Omeprazoledosage

Indication Recommended Adult Dosage Omeprazole and Sodium Bicarbonate for oral suspension or Omeprazole and Sodium Bicarbonate capsules Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks Active Benign Gastric Ulcer 40 mg once daily for 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily for up to 4 weeks Treatment of 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** 40 mg Omeprazole and Sodium Bicarbonate for oral suspension Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 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.

2.1 Important

Administration Instructions Omeprazole and Sodium Bicarbonate is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole. The sodium content of Omeprazole and Sodium Bicarbonate capsules and Omeprazole and Sodium Bicarbonate for oral suspension should be taken into consideration when prescribing this product: Omeprazole and Sodium Bicarbonate capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg. Omeprazole and Sodium Bicarbonate for oral suspension: each 20 mg and 40 mg packet of contains 1,680 mg (20 mEq) of sodium bicarbonate. The total content of sodium in each packet is 460 mg. Due to the sodium bicarbonate content of Omeprazole and Sodium Bicarbonate: Do not substitute two packets of 20 mg Omeprazole and Sodium Bicarbonate for oral suspension with one packet of 40 mg Omeprazole and Sodium Bicarbonate for oral suspension. Do not substitute two 20 mg Omeprazole and Sodium Bicarbonate capsules with one 40 mg Omeprazole and Sodium Bicarbonate capsule.

2.2 Dosage Regimen

The recommended dosage regimen by indication in adults of Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules is summarized in Table 1. Only 40 mg Omeprazole and Sodium Bicarbonate for oral suspension is indicated for the reduction of risk of upper GI bleeding in critically ill adult patients and the dosage regimen is summarized in Table 2. All recommended dosages are based upon omeprazole content.

Table 1: Recommended Dosage Regimen of Omeprazole and Sodium Bicarbonate for Oral Suspension and Omeprazole and Sodium Bicarbonate Capsules in Adults by Indication Indication Dosage of Omeprazole and Sodium Bicarbonate for oral suspension or Omeprazole and Sodium Bicarbonate capsules Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks *† Treatment of 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 † Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily Controlled studies do not extend beyond 12 months.

Table 2: Recommended Dosage Regimen of 40 mg Omeprazole and Sodium Bicarbonate for Oral Suspension in Adults by Indication Indication Dosage of 40 mg Omeprazole and Sodium Bicarbonate for oral suspension Treatment Duration Reduction of Risk of Upper GI Bleeding in Critically Ill Patients 40 mg initially; followed by 40 mg 6 to 8 hours later; and 40 mg once daily thereafter 14 days

2.3 Preparation and

Administration Omeprazole and Sodium Bicarbonate Capsules Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water. Take on an empty stomach at least one hour before a meal. Omeprazole and Sodium Bicarbonate for Oral Suspension Omeprazole and Sodium Bicarbonate for oral suspension is intended to be mixed with water and administered orally or via a nasogastric (NG) or orogastric (OG) tube. If administered orally, take on an empty stomach at least one hour before a meal. If administered via NG or OG tube, suspend enteral feeding approximately 3 hours before and 1 hour after administration of Omeprazole and Sodium Bicarbonate for oral suspension. Oral Administration Empty the contents of a packet into a small cup containing 5 to 10 mL of water. Do not mix with liquids or foods other than water. Stir well and drink immediately. Refill cup with water and drink immediately. Nasogastric (NG) or Orogastric (OG) Tube Administration