Fixed dose combinations bds[1].pptx pharmacology

Fixed dose combinations

1. Fixed dose combinations

2. OBJECTIVES: Fixed Dose Combination (FDC) WHO guidelines for rational FDC Advantages of FDC Disadvantages of FDC Rationality of FDC

3. Fixed Dose Combinations Fixed Dose Combinations refer to products containing one or more active ingredients used for a particular indication(s). 2 different classes of drugs 2types ---- Rationale and Irrationale Widely prescribed drugs instead of single drugs

4. According to WHO guidelines FDCs are rational when they had: - Active pharmacological ingredients (API) with complementary mechanism of action -Decrease the occurrence of resistance for antimicrobial agents -Increase the efficacy of combinations - Decrease the incidence of ADR or toxicity -Increase the compliance of drug therapy with decrease pill burden -Decrease the total cost of therapy -Dose of each API should be appropriate for defining or larger group of population.

5. 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

6. 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)

7. I.Tablet Sulfamethoxazole 400mg + Trimethoprim 80mg II.Tablet Sulfadoxine 500mg + Pyrimethamine 25mg III – Tab Amoxicillin 500mg+ Clavulinic acid 125mg IV – Tab Ciprofloxacin 500mg + Tinidazole 600mg   V – Tab Furazolidone 100mg + Metronidazole 300mg VI– Tab Atenolol 50mg + Nifedipine (SR) 20mg VII. Oral Rehydration Salt (ORS) – Sodium Chloride 3.5gm + Potassium Chloride 1.5gm + Sodium Citrate Dihydrate 2.9gm + Glucose 20mg. VIII. Tablet Ethinylestradiol 0.03mg +Levonorgestrel 0.15mg

8. XII – Tab Montelukast 5 mg + Levocetrizine 2.5mg QUESTIONS: 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

9. 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.

10. 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.

11. 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.

12. VII. Oral Rehydration Salt (ORS) – Sodium Chloride 3.5gm + Potassium Chloride 1.5gm + Sodium Citrate Dihydrate 2.9gm + Glucose 20mg. 1. Write the rationale for this combination above - 2 marks Sodium chloride, Potassium chloride are used to correct the Na+, K+ and Cl- loss respectively Glucose is added as it facilitates Na+ reabsorption (Glucose-Na+ Cotransport system is functional). Glucose also provides nutrition. Sodium citrate is used to correct acidosis.

13. 2. Write the indications -2 marks Diarrhea Cholera Burns

14. 3. What is super ORS - 2 marks Super ORS are special kinds of ORS where instead of mono sugars it comprises of more complex sugars and trace amounts of zinc. It may be food-based such as rice or starch-free like glycine/ alanine based or glucose polymer-based. Some of the benefits of using Super ORS includes it improves rehydration, lessen stool frequency and duration, offer more nutritional support, helps in gaining weight, prevent secondary disaccharide intolerance, replenishes fluid balance and strengthens the immune system.

15.   III – 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

16. III.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.

17. 2. Write the 4 indications of this combination . -3 marks Indications: Skin and soft tissue infections intra-abdominal sepsis and gynaecological sepsis urinary, biliary and respiratory tract infections Gonorrhoea

18. XI – Tab Aceclofenac + Paracetamol + Rabeprazole QUESTIONS: 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

19. 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 .

20. 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.

21. 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.

22. IV – Tab Ciprofloxacin 500mg + Tinidazole 600mg QUESTIONS: 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

23. IV – Tab Ciprofloxacin 500mg + Tinidazole 600mg 1. Is this FDC rationale. If yes give the rationale, If no, what is the reason, justify- 2 marks 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 .

24. 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.

25. Inj Lignocaine 2% + Adrenaline 1:100000 Questions: Justify rationale of given FDC mentioned above Write the advantage of this combination Write one precaution and one contraindication to use of this combination

26. 1. adrenaline by constricting blood vessels slows the absorbtion of local anaesthesia from the site of administration prolong the duration of action of local anaesthesia decrease the systemic toxicity of local anaesthesia decrease local bleeding Used for infiltration and nerve block administration 2. prolong the duration of action of local anaesthesia decrease the systemic toxicity of local anaesthesia decrease local bleeding

27. 3. lignocaine containing adrenalin should not used to treat ventricular tachycardia Should not be used in patients with myocardial diseases, arrhythmias, HTN, hyperthyroidism Should not be used at the tissues/organs supplied by end arteries for risk of ischaemic necrosis and gangrene