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NEOMYCIN SULFATE TABLETS

Category Antibacterial.

      Neomycin Sulfate Tablets contain the equivalent of not less than 90.0 per cent and not more than 125.0 per cent of the labelled amount of neomycin.

Strength available 500 mg.

Dose Adults----Diarrhea, enteropathogenic Escherichia coli: 50 mg per kg of body weight daily in four divided doses for 2 to 3 days. A dosage of 3 g daily is usually adequate.

      Encephalopathy, hepatic (adjunct): 4 to 12 g daily in four divided doses for 5 to 7 days.

Contra-indication It is contra-indicated in cases of intestinal obstruction or in patients with history of hypersensitivity reactions to any member of aminoglycosides.

Warning See under Gentamicin Sulfate, p. 111.

Precaution Because of the potential risk of the increased absorption of neomycin sulfate from the inflamed or ulcerated gastro-intestinal tract, it should be used with caution in such conditions.

      See also under Gentamicin Sulfate, p. 111. 

Additional information See under Neomycin Sulfate, p. 132.

Packaging and storage Neomycin Sulfate Tablets shall be kept in tightly closed containers.

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

Identification

      A. Comply with test for Identification B described under Neomycin Sulfate, p. 132. Apply separately to the plate, 2 μl of each of the following solutions. For solution (A) shake a portion of the powdered tablets containing 100 mg of neomycin with 25 ml of water and filter. Solution (B) is a 4 mg per ml solution of Neomycin Sulfate RS in water. At a third point, apply 2 μl of a mixture of equal volumes of solutions (A) and (B).

      B. The powdered tablets yield the reactions characteristic of sulfates (Appendix 5.1).

Loss on drying Not more than 10.0 per cent w/w after drying at 60º at a pressure not exceeding 0.7 kPa (about 5 Torr) for 3 hours (Appendix 4.15).

Disintegration Carry out the test as described in the “Disintegration Test for Tablets and Capsules” (Appendix 4.23). Disintegration occurs in not more than 60 minutes.

Assay Weigh and finely powder not less than 20 Neomycin Sulfate Tablets. Shake an accurately weighed portion of the powder with a sufficient accurately measured volume of Buffer 2 to obtain a stock solution having a convenient concentration. Dilute this stock solution quantitatively and stepwise with Buffer 2, and proceed as directed under the microbiological assay of Neomycin according to the “Microbiological Assay of Antibiotics” (Appendix 6.10).

Other requirements Comply with the requirements described under “Tablets” (Appendix 1.16).

MONOGRAPHS • NEOMYCIN SULFATE TABLETS
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หมายเหตุ / Note : TP II 2011 PAGE 132-133