Omeprazoledosage

Indication Recommended Adult and Pediatric Dosage Treatment of Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Omeprazole delayed-release capsules Amoxicillin Clarithromycin 20 mg 1000 mg 500 mg Each drug twice daily for 10 days * Dual Therapy: Omeprazole delayed-release capsules Clarithromycin 40 mg once daily for 14 days** 500 mg three times daily for 14 days Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Symptomatic GERD 20 mg once daily for up to 4 weeks See full prescribing information for weight based dosing in pediatric patients 2 years of age and older EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks *** Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily **** See full prescribing information for weight based dosing in pediatric patients 2 years of age and older Pathological Hypersecretory Conditions Starting dose is 60 mg once daily (varies with individual patient, see full prescribing information) as long as clinically indicated * if ulcer present, continue omeprazole delayed-release capsules 20 mg once daily for an additional 18 days. ** if ulcer present, continue omeprazole delayed-release capsules 20 mg once daily for an additional 14 days. *** an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8 week courses may be considered. **** studied for 12 months. Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child-Pugh Class A, B, or C) and Asian patients

2.1 Recommended

Adult Dosage Regimen by Indication Table 1 shows the recommended dosage of omeprazole delayed-release capsules in adult patients by indication.

Table 1: Recommended Dosage Regimen of Omeprazole Delayed-Release Capsules in Adults by Indication Indication Dosage of Omeprazole Delayed-Release Capsules Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks 1 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy Omeprazole delayed-release capsules 20 mg Amoxicillin 1000 mg Clarithromycin 500 mg Take all three drugs twice daily 10 days In patients with an ulcer present at the time of initiation of therapy, continue omeprazole delayed-release capsules 20 mg once daily for an additional 18 days for ulcer healing and symptom relief. Dual Therapy Omeprazole delayed-release capsules 40 mg once daily Clarithromycin 500 mg three times daily 14 days In patients with an ulcer present at the time of initiation of therapy, an additional 14 days of omeprazole delayed-release capsules 20 mg once daily is recommended for ulcer healing and symptom relief. Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily Up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily 4 to 8 weeks 2 Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily 3 Controlled studies do not extend beyond 12 months. Pathological Hypersecretory Conditions Starting dose is 60 mg once daily; adjust to patient needs Daily dosages of greater than 80 mg should be administered in divided doses. Dosages up to 120 mg three times daily have been administered. As long as clinically indicated. Some patients with Zollinger-Ellison syndrome have been treated continuously for more than 5 years. 1. Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing 2. The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered. 3. Dosage reduction to 10 mg once daily is recommended for patients with hepatic impairment (Child-Pugh Class A, B or C) and Asian patients when used for the maintenance of healing of EE.

2.2 Recommended

Pediatric Dosage Regimen by Indication Table 2 shows the recommended dosage of omeprazole delayed-release capsules in pediatric patients by indication.

Table 2: Recommended Dosage Regimen of Omeprazole Delayed-Release Capsules in Pediatric Patients by Indication Indication Omeprazole Delayed-Release Capsules Dosage Regimen and Duration Treatment of Symptomatic GERD Patient Age Weight-Based Dose (mg) Regimen and Duration 2 to 16 years 10 to less than 20 kg: 10 mg Once daily for up to 4 weeks 20 kg and greater: 20 mg Treatment of EE due to Acid-Mediated GERD 2 to 16 years 10 to less than 20 kg: 10 mg Once daily for 4 to 8 weeks 1 20 kg and greater: 20 mg Maintenance of Healing of EE due to Acid-Mediated GERD 2 to 16 years 10 to less than 20 kg: 10 mg Once daily. Controlled studies do not extend beyond 12 months 20 kg and greater: 20 mg 1. The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole delayed-release capsules may be considered.

2.3 Administration

Instructions

Take omeprazole delayed-release capsules before meals.

Antacids may be used concomitantly with omeprazole delayed-release capsules.

Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose. Omeprazole Delayed-Release Capsules

Swallow omeprazole delayed-release capsules whole; do not chew.

For patients unable to swallow an intact capsule, omeprazole delayed-release capsules can be opened and administered as follows: 1. Place one tablespoon of applesauce into a clean container (e.g., empty bowl). The applesauce used should not be hot and should be soft enough to be swallowed without chewing. 2. Open the capsule. 3. Carefully empty all of the pellets inside the capsule on the applesauce. 4. Mix the pellets with the applesauce. 5. Swallow applesauce and pellets immediately with a glass of cool water to ensure complete swallowing of the pellets. Do not chew or crush the pellets. Do not save the applesauce and pellets for future use.