Faropanam.pptx

MOA, Dosage and studies of Faropenem

1. Molecules: Faropenem sodium Class: Beta-lactam Subclass: Penems Strength: 200 mg Dosage form: Oral tablet Farobact

2. Indications Upper respiratory tract infections Lower respiratory tract infections ENT infections Skin and skin structure infections Gynecological infections Genito -urinary infections

3. Dosage and administration Indication Dosage Lower respiratory tract infections 200 mg - 300 mg t.i.d. ENT infections 200 mg - 300 mg t.i.d. Genito - urinary infections 200 mg - 300 mg t.i.d. Upper respiratory tract infections 150 mg - 200 mg t.i.d. Skin and skin structure infections 150 mg - 200 mg t.i.d. Gynecological infections 150 mg - 200 mg t.i.d. Duration of treatment: Depends upon the severity of infection

4. Chest Physicians Consulting Physicians Surgeons Target audience

5. Pneumonia (Community acquired) Other respiratory Tract infection (Routine/resistant) CHEST PHYSICIAN PHYSICIAN Lower Respiratory tract Urinary tract infections Skin & soft tissue infections Antibiotic Resistant infections Focused indications

6. Why to discuss Faropenem with Chest physicians/Physicians ? Among all the Infectious disease in India, LRTI’s causes around 20% of the mortality . Four million cases of community-acquired pneumonia occur annually As much as 20% of these require hospitalization . Gram-negative bacteria are the most common pathogens causing pneumonia in the Indian setting Lung India. 2012; 29( Suppl 2): S27–S62. doi : 10.4103/0970-2113.99248 Lung India. 2010; 27(2): 54-57

7. These 3 pathogens that accounts for approximately 85% of CAP cases S pneumoniae (penicillin-sensitive and -resistant strains), H influenzae (ampicillin-sensitive and -resistant strains), M catarrhalis (all strains penicillin-resistant). Similarly , among both outpatients and inpatients E. coli is the primary urinary tract pathogen causing more than 50% infections . http://emedicine.medscape.com/article/234240-overview#a1 last accessed on 11 th October, 2012 * community acquired pneumonia National Journal of Community Medicine. 2012; 3 (2): 255—258 Why to discuss Faropenem with Chest physicians/Physicians ?

8. What should we discuss? Faropenem shows 99.5 % clinical and bacteriological efficacy in patients with CAP . Faropenem is the most active β-lactam antibacterial against the MDR * strains, being 4 fold more active than amoxicillin/ clavulanate and cefuroxime (MIC 90 8mcg/ml) 3 Int J Antimicrob Agents. 2003 Jun;21(6): 581-4 Drugs R D. 2008; 9(2):115-24. *MDR: Multidrug resistant 1. Clinical efficacy of Faropenem

9. Table: Activity of Faropenem against S. pneumoniae, H. influenzae , M. catarrhalis and E.coli Organisms MIC 90 (µg/ml) S. pneumoniae 0.25 M. catarrhalis 0.5 H. influenzae 1 E.coli 0.25 Faropenem is the most potent oral agent with 98% of bacteria inhibited by just 1mcg/ml Int J Antimicrob Agents. 2003 Jun;21(6):581-4 Antimicrobial Agents and Chemotherapy. 2002; 46(2): 550–555 JAC.2003,52; 500-502 2. In vitro activity of Faropenem What should we discuss?

10. Faropenem activity was unaffected by β -lactamase production, since the MIC 90 were equivalent for both β -lactamase positive and negative isolates. Faropenem shows excellent activity against ciprofloxacin resistant bacteria and was as potent as imipenem . J Antimicrob Chemother . 2003 Jan; 51(1):196-9 J Antimicrob Chemother . 2003; 52(3):500-2. 3. Activity of Faropenem against resistant bacteria compared to others What should we discuss?

11. Table: MIC 90 (µg/ml) of Faropenem compared with different antibiotics Journal of Antimicrobial Chemotherapy.1997; 39:35–43 What should we discuss?

12. Post surgical infections (LRTI’s, SSI’s and UTI’s) Skin and soft tissue infections Genito -urinary tract infections SURGEONS Focused indications

13. SSI are the 3rd most frequently reported nosocomial infection At least 5% of patients undergoing surgical procedure will develop a surgical site infection. J of Clin and Diag Research, 2010;(4): 3114-3119 CDC, NICE Guidelines on Surgical site infections Why to discuss Faropenem with Surgeons?

