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Category Antifungal (oral-local).

      Nystatin Oral Suspension contains not less than 90.0 per cent and not more than 130.0 per cent of the labelled amount of nystatin. It contains suitable dispersants, flavours, preservatives, and suspending agents.​

Strength available 100,000 Units per ml.

Dose Adults and children: 400,000 to 600,000 Units four times a day.

      Infants: 200,000 Units four times a day.

      Premature and low-birth-weight infants: 100,000 Units four times a day.

Warning See under Nystatin, p. 136.

Additional information

      1. For oral candidiasis, oral suspension should be retained in each side of the mouth as long as possible before swallowing.

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

Packaging and storage Nystatin Oral Suspension shall be protected from light and stored at a temperature not exceeding 30º. 

Labelling The label on the container states the number of Units per ml.

Identification Shake a portion of the suspension 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. The ultraviolet absorption spectrum of the resulting solution, when immediately observed between 250 and 350 nm, exhibits three maxima at 291 nm, 305 nm and 319 nm. The ratios of the absorbances at the maxima at 291 nm and 319 nm to the absorbance at the maximum at 305 nm are 0.61 to 0.73 and 0.83 to 0.96, respectively. Use in the reference cell a solution prepared in exactly the same manner but omitting the preparation being examined.

pH 4.5 to 6.0, or if it contains glycerol, 5.3 to 7.5 (Appendix 4.11).

Uniformity of dosage units For suspension packaged in single-unit containers, it complies with the test described in the “Uniformity of Dosage Units” (Appendix 4.28).

      PROCEDURE FOR CONTENT UNIFORMITY (Note Use low-actinic glassware. The correction factor, F, calculated as directed in section (4) of Content Uniformity under “Uniformity of Dosage Units” (Appendix 4.28), is invalid if the value obtained by the formula in the second sentence is greater than 25; follow sections (5) and (6), except to substitute 0.750 for 0.9000.) Transfer the well-shaken contents of one container of Nystatin Oral Suspension to a 100-ml volumetric flask, dissolve in methanol, dilute with methanol to volume, and mix. Dilute an accurately measured volume of this solution quantitatively, and stepwise if necessary, with methanol to obtain a concentration of about 25 Units per ml. Measure the absorbance of the resulting solution at the maximum at about 304 nm (Appendix 2.2). Calculate the content, in Units, in the container by comparison with Nystatin RS similarly treated and concurrently examined.

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 an accurately measured volume of Nystatin Oral Suspension, freshly mixed and free from air bubbles, 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 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 “Oral Liquids” (Appendix 1.16).