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: PRILOSEC Amoxicillin Clarithromycin 20 mg 1000 mg 500 mg Each drug twice daily for 10 days * Dual Therapy: PRILOSEC 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 1 year of age and older EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks *** See full prescribing information for weight based dosing in pediatric patients 1 month of age and older 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 1 year 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 PRILOSEC 20 mg once daily for an additional 18 days. ** if ulcer present, continue PRILOSEC 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 PRILOSEC in adult patients by indication.

Table 1: Recommended Dosage Regimen of PRILOSEC in Adults by Indication Indication Dosage of PRILOSEC Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks Most patients heal within 4 weeks; some patients may require an additional 4 weeks of therapy to achieve healing Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy PRILOSEC 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 PRILOSEC 20 mg once daily for an additional 18 days for ulcer healing and symptom relief. Dual Therapy PRILOSEC 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 PRILOSEC 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 The efficacy of PRILOSEC 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 PRILOSEC may be considered. Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily 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. 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.

2.2 Recommended

Pediatric Dosage Regimen by Indication Table 2 shows the recommended dosage of PRILOSEC in pediatric patients by indication.

Table 2: Recommended Dosage Regimen of PRILOSEC in Pediatric Patients by Indication Indication PRILOSEC Dosage Regimen and Duration Patient Age Weight-Based Dose (mg) Regimen and Duration Treatment of Symptomatic GERD 1 to 16 years 5 to less than 10 kg: 5 mg Once daily for up to 4 weeks 10 to less than 20 kg: 10 mg 20 kg and greater: 20 mg Treatment of EE due to Acid-Mediated GERD 1 to 16 years 5 to less than 10 kg: 5 mg Once daily for 4 to 8 weeks The efficacy of PRILOSEC 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 PRILOSEC may be considered. 10 to less than 20 kg: 10 mg 20 kg and greater: 20 mg 1 month to less than 1 year 3 to less than 5 kg: 2.5 mg Once daily up to 6 weeks 5 to less than 10 kg: 5 mg 10 kg and greater: 10 mg Maintenance of Healing of EE due to Acid-Mediated GERD 1 to 16 years 5 to less than 10 kg: 5 mg Once daily. Controlled studies do not extend beyond 12 months 10 to less than 20 kg: 10 mg 20 kg and greater: 20 mg

2.3 Administration

Instructions

PRILOSEC is intended to be prepared in water and administered orally or via a nasogastric (NG) or gastric tube.

Take PRILOSEC before meals.

Antacids may be used concomitantly with PRILOSEC.

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. Oral Administration in Water 1. Empty the contents of a 2.5 mg packet into a container containing 5 mL of water. 2. Empty the contents of a 10 mg packet into a container containing 15 mL of water. 3. Stir. 4. Leave 2 to 3 minutes to thicken. 5. Stir and drink within 30 minutes. 6. If any material remains after drinking, add more water, stir and drink immediately. Administration with Water via a NG or Gastric Tube (Size 6 or Larger) 1. 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 through a nasogastric tube or gastric tube. 2. Immediately shake the syringe and leave 2 to 3 minutes to thicken. 3. Shake the syringe and inject through the nasogastric or gastric tube into the stomach within 30 minutes. 4. Refill the syringe with an equal amount of water. 5. Shake and flush any remaining contents from the nasogastric or gastric tube into the stomach.