1. TODAY We are honored to introduce: Medical Code:IR-0914-LNZ-1357-SP

2. Onset of action Efficacy Low drug interaction Safety Proved by Strong supporting studies OR ALL together ? OR ALL together ? To select a PPI for your patient …what do you usually look for? Duration of action

3. Summary of Product Generic Name: Lansoprazole FDA: approved in 1995 Brand Name: PREVACID (Takeda), LANZOR (Sanofi) Originator: PREVACID (Takeda) Category: Proton Pump Inhibitor Form: Capsules (enteric coated pellets) Dosage: 15 and 30 mg

4. Heartburn:15 mg orally once a day for 2 weeks GERD: 15 mg orally once a day for up to 8 weeks Erosive Esophagitis: 30 mg orally once a day for up to 8 weeks Duodenal Ulcer: 15 mg orally once a day up to 4 weeks Gastric Ulcer: 30mg orally once a day for 4 to 8 weeks Helicobacter pylori Infection: 30 mg orally combined with antibiotics for 14 days NSAID-Induced Gastric Ulcer: 30mg orally once a day for 8 weeks Zollinger-Ellison syndrome: 60 mg orally once a day Indications and dosage

5. Highest No. of FDA approved indications Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc; 2011. p.1975. 5 IR-0914-LNZ-1357-SP

6. Usual Pediatric Dose for GERD : Short term treatment of GERD (up to 12 weeks): 1 to 11 years: Less than or equal to 30 kg = 15 mg once daily Greater than 30 kg = 30 mg once daily NOTE: Should not be used in children under 1 year - Omeprazole is not recommended for age below 1 year too. - Pantoprazole is not recommended for use in children below 12 years. How to give the capsule to children: Pellets can be mixed in food such as applesauce, pudding, cottage cheese, or yogurt. The contents of the capsule may also be mixed in a small amount of juice such as apple, orange, pineapple, prune, or tomato. Do not crush the pellets. It is also important that child does not chew the pellets. Give the mixture of pellets and food to the child immediately after preparing it. Lansoprazole in children

7. Lanzo in children

8. Pharmacokinetics Onset of action : 2 to 3 hours following a single 15-mg dose, 1 to 2 hours following a single 30-mg dose Time to peak concentration (t max ): Approximately 1 to 2 hours Bioavailability: 80-85 % Half life: 1.3 -1.7 h Duration of action: more than 24 hours Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc; 2011. p.1975.

9. Elimination Renal: Approximately 14 to 23% of a dose of lansoprazole is excreted in the urine Biliary / fecal : Approximately two-thirds of a dose of lansoprazole is detected as metabolites in the feces. Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc; 2011. p.1975.

10. Pharmacokinetics Adapted from Drug Metab Dispos 2004; 32:821. Aliment Pharmacol Ther 14, 963-978

11. Efficacy

12. Mechanism of action

13. Superior Symptom Relief compared to Ranitidine In comparison with ranitidine (n=219) greater number of patients receiving lansoprazole (n=213) were symptom-free at both 2 and 4 weeks after treatment. 4 (p< 0.05) Aliment Pharmacol Ther 1997; 11(3): 541-546.

14. Lansoprazole, is more effective than Omeprazole Onset of heartburn relief was more rapid in lansoprazole-treated versus omeprazole-treated patients. (n=3510) Am J Gastroenterol 2001; 96: 3089-3098

15. Lansoprazole, goes stronger than Omeprazole Lansoprazole is more effective in acid exposure inhibition compared with omeprazole.. Aliment Pharmacol Ther 2002; 16(1): 35-39.Pharmacol

16. Lansoprazole, produces a faster onset of action than pantoprazole Higher values of 24h Intragastric pH compared to Pantoprazole Mean intragastric pH at post-dosing time intervals on day 1, *p <0.001, **p=0.01 Aliment Pharmacol Ther 2002; 16: 425-433.

17. Lansoprazole, produces greater degree of acid inhibition than Pantoprazole Lansoprazole had greater acid suppression effect compared to pantoprazole from the first day of treatment. Mean percentage of time intragastric pH above 3, 4 and 5 on day 1, * p<0.001 Aliment Pharmacol Ther 2002; 16: 425-433.

