PROTONIX

Pantoprazole sodium for injection peak serum concentration (C max ) and area under the serum concentration-time curve (AUC) increase in a manner proportional to intravenous doses from 10 mg to 80 mg. Pantoprazole sodium for injection does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing. Following the administration of pantoprazole sodium for injection, the serum concentration of pantoprazole sodium for injection declines biexponentially with a terminal eliminatio...

14.1 Gastroesophageal Reflux Disease (GERD) Associated with a History of Erosive Esophagitis (EE) A multicenter, double-blind, two-period placebo-controlled study was conducted to assess the ability of pantoprazole sodium for injection to maintain gastric acid suppression in patients switched from pantoprazole sodium delayed-release tablets to pantoprazole sodium for injection. GERD patients (n=65, 26 to 64 years; 35 female; 9 Black, 11 Hispanic, 44 White, 1 other) with a history of EE were randomized to receive either 20 or 40 mg of oral pantoprazole once per day for 10 days (period 1), and t...

The following serious adverse reactions are described below and elsewhere in labeling: Injection Site Reactions [see Warnings and Precautions (5.2) ] Potential for Exacerbation of Zinc Deficiency [see Warnings and Precautions (5.3) ] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.4) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.5) ] Bone Fracture [see Warnings and Precautions (5.6) ] Severe Cutaneous Adverse Reactions [see Warnings and Prec...

Pantoprazole sodium is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2 , 5.4 ) and Adverse Reactions (6) ] . Proton pump inh...

Gastric Malignancy : In adults, symptomatic response to therapy with pantoprazole sodium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Injection Site Reactions : Thrombophlebitis is associated with the administration of intravenous pantoprazole sodium. Assess the patient and remove the catheter if clinically indicated. ( 5.2 ) Potential Exacerbation of Zinc Deficiency : Consider zinc supplementation in patients who are prone t...

7 DRUG INTERACTIONS See the full prescribing information for a list of clinically important drug interactions. ( 7 ) Table 3 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further informati...