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Medical Code:IR-0914-LNZ-1357-SP
To select a PPI for your patient …what
do you usually look for?
Onset of action
Efficacy
Duration of action
Low drug interaction
Safety
Proved by
Strong supporting studies
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
Indications and dosage
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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
IR-0914-LNZ-1357-SP
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Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc; 2011. p.1975.
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.
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.
Pharmacokinetics
Adapted from Drug Metab Dispos 2004; 32:821.
Aliment Pharmacol Ther 14, 963-978
Let`s assess Lanzo in practice &
scientific literature
Efficacy
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
Lansoprazole, goes stronger than Omeprazole
Lansoprazole is more effective in acid exposure inhibition
compared with omeprazole.
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Aliment Pharmacol Ther 2002; 16(1): 35-39.
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: 425-433.
When you need fast and long-lasting remedy…
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Mean intragastric pH
3.5
p<0.05
3.3
3
2.5
2
2.4
2
2.1
Lansoprazole
1.6 1.6
1.5
Pantoprazole
Omeprazole
1
0.5
0
Daytime
Nighttime
Lansoprazole produced a higher intragastric pH when compared
with pantoprazole and omeprazole during the first day.
Aliment Pharmacol Ther 2003; 17: 1507–1514.
Let`s assess Lanzo in practice &
scientific literature
Safety
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; 2011. p.1975.
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
Updated: Feb 13, 2013
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
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
Key Messages
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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
Any question?
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