สารบัญ

Category Antibacterial (second-generation cephalosporin).

          Cefoxitin Sodium for Injection is a sterile material consisting of Cefoxitin Sodium with or without excipients equivalent to not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C₁₆H₁₇N₃O₇S₂.

Strengths available 1, 2 and 10 g (base).

Dose Adults: Deep Intramuscular or intravenous, 3 to 12 g daily in divided doses every 4 to 8 hours.
          Children and infants over 3 months: Deep Intramuscular or intravenous, 80 to 160 mg per kg of body weight daily divided into 4 to 6 equal doses. The maximum total dose should not exceed 12 g a day.

Contra-indication See under Cefoxitin Sodium, p. 46.

Warning
          1. Pain, tenderness and induration have been reported with intramuscular administration and thrombophlebitis may occur with intravenous administration.
          2. Concurrent use of nephrotoxic agents may increase the risk of nephrotoxicity.
          3. It may cause transient increase in serum aspartate transaminase (AST), alanine transaminase (ALT), lactate dehydrogenase (LDH) and alkaline phosphatase concentrations and jaundice.
          See also under Cephalexin, p. 58.

Additional information See under Cephelexin, p. 58.

Packaging and storage Cefoxitin Sodium for Injection shall be kept in Containers for Sterile Solids as described under “Parenteral Preparations” (Appendix 1.16).

Labelling The label on the container states the quantity equivalent to the amount of cefoxitin.

Identification
          A. The infrared absorption spectrum is concordant with the spectrum obtained from Cefoxitin RS (Appendix 2.1) or with the reference spectrum of Cefoxitin.
          B. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
          C. The ultraviolet absorption spectrum, when observed between 220 and 400 nm, of a 0.002 per cent w/v solution of the injection in phosphate buffer prepared by dissolving 1.0 g of potassium dihydrogenphosphate and 1.8 g of anhydrous disodium hydrogenphosphate in water to make 1000 ml, exhibits maxima at the same wavelengths as those of a similar solution of Cefoxitin Sodium RS, concomitantly measured (Appendix 2.2).
          D. It yields the reactions characteristic of sodium salts (Appendix 5.1).

pH 4.2 to 7.0, in a 1.0 per cent w/v solution (Appendix 4.11).

Water Not more than 1.0 per cent w/w (Karl Fischer Method, Appendix 4.12). Use 500 mg.

Constituted solution At the time of use, complies with the requirements described under “Constituted Solutions” (Appendix 4.20).

Particulate matter Complies with the requirements described under “Particulate Matter in Injections (Smallvolume Injections, Appendix 4.27).

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.13 Endotoxin Unit per mg of cefoxitin.

Assay Carry out the determination as described in the
“High-pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase, Phosphate buffer, Standard preparation, Chromatographic system and Procedure Proceed as directed in the Assay described under Cefoxitin Sodium, p 47.
          Assay preparation 1 (where it is represented as being in a single-dose container) Constitute Cefoxitin Sodium for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labelling. Withdraw all of the contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with water to obtain a solution containing about 300 μg of cefoxitin per ml. (Note Use this solution within 5 hours.)
          Assay preparation 2 (where the label states the quantity of cefoxitin in a given volume of constituted solution) Constitute Cefoxitin Sodium for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labelling. Dilute an accurately measured volume quantitatively with water to obtain a solution containing about 300 μg of cefoxitin per ml. (Note Use this solution within 5 hours.)
          Calculation Calculate the content of C₁₆H₁₇N₃O₇S₂ in the portion of the constituted Injection taken, using the declared content of C₁₆H₁₇N₃O₇S₂, in Cefoxitin RS.

Other requirements Complies with the requirements described under “Parenteral Preparations” (Appendix 1.16).