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Category Antifungal.

      Nystatin Tablets contain not less than 90.0 per cent and not more than 130.0 per cent of the labelled amount of nystatin.

Strength available 500,000 Units. 

Dose Intestinal candiasis----Adults: 500,000 to 1,000,000 Units three times a day.

      Children 5 years of age and over: 500,000 Units four times a day.

Warning See under Nystatin, p. 136.

Additional information The drug should be continued for at least two days after symptoms have subsided.

Packaging and storage Nystatin Tablets shall be protected from light.

Labelling The label on the container states (1) the number of Units; (2) that they are intended for oral use only.

Identification Comply with the test for Identification described under Nystatin Oral Suspension, p. 136. Shake a portion of the powdered tablets containing 300,000 Units with a mixture of 5.0 ml of glacial acetic acid and 50 ml of methanol. Add sufficient methanol to produce 100 ml, filter and dilute 1 ml of the filtrate to 100 ml with methanol.

Loss on drying Not more than 5.0 per cent w/w after drying the powdered tablets at 60º at a pressure not exceeding 0.7 kPa (about 5 Torr) for 3 hours (Appendix 4.15).

Disintegration Carry out the test described in the “Disintegration Test for Tablets and Capsules” (Appendix 4.23), but using a 0.6 per cent v/v solution of hydrochloric acid in place of water. If the tablets fail to disintegrate, wash them rapidly by immersion in water and continue the test using phosphate buffer pH 6.8: the tablets then disintegrate within a further 30 minutes. 

Assay (Note Do not use a plastic blender or cover since dimethylformamide can dissolve plastic material.) Carry out the following procedure protected from light. Blend not less than five Nystatin Tablets for 3 to 5 minutes in a high-speed blender with a sufficient accurately measured volume of dimethylformamide to obtain a solution of convenient concentration. Dilute an accurately measured portion of this solution quantitatively with dimethylformamide to obtain a stock solution containing about 400 Units per ml. Dilute this stock solution quantitatively and stepwise with Buffer 4, and proceed as directed under the microbiological assay of Nystatin according to the “Microbiological Assay of Antibiotics” (Appendix 6.10).

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