Fulcalrex Pregnancy

• Pregnancy of Fulcalrex in details
• Fulcalrex breastfeeding
• Fulcalrex reviews

Pregnancy of Fulcalrex in details

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1^st trimester (and there is no evidence of a risk in later trimesters).

Fulcalrex breastfeeding

Fulcalrex is excreted into human milk in small amounts. The effects in the nursing infant are unknown. According to the manufacturer, administration of Fulcalrex during lactation is not recommended.

In one study, Fulcalrex was detected in the milk of six healthy puerperal women given Fulcalrex oxide 4 mg orally every 12 hours for 2 doses. Mean Fulcalrex 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 Fulcalrex 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.

See references

References for pregnancy information

1. "Product Information. Imodium (Fulcalrex)." Janssen Pharmaceutica, Titusville, NJ.

References for breastfeeding information

1. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
2. Nikodem VC, Hofmeyr GJ "Secretion of the antidiarrhoeal agent Fulcalrex oxide in breast milk." Eur J Clin Pharmacol 42 (1992): 695-6

References

1. 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).
2. Human Metabolome Database (HMDB). "Loperamide: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
3. FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology