Label: METHOTREXATE tablet

  • NDC Code(s): 0555-0572-02, 0555-0572-35
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 21, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use METHOTREXATE TABLETS safely and effectively. See full prescribing information for METHOTREXATE TABLETS. METHOTREXATE tablets ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS

    • Methotrexate can cause embryo-fetal toxicity, including fetal death. For non- neoplastic diseases, methotrexate is 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 is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [Contraindications (4), Warnings and Precautions (5.2)].
    • 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 as appropriate [Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7, 5.8)].
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  • 1 INDICATIONS AND USAGE
    1.1 Neoplastic Diseases - Methotrexate tablets are indicated for the: treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 - Important Dosage and Safety Information - Verify pregnancy status in females of reproductive potential before starting methotrexate tablets [see Contraindications (4), Warnings and ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Tablets: Yellow, oval-shaped, film coated, scored, biconvex tablet. Debossed with b/572 on the scored side.
  • 4 CONTRAINDICATIONS
    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 ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 - Embryo-Fetal Toxicity - Based on published reports and its mechanism of action, methotrexate can cause fetal harm, including fetal death, when administered to a pregnant woman. Methotrexate ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Myelosuppression [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 - Effects of Other Drugs on Methotrexate - Drugs that Increase Methotrexate Exposure - Coadministration of methotrexate with the following products may increase methotrexate plasma ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Methotrexate is contraindicated in pregnant women with non-neoplastic diseases [see Contraindications (4)]. Based on published reports and its mechanism of action ...
  • 10 OVERDOSAGE
    Overdosage, including fatal overdosage, has occurred with methotrexate [see Warnings and Precautions (5. 9)]. Manifestations - Manifestations of methotrexate overdosage include adverse reactions ...
  • 11 DESCRIPTION
    Methotrexate, USP is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C20H22N8O5 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Methotrexate has been evaluated in a number of animal studies for carcinogenic potential with inconclusive results. There is evidence ...
  • 15 REFERENCES
    1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Methotrexate Tablets, USP are supplied as follows: 2.5 mg: Yellow, oval-shaped, film-coated, scored, biconvex tablet. Debossed with b/572 on the scored side. Available in bottles of 36 tablets ...
  • 17 PATIENT COUNSELING INFORMATION
    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 ...
  • SPL UNCLASSIFIED SECTION
    Dispense with Patient Package Insert available at: www.tevausa.com/PatientPI
  • PATIENT PACKAGE INSERT
    PATIENT INFORMATION ...
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL
    NDC 0555-0572-35 - Methotrexate Tablets, USP - 2.5 mg - Caution: Cytotoxic Agent - PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient. Rx only - 36 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information