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

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

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. Indications and dosage
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

5. 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: %
Half life: h
Duration of action: more than 24 hours
Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc; p.1975.

6. 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; p.1975.

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

8. Let`s assess Lanzo in practice & scientific literature
Efficacy

9. Mechanism of action

10. 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):

11. 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:

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

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

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

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

16. 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):

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

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

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

21. Recommended Treatment Regimens for Helicobacter pylori
Regimen (duration)
Drug 1
Drug2
Drug 3
Drug 4
Regimen 1
(7-14 days)
PPI
(full dose bid)
Clarithromycin
(500 mg bid)
Metronidazole
(500mg bid) _
Regimen 2
Amoxicillin
(1 g bid)
Regimen 3
(14 days)
Bismuth subsalicylate
(2 tabs qid)
Tetracycline HCL
(500 mg qid)
(500 mg tid)
Regimen 4
(5 days + 5 days)
(1 gr bid)
Tinidazole
Regimen 5
(10 days)
Amoxicililin (1 gr bid)
  Levofloxacin
(500 mg qd)
  _
Harrison ‘s principles of internal medicine th ed.: McGraw-Hill Companies, Inc; P

22. Let`s assess Lanzo in practice & scientific literature
Safety

23. Tolerability 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.
Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc; p.1975.

24. 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):

25. DRUG INTERACTIONS Lansoprazole Rabeprazole Esomeprazole Omeprazole
Pantoprazole
Low
High
Abbreviated Drug Class Review: Proton Pump Inhibitors Updated August 2006 VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory

26. Very Low Drug Interactions
Drug Safety 2006; 29:

27. Updated: Feb 13, 2013

28. 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.
Omeprazole has the highest interaction while Lansoprazole has the lowest
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2011

30. Management of GERD
Weight loss is recommended for GERD patients who are overweight or have had recent weight gain.
Head of bed elevation and avoidance of meals 2 – 3 h before bedtime should be recommended for patients with nocturnal GERD.
Routine global elimination of food that can trigger reflux (including chocolate, caffeine, alcohol, acidic and or spicy foods) is not recommended in the treatment of GERD.
An 8-week course of PPIs is the therapy of choice for symptom relief and healing of erosive esophagitis.
Traditional delayed release PPIs should be administered 30 – 60 min before meal for maximal pH control.

31. Management of GERD
PPI therapy should be initiated at once a day dosing, before the first meal of the day.
For patients with partial response to once daily therapy, tailored therapy with adjustment of dose timing and / or twice daily dosing should be considered in patients with night-time symptoms, or sleep disturbance.
Non-responders to PPI should be referred for evaluation.

32. Management of GERD
In patients with partial response to PPI therapy, increasing the dose to twice daily therapy or switching to a different PPI may provide additional symptom relief.
Maintenance PPI therapy should be administered for GERD patients with symptoms after PPI is discontinued, and in patients with complications including erosive esophagitis and Barrett’s esophagus.

33. Management of GERD
For patients who require long-term PPI therapy, it should be administered in the lowest effective dose, including on demand or intermittent therapy.
Therapy for GERD other than acid suppression, including prokinetic therapy, should not be used in GERD patients without diagnostic evaluation.

34. 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

35. Lansoprazole in children
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.

36. Lanzo has it all….. 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…..

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

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

39. Any question?

40. Thank you

41. Back-up Slide

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