Actual Medicinal Product (AMP) Sulfasalazine 500mg gastro-resistant tablets (Alliance Healthcare (Distribution) Ltd)

This product can't be added to an MCA list.

Stability Information

(Some stability information inherited from generic)

Stability
compatible_special_measures logo Lack of data and/or stability concerns exist. MCA use may be acceptable but is likely to be off-label and require mitigation measures. Keep medicines in MCAs for the shortest time necessary. Generally, up to 5 weeks maximum unless otherwise specified, or up to 8 weeks if the MCA is airtight (sealed). Consider the risk of potency loss or dose variability and monitor for changes in efficacy or adverse effects after MCA initiation.
Notes

Moisture sensitive medicine. Store in airtight (sealed) MCA. Original packaging may contain desiccant. Protect from light. Stability study supports 5 weeks in airtight (sealed) MCA when protected from light and moisture.

Provenance

This recommendation is based on the products Salazopyrin En-Tabs 500 mg gastro-resistant tablets (Pfizer limited) and sulfasalazine 500mg tablets (Hualan Pharmaceuticals Limited).

Generic
Sulfasalazine
Formulation
Sulfasalazine 500mg gastro-resistant tablets
  • Sulfasalazine
    • Sulfasalazine 500mg gastro-resistant tablets
      • Sulfasalazine 500mg gastro-resistant tablets (Alliance Healthcare (Distribution) Ltd)

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