Q14. What do you understand by fixed-dose drug combinations (FDCs)? Discuss their merits and demerits.

Model Answer:

Introduction

Fixed-dose drug combinations (FDCs) involve two or more active pharmaceutical ingredients combined in a single dosage form. Commonly used for conditions like diabetes, hypertension, HIV, and tuberculosis, FDCs aim to enhance patient compliance and therapeutic outcomes.

Body

Merits of FDCs

• Improved Compliance: Simplifies treatment by reducing the number of pills, encouraging adherence.
• Enhanced Efficacy: Combines drugs with synergistic effects, potentially increasing therapeutic effectiveness.
• Convenience and Accessibility: Fewer medications to track, especially beneficial in chronic or multi-drug therapy.
• Cost-effective: Reduces costs associated with treatment by bundling medications, often lowering the overall price.

Demerits of FDCs

• Dosing Inflexibility: Fixed doses may not suit every patient, leading to potential underdosing or overdosing.
• Adverse Drug Reactions (ADRs): Side effects from one component may limit or complicate the use of the entire combination.
• Risk of Antibiotic Resistance: Misuse of FDC antibiotics can promote resistance due to improper dosing.
• Quality Concerns: Requires stringent quality checks; without proper regulation, substandard FDCs may enter the market.

Conclusion

‍FDCs offer significant advantages for patient compliance and cost-effectiveness, particularly in chronic disease management. However, careful regulation and tailored dosing are essential to maximize benefits while minimizing risks of adverse effects and resistance.

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