ESOMEPRAZOLE SODIUM

AbsorptionThe pharmacokinetics of esomeprazole in healthy subjects following administration of esomeprazole sodium for injection 20 mg and 40 mg once daily as intravenous infusion over 30 minutes for 5 days are shown in Table 8.

Table 8Geometric Mean (95% CI) Pharmacokinetic Parameters of Esomeprazole Sodium for Injection Following Dosing for 5 Days Parameter Esomeprazole sodium for injection 20 mg (n=24) Esomeprazole sodium for injection 40 mg (n=38) AUC (micromol*h/L) 5.1 (4.0:6.6) 16.2 (14...

14.1 Acid Suppression in GERD Four multicenter, open-label, two-period crossover studies were conducted to compare the pharmacodynamic effects of esomeprazole following intravenous or oral administration on acid suppression in 206 patients with symptoms of GERD with or without erosive esophagitis. Patients were randomized to receive either 20 or 40 mg of esomeprazole sodium for injection or oral esomeprazole once daily for 10 days (Period 1), and then were switched in Period 2 to the other formulation for 10 days, matching their respective dose from Period 1. Esomeprazole sodium for injection,...

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) ] Hypomagnesemia and Mineral Metabolism [see Warnings a...

Esomeprazole sodium for injection 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 (6.2) ]. Proton pump inhibitors (...

Gastric Malignancy : In adults, symptomatic response to therapy with esomeprazole sodium for injection does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial 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...

7 DRUG INTERACTIONS Tables 5 and 6 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with esomeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table 5Clinically Relevant Interactions Affecting Drugs Co-Admi...