorouracil at 425 mg/m 2 by intravenous injection. 5-Fluorouracil and leucovorin should be administered separately to avoid the formation of a precipitate. Treatment is repeated daily for five days. This five-day treatment course may be repeated at 4 week (28-day) intervals, for 2 courses and then repeated at 4 to 5 week (28 to 35 day) intervals provided that the patient has completely recovered from the toxic effects of the prior treatment course. In subsequent treatment course, the dosage of 5-fluorouracil should be adjusted based on patient tolerance of the prior treatment course. The daily dosage of 5-fluorouracil should be reduced by 20% for patients who experienced moderate hematologic or gastrointestinal toxicity in the prior treatment course, and by 30% for patients who experienced severe toxicity (see PRECAUTIONS : Labo…
Warnings
WARNINGS In the treatment of accidental overdosages of folic acid antagonists, intravenous leucovorin should be administered as promptly as possible. As the time interval between antifolate administration (e.g., methotrexate) and leucovorin rescue increases, leucovorin's effectiveness in counteracting toxicity decreases. In the treatment of accidental overdosages of intrathecally adminstered folic acid antagonists, do not adminster leucovorin intrathecally. LEUCOVORIN MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY. Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin. Delayed methotrexate excretion may be caused by a third space fluid accumulation (i.e., ascites, pleural effusion), renal insufficiency, or inadequate hydration. Under such circumstances, higher doses of leucovorin or prolonged administration may be indicated. Doses higher than those recommended for oral use must be given intravenously. Because of the benzyl alcohol contained in certain diluents used for reconstituting Leucovorin Calcium for Injection, when doses greater than 10 mg/m 2 are administered, Leucovorin Calcium for Injectio…
Contraindications
CONTRAINDICATIONS Leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B 12 . A hematologic remission may occur while neurologic manifestations continue to progress.
Drug Interactions
Drug Interactions Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible pediatric patients. Preliminary animal and human studies have shown that small quantities of systemically administered leucovorin enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered methotrexate. Leucovorin may enhance the toxicity of 5-fluorouracil (see WARNINGS section).
Adverse Reactions
ADVERSE REACTIONS Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following the administration of both oral and parenteral leucovorin. No other adverse reactions have been attributed to the use of leucovorin per se . The following table summarizes significant adverse events occurring in 316 patients treated with the leucovorin/5-fluorouracil combinations compared against 70 patients treated with 5-fluorouracil alone for advanced colorectal carcinoma. These data are taken from the Mayo/NCCTG large multicenter prospective trial evaluating the efficacy and safety of the combination regimen. PERCENTAGE OF PATIENTS TREATED WITH LEUCOVORIN/FLUOROURACIL FOR ADVANCED COLORECTAL CARCINOMA REPORTING ADVERSE EXPERIENCES OR HOSPITALIZED FOR TOXICITY (High LV*) /5-FU (Low LV † ) /5-FU 5-FU Alone (N=155) (N=161) (N=70) Any ‡ Grade 3 +§ Any ‡ Grade 3 +§ Any ‡ Grade 3 +§ (%) (%) (%) (%) (%) (%) Leukopenia 69 14 83 23 93 48 Thrombocytopenia 8 2 8 1 18 3 Infection 8 1 3 1 7 2 Nausea 74 10 80 9 60 6 Vomiting 46 8 44 9 40 7 Diarrhea 66 18 67 14 43 11 Stomatitis 75 27 84 29 59 16 Constipation 3 0 4 0 1 - Lethargy/Malaise/Fatigue 13 3 12 2 6 3 Alopecia 42 5 43 …
Frequently Asked Questions
What is LEUCOVORIN CALCIUM used for?
LEUCOVORIN CALCIUM contains LEUCOVORIN CALCIUM. It is a tablet taken oral. Consult your doctor for specific uses.
Is LEUCOVORIN CALCIUM a controlled substance?
LEUCOVORIN CALCIUM is not classified as a controlled substance by the DEA.
What is the generic name for LEUCOVORIN CALCIUM?
The generic name for LEUCOVORIN CALCIUM is LEUCOVORIN CALCIUM. There are 11 other brand versions of LEUCOVORIN CALCIUM.
What is the NDC code for LEUCOVORIN CALCIUM 15 mg/1?
The NDC (National Drug Code) for LEUCOVORIN CALCIUM 15 mg/1 is 69315-186, listed by Leading Pharma, LLC.
Other LEUCOVORIN CALCIUM Dosages
Other Leucovorin Brands
See all →- Leucovorin Calcium5 mg/10054-8496
- Leucovorin Calcium350 mg/17.5mL25021-816
- Leucovorin Calcium350 mg/17.5mL0143-9552
- Leucovorin Calcium10 mg/142806-133
- Leucovorin Calcium15 mg/142806-134
- Leucovorin Calcium5 mg/150742-181
- Leucovorin Calcium100 mg/170436-117
- leucovorin calcium200 mg/20mL71288-162
- Leucovorin Calcium10 mg/10054-4497
- leucovorin calcium350 mg/17.5mL68001-650
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)