Trexall

DRUG DESCRIPTION

Trexall™ (methotrexate tablets, USP) (formerly Amethopterin) is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Chemically methotrexate is N-[4[[(2,4-diamino-6-pteridinyl) methyl] methyl-amino]benzoyl]-L-glutamic acid. The structural formula is:

Trexall™  (methotrexate) structural formula illustration

C20H22N8O5         Molecular Weight: 454.45

Trexall™ (methotrexate tablets), for oral administration, are available in 5 mg, 7.5 mg, 10 mg and 15 mg strengths.

Each tablet contains methotrexate sodium in an amount equivalent to the labeled amount of methotrexate, and contains the following inactive ingredients: anhydrous lactose, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium carbonate monohydrate, talc and titanium dioxide.

The 5 mg also contains: D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake and FD&C yellow no. 6 aluminum lake.

The 7.5 mg also contains: FD&C blue no.1 aluminum lake. The 10 mg also contains: FD&C red no. 40 aluminum lake. The 15 mg also contains: FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake.

What are the possible side effects of methotrexate (Rheumatrex Dose Pack, Trexall)?

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.

Stop using methotrexate and call your doctor at once if you have any of these serious side effects:

  • dry cough, shortness of breath;
  • diarrhea, vomiting, white patches or sores inside your mouth or on your lips;
  • blood in your urine or stools;
  • urinating less than usual or not at all;
  • fever, chills, body...

Read All Potential Side Effects and See Pictures of Trexall »

What are the precautions when taking methotrexate (Trexall)?

Before taking methotrexate, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease, severe kidney disease, severe lung disease (e.g., pulmonary fibrosis), alcohol use, suppressed immune system, blood cell/bone marrow disorders.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal diseases (e.g., peptic ulcer, ulcerative colitis), kidney disease, any active infection...

Read All Potential Precautions of Trexall »


Trexall Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, stomach pain, drowsiness or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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.

Tell your doctor immediately if any of these serious side effects occur: mouth sores, diarrhea, fever, fatigue, persistent sore throat, unusual bleeding or bruising, black stools, skin rash, enlarged glands/lymph nodes, dark urine, bone pain, unusual pain and discoloration of the skin.

Tell your doctor immediately if any of these unlikely but serious side effects occur: yellowing eyes/skin, change in the amount of urine, chest pain, dry cough, trouble breathing, calf pain/swelling, vision changes, irregular heartbeat, muscle weakness, mental/mood changes, seizures.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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.

PRECAUTIONS: Before taking methotrexate, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease, severe kidney disease, severe lung disease (e.g., pulmonary fibrosis), alcohol use, suppressed immune system, blood cell/bone marrow disorders.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal diseases (e.g., peptic ulcer, ulcerative colitis), kidney disease, any active infection (including chickenpox or recent exposure to it), folic acid deficiency.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.

Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised, or injured.

Wash your hands well to prevent the spread of infections.

Methotrexate must not be used during pregnancy. It may cause harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Pregnancy must be avoided, therefore males and females must use reliable form(s) of birth control during and for at least 3 months following the end of methotrexate treatment.

Methotrexate passes into breast milk and may harm a nursing infant. Do not breast-feed while using this drug.


Trexall Patient Information Including Side Effects

Brand Names: Rheumatrex Dose Pack, Trexall

Generic Name: methotrexate (oral) (Pronunciation: meth oh TREX ate)

  • What is methotrexate (Trexall)?
  • What are the possible side effects of methotrexate (Trexall)?
  • What is the most important information I should know about methotrexate (Trexall)?
  • What should I discuss with my healthcare provider before taking methotrexate (Trexall)?
  • How should I take methotrexate (Trexall)?
  • What happens if I miss a dose (Trexall)?
  • What happens if I overdose (Trexall)?
  • What should I avoid while taking methotrexate (Trexall)?
  • What other drugs will affect methotrexate (Trexall)?
  • Where can I get more information?

What is methotrexate (Trexall)?

Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat certain types of cancer of the breast, skin, head and neck, or lung. Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis.

Methotrexate is usually given after other medications have been tried without successful treatment of symptoms.

Methotrexate may also be used for other purposes not listed in this medication guide.

What are the possible side effects of methotrexate (Trexall)?

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.

Stop using methotrexate and call your doctor at once if you have any of these serious side effects:

  • dry cough, shortness of breath;
  • diarrhea, vomiting, white patches or sores inside your mouth or on your lips;
  • blood in your urine or stools;
  • urinating less than usual or not at all;
  • fever, chills, body aches, flu symptoms;
  • sore throat and headache with a severe blistering, peeling, and red skin rash;
  • pale skin, easy bruising or bleeding, weakness; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • nausea, vomiting, upset stomach;
  • dizziness, tired feeling;
  • headache;
  • bleeding of your gums; or
  • blurred vision.

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.

What is the most important information I should know about methotrexate (Trexall)?

You must use the correct dose of methotrexate for your condition. Methotrexate is usually taken once or twice per week and not every day. Follow the directions on your prescription label. Some people have died after taking methotrexate every day by accident. Ask your doctor if you have any questions about your dose of methotrexate or how often to take it.

Methotrexate can cause serious or life-threatening side effects on your liver, lungs, kidneys, and bone marrow (immune system). Do not take this medication in larger amounts, or take it for longer than prescribed. Follow the directions on your prescription label.

Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you have liver disease (especially if caused by alcoholism), a blood cell or bone marrow disorder, or if you are breast-feeding a baby.

This medication can cause birth defects in an unborn baby. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you are pregnant. Use an effective form of birth control, whether you are a man or a woman. Tell your doctor if you or your sexual partner become pregnant during treatment.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled appointments.

There are many other medicines that can interact with methotrexate. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Related Drug Centers
  • Trexall
  • Rheumatrex


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