Breast milk is superior in nutrition, It provides resistance against infections and allergies, It is naturally sterile. Despite all the advantages of breastfeeding some mothers choose to pause the breastfeeding in fear of harmful effects of medicines passing in breast milk. Are you wondering about breastfeeding and using Omeprazole | Sandoz Inc ? Know what is Omeprazole | Sandoz Inc and how it can affect your breast milk and whether Omeprazole | Sandoz Inc is safe for your kid or not.
What is Omeprazole | Sandoz Inc used for?
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 is 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.
Is Omeprazole | Sandoz Inc usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?
Active ingredient in Omeprazole | Sandoz Inc is Omeprazole and based on our analysis of Omeprazole it appears that using Omeprazole | Sandoz Inc is safe in breastfeeding. Below is analysis of Omeprazole while breastfeeding.
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.
Omeprazole | Sandoz Inc Breastfeeding Analsys
Omeprazole while Breastfeeding Safe
CAS Number: 73590-58-6
High plasma protein binding makes excretion into breast milk to be insignificant. No side effects were observed in breastfed infants of treated mothers. Shown to be labile in acid-pH environment must be administered in the form of micro-granules within an enteric-coated capsule. Any small quantity reaching the infant's stomach would be readily inactivated. Hyperprolactinemia and Galactorrhea have been reported.
Omeprazole | Sandoz Inc Breastfeeding Analsys - 2
Omeprazole while Breastfeeding
CAS Number: 73590-58-6
Limited information indicates that maternal omeprazole doses of 20 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants.
What if I already have used Omeprazole | Sandoz Inc?
As usage of Omeprazole | Sandoz Inc is mostly safe while breastfeeding hence there should not be any concern. In case of any change in behavior or health of your baby you should inform your health care provider about usage of Omeprazole | Sandoz Inc else no further action is required.
I am nursing mother and my doctor has suggested me to use Omeprazole | Sandoz Inc, is it safe?
Definitely, Omeprazole | Sandoz Inc is safe in lactation for baby. No wonder your doctor has recommended it.
If I am using Omeprazole | Sandoz Inc, will my baby need extra monitoring?
No extra baby monitoring required while mother is using Omeprazole | Sandoz Inc
Who can I talk to if I have questions about usage of Omeprazole | Sandoz Inc in breastfeeding?
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week