Prilosec Side Effects & Drug Interactions

Drug Library
Prilosec - Side Effects & Drug Interactions [Omeprazole]

Clarithromycin

Pregnancy Category C.

See WARNINGS (above) and full prescribing information for clarithromycin before using in pregnant women.

Nursing Mothers

It is not known whether omeprazole is excreted in human milk. In rats, omeprazole administration during late gestation and lactation at doses of 13.8 to 138 mg/ kg/ day (35 to 345 times the human dose) resulted in decreased weight gain in pups. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from omeprazole, and because of the potential for tumorigenicity shown for omeprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of PRILOSEC have been established in the age group 2 years to 16 years for the treatment of acid-related gastrointestinal diseases, including the treatment of symptomatic GERD, treatment of erosive esophagitis, and the maintenance of healing of erosive esophagitis. The safety and effectiveness of PRILOSEC have not been established for pediatric patients less than 2 years of age. Use of PRILOSEC in the age group 2 years to 16 years is supported by evidence from adequate and well-controlled studies of PRILOSEC in adults with additional clinical, pharmacokinetic, and safety studies performed in pediatric patients (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism: Omeprazole).

Treatment of Gastroesophageal Reflux Disease (GERD) Symptomatic GERD In an uncontrolled, open-label study of patients aged 2 years to 16 years with a history of symptoms suggestive of nonerosive GERD, 113 patients were assigned to receive a single daily dose of omeprazole (10 mg or 20 mg, based on body weight) either as an intact capsule or as an open capsule in applesauce. Results showed success rates of 60% (10 mg omeprazole) and 59% (20 mg omeprazole) in reducing the number and intensity of either pain-related symptoms or vomiting/ regurgitation episodes.