Pantoprazole - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS . • Gastric Malignancy: In adults, symptomatic response to therapy with pantoprazole sodium for injection does not preclude the presence of gastric malignancy.

Consider additional follow-up and diagnostic testing. • Injection Site Reactions: Thrombophlebitis is associated with the administration of pantoprazole sodium for injection.

Assess the patient and remove the catheter if clinically indicated. • Potential Exacerbation of Zinc Deficiency: Consider zinc supplementation in patients who are prone to zinc deficiency.

Caution should be used when other EDTA containing products are also co-administered intravenously. • Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. • Clostridioides difficile-Associated Diarrhea : PPI therapy may be associated with increased risk. • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. • Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. • Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue treatment and refer to specialist for evaluation. • Hepatic Effects: Elevations of transaminases observed. • Hypomagnesemia and Mineral Metabolism: Reported rarely with prolonged treatment with PPIs. • Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year.

Use the shortest duration of therapy.

5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with pantoprazole sodium for injection does not preclude the presence of gastric malignancy.

Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.

In older patients, also consider an endoscopy.

5.2 Injection Site Reactions Thrombophlebitis was associated with the administration of pantoprazole sodium for injection.

Assess the patient and remove the catheter if clinically indicated.

5.3 Potential for Exacerbation of Zinc Deficiency Pantoprazole sodium for injection contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc.

Therefore, zinc supplementation should be considered in patients treated with pantoprazole sodium for injection who are prone to zinc deficiency.

Caution should be used when other EDTA containing products are also co-administered intravenously [see Dosage and Administration ] .

5.4 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy.

Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia).

In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).

Discontinue pantoprazole sodium for injection and evaluate patients with suspected acute TIN [see Contraindications ] .

5.5 Clostridium difficile - Associated Diarrhea Published observational studies suggest that PPI therapy like pantoprazole sodium for injection may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients.

This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions ].

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

5.6 Bone Fracture Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.

The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration (2.2 , 2.4) , Adverse Reactions ] .

5.7 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs [see Adverse Reactions ].