METHOTREXATE, VIALS 6 Dosage Forms, Strengths, Composition and Packaging

methotrexate, vials

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Table 9: Dosage Forms, Strengths, Composition and Packaging
Route of AdministrationDosage Form / Strength/CompositionNon-Medicinal Ingredients
Intramuscular, intravenous, intra-arterial, intrathecal, intracerebroventricularSterile solution (preservative-free) /
10 mg/mL (20 mg/2 mL)
25 mg/mL (50 mg/2 mL)
Sodium Chloride
Sodium Hydroxide Hydrochloric Acid
IntravenousSterile 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:

Table 10: Methotrexate Injection USP Pharmacy Bulk Vials
25 mg/mL methotrexate500 mg/20 mL(contains no preservative)
25 mg/mL methotrexate1 g/40 mL (contains no preservative)
25 mg/mL methotrexate2.5 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.

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6 Dosage Forms, Strengths, Composition and Packaging

Table 9: Dosage Forms, Strengths, Composition and Packaging
Route of AdministrationDosage Form / Strength/CompositionNon-Medicinal Ingredients
Intramuscular, intravenous, intra-arterial, intrathecal, intracerebroventricularSterile solution (preservative-free) /
10 mg/mL (20 mg/2 mL)
25 mg/mL (50 mg/2 mL)
Sodium Chloride
Sodium Hydroxide Hydrochloric Acid
IntravenousSterile 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:

Table 10: Methotrexate Injection USP Pharmacy Bulk Vials
25 mg/mL methotrexate500 mg/20 mL(contains no preservative)
25 mg/mL methotrexate1 g/40 mL (contains no preservative)
25 mg/mL methotrexate2.5 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.

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