18. When you need fast and long-lasting remedy… Lansoprazole produced a higher intragastric pH when compared with pantoprazole and omeprazole during the first day. Mean intragastric pH Aliment Pharmacol Ther 2003; 17: 1507–1514.

19. Lansoprazole, faster and stronger in onset than rabeprazole The faster onset of action with lanzoprazole is a valuable advantage over rabeprazole at the start of symptomatic treatment. Clin Drug invest 2006; 26(1): 21-28.

20. Greater acid suppression effect compared to Rabeprazole from the first dose. Lansoprazole, stronger in onset of action than rabeprazole Clin Drug invest 2006; 26(1): 21-28.

22. H.pylori eradication rate was higher with Lansoprazole compared to omeprazole. Ulcer healing rate was higher in lansoprazole group compared to omeprazole. Lanzo, THE remedy for ulcer

23. Algorithm for the management of Helicobacter pylori Harrison ‘s principles of internal medicine 2012.18 th ed.: McGraw-Hill Companies, Inc; 2012. P.1264-1265

24. Recommended Treatment Regimens for Helicobacter pylori Regimen (duration) Drug 1Drug2Drug 3Drug 4 Regimen 1 (7-14 days) PPI (full dose bid) Clarithromycin (500 mg bid) Metronidazole (500mg bid) _ Regimen 2 (7-14 days) PPI (full dose bid) Clarithromycin (500 mg bid) Amoxicillin (1 g bid) _ Regimen 3 (14 days) PPI (full dose bid) Bismuth subsalicylate (2 tabs qid) Tetracycline HCL (500 mg qid) Metronidazole (500 mg tid) Regimen 4 (5 days + 5 days) PPI (full dose bid) Amoxicillin (1 gr bid) _ _ PPI (full dose bid) Clarithromycin (500 mg bid) Tinidazole (500 mg bid) _ Regimen 5 (10 days) PPI (full dose bid) Amoxicililin (1 gr bid) Levofloxacin (500 mg qd) _ Harrison ‘s principles of internal medicine 2012.18 th ed.: McGraw-Hill Companies, Inc; 2012. P.1264-1265

25. Safety

26. Reported side effects <4% Side effects: - Mild Headache - Mild Nausea, abdominal pain - Mild diarrhea or constipation No dose adjustment needed in elderly, severe renal impaired and hepatic impaired patients. Tolerability Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc; 2011. p.1975.

27. Lanzo, as safe as placebo In the four placebo-controlled studies, there is a marked similarity between the safety profiles for lansoprazole and placebo Drug Safety 1999; 20(2): 195-205

28. DRUG INTERACTIONS LansoprazoleRabeprazoleEsomeprazoleOmeprazolePantoprazole Abbreviated Drug Class Review: Proton Pump Inhibitors Updated August 2006 VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory High Low

29. Very Low Drug Interactions Drug Safety 2006; 29: 769-784

30. Updated: Feb 13, 2013

31. Interaction with Clopidogrel (Plavix) Concomitant use of drugs that inhibit CYP2C19 (e.g., omeprazole,esomperazole) should be discouraged. No dose adjustment of clopidogrel is necessary when administered with an approved dose of Lansoprazole. Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011 Omeprazole has the highest interaction while Lansoprazole has the lowest

35. Newest GERD guideline There are currently seven available PPIs including two that can be obtained OTC (omeprazole, lansoprazole), others are available only by prescription. ( strong evidence for safety of Lanzo) All of the PPIs should be administered 30 – 60 min before meals to assure maximal efficacy.(denies pantoprazole claim) Patients with known osteoporosis can remain on PPI therapy. Concern for hip fractures and osteoporosis should not affect the decision to use PPI long-term except in patients with other risk factors for hip fracture. Ref: American Journal of Gastroenterology 2013

36. Key Messages Highest number of FDA approved indications High efficacy and rapid acid-related symptoms relief Long duration of action As safe as placebo Very low drug interactions No interaction with clopidogrel based on FDA label 2012 Class B in pregnancy Lanzo has it all….. Lanzo has it all…..

37. Medical Code:IR-0914-LNZ-1357-SP Price per 14 Capsules pack or bottle For consume r: 49000 IRR

38. Medical Code:IR-0914-LNZ-1357-SP Price per 14 capsules consumer pack or bottle For consumer: 84000 IRR

39. Any question?

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