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FDC'S

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5 views8 pages

FDC'S

Uploaded by

jat74505
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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FIXED DOSE

COMBINATIONS
FIXED DOSE COMBINATIONS

Def: The combination of two different drugs in


a single pharmaceutical formulation is known
as fixed drug dose combination.
Rule for making a FDC
1. Two drugs to be combined should have approximately equal plasma
half life and –

2. The combination/ratio of drugs is depend on apparent volume of


distribution and plasma concentration.

EXAMPLE: Amoxycillin (t ½-1-2hr,Vd-0.21 L/kg) and


Clavulanic acid(t ½-1-1.5hr,Vd-0.2 L/kg) hence these
can be combined in their standard dose regimen...i.e
Amoxycillin 500mg+clavulanic acid 125mg can be
administered as 1 to 2 tab 8hrly .
ADVANTAGES:
 Convenience in dose schedule and better patient

compliance.
Enhanced effect of the combinations, e.g-oestrogen

+progesterone; Penicillin + Probenecid -


pharmacokinetic advantage.
Minimisation of side effects, e.g-levodopa+carbidopa

Thiazide + Potassium sparing diuretics (in

hypertension).
Disadvantages:
1. Chances of polypharmacy: E.g., paracetamol
+ dextropropoxyphene.
2. Pharmacokinetic profile:
3. Dose adjustment:
Adverse effects:
The patient is unnecessarily exposed to more than one

drug which may increase the risk of adverse effects.


Identification of drug responsible for the adverse

effect often becomes difficult.

e.g. FDC of Nimesulide+Paracetamol in children


increases risk of Hepatotoxicity.

FDC of Diclofenac + Serratopeptidase increases the


risk of bleeding in patients with unsuspected peptic
ulcer.
Cost:
Cost of the formulation may be increased due

to addition of two or more ingredients.


However, the packing cost may be reduced.
Guidelines for evaluation of a fixed drug combination preparation:

Check the therapeutic aim and whether the patient requires long / short
term treatment.
Check the ingredients and their dosage. Check whether any of the
ingredients are unnecessary?
Evaluate whether the combination is approved, rational, desirable and
should be prescribed?
Whether the patient is in a mild to moderate form of the disease, stable
and least likely to develop emergency situation?
Check the requirement of the patient and whether the patient needs all
the drugs in the formulation.
Find out the potential advantage of combining the ingredients (kinetic,
dynamic, therapeutic convenience, cost etc.).

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