DOSAGE AND ADMINISTRATION
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. (See INDICATIONS AND
USAGE.)
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 40mg 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 PRILOSEC 20 mg once daily is recommended for ulcer healing and symptom relief.
Please refer to clarithromycin full prescribing information for CONTRAINDICATIONS and WARNING, and for information regarding dosing in elderly and renally impaired patients (PRECAUTIONS: General, PRECAUTIONS: Geriatric Use and PRECAUTIONS: Drug Interactions).
Please refer to amoxicillin full prescribing information for CONTRAINDICATIONS and WARNINGS.
Gastric Ulcer
The recommended adult oral dose is 40 mg once a day for 4 -8 weeks. (See CLINICAL PHARMACOLOGY, Clinical Studies, Gastric Ulcer, and INDICATIONS AND USAGE, Gastric Ulcer.)
Gastroesophageal Reflux Disease (GERD)
The recommended adult oral dose for the treatment of patients with symptomatic GERD and no sophageal 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. (See INDICATIONS AND USAGE.)
Maintenance of Healing of Erosive Esophagitis)
The recommended adult oral dose is 20 mg daily. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
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 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 PRILOSEC for more than 5 years.
Pediatric Patients)
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:
| PATIENT WEIGHT |
OMEPRAZOLE DOSE |
| < 20 KG |
10 MG |
| >= 20 KG |
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.
Alternative Administration Options
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.
No dosage adjustment is necessary for patients with renal impairment or for the elderly.
PRILOSEC Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids
were used concomitantly with PRILOSEC.
Patients should be cautioned that the PRILOSEC Delayed-Release Capsule should not be opened,
chewed or crushed, and should be swallowed whole.
DIRECTIONS
- adults 18 years of age and older
- this product is to be used once a day (every 24 hours), every day for 14 days
- it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment
- swallow 1 tablet with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 tablet a day
- do not chew or crush the tablets
- do not crush tablets in food
- do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor
- children under 18 years of age: ask a doctor
HOW SUPPLIED
No. 3426 — PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and
amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body. They are supplied as
follows:
- NDC 0186-0606-31 unit of use bottles of 30
- NDC 0186-0606-68 bottles of 100
- NDC 0186-0606-28 unit dose packages of 100
- NDC 0186-0606-82 bottles of 1000.
No. 3440 — PRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored
capsules, coded 742 on cap and PRILOSEC 20 on body. They are supplied as follows:
- NDC 0186-0742-31 unit of use bottles of 30
- NDC 0186-0742-28 unit dose package of 100
- NDC 0186-0742-82 bottles of 1000.
No. 3428 — PRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body. They are supplied as follows:
-
- NDC 0186-0743-31 unit of use bottles of 30
- NDC 0186-0743-68 bottles of 100
- NDC 0186-0743-28 unit dose packages of 100
- NDC 0186-0743-82 bottles of 1000.
Storage
Store PRILOSEC Delayed-Release Capsules in a tight container protected from light and moisture.
Store between 15°C and 30°C (59°F and 86°F).
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