Lansoprazole (Prevacid) Contraindications and Precautions
- proton pump inhibitors (PPIs) hypersensitivity
- breast-feeding
- children
- gastric cancer
- hepatic disease
- infants
- phenylketonuria
- pregnancy
Lansoprazole (Prevacid) Contraindications and Precautions
Lansoprazole is contraindicated in patients with known hypersensitivity to lansoprazole or other substituted benzimidazoles such as omeprazole or esomeprazole (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.
Lansoprazole is classified as pregnancy category B. Animal studies have shown no teratogenic effects. Adequate studies have not been undertaken in humans. Lansoprazole should be used during pregnancy only when clearly needed.
Animal studies have indicated that lansoprazole is excreted into breast milk. Although no studies have been done to determine if lansoprazole is similarly excreted into human milk, lansoprazole use is not recommended during breast-feeding. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from lansoprazole in breast-fed infants, 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.
Lansoprazole elimination half-life is significantly prolonged in patients with hepatic disease. In patients with severe hepatic disease, dosage reduction of lansoprazole should be considered. Abnormal liver-function tests have been reported infrequently with lansoprazole use. No dosage adjustment is necessary in patients with renal insufficiency or the elderly (manufacturer’s information).
Safety and efficacy of lansoprazole have not been established in infants (i.e., age < 1 year). The manufacturer has established safety and efficacy for lansoprazole use in children aged 1 - 17 years for short-term treatment of symptomatic GERD and erosive esophagitis. Safety and effectiveness in the pediatric population has been determined from adult clinical trials with additional clinical, pharmacokinetic, and pharmacodynamic studies in children.
Antimicrobials, lansoprazole, omeprazole, and bismuth preparations suppress H.pylori. Ingestion of these substances within four (4) 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 must avoid the use lansoprazole and other agents which are known to suppress H.pylori.
Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric cancer or other malignancy.
Patients with phenylketonuria should be made aware that lansoprazole disintegrating tablets contain phenylalanine (2.5 mg per 15 mg tablet; 5.1 mg per 30 mg tablet). The capsule and syrup formulations do not contain phenylalanine.
[ Last revised: 7/6/2005 3:40:00 PM ]
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