(1) Methotrexate Injection USP is supplied in a carton containing 20 mg, 50 mg and 500 mg of methotrexate (as the sodium salt) as follows:
10 mg/mL methotrexate |
20 mg/2 mL* (contains no preservative) |
25 mg/mL methotrexate |
50 mg/2 mL* (contains no preservative) |
25 mg/mL methotrexate |
50 mg/2 mL+ (contains preservative) |
25 mg/mL methotrexate |
500 mg/20 mL+ (contains preservative) |
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Note: The 10 mg/mL presentation is available in packs of 5 vials. The 25 mg/mL presentations are available in packs of 5 vials (2 mL) or as single vials (2 mL and 20 mL).
(2) Methotrexate Injection USP Pharmacy Bulk Vials which are packaged in a carton, are for intravenous use only and are supplied to hospitals with a recognized intravenous admixture program only, as follows:
25 mg/mL methotrexate |
500 mg/20 mL (contains no preservative) |
25 mg/mL methotrexate |
1 g/40 mL (contains no preservative) |
25 mg/mL methotrexate |
2.5 g/100 mL (contains no preservative) |
Composition: Methotrexate Injection USP is a sterile, isotonic solution containing:
- Methotrexate Sodium equivalent to 10 mg/mL Methotrexate with 7.0 mg/mL Sodium Chloride, (unpreserved), with Sodium Hydroxide and Hydrochloric Acid as pH adjusters.
- Methotrexate Sodium equivalent to 25 mg/mL Methotrexate with 4.9 mg/mL Sodium Chloride, (unpreserved), with Sodium Hydroxide and Hydrochloric Acid as pH adjusters.
- Methotrexate Sodium equivalent to 25 mg/mL Methotrexate with 2.6 mg/mL Sodium Chloride and 0.9% v/v Benzyl alcohol (preserved), with Sodium Hydroxide and Hydrochloric Acid as pH adjusters.
Note: 50 mg/2 mL and 500 mg/20 mL Methotrexate Injection USP, with benzyl alcohol (as preservative) are supplied as multidose vials. Please see STORAGE AND STABILITY for special storage conditions once the vials are punctured.
Latex-free Stoppers – Stoppers contain no dry natural rubber
Submission Control No.: 224776
July 08, 2019