Methotrexate tablets are contraindicated in: Pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see Warnings and Precautions (5.2) ] .
Methotrexate tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate tablets are contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications (4) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Methotrexate tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [see Contraindications (4) , Warnings and Precautions (5.2) ] . Methotrexate tablets when inadvertently administered once daily have resulted in death [see Warnings and Precautions (5.9) ] . Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate tablets as appropriate [see Warnings and Precautions (5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8) ] .
Methotrexate tablets are contraindicated in: Pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see Warnings and Precautions (5.2) ] .
Methotrexate Tablets, USP are available containing 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. The 2.5 mg tablets are orange, round, scored tablets debossed with M above the score and 14 below the score on one side of the tablet and blank on the other side of the tablet.
Overdosage, including fatal overdosage, has occurred with methotrexate [see Warnings and Precautions (5.9) ]. Manifestations: Manifestations of methotrexate overdosage include adverse reactions reported at pharmacologic doses, particularly hematologic and gastrointestinal reactions (e.g., leukopenia, thrombocytopenia, anemia, pancytopenia, myelosuppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration, or gastrointestinal bleeding). In some cases, no symptoms were reported; however, sepsis or septic shock, renal failure, and aplastic anemia were also reported. Management: Leucovorin and levoleucovorin are indicated for diminishing the methotrexate adverse reactions of methotrexate overdosage. Administer leucovorin or levoleucovorin as soon as possible after methotrexate overdosage). Monitor serum creatinine and methotrexate levels to guide leucovorin or levoleucovorin therapy. Refer to the leucovorin or levoleucovorin prescribing information for additional dosage information. Glucarpidase is indicated for the treatment of toxic plasma methotrexate concentrations (> 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Refer to the glucarpidase prescribing information for additional dosage information. Administer concomitant hydration and urinary alkalinization. Neither hemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination; however, methotrexate has been effectively cleared with acute, intermittent hemodialysis using a high-flux dialyzer.
Methotrexate Tablets, USP are available containing 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. The 2.5 mg tablets are orange, round, scored tablets debossed with M above the score and 14 below the score on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 51407-121-01 bottles of 100 tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Methotrexate tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
NDC 51407-121-01 Methotrexate Tablets, USP 2.5 mg PHARMACIST: Dispense the Patient Information. Caution: Cytotoxic Agent Rx only 100 Tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Keep this and all medication out of the reach of children. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.] Protect from light. Recommended Dosage: See accompanying prescribing information. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in Germany Marketed by: GSMS, Inc. Camarillo, CA 93012 USA
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE 101 | 7T9FYH5QMK | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM CARBONATE MONOHYDRATE | 2A1Q1Q3557 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHOTREXATE SODIUM | 3IG1E710ZN | ACTIM |
Methotrexate tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate tablets are contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications (4) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] . Methotrexate tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [see Contraindications (4) , Warnings and Precautions (5.2) ] . Methotrexate tablets when inadvertently administered once daily have resulted in death [see Warnings and Precautions (5.9) ] . Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate tablets as appropriate [see Warnings and Precautions (5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8) ] .
Methotrexate Tablets, USP are available containing 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. The 2.5 mg tablets are orange, round, scored tablets debossed with M above the score and 14 below the score on one side of the tablet and blank on the other side of the tablet.
Methotrexate tablets are contraindicated in: Pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see Warnings and Precautions (5.2) ] .
