Consists of calcium, L-lysine, methionine, niacinamide, vitamin B1, vitamin B12, vitamin B2, vitamin B6
Pregnancy of Calcium in details
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Pregnancy of Niacinamide in details
Niacinamide has not been formally assigned to a pregnancy category by the FDA. Niacinamide has been assigned to pregnancy category A by Briggs, et.al, and is considered compatible with pregnancy. The National Academy of Sciences recommended dietary allowance for niacin (which is converted in humans to niacinamide) is 17 mg. and is an essential nutrient required for lipid metabolism, tissue respiration, and glycogenolysis. Niacinamide is actively transported to the fetus. Higher concentrations are found in the fetus and newborn, rather than in the mother. Deficiency of niacinamide in pregnancy is uncommon except in women with poor nutrition. Niacinamide use in excess of the recommended daily allowance (RDA) during normal pregnancy should be avoided.
See references
Niacinamide breastfeeding
Niacin is actively excreted into breast milk. It is unknown if niacinamide is excreted into breast milk, but it is probable that it also is actively transferred. The National Academy of Sciences recommended dietary allowance for niacin is 20 mg. If the diet of the lactating woman adequately supplies this amount, supplementation with niacinamide is not needed. Maternal supplementation with the RDA for niacinamide is recommended only for those patients with inadequate nutritional intake. Niacinamide use in excess of the recommended daily allowance (RDA) during lactation should be avoided.
See references
References for pregnancy information
- Briggs GG, Freeman RK, Yaffe SJ. "Drugs in Pregnancy and Lactation. 8th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2008):
References for breastfeeding information
- Briggs GG, Freeman RK, Yaffe SJ. "Drugs in Pregnancy and Lactation. 8th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2008):
Pregnancy of Vitamin B12 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 1st trimester (and there is no evidence of a risk in later trimesters).
Pregnancy of Vitamin B6 in details
Category A: Controlled studies in women fail to demonstrate a risk to the foetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of foetal harm remains remote.
References
- DailyMed. "CALCIUM: 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).
- Human Metabolome Database (HMDB). "L-Lysine: 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).
- 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
