This document provides information on the drug Omeprazole including its indications, dosage, administration instructions, drug interactions, and safety. It can be used by healthcare professionals and patients to understand how to safely use Omeprazole to treat conditions like ulcers and gastroesophageal reflux disease. Key details include that Omeprazole is available as capsules, tablets, and suspensions, is usually taken once daily with food, and common side effects include hypomagnesaemia and allergic reactions. Medical advice should be sought for any questions or concerns about use.

1. Disclaimer
“ Use at your own risk”
“This data is not medical advice”
“Consult physician and qualified health professional for medical condition ”

2. Who Can Use?
o Information can be used by those who need updated and good quality
knowledge about medicine.
o Healthcare providers, such as doctors, pharmacists or nurses and allied
health care professionals to help them prescribe ,dispense and administer
medicines safely.
o Patients or their care givers, Researchers and General public.

3. OMEPRAZOLE
PPI

4. Dosage form
• Capsule
• Tablet
• Powder for oral Suspension
• Powder for Solution for Infusion
Route of Administration
• Oral
• IV
• NG
• PEG tubes of size 6 Fr to 16 Fr.
Strength
• 10mg
• 20 mg
• 40mg

5. Brands

6. Indications & Posology

7. Treatment and Prevention of relapse, duodenal and gastric ulcers.
20mg OD, can be increased to 40mg OD for 2 to 8 weeks depending upon prognosis
Treatment and Prevention of NSAID-associated gastric and duodenal ulcers.
20mg OD for 4 weeks depending upon prognosis can be increased to 8 weeks.
H. pylori eradication in peptic ulcer in combination with antibiotics.
Treatment of reflux oesophagitis
20mg OD for 4 weeks depending upon prognosis can be increased to 8 weeks.
Treatment of symptomatic gastro-oesophageal reflux disease
20mg OD x 4
Treatment of Zollinger-Ellison syndrome
60mg OD initial dose
20-120mg OD maintenance dose ( >80mg should be in divided doses).

8. Paediatric use
Children over 1 year of age and ≥10 kg
Treatment of reflux esophagitis
Symptomatic treatment of heartburn and acid regurgitation in GERD
Children and adolescents over 4 years of age
In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori
When selecting appropriate combination therapy, consideration should be given to official
national, regional and local guidance regarding bacterial resistance, duration of treatment (most
commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents

9. Administration

10. •
•It is recommended to take Omeprazole capsules or delayed-release capsules in the morning,
swallowed whole with half a glass of water.
•Omeprazole tablets may be taken with food or on an empty stomach.
•Take omeprazole powder for oral suspension on an empty stomach at least 1 hour before a
meal.
•For patients receiving continuous feeding through a tube, feeding should be temporarily stopped
about 3 hours before and 1 hour after administration of omeprazole powder for oral suspension.
•The capsules must not be chewed or crushed.
For patients with swallowing difficulties and for children who can drink or swallow semi-solid
food
•Patients can open the capsule and swallow the contents with half a glass of water or after mixing
the contents in a slightly acidic fluid e.g., fruit juice or applesauce, or in non-carbonated water.
•Patients should be advised that the dispersion should be taken immediately (or within 30
minutes) and always be stirred just before drinking and rinsed down with half a glass of water.

11. •
•Omeprazole is to be administered in an intravenous infusion for 20-30 minutes.
What if my child is sick (vomits)?
•If your child is sick less than 30 minutes after having a dose of omeprazole, give them the same
dose again.
•If your child is sick more than 30 minutes after having a dose of omeprazole, you do not need to
give them another dose. Wait until the next normal dose.

12. Storage
Shelf life

13. Store below 25°C
Constituted suspension for oral use: 28 days.
The constituted suspension should be stored in a refrigerator (2°C - 8°C). For up to 2 days it may
be stored below 25°C.
Indoor Guidelines for Reconstituted solution:
 below 25°C.
Chemical and physical in-use stability has been demonstrated for 12 hours when dissolved in
NaCl 0.9% solution.
•For 6 hours in 5% glucose when reconstituted under controlled aseptic conditions and stored
at 2-8°C
•Chemical and physical in-use stability has also been demonstrated for 24 hours in both NaCl
0.9% solution and 5% glucose.
From a microbiological point of view, the product should be used immediately.

14. Drug Interaction
CI

15. •Co-administration of atazanavir with proton pump inhibitors is not recommended.
If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close
clinical monitoring (e.g virus load) is recommended in combination with an increase in the dose
of atazanavir to 400 mg with 100 mg of ritonavir; omeprazole 20 mg should not be exceeded.
•Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12.
•Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine
tumours. To avoid this interference, omeprazole treatment should be stopped for at least 5 days
before CgA measurements. If CgA and gastrin levels have not returned to reference range after
initial measurement, measurements should be repeated 14 days after cessation of proton pump
inhibitor treatment

16. Pregnancy Category
&
Nursing Mothers

17. • If you're pregnant, it's always better to try to treat indigestion without taking a medicine.
•Results from three prospective epidemiological studies (more than 1000 exposed outcomes)
indicate no adverse effects of omeprazole on pregnancy or on the health of the fetus/newborn
child. Omeprazole can be used during pregnancy.
•Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic
doses are used.

18. Missed Dose

19. •If you usually take it once a day, take the missed dose as soon as you remember, unless it's within
12 hours of your next dose, in which case skip the missed dose.
•If you usually take it twice a day, take the missed dose as soon as you remember, unless it's
within 4 hours of your next dose, in which case skip the missed dose.

20. Side Effects

21. Severe hypomagnesaemia has been reported in patients treated with PPIs like omeprazole for at
least three months, and in most cases for a year.
If your child develops a rash, swelling of the face, lips, tongue or throat, or has difficulty
breathing or swallowing, they may be allergic to omeprazole

22. Special Populations

23. •Hepatic impairment
Omeprazole has not shown any tendency to accumulate with once daily dosing.
Renal impairment
The pharmacokinetics are unchanged in patients with reduced renal function.
Elderly
The metabolism rate of omeprazole is somewhat reduced in elderly subjects (75-79 years of age).
Paediatric patients
During treatment with the recommended doses to children from the age of 1 year, similar plasma
concentrations were obtained as compared to adults.

24. Overdose

25. •Treatment, if needed, is symptomatic.

26. References

27. • BNF 77 (March-September 2019)
• Electronic medicines compendium (emc).
• Mayo Foundation for Medical Education and Research.(MFMER)©1998-2020.
• RxList Inc. Copyright © 2020.