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Myelosuppression [see Warnings and Precautions (5.3) ] Gastrointestinal Toxicity [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Pulmonary Toxicity [see Warnings and Precautions (5.6) ] Dermatologic Reactions [see Warnings and Precautions (5.7) ] Renal Toxicity [see Warnings and Precautions (5.8) ] Serious Infections [see Warnings and Precautions (5.11) ] Neurotoxicity [see Warnings and Precautions (5.12) ] Secondary Malignancies [see Warnings and Precautions (5.13) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.14) ] Increased Risk of Adverse Reactions Due to Third-Space Accumulation [see Warnings and Precautions (5.17) ]
Overdosage, including fatal overdosage, has occurred with methotrexate [see Warnings and Precautions (5.9) ]. Manifestations: Manifestations of methotrexate overdosage include adverse reactions reported at pharmacologic doses, particularly hematologic and gastrointestinal reactions (e.g., leukopenia, thrombocytopenia, anemia, pancytopenia, myelosuppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration, or gastrointestinal bleeding). In some cases, no symptoms were reported; however, sepsis or septic shock, renal failure, and aplastic anemia were also reported. Management: Leucovorin and levoleucovorin are indicated for diminishing the methotrexate adverse reactions of methotrexate overdosage. Administer leucovorin or levoleucovorin as soon as possible after methotrexate overdosage). Monitor serum creatinine and methotrexate levels to guide leucovorin or levoleucovorin therapy. Refer to the leucovorin or levoleucovorin prescribing information for additional dosage information. Glucarpidase is indicated for the treatment of toxic plasma methotrexate concentrations (> 1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Refer to the glucarpidase prescribing information for additional dosage information. Administer concomitant hydration and urinary alkalinization. Neither hemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination; however, methotrexate has been effectively cleared with acute, intermittent hemodialysis using a high-flux dialyzer.
Methotrexate is dihydrofolate reductase inhibitor with the chemical name of N-[4-[[(2,4 diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L glutamic acid. The molecular formula is C 20 H 22 N 8 O 5 and the molecular weight is 454.4 g/mol. The structural formula is: Methotrexate Tablets, USP for oral use are available in bottles of 100 tablets. Each methotrexate tablet contains 2.5 mg methotrexate equivalent to 2.74 mg methotrexate sodium and the following inactive ingredients: colloidal silicon dioxide, FD&C Red No. 40 Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), sodium carbonate (monohydrate), sodium lauryl sulfate and sodium starch glycolate (potato).
“OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
Methotrexate Tablets, USP are available containing 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. The 2.5 mg tablets are orange, round, scored tablets debossed with M above the score and 14 below the score on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 51407-121-01 bottles of 100 tablets Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Methotrexate tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
Advise the patient to read the FDA-approved patient labeling ( Patient Information ). Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1) ]. Advise females of reproductive potential to use effective contraception during treatment with methotrexate tablets and for 6 months after the final dose [see Use in Specific Populations (8.3) ]. Advise males of reproductive potential to use effective contraception during treatment with methotrexate tablets and for 3 months after the final dose [see Use in Specific Populations (8.3) ]. Hypersensitivity Reactions: Advise patients and their caregivers of the potential risk of hypersensitivity and that methotrexate tablets are contraindicated in patients with a history of hypersensitivity reactions to methotrexate. Instruct patients to seek immediate medical attention for signs of a hypersensitivity reaction [see Warnings and Precautions (5.2) ]. Myelosuppression and Serious Infections: Inform patients and their caregivers that methotrexate tablets can cause myelosuppression and the need for frequent monitoring of blood cell counts. Advise patients and their caregivers to immediately report new onset fever, symptoms of infection, easy bruising or persistent bleeding to their healthcare provider [see Warnings and Precautions (5.3 , 5.11) ]. Gastrointestinal Toxicity: Advise patients and their caregivers to report new or worsening diarrhea, vomiting, or stomatitis to their healthcare provider. Advise patients to immediately contact their healthcare provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, hematemesis, or melena [see Warnings and Precautions (5.4) ]. Hepatotoxicity: Advise patients and their caregivers to report signs or symptoms of hepatic toxicity to their healthcare provider [see Warnings and Precautions (5.5) ]. Pulmonary Toxicity: Advise patients and their caregivers to report new or worsening cough, fever, or dyspnea to their healthcare provider [see Warnings and Precautions (5.6) ]. Dermatologic Reactions: Advise patients and their caregivers that methotrexate tablets can cause serious skin rash and to immediately contact their healthcare provider for new or worsening skin rash. Advise patients and their caregivers to avoid excessive sun exposure and use sun protection measures [see Warnings and Precautions (5.7) ]. Renal Toxicity: Advise patients and their caregivers to immediately contact their healthcare provider for signs or symptoms of renal toxicity, such as marked increases or decreases in urinary output [see Warnings and Precautions (5.8) ]. Risk of Serious Adverse Reactions with Medication Error: For patients who are prescribed a once weekly dosing regimen, advise patients and caregivers that the recommended dosage is to be taken once weekly as a single dose and that mistakenly taking the recommended weekly dosage once daily has led to fatal adverse reactions [see Warnings and Precautions (5.9) ]. Neurotoxicity: Advise patients and their caregivers to report new neurological signs or symptoms to their healthcare provider [see Warnings and Precautions (5.12) ]. Secondary Malignancies: Advise patients on the risk of second primary malignancies during treatment with methotrexate tablets [see Warnings and Precautions (5.13) ]. Lactation: Instruct women not to breastfeed during treatment with methotrexate tablets and for 1 week after the final dose [see Use in Specific Populations (8.2) ]. Infertility: Advise females and males of reproductive potential that methotrexate may impair fertility [see Warnings and Precautions (5.16) , Use in Specific Populations (8.3) ]. Drug Interactions: Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7) ].
