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    Rational Use of Combination Therapy

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    phdgandusir
    The document discusses fixed dose drug combinations (FDCs), including their rationality, advantages, and disadvantages. Rational FDCs combine drugs with different mechanisms of action and similar pharmacokinetics. Advantages include convenience and improved compliance. Disadvantages are the inability to adjust doses independently and increased risk of adverse drug reactions when pharmacokinetics differ.

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    Rational Use of Combination Therapy

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    phdgandusir
    15 views7 pages
    The document discusses fixed dose drug combinations (FDCs), including their rationality, advantages, and disadvantages. Rational FDCs combine drugs with different mechanisms of action and similar pharmacokinetics. Advantages include convenience and improved compliance. Disadvantages are the inability to adjust doses independently and increased risk of adverse drug reactions when pharmacokinetics differ.

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    The document discusses fixed dose drug combinations (FDCs), including their rationality, advantages, and disadvantages. Rational FDCs combine drugs with different mechanisms of action and similar pharmacokinetics. Advantages include convenience and improved compliance. Disadvantages are the inability to adjust doses independently and increased risk of adverse drug reactions when pharmacokinetics differ.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    15 views7 pages

    Rational Use of Combination Therapy

    Uploaded by

    phdgandusir
    The document discusses fixed dose drug combinations (FDCs), including their rationality, advantages, and disadvantages. Rational FDCs combine drugs with different mechanisms of action and similar pharmacokinetics. Advantages include convenience and improved compliance. Disadvantages are the inability to adjust doses independently and increased risk of adverse drug reactions when pharmacokinetics differ.

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    of 7

    31-07-2022

    Dr Rajesh Choudhary
    Associate Professor
    (Pharmacology)

    Rational to
    Combination Therapy
    Fixed Dose Drug Combination (FDC)

    Fixed Dose Drug Combination (FDC)


    Combination of two or more active drugs in a single dosage form known as
    fixed dose drug combinations (FDCs).
    The Food and Drug Administration, USA defines a combination product as ‘a
    product composed of any combination of-
    ✓ Drug + Device
    ✓ Biological Product + Device
    ✓ Drug + Biological Product
    ✓ Drug + Device + Biological Product
    Fixed ratio combination products are acceptable only when the dosage of
    each ingredient meets the requirement of a defined population group and
    when the combination has a proven advantage over single or monotherapy in
    therapeutic effect, safety or compliance

    1
    31-07-2022

    Rationality of FDCs

    Rationality of FDCs
    The rationality of FDCs should be based on certain aspects such as
    1. The drugs in the combination should act by different mechanisms
    E.g. FDC- Amlodipine (5 mg) + Atenolol (50 mg)
    Amlodipine- CCB & Atenolol-B Blocker
    2. The pharmacokinetics must not be widely different
    Both have approximately similar t-half and Vd.
    E.g. FDC- Amoxicillin (500 mg) + Clavulanic acid (125 mg). Amoxicillin
    (t1/2= 1-2 h & Vd= 0.21 L/kg) + Clavulanic acid (t1/2= 1-1.5 h & Vd= 0.2
    L/kg).
    3. The combination should not have supra-additive toxicity of the ingredients.

    2
    31-07-2022

    Advantages of FDCs
    The rationality of FDCs should have advantages over monotherapy:
    Convenience in dose schedule and administration for the patients.
    FDCs enhance the effects by synergism
    FDCs enhance the therapeutic efficacy and therapeutic benefits
    FDCs reduces the side effects
    FDCs can improve compliance in the treatment of chronic
    infective diseases like TB and HIV

    Rational FDCs
    The rational FDCs are:
    L-dopa (200 mg) + Carbidopa – Antiparkinsonian FDCs
    Aceclofenac (100 mg) + Paracetamol (325 mg) + Tramadol (37.5
    mg) – Analgesic and Antipyretic
    Amoxycillin (500 mg) + Clavulanic Acid (125 mg) - Antibiotics

    3
    31-07-2022

    Rational FDCs
    Enalapril (10 mg) + Hydrochlorthiazide (25 mg)- Antihypertensive
    Rifampicin (150 mg) + INH (75 mg) + Pyrazinamide (400 mg) +
    Ethambutol (275 mg)- Anti TB
    Efavirenz (600 mg) + Emtricitabin (200 mg) + Tenofovir (300 mg)-
    Anti HIV

    Irrationality of FDCs

    4
    31-07-2022

    Disadvantages of FDCs
    The Disadvantages of FDCs:
    Dose cant be adjusted independently.
    If some ADRs are observed, it becomes difficult to identify one
    particular drug which is causing harmful effects
    Pharmacokinetic properties of both drugs must be similar.
    Different in pharmacokinetic profile, changes the frequency of
    administration of individual drug
    FDCs should not be harmful drug interaction
    Some combination increase the ADR (Nimesulide + paracetamol)

    Disadvantages of FDCs
    The Disadvantages of FDCs:
    Unnecessary combination increase the price (Ibuprofen +
    paracetamol + caffeine)
    Inappropriate FDC becomes a dangerous (CCB + Digitalis-
    cardiac arrest)

    5
    31-07-2022

    Irrational FDCs
    Irrational FDCs are:
    Nimesulide + paracetamol – increase Hapetotoxicity
    Rebeprazole + Domperidone- Increase Rhabdomylosis
    Ranitidine + Dicyclomine – acidic gastric pain is control by H2
    blocker (ranitidine) only, No need to added antispasmodic
    (Dicyclomine)

    Recommendation for FDCs


    As per WHO expert committee,
    FDCs should be only used when
    there are no alternative of single
    drug is available or Therapeutic
    benefit or cost effective for the
    purpose

    6
    31-07-2022

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