Methotrexate (Oral route, injection route)
Warnings:Injection route(Powder for Solution;Solution)
Only for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteonecrosis with concomitant radiotherapy. Malignant lymphoma may occur. Use extreme caution with high dose regimen for osteosarcoma. Do not use formulations/diluents with preservatives for intrathecal or high dose therapy .Oral route(Tablet)
Only for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteonecrosis with concomitant radiotherapy. Malignant lymphoma may occur .
Uses of This Medicine:
Methotrexate belongs to the group of medicines known as antimetabolites. It is used to treat cancer of the breast, head and neck, lung, blood, bone, and lymph, and tumors in the uterus. It may also be used to treat other kinds of cancer, as determined by your doctor.
Methotrexate blocks an enzyme needed by the cell to live. This interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by methotrexate, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.
Before you begin treatment with methotrexate, you and your doctor should talk about the good this medicine will do as well as the risks of using it.
Methotrexate is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, methotrexate is used in certain patients with the following medical conditions:
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Newborns and other infants may be more sensitive to the effects of methotrexate. However, in other children it is not expected to cause different side effects or problems than it does in adults.
Side effects may be more likely to occur in the elderly, who are usually more sensitive to the effects of methotrexate.
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.
Methotrexate is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.
While you are using methotrexate, your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug to pass from the body, and will prevent kidney problems and keep your kidneys working well.
Methotrexate commonly causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.
If you vomit shortly after taking a dose of methotrexate, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Call your doctor or pharmacist for instructions.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Do not drink alcohol while using this medicine. Alcohol can increase the chance of liver problems.
Some patients who take methotrexate may become more sensitive to sunlight than they are normally. When you first begin taking methotrexate, avoid too much sun and do not use a sunlamp until you see how you react to the sun, especially if you tend to burn easily. In case of a severe burn, check with your doctor.
Do not take medicine for inflammation or pain (aspirin or other salicylates, diclofenac, diflunisal, fenoprofen, ibuprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, naproxen, phenylbutazone, piroxicam, sulindac, suprofen, tolmetin) without first checking with your doctor. These medicines may increase the effects of methotrexate, which could be harmful.
While you are being treated with methotrexate, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Methotrexate may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Methotrexate can lower the number of white blood cells in your blood temporarily, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Side Effects of This Medicine:
Along with their needed effects, medicines like methotrexate can sometimes cause unwanted effects such as blood problems, kidney problems, stomach or liver problems, loss of hair, and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.
Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
This medicine may cause a temporary loss of hair in some people. After treatment with methotrexate has ended, normal hair growth should return.
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 6/13/2013
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