Omeprazole instructions for administration
- 1 Instructions for administration
- 1.1 Short-term treatment of active duodenal ulcer
- 1.2 H. pylori/duodenal ulcer recurrence
- 1.3 Gastric ulcer
- 1.4 Gastroesophageal reflux disease
- 1.5 Maintenance of healing of erosive esophagitis
- 1.6 Pathological hypersecretory conditions
- 1.7 Pediatric patients
- 1.8 Alternative administration options
Instructions for administration
Short-term treatment of active duodenal ulcer
The recommended adult oral dose of Omeprazole Delayed-Release Capsules is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Return to top
H. pylori/duodenal ulcer recurrence
Triple therapy (omeprazole/clarithromycin/amoxicillin)
The recommended adult oral regimen is Omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg each given twice daily for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of Omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief. Return to top
Dual therapy (omeprazole/clarithromycin)
The recommended adult oral regimen is Omeprazole 40 mg once daily plus clarithromycin 500 mg t.i.d. for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of Omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief. Return to top
The recommended adult oral dose is 40 mg once a day for 4-8 weeks. Return to top
Gastroesophageal reflux disease
The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20 mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20 mg daily for 4 to 8 weeks. Return to top
Maintenance of healing of erosive esophagitis
The recommended adult oral dose is 20 mg daily. Return to top
Pathological hypersecretory conditions
The dosage of Omeprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg t.i.d. have been administered. Daily dosages of greater than 80 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with Omeprazole for more than 5 years. Return to top
For the treatment of GERD or other acid-related disorders, the recommended dose for pediatric patients 2 years of age and older is as follows: If patient weight < 20 kg, then Omeprazole dose is 10 mg; If patient weight ≥ 20 kg , then Omeprazole dose is 20 mg.
On a per kg basis, the doses of Omeprazole required to heal erosive esophagitis are greater than those for adults.
For pediatric patients unable to swallow an intact capsule, see Alternative Administration Options subsection below. Return to top
Alternative administration options
For patients who have difficulty swallowing capsules, the contents of an Omeprazole Delayed-Release Capsule can be added to applesauce. One tablespoon of applesauce should be added to an empty bowl and the capsule should be opened. All of the microtablets inside the capsule should be carefully emptied on the applesauce. The microtablets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the microtablets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The microtablets should not be chewed or crushed. The microtablets/applesauce mixture should not be stored for future use.
No dosage adjustment is necessary for patients with renal impairment or for the elderly.
Omeprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Omeprazole.
Patients should be cautioned that the Omeprazole Delayed-Release Capsule should not be opened, chewed or crushed, and should be swallowed whole. Return to top
Adapted from the FDA Package Insert.