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Calcium gluconate Pregnancy and Breastfeeding Warnings

Calcium gluconate is also known as: Cal-G, Cal-GLU, Kalcinate

Medically reviewed by Drugs.com. Last updated on Sep 2, 2018.

Calcium gluconate Pregnancy Warnings

Animal studies are not available. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned

Comments:
-The limited data on use in pregnant women is insufficient to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Hypocalcemia carries risks to the mother and fetus, including increased spontaneous abortion, dysfunctional or premature labor, and preeclampsia.
-Infants of mothers with hypocalcemia may have neonatal hyperparathyroidism, which may lead to fetal and neonatal skeletal demineralization, subperiosteal bone resorption, osteitis fibrosa cystica, and seizures.
-Carefully monitor infants of hypocalcemic mothers for abnormal calcium levels; signs include neuromuscular irritability, apnea, cyanosis, and cardiac arrhythmias.

See references

Calcium gluconate Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-Calcium is a normal component of human milk; it is unknown if use of this drug alters the calcium concentration in breast milk.
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Calcium Gluconate (calcium gluconate)." Fresenius Kabi USA, LLC, Lake Zurich, IL.
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):

References for breastfeeding information

  1. "Product Information. Calcium Gluconate (calcium gluconate)." Fresenius Kabi USA, LLC, Lake Zurich, IL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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