fastdosekombinasjon

Fastdosekombination, known in English as fixed-dose combination (FDC), refers to pharmaceutical products that contain two or more active ingredients in fixed amounts within a single dosage form, such as a tablet or capsule. The components are intended to be co-administered at the same time and in fixed ratios.

Rationale and use: FDCs are used to treat conditions where multiple therapeutic actions are required, including HIV, tuberculosis, hypertension, diabetes, and chronic respiratory or pain conditions. They can simplify prescribing, improve patient adherence, and reduce pill burden, while promoting the co-delivery of complementary agents.

Advantages: improved adherence and convenience; reduced pill burden; potential cost savings in some settings; synchronized pharmacokinetics and improved therapeutic outcomes where drug interactions are beneficial.

Limitations and risks: limited dosing flexibility; exposure to unnecessary components if one ingredient is not needed; potential drug–drug interactions; slower adjustment to changing patient needs; manufacturing and supply chain complexities; regulatory challenges.

Regulatory and manufacturing aspects: FDCs require evaluation for safety and efficacy of the combination, and may demand compatibility and bioavailability data for all components. Quality control must ensure the stability and correct proportion of ingredients; pharmacovigilance is essential to monitor adverse effects.

Examples: HIV fixed-dose regimens such as lamivudine/zidovudine (Combivir) and emtricitabine/tenofovir disoproxil fumarate (Truvada); tuberculosis regimens combining rifampicin/isoniazid/pyrazinamide/ethambutol; antihypertensive combinations such as amlodipine/benazepril or losartan/hydrochlorothiazide; diabetes combination metformin/sitagliptin.

See also: single-pill combination.