Fixed-Dose Combinations

Abstract

Fixed-dose combinations or FDCs are combinations of two or more active pharmaceutical ingredients in a single dosage form in a fixed ratio usually for the same indication. FDCs aim to improve the therapeutic efficacy of each component of the medication while reducing the adverse drug reactions. When produced appropriately, they have the advantage of decreasing the total cost of the medication while improving the ease of administration and adherence to the medication. FDCs make it difficult to identify the causal relationship of toxicity when it occurs and to make dose changes to the individual components. Further, many irrational combinations increase patient’s drug exposure aiming to improve the profit margins of the pharmaceutical companies. Strong and rigid guidelines need to be implemented to make FDCs rational and safe.