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Fixed Dose Combinations-II

1. The document discusses fixed dose combinations (FDCs), their properties, advantages, and disadvantages. 2. It provides examples of several FDCs and justifies their rationales and uses, including atenolol-nifedipine for hypertension and angina, amoxicillin-clavulanic acid for infections, and furosemide-spironolactone for edema and heart failure. 3. It also questions the rationale of some FDCs like ciprofloxacin-tinidazole and suggests that single drugs should be used depending on the specific infection.

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47 views

Fixed Dose Combinations-II

1. The document discusses fixed dose combinations (FDCs), their properties, advantages, and disadvantages. 2. It provides examples of several FDCs and justifies their rationales and uses, including atenolol-nifedipine for hypertension and angina, amoxicillin-clavulanic acid for infections, and furosemide-spironolactone for edema and heart failure. 3. It also questions the rationale of some FDCs like ciprofloxacin-tinidazole and suggests that single drugs should be used depending on the specific infection.

Uploaded by

netra angadi
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-II
Department of Pharmacology
JNMC, Belagavi
Fixed Dose Combinations

2 different classes of drugs

2types ---- Rationale and Irrationale

Widely prescribed drugs instead of single drugs


Properties of FDCs

Pharmacokinetics (t1/2, Apparent volume of distribution, peak plasma


concentration)

Metabolism (liver, Bile, kidney etc) SYNERGISM --- increased efficacy


and decrease S/E

Convince to patients—increase compliance of drugs

Decrease side effects


Advantages of FDCs

Efficacy increases

Synergistic effect

Decrease adverse effects

To reduce the drug resistance

Decrease the cost of treatment (maybe or may not)

Convince to patients—improve compliance


Disadvantages:

We cannot able to rule out the side effects d/t which drug in combination

Dose adjustment is not possible

Chronic or co-morbid patients we can’t give FDCs

Sometimes side effects may increase

Cost increase (maybe or may not)


VII – Tab Atenolol 50mg + Nifedipine (SR) 20mg

QUESTIONS:
•Justify rationale of the given FDC mentioned above - 2 marks
•Write two indications and two adverse effects -3 marks
VII – Tab Atenolol 50mg + Nifedipine (SR) 20mg
1. Justify rationale of the given FDC mentioned above - 2 marks

This combination of cardioselective β1 receptor blocker Atenolol and calcium channel blocker
Nifedipine, an arteriolar dilator is used as it provides;

a. An additive antihypertensive effect – Atenolol decreases cardiac output and Nifedipine


decreases peripheral resistance.

b. An additive antianginal effect – the 2 drugs decreases myocardial oxygen requirement by


acting through different mechanisms viz. Atenolol decreases heart rate and force of contraction
by blocking cardiac β1 receptors, Nifedipine decreases afterload by dilating arterioles

c. Further Atenolol counteracts Nifedipine induced reflex tachycardia and palpitations.


2.Write two indications and two adverse effects -3 marks

 Indication:
1. Moderate to severe hypertension
2. Exertional angina

 Adverse effects:
1. Rebound hypertension
2. Headache
 VIII – Tab Amoxicillin 500mg+ Clavulinic acid 125mg
 

QUESTIONS:
Justify rationale of the given FDC mentioned above - 2 marks

Write the 4 indications of this combination -3 marks


VIII.Tab Amoxicillin500mg + Clavulinic acid 125mg
1. Justify rationale of the given FDC mentioned above - 2 marks.
β-lactamases are a family of enzymes produced bymany gram-positive and gram-negative
bacteriathat inactivate β-lactam antibiotics by openingthe β-lactam ring.
 Clavulanic acidinhibits awide variety (class II to class V) of β-lactamasesproduced byboth
gram-positive and gram-negative bacteria.
Addition of clavulanic acid re-establishesthe activity of amoxicillin against β-
lactamaseproducing resistant organisms.
2.Write the 4 indications of this combination. -3 marks

Indications:

1. Skin and soft tissue infections


2. intra-abdominal sepsis and gynaecological sepsis
3. urinary, biliary and respiratory tract infections
4. Gonorrhoea
IX – Tab Furosemide 20mg + Spironolactone 50mg

QUESTIONS:
1. Justify rationale of the given FDC mentioned above - 2 marks

2. Write four indications of this combination. -3 marks


IX.Tab Furosemide 20mg + Spironolactone 50mg

1.Justify rationale of the given FDC mentioned above - 2 marks 


 Spironolactone antagonises K+ loss induced by furosemide and adds to its
natriuretic effect.

