RiteMED Pantoprazole Special Precautions

Gastric Malignancy: Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy or any alarm symptom (e.g., significant weight loss, recurrent vomiting, dysphagia, hematemesis, anemia, or melena). When gastric ulcer is suspected or present, malignancy should be excluded.
Acute Interstitial Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs including pantoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Pantoprazole should be discontinued if acute interstitial nephritis develops.
Clostridium difficile-Associated Diarrhea: Decreased gastric acidity due to any means, including PPIs, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with PPIs can lead to an increased risk of gastrointestinal infections such as Salmonella, Campylobacter, and Clostridium difficile.
PPI therapy, such as pantoprazole, may be associated with an increased risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients, the use of antibiotics, old age, and the presence of co-morbidities. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest dose and the shortest duration of PPI therapy appropriate to the condition being treated.
Bone Fracture: 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.
Hypomagnesemia: Symptomatic and asymptomatic hypomagnesemia has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), physicians may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Cyanocobalamin (Vitamin B₁₂) Deficiency: The prolonged use of PPIs (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (Vitamin B12) caused by hypo- or achlorhydria and may contribute to the development of cyanocobalamin deficiency. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported.
Atrophic Gastritis: Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with pantoprazole, particularly in patients with H. pylori.
Respiratory Effects: Administration of PPIs has been associated with an increased risk of developing certain infections such as community-acquired pneumonia.
Subacute Cutaneous Lupus Erythematosus (SCLE): PPIs, such as pantoprazole, are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help immediately. Discontinuation of pantoprazole treatment should be considered.
Hypersensitivity and Severe Skin Reactions: Anaphylaxis and other serious reactions such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN) have been reported with the use of IV pantoprazole. An emergency medical treatment may be required.
Effects on Ability to Drive and Use Machine: Pantoprazole causes headache, dizziness, and visual disturbances. Patients should be cautioned against engaging in activities requiring alertness such as operating machinery or driving a car.
Hepatic Impairment: The liver enzymes of patients with severe hepatic impairment should be monitored during pantoprazole treatment, particularly on long-term use. If the liver enzymes increased, the treatment should be discontinued.
Dose reduction should be considered in patients with severe hepatic impairment. Daily doses higher than 40 mg/day have not been studied.
Renal Impairment: The recommended dose should not be exceeded in patients with renal impairment.
Use in Children: The safety and efficacy of pantoprazole in pediatric patients 1 to 16 years of age have been established for short-term treatment of erosive esophagitis associated with GERD. However, the efficacy of pantoprazole in pediatric patients less than 1 year of age has not been established.
Use in the Elderly: No significant differences in safety and efficacy were observed between the elderly and younger individuals.
Benefits of pantoprazole treatment should be weighed against the increased risk of fractures as patients in this group may already be at high risk for osteoporosis-related fractures. If pantoprazole treatment is required, patients should be carefully managed according to established treatment guidelines.