สารบัญ

Category Antibacterial.

      Tobramycin Sulfate Injection is a sterile solution of Tobramycin Sulfate in Water for Injection, or of Tobramycin in Water for Injection prepared with the aid of Sulfuric Acid. It contains not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C₁₈H₃₇N₅O₉.

Description Clear, colourless solution.

Strengths available 10, 20, 40, 60, and 80 mg (base) per ml.

Dose Adults: Intramuscular or slow intravenous infusion (over 30 to 60 minutes), 0.75 to 1.25 mg per kg of body weight every 6 hours or 1 to 1.7 mg per kg of body weight every 8 hours for 7 to 10 days or more or up to 8 mg per kg of body weight daily.

      Children and infants: Intramuscular or slow intravenous infusion (over 30 to 60 minutes), 1.5 to 1.9 mg per kg of body weight every 6 hours or 2 to 2.5 mg per kg of body weight every 8 to 16 hours.

      Premature or full-term neonates: Intramuscular or slow intravenous infusion (over 30 to 60 minutes), up to 2 mg per kg of body weight every 12 to 24 hours. The maximum total dose should not exceed 4 mg per kg of body weight daily.

Contra-indication; Warning; Precaution See under Gentamicin Sulfate, p. 111. 

Additional information Tobramycin Sulfate Injection may also be administered as an aerosol nebulization.

      See also under Gentamicin Sulfate, p. 111.

Packaging and storage Tobramycin Sulfate Injection shall be kept in single-dose or in multiple-dose containers, preferably of Type I glass.

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

Identification

      A. Complies with the test for Identification B described under Tobramycin, p. 160. For solution (A), dilute the injection with water to obtain a solution containing 6 mg of tobramycin per ml.

      B. The retention time of the major peak in the chromatogram of the Derivatized assay preparation corresponds to that in the chromatogram of the Derivatized standard preparation, as obtained in the Assay.

      C. It yields the reactions characteristic of sulfate (Appendix 5.1).

pH 3.0 to 6.5 (Appendix 4.11).

Particulate matter Complies with the requirments 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 2.00 Endotoxin Units per mg of tobramycin.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

      Mobile phase, 2,4-Dinitrofluorobenzene reagent, Tris(hydroxymethyl)aminomethane reagent, Standard preparation, Derivatization procedure, Resolution solution, Chromatographic system, and Procedure Proceed as directed in the Assay under Tobramycin, p 161.

      Assay preparation Dilute an accurately measured volume of Tobramycin Sulfate Injection quantitatively, and stepwise if necessary, with water to obtain a solution containing the equivalent of about 200 μg of tobramycin per ml.

      Calculation Calculate the content of C₁₈H₃₇N₅O₉ in each ml of the Injection taken, using the declared content of C₁₈H₃₇N₅O₉ in Tobramycin RS.

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