Methotrexate (Page 2 of 7)

2.6 Dosage Modifications for Adverse Reactions

Discontinue Methotrexate Tablets for:Discontinue Methotrexate Tablets for:

  • Anaphylaxis or other severe hypersensitivity reactions [see Warnings and Precautions ( 5.2)]
  • Lymphoproliferative disease [see Warnings and Precautions ( 5.13)]

Withhold, dose reduce or discontinue Methotrexate Tablets as appropriate for:Withhold, dose reduce or discontinue Methotrexate Tablets as appropriate for:

  • Myelosuppression [see Warnings and Precautions ( 5.3)]

Methotrexate Tablets as appropriate for: Withhold or discontinue Methotrexate Tablets as appropriate for:

  • Severe gastrointestinal toxicity [see Warnings and Precautions ( 5.4)]
  • Hepatotoxicity [see Warnings and Precautions ( 5.5)]
  • Pulmonary toxicity [see Warnings and Precautions ( 5.6)]
  • Severe dermatologic reactions [see Warnings and Precautions ( 5.7)]
  • Severe renal toxicity [see Warnings and Precautions ( 5.8)]
  • Serious infections [see Warnings and Precautions ( 5.11)]
  • Neurotoxicity [see Warnings and Precautions ( 5.12)]

3 DOSAGE FORMS AND STRENGTHS

Methotrexate Tablets, USP contain an amount of 2.5 mg of methotrexate equivalent to 2.74 mg methotrexate sodium and are pale yellow to yellow, round shaped, biconvex, uncoated tablets, debossed on one side HZ” and “1” on either side of the score line and plain on other side.

4 CONTRAINDICATIONS

is contraindicated in: Methotrexate Tablets is 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)].

5 WARNINGS AND PRECAUTIONS

5.1 Embryo-Fetal Toxicity

and its mechanism of action, Methotrexate Tablets can cause fetal harm, including fetal death, when administered to a pregnant woman. Methotrexate Tablets is contraindicated for use in pregnant women receiving Methotrexate Tablets for the treatment of non-malignant diseases. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Methotrexate Tablets and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during Methotrexate Tablets treatment and for 3 months after the final dose Based on published reports and its mechanism of action, Methotrexate Tablets can cause fetal harm, including fetal death, when administered to a pregnant woman. Methotrexate Tablets is contraindicated for use in pregnant women receiving Methotrexate Tablets for the treatment of non-malignant diseases. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Methotrexate Tablets and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during Methotrexate Tablets treatment and for 3 months after the final dose [see Contraindications ( 4), Use in Specific Populations ( 8.1, 8.3)].

5.2 Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, can occur with methotrexate [see Contraindications ( 4), Adverse Reactions ( 6.1)].

If anaphylaxis or other serious hypersensitivity reaction occurs, immediately and permanently discontinue Methotrexate Tablets [see Dosage and Administration ( 2.6)].

5.3 Myelosuppression

hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia Methotrexate suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia [see Adverse Reactions ( 6.1)].

Obtain blood counts at baseline, periodically during treatment, and as clinically indicated. Monitor patients for clinical complications of myelosuppression. Withhold, dose reduce, or discontinue Methotrexate Tablets taking into account the importance of Methotrexate Tablet treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy [see Dosage and Administration ( 2.6)].

5.4 Gastrointestinal Toxicity

vomiting, nausea, and stomatitis occurred in up to 10% of patients receiving methotrexate for treatment of non-neoplastic diseases. Hemorrhagic enteritis and fatal intestinal perforation have been reported Patients with peptic ulcer disease or ulcerative colitis are at a greater risk of developing severe gastrointestinal adverse reactions Diarrhea, vomiting, nausea, and stomatitis occurred in up to 10% of patients receiving methotrexate for treatment of non-neoplastic diseases. Hemorrhagic enteritis and fatal intestinal perforation have been reported [see Adverse Reactions ( 6.1, 6.2)]. Patients with peptic ulcer disease or ulcerative colitis are at a greater risk of developing severe gastrointestinal adverse reactions [see Drug Interactions ( 7.1)].

or discontinue Methotrexate Tablets for severe gastrointestinal toxicity taking into account the importance of Methotrexate Tablet treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy Withhold or discontinue Methotrexate Tablets for severe gastrointestinal toxicity taking into account the importance of Methotrexate Tablet treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy [see Dosage and Administration ( 2.6)].

5.5 Hepatotoxicity

Methotrexate can cause severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure The safety of Methotrexate Tablets in patients with hepatic disease is unknown. Methotrexate can cause severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure [see Adverse Reactions ( 6.1)]. The safety of Methotrexate Tablets in patients with hepatic disease is unknown.

is increased with heavy alcohol consumption. In patients with psoriasis, fibrosis or cirrhosis may occur in the absence of symptoms or abnormal liver tests; the risk of hepatotoxicity appears to increase with total cumulative dose and generally occurs after receipt of a total cumulative dose of 1.5 g or more. The risk of hepatotoxicity is increased with heavy alcohol consumption. In patients with psoriasis, fibrosis or cirrhosis may occur in the absence of symptoms or abnormal liver tests; the risk of hepatotoxicity appears to increase with total cumulative dose and generally occurs after receipt of a total cumulative dose of 1.5 g or more.

Monitor liver tests at baseline, periodically during treatment and as clinically indicated. Withhold or discontinue Methotrexate Tablets taking into account the importance of Methotrexate Tablet treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy Monitor liver tests at baseline, periodically during treatment and as clinically indicated. Withhold or discontinue Methotrexate Tablets taking into account the importance of Methotrexate Tablet treatment in the context of the severity of the disease being treated, the severity of the adverse drug reaction, and availability of alternative therapy [see Dosage and Administration ( 2.6)].

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