Leucovorin Calcium (Leucovorin Calcium Tablets)
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Leucovorin Calcium (Leucovorin Calcium Tablets)

Leucovorin Calcium Tablet

DRUG DESCRIPTION

Leucovorin Calcium Tablets contain either 5 mg or 25 mg leucovorin as the calcium salt of N-[4-[[(2-amino-5-formyl-1, 4, 5, 6, 7, 8-hexahydro-4-oxo-6-pteridinyl)-methyl]amino]benzoyl]-L-glutamic acid. This is equivalent to 5.40 mg or 27.01 mg of anhydrous leucovorin calcium (leucovorin calcium (leucovorin calcium (leucovorin calcium tablets) tablets) tablets) . In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 25mg tablet also contains D&C yellow no. 10 and FD&C blue no. 1.

Leucovorin is a water soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only. The structural formula of leucovorin calcium (leucovorin calcium (leucovorin calcium (leucovorin calcium tablets) tablets) tablets) is:

Leucovorin Calcium Structural Formula Illustration

C20H21CaN7O7........M.W.=511.51

What are the possible side effects of leucovorin ()?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Leucovorin Calcium »

What are the precautions when taking leucovorin calcium tablets (Leucovorin Calcium)?

Before taking leucovorin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain anemias (due to vitamin B12 deficiency).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Leucovorin Calcium »

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Leucovorin calcium tablets are indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists.

DOSAGE AND ADMINISTRATION

Leucovorin calcium (leucovorin calcium (leucovorin calcium (leucovorin calcium tablets) tablets) tablets) tablets are intended for oral administration. Because absorption is saturable, oral administration of doses greater than 25 mg is not recommended.

Impaired Methotrexate Elimination or Inadvertent Overdosage

Leucovorin rescue should begin as soon as possible after an inadvertent overdosage and within 24 hours of methotrexate administration when there is delayed excretion (see WARNINGS). Leucovorin 15 mg (10 mg/m2) should be administered IM, IV, or PO every 6 hours until serum methotrexate level is less than 10 -8 M. In the presence of gastrointestinal toxicity, nausea, or vomiting, leucovorin should be administered parenterally.

Serum creatinine and methotrexate levels should be determined at 24 hour intervals. If the 24 hour serum creatinine has increased 50% over baseline or if the 24 hour methotrexate level is greater than 5 x 10 -6 M or the 48 hour level is greater than 9 x 10-7 M, the dose of leucovorin should be increased to 150 mg (100 mg/m2) IV every 3 hours until the methotrexate level is less than 10-8 M. Doses greater then 25 mg should be given parenterally (see CLINICAL PHARMACOLOGY).

Hydration (3L/d) and urinary alkalinization with sodium bicarbonate should be employed concomitantly. The bicarbonate dose should be adjusted to maintain the urine pH at 7.0 or greater.

The recommended dose of leucovorin to counteract hematologic toxicity from folic acid antagonists with less affinity for mammalian dihydrofolate reductase than methotrexate (i.e., trimethoprim, pyrimethamine) is substantially less and 5 to 15 mg of leucovorin per day has been recommended by some investigators.

Patients who experience delayed early methotrexate elimination are likely to develop reversible non-oliguric renal failure. In addition to appropriate leucovorin therapy, these patients require continuing hydration and urinary alkalinization, and close monitoring of fluid and electrolyte status, until serum methotrexate level has fallen to below 0.05 micromolar and the renal failure has resolved.

Some patients will have abnormalities in methotrexate elimination or renal function following methotrexate administration, which are significant but less severe. These abnormalities may or may not be associated with significant clinical toxicity. If significant clinical toxicity is observed, leucovorin rescue should be extended for an additional 24 hours (total 14 doses over 84 hours) in subsequent courses of therapy. The possibility that the patient is taking other medications which interact with methotrexate (e.g., medications which may interfere with methotrexate elimination or binding to serum albumin) should always be reconsidered when laboratory abnormalities or clinical toxicities are observed.

