Generic name: OMEPRAZOLE MAGNESIUM 10mg
Dosage form: capsule, delayed release; granule, delayed release
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
PRILOSEC Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with PRILOSEC.
Patients should be informed that the PRILOSEC Delayed-Release Capsule should be swallowed whole.
For patients unable to swallow an intact capsule, alternative administration options are available [see Dosage and Administration (2.8)].
Short-Term Treatment of Active Duodenal Ulcer
The recommended adult oral dose of PRILOSEC is 20 mg once daily. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
H. pylori Eradication for the Reduction of the Risk of Duodenal Ulcer Recurrence
Triple Therapy (PRILOSEC/clarithromycin/amoxicillin) — The recommended adult oral regimen is PRILOSEC 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 PRILOSEC 20 mg once daily is recommended for ulcer healing and symptom relief.
Dual Therapy (PRILOSEC/clarithromycin) — The recommended adult oral regimen is PRILOSEC 40 mg once daily plus clarithromycin 500 mg three times daily for 14 days. In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of PRILOSEC 20 mg once daily is recommended for ulcer healing and symptom relief.
Gastroesophageal Reflux Disease (GERD)
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.
Maintenance of Healing of Erosive Esophagitis
The recommended adult oral dose is 20 mg daily. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.4)].
Pathological Hypersecretory Conditions
The dosage of PRILOSEC in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120 mg three times daily 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 PRILOSEC for more than 5 years.
For the treatment of GERD and maintenance of healing of erosive esophagitis, the recommended daily dose for pediatric patients 1 to 16 years of age is as follows:
|Patient Weight||Omeprazole Daily Dose|
5 < 10 kg
10 < 20 kg
≥ 20 kg
On a per kg basis, the doses of omeprazole required to heal erosive esophagitis in pediatric patients are greater than those for adults.
Alternative administrative options can be used for pediatric patients unable to swallow an intact capsule [see Dosage and Administration (2.8)].
Alternative Administration Options
PRILOSEC is available as a delayed-release capsule or as a delayed-release oral suspension.
For patients who have difficulty swallowing capsules, the contents of a PRILOSEC 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 pellets inside the capsule should be carefully emptied on the applesauce. The pellets should be mixed with the applesauce and then swallowed immediately with a glass of cool water to ensure complete swallowing of the pellets. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The pellets should not be chewed or crushed. The pellets/applesauce mixture should not be stored for future use.
PRILOSEC For Delayed-Release Oral Suspension should be administered as follows:
- Empty the contents of a 2.5 mg packet into a container containing 5 mL of water.
- Empty the contents of a 10 mg packet into a container containing 15 mL of water.
- Leave 2 to 3 minutes to thicken.
- Stir and drink within 30 minutes.
- If any material remains after drinking, add more water, stir and drink immediately.
For patients with a nasogastric or gastric tube in place:
- Add 5 mL of water to a catheter tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). It is important to only use a catheter tipped syringe when administering PRILOSEC through a nasogastric tube or gastric tube.
- Immediately shake the syringe and leave 2 to 3 minutes to thicken.
- Shake the syringe and inject through the nasogastric or gastric tube, French size 6 or larger, into the stomach within 30 minutes.
- Refill the syringe with an equal amount of water.
- Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.
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