Methotrexate Tablets, USP (meth" oh trex' ate) What is the most important information I should know about methotrexate tablets? Methotrexate tablets can cause serious side effects that may be severe and lead to death, including: Harm to an unborn baby, including birth defects or death of an unborn baby. Females who can become pregnant: Your healthcare provider should do a pregnancy test before you start taking methotrexate tablets to see if you are pregnant. If you are being treated for a medical condition other than cancer, do not take methotrexate tablets if you are pregnant. See “Who should not take methotrexate tablets?” If you are taking methotrexate tablets to treat your cancer, you and your healthcare provider will decide if you will take methotrexate tablets if you are pregnant. Use effective birth control (contraception) during treatment and for 6 months after your final dose of methotrexate tablets. Ask your healthcare provider what forms of birth control you can use during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with methotrexate tablets. Males with female partners who are able to become pregnant: Use effective birth control during treatment and for 3 months after your final dose of methotrexate tablets. Tell your healthcare provider right away if your female partner becomes pregnant during treatment with methotrexate tablets. Severe allergic reactions . Severe allergic reactions can happen with methotrexate tablets. Signs and symptoms of a severe allergic reaction may include: skin rash, itching and hives swelling of the face, lips, tongue, or throat dizziness trouble breathing wheezing fast heart rate feeling faint stomach-area pain vomiting or diarrhea Do not take methotrexate tablets if you have had a severe allergic reaction to methotrexate in the past. Get medical help right away if you develop any of the signs or symptoms of a severe allergic reaction listed above. Decreased blood cell counts. Methotrexate tablets can affect your bone marrow and cause decreases in red blood counts, white blood cell counts, and platelets that can be severe and life-threatening. Your healthcare provider will check your blood cell counts when you start and during treatment with methotrexate tablets. Call your healthcare provider right away if you develop any of the following: a new fever symptoms of infection Easy bruising or bleeding that will not stop (persistent bleeding) Severe stomach and intestine problems (gastrointestinal) problems. Diarrhea, vomiting, nausea, and mouth sores can happen in people who take methotrexate tablets. Inflammation of the intestine with severe bleeding and a tear in the intestinal wall (perforation) have happened with methotrexate tablets and cause death. People who have stomach ulcers (peptic ulcer disease) or ulcerative colitis (UC) have a greater risk of developing severe stomach or intestine problems with methotrexate tablets. Tell your healthcare provider if you develop new or worsening diarrhea, vomiting, or mouth sores during treatment with methotrexate tablets. Tell your healthcare provider right away if you develop high fever, shaking chills (rigors), pain in your stomach-area (abdomen) that will not go away or is severe, severe constipation, if you are vomiting blood or have blood in your stools. Liver problems. Methotrexate tablets can cause severe liver problems including liver scarring (fibrosis), cirrhosis, and liver failure that may not get better (possibly irreversible) and can cause death. In people with psoriasis who take methotrexate tablets, liver fibrosis or cirrhosis may happen without any symptoms or abnormal liver tests. The risk for liver problems in people with psoriasis increases as with the amount of methotrexate tablets that you take over time. Your healthcare provider will do tests to monitor your liver function before you start and during treatment with methotrexate tablets. Tell your healthcare provider if you have any signs or symptoms of liver problems during treatment with methotrexate tablets, including: tiredness easy bleeding or bruising loss of appetite nausea difficulty thinking clearly swelling in your legs, feet or ankles weight loss itchy skin yellowing of your skin or the white part of your eyes weakness