14. About 70% of the bacteria that cause infections are resistant to at least one of the drugs most commonly used for treatment SSTI’s are among the most commonest infections which accounts for 50% hospitals visit. Estimated 150 million urinary tract infections per annum occur worldwide Why to discuss Faropenem with Surgeons ?

15. What is sequential therapy? The change from a broad-spectrum parenteral agent (IV) to an oral agent; is referred to as a "sequential," or "step-down," or "switch" therapy.

16. Benefits of using the sequential therapy BMC Infectious Diseases 2006, 6:94 Drugs of Today 2001, 37 (5): 311-319 Journal of Antimicrobial Chemotherapy (2009), 64, 188-199 Switching from IV to oral as soon as patients are clinically stable can reduce the length of hospitalization and lower associated costs. Reduces the risk factors for HAI (Hospital acquired infections). Decreases the work load/ hours of clinicians, nursing and pharmacy staff. Increases the patients comfort, mobility & independence.

17. Can sequential therapy be given to all patients ? Patients who are suitable for a sequential therapy are as follows; After completion of 48-72 hours of IV therapy Functioning gastrointestinal tract Afebrile (not having fever) <99.6°F for 8-24 hours WBC count <15,000/mm 3 and/or decreasing Improvement of signs and symptoms of infection from initial presentation http://www.medscape.com/viewarticle/408980

18. Ideal antibiotic for sequential therapy? Antibiotic with same/matching spectrum Same /similar microbiologic activity High/ acceptable bioavailability Well tolerated by GI tract with Minimal GI side effects Low allergic potential Low incidence of serious side effects Low dosing interval Low Drug – Drug interaction Low Resistance potential Relatively inexpensive compared to iv therapy Better patient Compliance Ref: Drugs of today 2001, 37 (5): 311-319

19. Can Farobact be used for sequential therapy? Yes, it is the only currently available Penem. An attractive option for the treatment of community-acquired infections and for step-down or sequential therapy following carbapenem treatment.

20. Faropenem as a sequential therapy Similar spectrum to that of carbapenem with same /similar microbiologic activity Inexpensive compared to IV therapy Minimal GI side effects thus better patient Compliance Low propensity for resistance development Biochem Pharmacol. 2006; 71(7):1085-95, Diag Microbiol Infect Dis.1997, 28:157-63, Pharmacotherapy 2003;23 (11): 1497-150

21. Ceftriaxone Meropenem Imipenem Cefuroxime 1. Same Spectrum/similar microbiological activity 2. Well tolerated by GI tract with minimal GI side effects 3. Low resistance potential For sequential therapy F arobact exhibits

22. The only oral Penem currently available The most potent oral antibiotic 2 Superior spectrum coverage Powerfully kills Gram - ve , Gram- ve and anaerobic pathogens 3 Faster control of infection CAP, AECB, Pharyngitis, Tonsillitis ,Sinusitis ,SSTI 3,4 Less chance of treatment failure Potential to address most of the relevant resistance issues 1 Matching Spectrum to IV Ideal switch over therapy from IV Meropenem, Imipenem, Piperacillin-Tazobactam and cephalosporin's 1,5 High patient compliance due to less GI side effects Compared to Cefuroxime and Coamoxyclav 3,6,7 USPs of Farobact

23. Competitors Sr. No Brands Company 200 mg 1 Faronem Ranbaxy 390 2 Faronac Microlabs 380 3 Duonem Zydus 158.5(3Tabs) 4 Farozet Glenmark 317.5 5 Orpenem Macleods 329.5

24. Scientific Inputs Sl. No. Inputs Month April May June July Aug Sept 1 PDA Y Y Y Y Y Y 2 Antibiotic Use & Misuse Y           3 101 Chest X-Ray     Y       4 Antimicrobial Therapy Guide         Y   5 Farobact Case study   Y     6 Farobact Expert opinion  Y Y   Gift Inputs Sl. No. Inputs Month April May June July Aug. Sept. Oct. 1 Farobact Silicon Speaker Y             2 Farobact Surgical gloves   Y     3 Farobact Surgical gown     Y     4 Farobact Italia Pen           Y   Input support

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