Resistance to frusemide that develops due to secondaryhyperaldosteronism is


reversed.
2. Write 4 indications of the combination. -3 marks
 Indication:

1. Edema
2. Acute pulmonary edema
3. Hypertension
4. Heart failure
X – Tab Ciprofloxacin 500mg + Tinidazole 600mg

QUESTIONS:
1. Is this FDC rationale. If yes give the rationale, If no, what is the reason, justify. – 2
marks

2. Write justification for inclusion of such ingredients, special precaution if any and your
general comment on the combination – 3 marks
X – Tab Ciprofloxacin 500mg + Tinidazole 600mg

1. Is this FDC rationale. If yes give the rationale, If no, what is the reason, justify-
2marks

 No. This FDC is irrational.


 The patient suffers from only one type of diarrhea. i.e. bacterial or amoebic.
 It is highly unlikely for the patient to have both infections simultaneously.
 Using this combination adds to cost, adverse effects and may encourage resistance.
2. Write justification for inclusion of such ingredients, special precaution if
any and your general comment on the combination -3 marks

 Depending on the cause of diarrhea a single specific drug should only be


used and such type of shotgun therapy using multiple drugs in FDC should be
avoided.

 Hence using such FDC is not rational.

 Not justified and cannot be recommended.


XI – Tab Aceclofenac+ Paracetamol+ Rabeprazole

QUESTIONS:
1. Is this FDC rationale. If yes give the rationale, If no, what is the reason, justify. – 2 marks

2. Write justification for inclusion of such ingredients, special precaution if any and your
general comment on the combination. -3 marks
XI. FDC – Tab Aceclofenac+ Paracetamol+ Rabeprazole

• 1. Is this FDC rationale. If yes give the rationale, If no, what is the reason, justify. – 2
marks
• No. This FDC is irrational.
• Acceclofenac and Paracetamol both belongs to same group (NSAIDS) so it increases the
adverse effects like hepatotoxicity, renal toxicity, increased risk of heart attack & stroke with
acceclofenac.
• 2).Write justification for inclusion of such ingredients, special precaution if any and your
general comment on the combination. - 3 marks

• Aceclofenac + Paracetamol + Rabeprazole is a combination of two pain relievers


(Aceclofenac , Paracetamol ) and a proton pump inhibitor ( Rabeprazole).
• The pain relievers work by blocking the release of certain chemical messengers that cause
pain and inflammation (redness and swelling).
• However, they may cause damage to the stomach lining.
• The proton-pump inhibitor is added to reduce acid secretion and prevent this damage.
• It is indicated for the relief of pain and inflammation in osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis and other painful condition.

• Precautions- aceclofenac should be avoided in heart disease, stroke, kidney failure and liver
failure patients.

• Paracetamol is hepatotoxic so should not be used in liver diseases.


XII – Tab Montelukast 5 mg +Levocetrizine 2.5mg

QUESTIONS:
1. Is this FDC rationale. If yes give the rationale, If no, what is the reason, justify. – 2 marks

2. Write justification for inclusion of such ingredients, special precaution if any and your
general comment on the combination – 3marks
XII. Tab Montelukast 5 mg +Levocetrizine 2.5mg
1. Is this FDC rationale. If yes give the rationale, If no, what is the reason, justify. – 2 marks

• No. This FDC is irrational.


•  Montelukast sodium is alkaline stable and levocetirizine dihydrochloride is acid stable, when
we prepare a matrix tablet, both the drugs would be in contact and make it unstable during the
shelf life of the formulation.
• Hence it is recommended to prepare bilayer tablet, as it improves and increases the stability of
both the drugs in combination.
2. Write justification for inclusion of such ingredients, special precaution if any and
your general comment on the combination. - 3 marks

• Levocetirizine + Montelukast is used for sneezing and runny nose due to allergies, Hay
fever and Allergic skin conditions.
• Common side effects of Levocetirizine + Montelukast: Nausea, Diarrhea, Vomiting,
Dryness in mouth, Headache, Fatigue, Sleepiness.
• Be cautious while driving or doing anything that requires concentration as Levocetirizine +
Montelukast can cause dizziness and sleepiness.

• Do not drink alcohol while taking Levocetirizine + Montelukast as it may cause increased
sleepiness.

• Dry mouth may occur as a side effect. Frequent mouth rinses, good oral hygiene, increased
water intake and sugarless candy may help.

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