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Levoleucovorin Calcium

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Last Updated: 22 October 2020

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General | Latest Info

Folic acid in large amounts may counteract antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible children. It is not know whether folinic acid has the same effects. However, both folic and folinic acids share some common metabolic pathways. Caution should be taken when taking folinic acid in combination with anticonvulsant drugs. Preliminary human studies have shown that small quantities of systemically administered leucovorin enter CSF, primarily as its major metabolite, 5-methyltetrahydrofolate. In humans, CSF levels of 5-MTHFA remain 1 to 3 orders of magnitude lower than usual methotrexate concentrations following intrathecal administration. Levoleucovorin is levo isomeric form of racemic d, l-leucovorin, present as calcium salt. Levoleucovorin is a pharmacologically active isomer of leucovorin. Levoleucovorin Injection contains levoleucovorin calcium, which is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to inhibition of dihydrofolate reductase by methotrexate. This compound has chemical designation calcium-n {4-amino] Benzoyl}-Lglutamate Mixed hydrates. Molecular weight is 565. 6 to 619. 6 and structural formula is: its molecular formula is: C 20 H 21 CaN 7 O 7 nH 2 O. Levoleucovorin Injection is supplied as sterile solution of 175 mg levoleucovorin in 17. 5 mL. Each mL contains levoleucovorin calcium mixed hydrate equivalent to 10 mg of levoleucovorin and 8. 3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to pH 8. 1. Levoleucovorin Injection, 175 mg, contains 17. 5 mL sterile solution in single-dose vial. Each mL contains levoleucovorin calcium mixed hydrate equivalent to 10 mg of levoleucovorin, 8. 3 mg sodium chloride and sodium hydroxide for pH adjustment to pH 8. 1. Store in refrigerator at 2 to 8C. Protect from light. Store in a carton until the contents are used.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

levoleucovorin injection

The following regimens have been used historically for treatment of colorectal Cancer: Levoleucovorin injection is administered at 100 mg / m 2 by slow intravenous injection over a minimum of 3 minutes, followed by 5-FU at 370 mg / m 2 by intravenous injection. Levoleucovorin injection is administered at 10 mg / m 2 by intravenous injection followed by 5-FU at 425 mg / m 2 by intravenous injection. 5-fu and Levoleucovorin injection should be administered separately to avoid formation of precipitate. Treatment is repeated daily for five days. This five-day Treatment course may be repeated at 4 week intervals, for 2 courses and then repeated at 4 to 5 week intervals provide that the patient has completely recovered from the toxic effects of the prior Treatment course. In subsequent treatment courses, dosage of 5-FU should be adjusted based on patient tolerance of prior treatment course. The daily dosage of 5-FU should be reduced by 20% for patients who experience moderate hematologic or gastrointestinal toxicity in the prior treatment course, and by 30% for patients who experience severe toxicity. For patients who experience no toxicity in the prior treatment course, 5-FU dosage may be increased by 10%. Levoleucovorin injection dosages are not adjusted for toxicity.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

DESCRIPTION

Levoleucovorin is levo isomeric form of racemic d, l-leucovorin, present as calcium salt. Levoleucovorin is a pharmacologically active isomer of leucovorin. Levoleucovorin injection contains levoleucovorin calcium, which is one of several active, chemically reduced derivatives of folic acid. It is useful as an antidote to inhibition of dihydrofolate reductase by methotrexate. This compound has the chemical designation calcium-n {4-amino] Benzoyl}-L Glutamate pentahydrate. The molecular weight is 601. 6 and structural formula is: its molecular formula is: C 20 H 21 CaN 7 O 7 5 H 2 O. Levoleucovorin injection is supplied as sterile solution of either 175 mg levoleucovorin in 17. 5 mL or 250 mg levoleucovorin in 25 mL. Each mL contains levoleucovorin calcium pentahydrate equivalent to 10 mg levoleucovorin and 8. 3 mg sodium chloride. Sodium hydroxide is used for pH adjustment to 6.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

DOSAGE AND ADMINISTRATION

Available as levoleucovorin calcium; Dosage expressed in terms of levoleucovorin. 1 levoleucovorin is dosed at one-half usual dosage of racemic leucovorin. 1 2 7. 5 mg every 6 hours For 10 doses, starting at 24 hours after initiation of methotrexate infusion For patients with normal methotrexate elimination at 72 hours after Administration. 1 continue therapy and maintain adequate hydration and urinary alkalinization pH 7 until methotrexate concentration declines to < 0. 05 micromolar 5 10 8 M. 1 If substantial clinical toxicity occurs in patients with mild abnormalities in methotrexate elimination or renal function, extend Rescue therapy for an additional 24 hours i. E, 14 doses over 84 hours for subsequent methotrexate courses. 1 adjust dosage and duration of therapy based on methotrexate elimination pattern and patients ' renal function. 1 See Table 1 and Table 2. 7. 5 mg approximately 5 mg / M 2 every 6 hours until serum methotrexate concentration declines to < 0. 01 micromolar 10 8 M; initiate Administration as soon as possible after overdosage and within 24 hours following methotrexate Administration If delay elimination is detect. 1 If 24-hour S cr increases 50% over baseline, 24-hour methotrexate concentration is > 5 micromolar 510 6 M, or 48-hour methotrexate concentration is > 0. 9 micromolar 9 10 7 M, increase dosage immediately to 50 mg / M 2 IV every 3 hours until serum methotrexate concentration declines to < 0. 01 micromolar 10 8 M. 1 levoleucovorin 100 mg / M 2 by IV Injection over 3 minutes followed by IV fluorouracil 370 mg / M 2 or levoleucovorin 10 mg / M 2 followed by IV fluorouracil 425 mg / M 2; Administer both drugs daily For 5 days and repeat regimen at 4-week intervals For 2 additional courses; thereafter may repeat regimen at intervals of 4-5 weeks provide toxicity from previous course has resolve completely. 1 levoleucovorin Dosage is not adjusted for toxicity. 1 Reduce daily fluorouracil dosage by 20% for moderate hematologic or GI toxicity in prior course and by 30% for severe toxicity. 1 If no toxicity occurs in the prior course, may increase fluorouracil dosage by 10%.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

