METHOTREXATE, VIALS 2 Contraindications

methotrexate, vials

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Methotrexate Injection USP is contraindicated: 

  • In patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 Dosage forms, strengths, composition and packaging).
  • In patients with severe renal impairment including end stage renal disease with and without dialysis (see 7.1 WARNINGS AND PRECAUTIONS: Renal, 1 Special populations and 4.2 Recommended dose and dosage adjustment: Special populations).
  • In pregnant patients with psoriasis or rheumatoid arthritis and should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus.
  • In women of childbearing potential until pregnancy is excluded.
  • In nursing mothers.
  • In patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease.
  • In patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of immunodeficiency syndromes.
  • In patients with psoriasis or rheumatoid arthritis who have pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia.
  • With nitrous oxide anesthesia (see 7 WARNINGS AND PRECAUTIONS: Renal and 4 Drug-Drug Interactions). 

Methotrexate Injection USP formulations containing benzyl alcohol are also contraindicated: 

  • To use for intrathecal, intracerebroventricular, or high-dose therapy.
  • To use in neonates (children less than one month age).
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2 Contraindications

Methotrexate Injection USP is contraindicated: 

  • In patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 Dosage forms, strengths, composition and packaging).
  • In patients with severe renal impairment including end stage renal disease with and without dialysis (see 7.1 WARNINGS AND PRECAUTIONS: Renal, 1 Special populations and 4.2 Recommended dose and dosage adjustment: Special populations).
  • In pregnant patients with psoriasis or rheumatoid arthritis and should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus.
  • In women of childbearing potential until pregnancy is excluded.
  • In nursing mothers.
  • In patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease.
  • In patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of immunodeficiency syndromes.
  • In patients with psoriasis or rheumatoid arthritis who have pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia.
  • With nitrous oxide anesthesia (see 7 WARNINGS AND PRECAUTIONS: Renal and 4 Drug-Drug Interactions). 

Methotrexate Injection USP formulations containing benzyl alcohol are also contraindicated: 

  • To use for intrathecal, intracerebroventricular, or high-dose therapy.
  • To use in neonates (children less than one month age).

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