Ranitidine Syrup while Breastfeeding

Most health expert recommend six month of exclusive breastfeeding but statics suggest that numbers are not good, almost 95% mothers start breastfeeding but this number drops to 40% in first three month and further it drops to 15% till fifth month. Sometime its due to need of medication usage. Because of these statics its important to provide good information on safety of drugs in breastfeeding so that it can be improved when possible. In this FAQ sheet we will discuss about exposure to Ranitidine Syrup while breastfeeding. We will also discuss about common side effects and warnings associated with Ranitidine Syrup.

Ranitidine oral solution, USP is indicated in: Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine oral solution, USP 150 mg twice daily. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine oral solution, USP 150 mg 4 times daily. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers Ranitidine is secreted in human milk. Caution should be exercised when ranitidine oral solution, USP is administered to a nursing mother.