Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux , ulcers). The safety and effectiveness of Omeprazole Delayed-Release Capsules have been established in pediatric patients 1 to 16 years for the treatment of symptomatic GERD, treatment of EE due to acid-mediated GERD, and maintenance of healing of EE due to acid-mediated GERD. Use of Omeprazole Delayed-Release Capsules in this age group is supported by adequate and well-controlled studies in adults and uncontrolled safety, efficacy and pharmacokinetic studies performed in pediatric and adolescent patients see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.8 ).
Teratogenicity was not observed in animal reproduction studies with administration of oral esOmeprazole (an enantiomer of Omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esOmeprazole or 40 mg Omeprazole (based on body surface area for a 60 kg person). Changes in bone go!! morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esOmeprazole or 40 mg Omeprazole. When maternal administration was confined to gestation only, there were no effects on the bone physeal morphology in the offspring at any age see Data.
Concomitant administration of Omeprazole and voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) resulted in more than doubling of the Omeprazole exposure. When voriconazole (400 mg every 12 hours for one day, followed by 200 mg once daily for 6 days) was given with Omeprazole (40 mg once daily for 7 days) to healthy subjects, the steady-state Cmax and AUC0-24 of Omeprazole significantly increased: an average of 2 times (90% CI: 1.8, 2.6) and 4 times (90% CI: 3.3, 4.4), respectively, as compared to when Omeprazole was given without voriconazole see Drug Interactions ( 7 ).
The course of Barrett’s esophagus in 106 patients was evaluated in a U.S. double-blind controlled study of Omeprazole Delayed-Release Capsules 40 mg twice daily for 12 months followed by 20 mg twice daily for 12 months or ranitidine 300 mg twice daily for 24 months. No clinically significant impact on Barrett’s mucosa by antisecretory therapy was observed. Although neosquamous epithelium developed during antisecretory therapy, complete elimination of Barrett’s mucosa was not achieved. No significant difference was observed between treatment groups in development of dysplasia in Barrett’s mucosa and no patient developed esophageal carcinoma during treatment. No significant differences between treatment groups were observed in development of ECL cell hyperplasia, corpus atrophic gastritis, corpus intestinal metaplasia, or colon polyps exceeding 3 mm in diameter.
Low magnesium levels warning: Taking this drug for three months or longer can cause low magnesium levels in your body. Your risk is higher if you take omeprazole for a year or longer. Call your doctor right away if you have symptoms of low magnesium. These can include seizures, abnormal or fast heart rate, jitteriness, jerking movements or shaking, and muscle weakness. They can also include cramps or muscle aches and spasms of your hands, feet, and voice box. Your doctor may check your magnesium levels before and during your treatment with this drug.