PRILOSEC

Absorption PRILOSEC for delayed-release oral suspension contains omeprazole magnesium granules and inactive granules to be administered in water. Absorption of omeprazole begins only after the gastro-resistant granules leave the stomach. The pharmacokinetics of omeprazole are time dependent, with higher plasma concentrations at steady state compared to after a single dose. The systemic exposure (AUC and C max ) to omeprazole following once daily dosing of 20 mg delayed-release oral suspension fo...

14.1 Active Duodenal Ulcer In a multicenter, double-blind, placebo-controlled study of 147 patients with endoscopically documented duodenal ulcer, the percentage of patients healed (per protocol) at 2 and 4 weeks was significantly higher with omeprazole magnesium delayed-release capsules 20 mg once daily than with placebo (p ≤ 0.01). Treatment of Active Duodenal Ulcer % of Patients Healed omeprazole magnesium delayed-release capsules 20 mg a.m. (n=99) Placebo a.m. (n=48) Week 2 41 (p≤0.01) 13 Week 4 75 27 Complete daytime and nighttime pain relief occurred significantly faster (p ≤ 0.01) in pa...

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )]
• Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.3 )]
• Bone Fracture [see Warnings and Precautions ( 5.4 )]
• Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )]
• Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6 )]
• Cyanocobalamin (Vitamin B-12) Defici...

• PRILOSEC is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6 )] .
• Proton pump inhibitors (PPIs), including PRI...

• Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 )
• Acute Tubulointerstital Nephritis : Discontinue treatment and evaluate patients. ( 5.2 )
• Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.3 )
• Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fr...

7 DRUG INTERACTIONS Table 3 and Table 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table 3Clinically Relevant Interactions Affecting Drugs Co-A...