Excipient-related adverse drug reactions : a clinical Approach

Formulations of the same active pharmaceutical ingredients (API) may contain a variety of inactive pharmaceutical ingredients (IPI) or excipients. Package inserts are important sources of information to clinicians and should provide details of both the API and the excipients in the pharmaceutical preparation. The Medicine Control Council's published guidelines recommend the inclusion of excipients (qualitative) in the package insert, but this is not adequately enforced. Excipient-related adverse drug reactions (ADR) are common in clinical practice.

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