Ezoprole Special Precautions

Gastric Malignancy: Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric malignancy, thus the possibility of malignancy should be excluded prior to starting treatment with esomeprazole.
Acute Interstitial Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs including esomeprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Esomeprazole 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 Clostridum difficile, Salmonella, and Campylobacter. PPI therapy, such as esomeprazole, 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 have been rarely reported 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 PPI therapy have been reported.
Atrophic Gastritis: Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which esomeprazole is an enantiomer.
Helicobacter pylori (H. pylori) Eradication: When prescribing esomeprazole for eradication of H. pylori, possible drug interactions for all components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for clarithromycin should be considered when the triple therapy is used in patients taking other drugs metabolized via CYP3A4 such as cisapride.
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 esomeprazole, 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 esomeprazole treatment should be considered.
Effects on Ability to Drive and Use Machines: Esomeprazole may cause somnolence, dizziness, vertigo, and visual disturbances. Patients should exercise caution when driving vehicles or operating machinery.
Use in Children: The safety and efficacy of esomeprazole in pediatric patients 1 to 17 years of age and 1 month to less than 1 year of age have been established for short-term treatment of GERD and erosive esophagitis, respectively. However, the safety and efficacy of esomeprazole in pediatric patients less than 1 month have not been established.
Use in the Elderly: No significant differences in safety and efficacy were observed between the elderly and younger individuals. However, increased sensitivity of some older individuals cannot be ruled out.
Benefits of esomeprazole 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. Patients should be carefully monitored if esomeprazole treatment is required.