Consists of Calcium Carbonate, Vitamin D3
Pregnancy of Calcium Carbonate (Prompcal) in details
Calcium Carbonate (Prompcal) has not been formally assigned to a pregnancy category by the FDA. Animal reproductive studies and data from controlled human studies are not available. Calcium Carbonate (Prompcal) is commonly used safely to provide calcium supplementation during human pregnancy. Calcium Carbonate (Prompcal) should only be used during pregnancy when benefit outweighs risk.
Calcium is transported across the human placenta. The human fetus is entirely dependent on its mother for the supply of nutrients--including calcium--and oxygen and removal of waste products. Fetal accumulation of calcium occurs mainly during the third trimester. By the end of normal human pregnancy the fetus acquires approximately 28 grams of calcium and 16 grams of phosphorus for skeletal development. The recommended daily calcium supplementation for a pregnant woman averages 1,200 mg (compared to 800 mg/day in the nonpregnant adult), with an additional 250 to 300 mg/day recommended during the last trimester. One quart of milk contains approximately 1,200 mg of calcium; women who do not consume milk or milk products may require calcium supplementation. The milk-alkali syndrome associated with Calcium Carbonate (Prompcal) has been reported during human pregnancy. In one case, after resolution of hypercalcemia, a 31-year-old woman delivered a stillborn fetus with short limbs and low-set ears at 37 weeks' gestation. Chromosomal analysis was normal, and autopsy revealed no evidence of tissue calcification. In another case, a 31-year-old woman delivered a normal 2,950 gram male infant.
Calcium Carbonate (Prompcal) breastfeeding
The calcium content of human milk averages 30 mg/dl. The recommended daily allowance (RDA) for calcium in the lactating woman is 1,200 mg (compared to 400 mg/day in the nonlactating adult). One quart of milk contains approximately 1,200 mg of calcium. Women who do not consume milk or milk products may require calcium supplementation.
There are no data on the excretion of Calcium Carbonate (Prompcal) into human milk. Calcium is considered a normal component of human milk.
See references
References for pregnancy information
- Kleinman GE, Rodriquez H, Good MC, Caudle MR "Hypercalcemic crisis in pregnancy associated with excessive ingestion of Calcium Carbonate (Prompcal) antacid (milk-alkali syndrome): successful treatment with hemodialysis." Obstet Gynecol 78 (1991): 496-9
- Picolos MK, Sims CR, Mastrobattista JM, Carroll MA, Lavis VR "Milk-alkali syndrome in pregnancy." Obstet Gynecol 104 (2004): 1201-4
- "Product Information. Calci-Chew (Calcium Carbonate (Prompcal))." R & D Laboratories Inc, Marina Del Rey, CA.
- Danforth D, Scott J, DiSaia P, Hammond C, Spellacy W, Eds. "Obstetrics and Gynecology, Fifth Edition." JB Lippincott Company, Philadelphia 1 (1986): 181-93
- Crawford JS "Maternal and cord blood at delivery. IV. Glucose, sodium, potassium, calcium and chloride." Biol Neonat 8 (1965): 222-37
- Ullian ME, Linas SL "The milk-alkali syndrome in pregnancy. Case report." Miner Electrolyte Metab 14 (1988): 208-10
References for breastfeeding information
- Danforth D, Scott J, DiSaia P, Hammond C, Spellacy W, Eds. "Obstetrics and Gynecology, Fifth Edition." JB Lippincott Company, Philadelphia 1 (1986): 181-93
- "Product Information. Calci-Chew (Calcium Carbonate (Prompcal))." R & D Laboratories Inc, Marina Del Rey, CA.
Pregnancy of Vitamin D3 (Prompcal) 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 CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE: 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).
- DailyMed. "CHOLECALCIFEROL: 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).
- 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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
