Omeprazole Delayed-release | Omeprazole Capsule, Delayed Release while Breastfeeding

It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Omeprazole Delayed-release | Omeprazole Capsule, Delayed Release is safe for baby while breastfed.

Omeprazole is a proton pump inhibitor indicated for: • Treatment of duodenal ulcer in adults (1.1) • Treatment of gastric ulcer in adults (1.2) • Treatment of gastroesophageal reflux disease (GERD) in pediatric patients and adults (1.3) • Maintenance of healing of erosive esophagitis in pediatric patients and adults (1.4) • Treatment of pathological hypersecretory conditions in adults (1.5) The safety and effectiveness of omeprazole in pediatric patients <1 year of age have not been established. (8.4) 1.1 Duodenal Ulcer (adults) Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole delayed-release capsules, in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1 year history) to eradicate H. pylori in adults. Omeprazole delayed-release capsules, in combination with clarithromycin are indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)]. Among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin are more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted. [See Microbiology section (12.4)], and the clarithromycin package insert, Microbiology section.) 1.2 Gastric Ulcer (adults) Omeprazole delayed-release capsules are indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults. [See Clinical Studies (14.2)] 1.3 Treatment of Gastroesophageal Reflux Disease (GERD) (adults and pediatric patients) Symptomatic GERD Omeprazole delayed-release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults. Erosive Esophagitis Omeprazole delayed-release capsules are indicated for the short-term treatment (4-8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [See Clinical Studies (14.4)] The efficacy of omeprazole delayed-release capsules used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of omeprazole may be considered. 1.4 Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients) Omeprazole delayed-release capsules are indicated to maintain healing of erosive esophagitis in pediatric patients and adults. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)] 1.5 Pathological Hypersecretory Conditions (adults) Omeprazole delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Omeprazole concentrations have been measured in breast milk of a woman following oral administration of 20 mg. The peak concentration of omeprazole in breast milk was less than 7% of the peak serum concentration. This concentration would correspond to 0.004 mg of omeprazole in 200 mL of milk. Because omeprazole is 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.