This document outlines criteria for using high-dose oral proton pump inhibitors like Omeprazole 40 mg. It recommends high-dose PPI as initial therapy for certain conditions like gastric ulcers or pathologic hypersecretory conditions. High-dose PPI is also indicated when there is insufficient improvement with standard-dose PPI for conditions like GERD, NSAID-related ulcers, or after a PPI test. Preventing rebleeding of peptic ulcers is another indication. The document discusses reasons for lack of response to standard-dose PPI and evaluating for compliance or alternative diagnoses before increasing to high-dose PPI.

1. CRITERIA FOR USE:
HIGH DOSE ORAL
PROTON PUMP INHIBITOR
ANTONIO C. COMIA, MD

2. GOOD EVENING!

3. CRITERIA FOR USE:
HIGH DOSE ORAL
PROTON PUMP INHIBITOR
(THE PROMISE OF OMEPRON 40)
ANTONIO C. COMIA, MD

4. DOSING ISSUES
 STANDARD DOSE: OMEPRAZOLE 20 MG
 HIGH DOSE
 DOUBLE OR QUADRUPLE DOSE: 20 BID, 40 OD, 40 BID
 AS INITIAL THERAPY?
 IF INADEQUATE IMPROVEMENT WITH INITIAL STANDARD
THERAPY?

5. WHEN TO GIVE HIGH DOSE PPI
(OMEPRON 40) AS
INITIAL THERAPY

6. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS:
DIAGNOSIS
Diagnostic trial (PPI test)
 Uncomplicated GERD: no alarm symptoms
 An 8-week therapeutic or empiric trial of double-dose
PPI may be considered
 Treatment plan should be re-evaluated if there is no
response after 8 weeks.

7. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS:
GERD-RELATED COUGH
 GERD-related chronic nonspecific cough
 dry and non-productive cough of ≥ 3 weeks’ duration
without any other respiratory symptom, sign, or
systemic illness)

8. CHRONIC COUGH AND GERD
 When GERD is the cause of chronic cough there may be no
GI symptoms – silent GERD
 24 hour esophageal pH monitoring provides a sensitive and
specific test for the presence of GERD
 GERD related cough may take 2 – 3 months to resolve with
therapy
 Definitive diagnosis of cough resulting from GERD can only
be made if the cough resolves with anti-GERD therapy

9. CHRONIC COUGH AND GERD
 Accurate diagnosis and therapy of chronic cough due to
GERD is difficult
 Therapeutic, empiric trial with PPI is reasonable initial
diagnostic approach
 Non-response does not rule out GERD as cause of chronic
cough
 Objective investigations for GERD are suggested
(esophageal pH monitoring)

10. Laryngopharyngeal reflux (LPR)
 Hoarseness, throat pain, dysphagia, throat clearing, dyspnea,
chronic cough
 May not have the classic symptoms of GERD
 Also called silent reflux.
 Cause: LES dysfunction, acid reflux upwards to throat
 PPI TEST: useful in diagnosis and treatment
 Double dose, given at east 8 weeks

11. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS AS
INITIAL THERAPY
 Gastric Ulcers – may give Omeprazole 40 mg as initial
dose, specially in high risk NSAID patients
 Pathologic hypersecretory conditions (e.g., Zollinger-
Ellison syndrome) – up to 240 mg/day
 Helicobacter pylori eradication to reduce recurrence of
duodenal ulcers, as part of dual or triple antibiotic-based
therapy – given together with antibiotics
 Double-dose PPI therapy, typically for 1–2 weeks

12. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS:
 Endoscopic evidence of severe erosive esophagitis
 presence of ulceration, stricture, perforation, or bleeding
 Presence of Barrett’s
 Double-dose PPI as initial therapy
 May continue with double dose as maintenance therapy.

13. Treatment and maintenance doses
for severe reflux esophagitis
 Relapse rates during maintenance of severe reflux
esophagitis
 17.5% for healing doses (high dose PPI)
 29.1% for half-healing doses (standard dose PPI)
 Double dose (OMEPRON 40 MG) for healing and maintenance

14. HIGH DOSE PPI IN ULCER
REBLEEDING
 Acid suppression with PPI use significantly reduces the risk
of re-bleeding in bleeding peptic ulcers.
 The mechanism of action is thought to be related to clot
stabilization by increasing gastric pH.
 Both oral and intravenous PPIs have been demonstrated to
decrease hospital stay, re-bleeding rate and the need for
blood transfusion in patients treated with endoscopic therapy.

15. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS:
 Prevention of acute rebleeding of peptic ulcers after
endoscopic hemostasis
 IV PPI initially for 72 hours: 80 MG LD, 8 MG PER HOUR
 Quadruple-dose oral PPI may be given in 2 divided doses for
5 days
 Standard doses should be used thereafter.

16. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS:
 Reduction of risk of upper gastrointestinal bleeding in
critically ill patients (STRESS BLEEDING)
 who have documented intolerance, contraindication, or
insufficient response to intravenous H2RA therapy
 Double-dose PPI for up to 2 weeks

17. WHEN TO GIVE HIGH DOSE PPI:
INADEQUATE IMPROVEMENT
WITH STANDARD THERAPY

18. REASONS FOR LACK OF
RESPONSE
 WRONG DIAGNOSIS – MALIGNANCY, NOT ACID-
RELATED (GALLSTONES, PANCREATIC DISEASE,
COLONIC) – PPI WILL NOT WORK
 PATIENT COMPLIANCE, TIMING OF MEDICATIONS
 GERD
 NOCTURNAL ACID BREAKTHROUGH
 ESOPHAGEAL AND GASTRIC MOTILITY DISORDERS
 LES DYSFUNCTION

19. REASONS FOR LACK OF
RESPONSE
 BARRETT’S AND LPR – INADEQUATE RESPONSE
 PEPTIC ULCERS – CONTINUED ASPIRIN/NSAID USE
 RESISTANCE? TOLERANCE?

20. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS
 Insufficient improvement in OR recurrence of symptoms
of GERD or other acid-related disorders (such as high-
risk NSAID-related gastric ulcers)
 after an adequate trial (≥ 4 to 8 weeks) of standard-dose PPI
 Double-dose PPI (for ≥ 4 weeks) may be started
empirically without further diagnostic testing

21. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS:
 Insufficient improvement in or recurrence of symptoms
of GERD or other acid-related disorders (such as high-
risk NSAID-related gastric ulcers) after an adequate trial
(≥ 4 to 8 weeks) of double-dose PPI therapy
 Higher than double-dose PPI therapy may be started
while awaiting further consultation and testing, and
continued as maintenance therapy

22. INDICATIONS FOR HIGH DOSE
PROTON PUMP INHIBITORS:
 Step-down: titrate according to symptom control.
 If test results suggest possible relative “resistance” to
that particular PPI, then consider switching to another
PPI at double the standard dose.

23. SUMMARY:
Selected Indications for High-Dose
PPI (OMEPRON 40)
 Diagnostic PPI Test for Uncomplicated GERD, and Non-
cardiac Chest Pain
 GERD-related chronic cough
 Empiric diagnosis and treatment of LPR

24. Selected Indications for High-Dose
PPI (OMEPRON 40)
 Treatment and maintenance of severe reflux esophagitis
 Prevention of rebleeding of peptic ulcers

26. THANK YOU!