HOW SUPPLIED

Leucovorin Calcium (leucovorin calcium (leucovorin calcium (leucovorin calcium tablets) tablets) tablets) Tablets, USP are available as:

White, round, unscored, biconvex tablets. Debossed with stylized b on one side and 484 on the other side. Available in bottles of:

20................................NDC 0555-0484-18

5 mg:

30................................NDC 0555-0484-01
100................................NDC 0505-0484-02
1000................................NDC 0555-0484-05

Pale green, round, unscored, biconvex tablets. Debossed with stylized b on one side and 485 on the other side. Available in bottles of:

25 mg:

25................................NDC 0555-0485-27
500................................NDC 0555-0485-04

Protect from light and moisture.

Dispense with a child-resistant closure in a tight, light-resistant container.

Store at controlled room temperature 15°-25°C (59°-77°F) [See USP].

REFERENCES

1. Grem JL, Shoemaker DD, Petrelli NJ, Douglas HO Jr: Severe and fatal toxic effects observed in treatment with high- and low-dose leucovorin plus 5-Fluorouracil for colorectal carcinoma. Cancer Treat Rep 1987;71:1122.

2. Link MP, Goorin AM, Miser AW et al. The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity. N Engl J Med. 1986: 314:1600-1606.

MANUFACTURED BY BARR LABORATORIES, INC. POMONA, NY 10970. OCTOBER 2002. FDA Rev date: 12/26/2000

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following the administration of both oral and parenteral leucovorin.

Read the Leucovorin Calcium (leucovorin calcium tablets) Side Effects Center for a complete guide to possible side effects »

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 children.

Preliminary animal and human studies have shown that small quantities of systemically administered leucovorin enter CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than 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 fluorouracil (see WARNINGS).

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

In the treatment of accidental overdosage of folic acid antagonists, 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 hematologic toxicity decreases.

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.

Leucovorin may enhance the toxicity of fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil.1 Concomitant granulocytopenia and fever were present in some but not all of the patients.

The concomitant use of leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and mortality in a placebo controlled study.

PRECAUTIONS

General

Parenteral administration is preferable to oral dosing if there is a possibility that the patient may vomit or not absorb the leucovorin. Leucovorin has no effect on other established toxicities of methotrexate, such as the nephrotoxicity resulting from drug and/or metabolite precipitation in the kidney.

Pregnancy

Teratogenic Effects

Pregnancy Category C.

Animal reproduction studies have not been conducted with leucovorin. It is also not known whether leucovorin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Leucovorin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when leucovorin is administered to a nursing mother.

Pediatric Use

See DRUG INTERACTIONS.

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Excessive amounts of leucovorin may nullify the chemotherapeutic effect of folic acid antagonists.

CONTRAINDICATIONS

Leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B12. A hematologic remission may occur while neurological manifestations continue to progress.

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Leucovorin is a racemic mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid. The biologically active compound of the mixture is the (-)-L-isomer, known as Citrovorum factor, or (-)-folinic acid. Leucovorin does not require reduction by the enzyme dihydrofolate reductase in order to participate in reactions utilizing folates as a source of "one-carbon" moieties. Following oral administration, leucovorin is rapidly absorbed and enters the general body pool of reduced folates. The increase in plasma and serum folate activity (determined microbiologically with Lactobacillus casei) seen after oral administration of leucovorin is predominantly due to 5-methyltetrahydrofolate.

Twenty normal men were given a single, oral 15 mg dose (7.5 mg/m2) of leucovorin calcium and serum folate concentrations were assayed with L. casei. Mean values observed (± one standard error) were:

  1. Time to peak serum folate concentration: 1.72 ± 0.08 hours,
  2. Peak serum folate concentration achieved: 268 ± 18 ng/mL,
  3. Serum folate half-disappearance time: 3.5 hours.

Oral tablets yielded areas under serum folate concentration-time curves (AUCs) that were 12% greater than equal amounts of leucovorin given intramuscularly and equal to the same amounts given intravenously. Oral absorption of leucovorin is saturable at doses above 25 mg. The apparent bioavailability of leucovorin was 97% for 25 mg, 75% for 50 mg and 37% for 100 mg.

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Leucovorin Calcium Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LEUCOVORIN - ORAL

(lew-ko-VORE-in)

USES: This medication is used to treat or prevent serious blood cell disorders (such as thrombocytopenia, neutropenia, anemia) caused by certain drugs (folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine).

HOW TO USE: Take this medication by mouth with or without food, usually every 6 hours or once daily or as directed by your doctor.