SIDE EFFECTS

Leucovorin Calcium is a form OF folic acid used to reduce side effects OF large doses or accidental overdose OF medications that can reduce the effects OF folic acid in the body. These medications include methotrexate, pyrimethamine, trimethoprim, and others. Leucovorin Calcium is available in generic form. Many people use LEUCOVORIN Calcium does not have serious side effects. Infrequent Side Effects OF LEUCOVORIN Calcium include: facial flushing, nausea, and vomiting. Dosage OF LEUCOVORIN Calcium is based on the patient's medical condition and response to treatment. Doses above 25 milligrams are not recommend. Leucovorin Calcium may interact WITH FLUOROURACIL, phenytoin, fosphenytoin, ethotoin, phenobarbital, or primidone. Tell your doctor all the medications and supplements you use. During pregnancy, LEUCOVORIN Calcium should be used only when prescribe. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding. Our LEUCOVORIN Calcium Side Effects Drug Center provides a comprehensive view of available drug information on potential side effects when taking this medication. This is not a complete list of Side Effects and others may occur. Call your doctor FOR medical advice about Side Effects. You may report Side Effects to FDA at 1-800-FDA-1088.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

PRECAUTIONS

Levoleucovorin is a pharmacologically active isomer of 5-formyl tetrahydrofolic acid. Levoleucovorin does not require reduction by enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as source of one-carbon moieties. Administration of levoleucovorin counteracts therapeutic and toxic effects of folic acid antagonists such as methotrexate, which act by inhibiting dihydrofolate reductase. Levoleucovorin enhances the therapeutic and toxic effects of fluorouracil. Fluorouracil is metabolized to 5-fluoro-2 -deoxyuridine-5 -monophosphate, which bind to and inhibits thymidylate synthase. Levoleucovorin is converted to another reduced folate, 5 10-methylenetetrahydrofolate, which acts to stabilize binding of FdUMP to thymidylate synthase and thereby enhancing inhibition of thymidylate synthase.

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* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

CLINICAL PHARMACOLOGY

Safety and efficacy of levoleucovorin Rescue following high-dose methotrexate were Evaluate in 16 patients aged 6-21 who received 58 courses of therapy for osteogenic sarcoma. High-dose methotrexate was one component of several different combination chemotherapy regimens Evaluate across several trials. Methotrexate 12 g / m IV over 4 hours was administered to 13 patients, who received levoleucovorin 7. 5 mg every 6 hours for 60 hours or longer beginning 24 hours after completion of methotrexate. Three patients received methotrexate 12. 5 g / m IV over 6 hours, followed by levoleucovorin 7. 5 mg every 3 hours For 18 doses beginning 12 hours after completion of methotrexate. The mean number of levoleucovorin doses per course was 18. 2 and mean total dose per course was 350 mg. Efficacy of levoleucovorin Rescue following high-dose methotrexate was based on adverse reaction profile.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

6.3 Postmarketing Experience

Since clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drug cannot be directly compared to rates in clinical trials of another drug and may not reflect rates observed in practice. The following table presents the frequency of adverse reactions which occur during administration of 58 courses of high-dose methotrexate 12 grams / m 2 followed by levoleucovorin Rescue For osteosarcoma in 16 patients aged 6-21. Most patients receive levoleucovorin 7. 5 mg every 6 hours for 60 hours or longer beginning 24 hours after completion of methotrexate. The incidence of adverse reactions may be underestimated because not all patients were fully evaluable for toxicity for all cycles in clinical trials. Leukopenia and thrombocytopenia were observe, but could not be attributed to high-dose methotrexate with levoleucovorin Rescue because patients were receiving other myelosuppressive chemotherapy. A randomized control trial conducted by North Central Cancer Treatment Group in patients with advanced colorectal Cancer failed to show superiority of regimen of 5-FU + levoleucovorin to 5-FU + d, L-leucovorin in overall survival. Patients were randomized to 5-FU 370 mg / m 2 intravenously and levoleucovorin 100 mg / m 2 intravenously, both daily for 5 days, or with 5-FU 370 mg / m 2 intravenously and d, L-leucovorin 200 mg / m 2 intravenously, both daily for 5 days. Treatment was repeated week 4 and week 8, and then every 5 weeks until disease progression or unacceptable toxicity. The following table presents the most frequent adverse reactions which occur in patients in 2 treatment arms. Since adverse reactions from spontaneous reports are provided voluntarily from population of uncertain size, it is not always possible to estimate reliably their frequency or establish causal relationship to drug exposure. Spontaneously reported adverse reactions collected by WHO Collaborating Center For International Drug Monitoring in Uppsala, Sweden have yielded seven cases where levoleucovorin was Administer with regimen of methotrexate. Events were dyspnea, pruritus, rash, temperature change and rigors. For 217 adverse reactions where levoleucovorin was suspect or interacting with medication, there were 40 occurrences of possible allergic reactions. In an analysis where calcium levoleucovorin was reported as the primary suspect drug and fluorouracil was reported as concomitant medication, possible allergic reactions were reported among 47 cases.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

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