Lung problems. Lung problems can happen suddenly (acute) with methotrexate tablets or they can develop over a long period-of-time (chronic). Lung problems may not get better (possibly irreversible) and can cause death. Tell your healthcare provider if you have any new or worsening symptoms including: cough (especially a dry cough), fever, or trouble breathing. Severe skin reactions. Severe skin reactions can happen with methotrexate tablets and can lead to death. In people with psoriasis: Your psoriasis may get worse if you are exposed to sunlight or other types of ultraviolet light. Methotrexate tablets can cause reactivation of skin reactions that can happen after radiation therapy (radiation recall dermatitis) and cause sunburn to come back (photodermatitis). Limit sunlight exposure during treatment with methotrexate tablets. Use sunscreen and wear protective clothing when you will be exposed to sunlight during treatment with methotrexate tablets. Tell your healthcare provider right away about any new or worsening skin rash during treatment with methotrexate tablets. Kidney problems. Kidney problems can happen with methotrexate tablets, including kidney failure which can happen suddenly (acute) and may not go away (irreversible). Your healthcare provider will check your kidney function before you start and during treatment with methotrexate tablets. Tell your healthcare provider right away if you have any signs or symptoms of kidney problems, including: a big change (either increase or decrease) in the amount of urine you produce swelling in your legs, ankles or feet shortness of breath tiredness weight gain See “What are the possible side effects of methotrexate tablets” for more information about side effects. What are methotrexate tablets? Methotrexate tablets are a prescription medicine used: in combination with other chemotherapy medicines in adults and children, for maintenance treatment of acute lymphoblastic leukemia (ALL) to treat adults with mycosis fungoides (cutaneous T-cell lymphoma) in combination with other therapies to treat adults with non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory) to treat adults with rheumatoid arthritis to treat children with polyarticular juvenile idiopathic arthritis (pJIA) to treat adults with severe psoriasis It is not known if methotrexate tablets are safe and effective in treating children with any disease other than ALL as part of a combination regimen used for maintenance therapy of their cancer, and for the treatment of pJIA. It is not known if methotrexate tablets are safe in people with liver problems. Do not take methotrexate tablets if you: are pregnant and are being treated or will be treated with methotrexate tablets for rheumatoid arthritis, pJIA, or severe psoriasis or for any disease other than cancer). Methotrexate tablets can cause harm to an unborn baby, including birth defects or death of an unborn baby. See “What is the most important information I should know about methotrexate tablets?” have or had a severe allergic reaction to methotrexate in the past. See “What is the most important information I should know about methotrexate tablets?” See the end of this leaflet for a complete list of ingredients in methotrexate tablets. Before taking methotrexate tablets tell your healthcare provider about all of your medical conditions, including if you: have problems swallowing tablets have kidney problems or are receiving dialysis treatments have liver problems drink alcohol-containing beverages and, during treatment with methotrexate tablets, if there are any changes in the amount o...
NDC 51407-121-01 Methotrexate Tablets, USP 2.5 mg PHARMACIST: Dispense the Patient Information. Caution: Cytotoxic Agent Rx only 100 Tablets Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Keep this and all medication out of the reach of children. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). [See USP Controlled Room Temperature.] Protect from light. Recommended Dosage: See accompanying prescribing information. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in Germany Marketed by: GSMS, Inc. Camarillo, CA 93012 USA
Official SPL XML cached by FDA.report · DailyMed PDF
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