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Category Antibacterial.

      Gentamicin Sulfate Injection is a sterile solution of Gentamicin Sulfate in Water for Injection. It contains the equivalent of not less than 90.0 per cent and not more than 125.0 per cent of the labelled amount of gentamicin. It may contain suitable buffers, preservatives and sequestering agents, unless it is intended for intrathecal use, in which case it contains only suitable tonicity agents. 

Strengths available 10 and 40 mg (base) per ml.

Dose Adults: Intramuscular or slow intravenous infusion (over 30 to 60 minutes), 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 in severe, life-threatening infections. (Note Doses up to 15 mg per kg of body weight daily have been used in the treatment of intraocular infections.)

      Children: Intramuscular or slow intravenous infusion (over 30 to 60 minutes), 2 to 2.5 mg per kg of body weight every 8 hours for 7 to 10 days or more.

      Older neonates and infants: Intramuscular or slow intravenous infusion (over 30 to 60 minutes), 2.5 mg per kg of body weight every 8 to 16 hours for 7 to 10 days or more.

      Premature or full-term neonates up to 1 week of age: Intramuscular or slow intravenous infusion (over 30 to 60 minutes) 2.5 mg per kg of body weight every 12 to 24 hours for 7 to 10 days or more.

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

Additional information

      1. In patients with impaired renal function, intramuscular and intravenous doses and/or frequency of administration of gentamicin must be modified in response to serum concentrations of the drug and the degree of renal impairment.

      2. Extemporaneous admixtures with some drugs, especially betalactam antibacterials, should be avoided.

See also under Gentamicin Sulfate, p. 111.

Packaging and storage Gentamicin Sulfate Injection shall be kept in single-dose or in multiple-dose containers, preferably of Type I glass, and stored at a temperature not exceeding 30º.

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

Identification Complies with the test for Identification C described under Gentamicin Sulfate, p. 111. 

pH 3.0 to 5.5 (Appendix 4.11).

Particulate matter Complies with the requirements described under “Particulate Matter in Injections” (Small-volume Injections, Appendix 4.27).

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.71 Endotoxin Unit per mg of gentamicin.

Assay Proceed as directed under the microbiological assay of Gentamicin Sulfate according to the “Microbiological Assay of Antibiotics” (Appendix 6.10), using an accurately measured volume of Gentamicin Sulfate Injection.

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