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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

e r ?
Efficacy

get h
Duration of action

L L to Proved by
Strong supporting studies

OR A
Low drug interaction

Safety
 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

• 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
 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
Mechanism of action
 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.

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. .

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.

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: 425-433.

When you need fast and long-lasting remedy…

4 p<0.05
3.5 3.3
3
Mean intragastric pH

2.5 2.4
2 2.1 Lansoprazole
2
1.6 1.6 Pantoprazole
1.5 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.

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.
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): 21-28.

 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.
 Algorithm for the management of Helicobacter
pylori

Harrison ‘s principles of internal medicine 2012.18th ed.: McGraw-Hill Companies, Inc; 2012. P.1264-1265
 Recommended Treatment Regimens for
Helicobacter pylori

Regimen Drug 1 Drug2 Drug 3 Drug 4

(duration)
Regimen 1 PPI Clarithromycin Metronidazole _
(7-14 days) (full dose bid) (500 mg bid) (500mg bid)
Regimen 2 PPI Clarithromycin Amoxicillin _
(7-14 days) (full dose bid) (500 mg bid) (1 g bid)

Bismuth
Regimen 3 PPI subsalicylate Tetracycline HCL Metronidazole
(14 days) (full dose bid) (2 tabs qid) (500 mg qid) (500 mg tid)

PPI Amoxicillin _
Regimen 4 _
(full dose bid) (1 gr bid)
(5 days + 5 days)
PPI Clarithromycin Tinidazole _
(full dose bid) (500 mg bid) (500 mg bid)

Amoxicililin (1 gr
Regimen 5 PPI   Levofloxacin   _
bid)
(10 days) (full dose bid) (500 mg qd)
Harrison ‘s principles of internal medicine 2012.18 th ed.: McGraw-Hill Companies, Inc; 2012. P.1264-1265
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

 DRUG INTERACTIONS

Low

Lansoprazole Pantoprazole

Rabeprazole

Esomeprazole

Omeprazole

High

Abbreviated Drug Class Review: Proton Pump Inhibitors Updated August 2006 VHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory
Very Low Drug Interactions

Drug Safety 2006; 29: 769-784

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
 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.
 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 .

 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.
 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.
 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
 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.
 Key Messages

•
..
Highest number of FDA approved indications
l l…
•
a
High efficacy and rapid acid-related symptoms relief
i t
•
as
Long duration of action
o h
•
• nz
As safe as placebo
La
Very low drug interactions
• No interaction with clopidogrel based on FDA label
2012
• Class B in pregnancy
 Price per 14 Capsules
pack or bottle

For consumer:

49000 IRR

Medical Code:IR-0914-LNZ-1357-SP
 Price per 14 capsules
pack or bottle

For consumer:

84000 IRR

Medical Code:IR-0914-LNZ-1357-SP
Any question?
Back-up Slide
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Drug Facts and Comparisons. St. Louis, MO: Wolters Kluwer Health, Inc; 2011. p.1975.