Dosage is based on your medical condition and response to treatment. Doses above 25 milligrams are not recommended.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if you are unable to take this medication because of nausea/vomiting. You may need to be switched to the injection form of this medication.

Disclaimer

Leucovorin Calcium Consumer (continued)

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Leucovorin Calcium (leucovorin calcium tablets) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking leucovorin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain anemias (due to vitamin B12 deficiency).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Leucovorin Calcium Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain drugs to treat seizures (phenobarbital, phenytoin, primidone).

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as kidney function, complete blood count, folic acid antagonist blood levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

Leucovorin Calcium Patient Information Including Side Effects

Brand Names:

Generic Name: leucovorin (oral) (Pronunciation: loo koe VOR in)

What is leucovorin ?

Leucovorin is a form of folic acid. Folic acid helps your body produce and maintain new cells, and also helps prevent changes to DNA that may lead to cancer. Folic acid is present in many foods such as dried beans, peas, oranges, spinach, and others.

Leucovorin is used to reduce the side effects of large doses or accidental overdose of medications that can reduce the effects of folic acid in the body. This includes methotrexate (Rheumatrex), pyrimethamine (Daraprim), trimethoprim (Trimpex, Proloprim), and others.

Leucovorin may also be used to treat anemia (lack of red blood cells) caused by chemotherapy.

Leucovorin may also be used for purposes other than those listed in this medication guide.

Leucovorin 10 mg-ROX

round, white, imprinted with 54 942

Leucovorin 15 mg-ROX

round, yellow, imprinted with 54 650

Leucovorin 25 mg-BAR

round, green, imprinted with b, 485

Leucovorin 25 mg-ROX

round, yellow, imprinted with 54 013

Leucovorin 5 mg-BAR

round, white, imprinted with b, 484

Leucovorin 5 mg-ROX

round, white, imprinted with 54 293

What are the possible side effects of leucovorin ?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Leucovorin Calcium (leucovorin calcium tablets) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about leucovorin ?

Do not take leucovorin if you have anemia that is caused by a lack of vitamin B12.

Before taking leucovorin, tell your doctor if you are allergic to any drugs, or if you have kidney, liver, or lung disease.

Before taking leucovorin, tell your doctor if you are using fluorouracil (Adrucil), phenytoin (Dilantin), fosphenytoin (Cerebyx), ethotoin (Peganone), phenobarbital (Luminal, Solfoton), or primidone (Mysoline).

When treating an accidental overdose, leucovorin should be started as soon as possible for best effect.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with leucovorin.

Side Effects Centers

Leucovorin Calcium Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking leucovorin ?

Do not take leucovorin if you have anemia that is caused by a lack of vitamin B12.

Before taking leucovorin, tell your doctor if you are allergic to any drugs, or if you have:

  • kidney disease;
  • liver disease; or
  • lung disease.

If you have any of these conditions, you may not be able to take leucovorin, or you may need to use an injection form of leucovorin (given through a needle placed into a vein).

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether leucovorin passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take leucovorin ?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take leucovorin with a full glass of water.

When treating an accidental overdose, leucovorin should be started as soon as possible for best effect.

You may also be treated with IV fluids to keep you from getting dehydrated during your treatment with leucovorin.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with leucovorin.

Store this medication at room temperature away from moisture, heat, and light.

Side Effects Centers

Leucovorin Calcium Patient Information including If I Miss a Dose

What happens if I miss a dose ?

If you receive this medication in a hospital, it is not likely that you will miss a dose. If you are taking the medication at home and you miss a dose, call your doctor for instructions.

What happens if I overdose ?

An overdose of leucovorin is not likely to cause life-threatening symptoms. However, an overdose can make other medications less effective.

Seek emergency medical attention if you think you have used too much of this medicine.

What should I avoid while taking leucovorin ?

There are no restrictions on food, beverages, or activities unless otherwise directed by your doctor.

What other drugs will affect leucovorin ?

Before taking leucovorin, tell your doctor if you are using any of the following drugs:

  • fluorouracil (Adrucil);
  • phenytoin (Dilantin), fosphenytoin (Cerebyx), or ethotoin (Peganone);
  • phenobarbital (Luminal); or
  • primidone (Mysoline).

If you are using any of these drugs, you may not be able to take leucovorin, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect leucovorin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about leucovorin written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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