5 Interactions found for:

The following applies to the ingredients: Empagliflozin (found in Jardiance)

Use should be avoided, especially during the second and third trimesters of pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not Assigned

Risk Summary: There is limited data in pregnant women to determine a drug-associated risk for major birth defects and miscarriage. Based on animal data, this drug may cause adverse renal effects in the developing fetus.

Comments:
-Poorly controlled diabetes in pregnancy increases the risk of adverse maternal and fetal outcomes.

Animal studies have revealed evidence of adverse renal changes and embryofetal toxicity. Administration of this drug to pregnant animals during the period of organogenesis at doses up to 154 times the maximum clinical dose based on AUC resulted in maternal/fetal toxicity, malformations, and reduced offspring body weights. In juvenile rats, direct exposure to this drug at doses approximately 13 times the maximum clinical dose caused increased kidney weights and renal tubular/pelvic dilatations. These findings occurred during a period of renal development in rats corresponding to the late second and third trimester of human renal development. Animal studies do not indicate direct or indirect harmful effects with respect to fertility. There are no controlled data in human pregnancy.

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. Fetal risks of poorly controlled diabetes in pregnancy include an increased risk for major birth defects, stillbirth, and macrosomia-related morbidity.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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 following applies to the ingredients: Cholecalciferol (found in Vitamin D3)

Use is not recommended unless there is a deficiency.

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

Comments:
-Vitamin D supplementation should begin a few months prior to pregnancy.

Animal studies at high doses have shown teratogenicity. There are no controlled data in human pregnancy. Because vitamin D raises calcium levels, it is suspect in the pathogenesis of supravalvular aortic stenosis syndrome, which is often associated with idiopathic hypercalcemia of infancy, but excessive vitamin D intake or retention has not been found consistently in these mothers. A study of 15 patients with maternal hypoparathyroidism, treated with high dose vitamin D during pregnancy (average 107,000 international units per day) to maintain normal calcium levels, produced all normal children. Vitamin D deficiency is associated with reduced fetal growth, neonatal hypocalcemia (with and without convulsions), rickets, and defective tooth enamel.

AU TGA pregnancy category Exempt: Medicines 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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

The following applies to the ingredients: Empagliflozin (found in Jardiance)

Use is not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-A risk to the breastfed infant cannot be excluded; there is a potential for serious adverse effects on postnatal renal development.
-An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug accumulation was observed in the milk of lactating animals. Studies in juvenile rats with direct exposure demonstrated pelvic and tubular dilations of the kidney during maturation. Human kidney maturation occurs in utero and during the first 2 years of life; thus, a potential for serious harm to the developing kidney may exist for infants exposed to this drug during breastfeeding. However, some experts anticipate low amounts of this drug in human breastmilk due to high levels of plasma protein binding.

The following applies to the ingredients: Cholecalciferol (found in Vitamin D3)

Use is not recommended unless the clinical condition of the woman requires treatment.

Excreted into human milk: Yes

Comments:
-Make allowance for any maternal dose if prescribing this product to a breast fed infant.
-Consider monitoring the infant's serum calcium if the mother is receiving pharmacologic doses of vitamin D.
-Vitamin D supplementation is recommended in exclusively breast fed infants.

The required dose of vitamin D during lactation has not been adequately studied; doses similar to those for pregnant women have been suggested.

Chronic ingestion of large doses of vitamin D by the mother may lead to hypercalcemia in the breastfed infant.