Esomeprazole (Nexium) Contraindications and Precautions
- proton pump inhibitors (PPIs) hypersensitivity
- breast-feeding
- children
- gastric cancer
- hepatic disease
- pregnancy
Esomeprazole (Nexium) Contraindications and Precautions
Esomeprazole is contraindicated in patients with known hypersensitivity to esomeprazole or other substituted benzimidazoles such as omeprazole or lansoprazole (i.e., known proton pump inhibitors (PPIs) hypersensitivity). Although rare, occasionally such reactions can be serious (e.g., result in anaphylaxis or angioedema). There has been evidence of PPI cross-sensitivity in some sensitive individuals in literature reports.
Esomeprazole undergoes extensive hepatic metabolism. Patients with severe hepatic disease should not exceed a dose of 20 mg per day. No dosage adjustment is recommended in patients with mild to moderate hepatic impairment.
Antimicrobials, proton pump inhibitors, and bismuth preparations suppress Helicobacter pylori. Ingestion of these substances within four weeks prior to performing urease or breath-tests for H. pylori detection may lead to false negative results. In the four weeks prior to performing the test, the patient should avoid the use of esomeprazole and other agents which known to suppress H. pylori.
Symptomatic response to therapy with esomeprazole does not preclude the presence of gastric cancer or other malignancy.
No overall differences in safety and efficacy were observed between the elderly and younger individuals receiving esomeprazole. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity for some older individuals cannot be ruled out.
Esomeprazole is classified an FDA pregnancy risk category B drug. There are no adequate and well-controlled studies in pregnant women. Sporadic reports of congenital abnormalities in infants have been received with the use of omeprazole during pregnancy. Esomeprazole should be used during pregnancy only when clearly needed.
The excretion of esomeprazole in milk has not been studied. However, omeprazole concentrations have been measured in human breast milk. Because esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of the drug to the mother.
The safety and efficacy of esomeprazole in children has not been established.
[ Last revised: 6/12/2005 1:06:00 PM ]
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