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Levoleucovorin

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Overview

What is Levoleucovorin?

Levoleucovorin is the levo isomeric form of racemic -leucovorin, present as the calcium salt. Levoleucovorin is the pharmacologically active isomer of leucovorin [(6-)-leucovorin].

Levoleucovorin for 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 -[-[[[(6)-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6- pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1) mixed hydrdate. The molecular weight is 565.6 to 619.6 and the structural formula is:

Levoleucovorin for Injection is supplied as a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrdate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol per 50 mg vial. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH during manufacture. It is intended for intravenous administration after reconstitution with 5.3 mL of sterile 0.9% sodium chloride injection []



What does Levoleucovorin look like?



What are the available doses of Levoleucovorin?

Levoleucovorin for Injection: Each 50 mg single-use vial of levoleucovorin contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrdate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. (3, 11, 16) It is intended for intravenous administration after reconstitution with 5.3 mL of sterile 0.9% sodium chloride injection. (2.6, 11)

What should I talk to my health care provider before I take Levoleucovorin?

How should I use Levoleucovorin?

Limitations of Use

Levoleucovorin for Injection is not approved for pernicious anemia and megaloblastic anemias. Improper use may cause a hematologic remission while neurologic manifestations continue to progress. (1.1)

Levoleucovorin for Injection is dosed at the usual dose of racemic -leucovorin.

Levoleucovorin for injection is indicated for intravenous administration only

Do not administer

intrathecally


What interacts with Levoleucovorin?

Sorry No Records found


What are the warnings of Levoleucovorin?

Sorry No Records found


What are the precautions of Levoleucovorin?

Sorry No Records found


What are the side effects of Levoleucovorin?

Sorry No records found


What should I look out for while using Levoleucovorin?

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?

No data are available for overdosage with levoleucovorin.


How should I store and handle Levoleucovorin?

Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2Levoleucovorin for Injection is supplied as follows: Each 50 mg single-use vial contains a sterile lyophilized powder consisting of 64 mg levoleucovorin calcium mixed hydrate (equivalent to 50 mg levoleucovorin) and 50 mg mannitol. NDC 0143-9558-01Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Retain in carton until contents are used. Manufactured by:HIKMA FARMACÊUTICA (PORTUGAL), S.A.Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGALDistributed by:West-Ward PharmaceuticalsEatontown, NJ 07724 USARevised June 2016PIN396-WES/2


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Clinical Information

Chemical Structure

No Image found
Clinical 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.

Because of the Cacontent of the levoleucovorin solution, no more than 16 mL (160 mg of levoleucovorin) should be injected intravenously per minute.

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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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Professional

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Interactions

Interactions

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