| Route of Administration | Dosage Form / Strength/Composition | Non-Medicinal Ingredients |
|---|---|---|
| Intramuscular, intravenous, intra-arterial, intrathecal, intracerebroventricular | Sterile solution (preservative-free) / 10 mg/mL (20 mg/2 mL) 25 mg/mL (50 mg/2 mL) | Sodium Chloride Sodium Hydroxide Hydrochloric Acid |
| Intravenous | Sterile solution (Pharmacy Bulk vial; preservative-free) / 25 mg/mL (500 mg/20 mL; 1 g/40 mL; 2.5 g/100 mL) | Sodium Chloride Sodium Hydroxide Hydrochloric Acid |
| Intramuscular, intravenous, intra-arterial | Sterile solution (with preservative) / 25 mg/mL (50 mg/2 mL; 500 mg/20 mL) | Benzyl alcohol as preservative Sodium Chloride Sodium Hydroxide Hydrochloric Acid |
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)
* Single-use vials
+ Multidose vials
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).
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 (preservative), 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 11 STORAGE, STABILITY AND DISPOSAL for special storage conditions once the vials are punctured.
The vial stoppers are not made with natural rubber latex.
)| Route of Administration | Dosage Form / Strength/Composition | Non-Medicinal Ingredients |
|---|---|---|
| Intramuscular, intravenous, intra-arterial, intrathecal, intracerebroventricular | Sterile solution (preservative-free) / 10 mg/mL (20 mg/2 mL) 25 mg/mL (50 mg/2 mL) | Sodium Chloride Sodium Hydroxide Hydrochloric Acid |
| Intravenous | Sterile solution (Pharmacy Bulk vial; preservative-free) / 25 mg/mL (500 mg/20 mL; 1 g/40 mL; 2.5 g/100 mL) | Sodium Chloride Sodium Hydroxide Hydrochloric Acid |
| Intramuscular, intravenous, intra-arterial | Sterile solution (with preservative) / 25 mg/mL (50 mg/2 mL; 500 mg/20 mL) | Benzyl alcohol as preservative Sodium Chloride Sodium Hydroxide Hydrochloric Acid |
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)
* Single-use vials
+ Multidose vials
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).
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 (preservative), 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 11 STORAGE, STABILITY AND DISPOSAL for special storage conditions once the vials are punctured.
The vial stoppers are not made with natural rubber latex.
*Contact Medical Information. 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product:
You may also contact the Canada Vigilance Program directly to report adverse events or product quality concerns at 1-866-234-2345 or www.healthcanada.gc.ca/medeffect.