Loperamide Pregnancy and Breastfeeding Warnings
Loperamide is also known as: Anti-Diarrheal, Diamode, Diar-Aid, Imodium, Imodium A-D, Imotil, Kao-Paverin, Kaopectate 1-D, Kaopectate II, Neo-Diaral, Pepto Diarrhea Control, Up and Up Anti-Diarrheal Solution
Loperamide Pregnancy Warnings
Loperamide has been assigned to pregnancy category C by the FDA. Animal studies failed to reveal evidence of teratogenicity or fetal harm. There are no controlled data in human pregnancy. Loperamide should only be given during pregnancy if the potential benefits outweighs the risks.
Loperamide Breastfeeding Warnings
Loperamide is excreted into human milk in small amounts. The effects in the nursing infant are unknown. According to the manufacturer, administration of loperamide during lactation is not recommended.
In one study, loperamide was detected in the milk of six healthy puerperal women given loperamide oxide 4 mg orally every 12 hours for 2 doses. Mean loperamide milk (serum) concentrations ranged from 0.18 (0.36) ng/mL immediately prior to the second dose to 0.27 (0.73) ng/mL and 0.19 (0.54) ng/mL six and 24 hours after the second dose, respectively. The authors estimated that if an infant drank 165 mL/kg/day, the ingested dose of loperamide would be 2000 times less than the usual therapeutic dose of 0.2 mg/kg/day. The infants did not breast-feed in this study.
References for pregnancy information
- "Product Information. Imodium (loperamide)." Janssen Pharmaceutica, Titusville, NJ.
References for breastfeeding information
- Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
- Nikodem VC, Hofmeyr GJ "Secretion of the antidiarrhoeal agent loperamide oxide in breast milk." Eur J Clin Pharmacol 42 (1992): 695-6
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.