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Levoleucovorin
Overview
What is Levoleucovorin Calcium?
Levoleucovorin is the levo isomeric form of racemic -leucovorin, present as the calcium salt. Levoleucovorin is the pharmacologically active isomer of leucovorin [(6-S)-leucovorin].
Levoleucovorin Injection contains levoleucovorin calcium, which is one of several active, chemically reduced derivatives of folic acid. It is useful as antidote to the inhibition of dihydrofolate reductase by methotrexate. This compound has the chemical designation calcium (6S)-N-{4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl] amino]benzoyl}-L-glutamate mixed hydrates. The molecular weight is 565.6 to 619.6 and the structural formula is:
Its molecular formula is: CHCaNO •nHO (n = 3 to 6).
Levoleucovorin Injection is supplied as a sterile solution of 175 mg levoleucovorin in 17.5 mL. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin and 8.3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8.1 (6.5 to 8.5).
What does Levoleucovorin Calcium look like?
What are the available doses of Levoleucovorin Calcium?
Levoleucovorin Injection: 17.5 mL of a sterile solution containing levoleucovorin calcium mixed hydrates equivalent to 175 mg levoleucovorin and 0.83% sodium chloride. (, , )
What should I talk to my health care provider before I take Levoleucovorin Calcium?
How should I use Levoleucovorin Calcium?
Levoleucovorin injection is a folate analog indicated for:
Limitations of Use
Levoleucovorin injection is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress. ()
Levoleucovorin injection is dosed at the usual dose of racemic -leucovorin.
Levoleucovorin injection is indicated for intravenous administration only.
Do not administer intrathecally.
What interacts with Levoleucovorin Calcium?
Sorry No Records found
What are the warnings of Levoleucovorin Calcium?
Sorry No Records found
What are the precautions of Levoleucovorin Calcium?
Sorry No Records found
What are the side effects of Levoleucovorin Calcium?
Sorry No records found
What should I look out for while using Levoleucovorin Calcium?
Levoleucovorin is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.
What might happen if I take too much Levoleucovorin Calcium?
No data are available for overdosage with levoleucovorin.
How should I store and handle Levoleucovorin Calcium?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Protect from moisture, freezing and excessive heat.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Protect from moisture, freezing and excessive heat.Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00Levoleucovorin Injection, , contains 17.5 mL sterile solution in a single-dose vial. Each mL contains levoleucovorin calcium mixed hydrates equivalent to 10 mg levoleucovorin, 8.3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8.1 (6.5 to 8.5).175 mg/17.5 mL (10 mg/mL) solution: NDC 70121-1572-1Store in refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until contents are used.Manufactured by:Amneal Pharmaceuticals Pvt. Ltd. Parenteral UnitPlot No. 15, PHARMEZ Special Economic Zone,Sarkhej-Bavla N.H. No. 8A,Vil.: Matoda, Tal.: Sanand,Ahmedabad, Gujarat 382213, INDIADistributed by:Amneal Biosciences LLC Bridgewater, NJ 08807Rev. 06-2017-00
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
12.1.1 Levoleucovorin effects during high-dose methotrexate therapy
Levoleucovorin is the pharmacologically active isomer of 5-formyl tetrahydrofolic acid. Levoleucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of “one-carbon” moieties. Administration of levoleucovorin can counteract the therapeutic and toxic effects of folic acid antagonists such as methotrexate, which act by inhibiting dihydrofolate reductase.
Non-Clinical Toxicology
Levoleucovorin is contraindicated for patients who have had previous allergic reactions attributed to folic acid or folinic acid.Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/or conduction (see ). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem (see ).
As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.
Anesthetics:
Benzodiazepines:
Beta-blockers:
Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. , propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see ).
Buspirone:
Carbamazepine:
Cimetidine:
Clonidine:
Cyclosporine:
The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.
Quinidine:
Rifampin:
Statins:
In a healthy volunteer cross-over study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem sustained-release resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.
In a ten-subject randomized, open label, 4-way cross-over study, coadministration of diltiazem (120 mg BID diltiazem sustained-release for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and C versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and C during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.
Because of the Ca content of the levoleucovorin solution, no more than 16 mL (160 mg of levoleucovorin) should be injected intravenously per minute.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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