Consists of cyanocobalamin, Pyridoxine, thiamine
Pregnancy of Cyanocobalamin (Demoton-B12) in details
Cyanocobalamin (Demoton-B12) has been assigned to pregnancy category C by the FDA. Studies have revealed a progressive decline in the maternal serum level and an increase in the urinary excretion of vitamin B12 during pregnancy. The fetus has been shown to concentrate vitamin B12 since fetal cord serum levels are approximately three times maternal values. In view of a demonstrated increase in urinary excretion of vitamin B12 during pregnancy, the recommended daily allowance (RDA) during pregnancy includes the addition of 1 mcg/day above the basal requirement of 3 mcg/day.
See references
Cyanocobalamin (Demoton-B12) breastfeeding
In animals, vitamin B12 deficiency is associated with teratogenic effects. Methylmalonic aciduria, homocystinuria, megaloblastic anemia and neurologic abnormalities have been reported in breast-fed infants whose mothers were strict vegetarians. In general, severe maternal vitamin B12 deficiency may result in megaloblastic anemia with subsequent infertility and poor pregnancy outcomes. Milk concentrations are proportional to the daily intake of the vitamin. Women given daily doses of 1 to 200 micrograms/day had milk levels increase from a level of 79 pg/mL to 100 pg/mL. In a study using 8 micrograms/day of Cyanocobalamin (Demoton-B12), mean milk levels of 1650 pg.mL at 1 week and 1100 pg/mL at 6 weeks were measured. Corresponding levels in unsupplemented mothers were 1220 and 610 pg./mL, respectively.
Cyanocobalamin (Demoton-B12) is excreted into human milk. Cyanocobalamin (Demoton-B12) is considered compatible with breast-feeding by the American Academy of Pediatrics
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References for pregnancy information
- Berkowitz R, Coustan D, Mochizuki T. "Handbook for Prescribing Medications During Pregnancy. 2nd ed." Boston, MA: Little, Brown, and Company (1986): 242
References for breastfeeding information
- Berkowitz R, Coustan D, Mochizuki T. "Handbook for Prescribing Medications During Pregnancy. 2nd ed." Boston, MA: Little, Brown, and Company (1986): 242
Pregnancy of Pyridoxine (Demoton-B12) in details
Pyridoxine has been assigned to pregnancy category A by the FDA or category C in doses that exceed the RDA. There are no controlled data in human pregnancy. Pyridoxine is only recommended for use during pregnancy when benefit outweighs risk.
The recommended dietary allowance (RDA) of pyridoxine (vitamin B6) for pregnant women is 1.9 mg/day regardless of age.
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Pyridoxine (Demoton-B12) breastfeeding
Pyridoxine is excreted into human milk. Neonatal seizures have been reported in infants whose mothers' breast milk contained 67 mcg/day. These seizures responded to pyridoxine therapy. Pyridoxine is considered compatible with breast-feeding by the American Academy of Pediatrics.
Pyridoxine has been reported to inhibit lactation at large doses. The recommend dietary allowance (RDA) of pyridoxine (vitamin B6) for lactating women is 2 mg/day, regardless of age, to ensure a vitamin B6 concentration of milk of 130 ng/mL.
See references
References for pregnancy information
- "Multum Information Services, Inc. Expert Review Panel"
- "Product Information. Nestrex (pyridoxine)." Fielding Company, Maryland Heights, MO.
References for breastfeeding information
- "Product Information. Nestrex (pyridoxine)." Fielding Company, Maryland Heights, MO.
- "Multum Information Services, Inc. Expert Review Panel"
Pregnancy of Thiamine (Demoton-B12) in details
Water soluble vitamins cross the placenta. Thiamine (Demoton-B12) requirements are increased in during pregnancy (IOM 1998).
Pregnant females are at increased risk of Thiamine (Demoton-B12) deficiency when prolonged nausea and vomiting (including hyperemesis gravidarum) occurs; deficiency may present as a polyneuropathy or Wernicke encephalopathy (Chiossi 2006; Karjalainen 1965; WHO 1999).
Thiamine (Demoton-B12) supplementation is recommended in pregnant females with prolonged vomiting. Initial treatment with IV Thiamine (Demoton-B12) is needed when Wernicke encephalopathy is suspected.
Oral, IM, or IV therapy may be considered depending on severity of Thiamine (Demoton-B12) deficiency (Berdai 2016; Chiossi 2006; Palacios-Marqués 2012). When intravenous hydration is used in the management of hyperemesis gravidarum, Thiamine (Demoton-B12) should be administered prior to infusing dextrose to prevent Wernicke encephalopathy (ACOG 189 2018).
Thiamine (Demoton-B12) breastfeeding
There are no data on the excretion of Thiamine (Demoton-B12) into human milk. The manufacturer recommends that caution be used when administering Thiamine (Demoton-B12) to nursing women.
The recommended daily allowance (RDA) for Thiamine (Demoton-B12) during lactation is 1.4 mg/day regardless of a woman's age. Women who are breast-feeding more than one infant may have increased needs for Thiamine (Demoton-B12).
See references
References for pregnancy information
- The National Academy of Sciences "Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Available from: URL: http://www.nap.edu/openbook/0309065542/html/58.html." ([1999, 2000]):
- "Product Information. Vitamin B1 (Thiamine (Demoton-B12))." Dixon-Shane Inc, Philadelphia, PA.
- The National Academy of Sciences "Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Available from: URL: http://www.nap.edu/openbook/0309065542/html/566.html." ([1999, 2000]):
References for breastfeeding information
- The National Academy of Sciences "Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Available from: URL: http://www.nap.edu/openbook/0309065542/html/566.html." ([1999, 2000]):
- The National Academy of Sciences "Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Available from: URL: http://www.nap.edu/openbook/0309065542/html/58.html." ([1999, 2000]):
- "Product Information. Vitamin B1 (Thiamine (Demoton-B12))." Dixon-Shane Inc, Philadelphia, PA.
References
- DailyMed. "ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K: 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. "Thiamine (Vitamin B1): 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. "Rodex: 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
