Pregnancy of Lopra in details
Lopra 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. Lopra should only be given during pregnancy if the potential benefits outweighs the risks.
Lopra is excreted into human milk in small amounts. The effects in the nursing infant are unknown. According to the manufacturer, administration of Lopra during lactation is not recommended.
In one study, Lopra was detected in the milk of six healthy puerperal women given Lopra oxide 4 mg orally every 12 hours for 2 doses. Mean Lopra 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 Lopra 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 (Lopra)." 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 Lopra oxide in breast milk." Eur J Clin Pharmacol 42 (1992): 695-6
- DailyMed. "OMEPRAZOLE MAGNESIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Loperamide (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- PubMed Health. "Citalopram (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology