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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