6 Interactions found for:

The following applies to the ingredients: Allopurinol

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Safety has not been established.
-According to some authorities: This drug is only recommended for use during pregnancy when there are no safer alternatives and the benefit outweighs the risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk Summary: Based on findings in animals, this drug may cause fetal harm.

Comments:
-Animals exposed to this drug have shown negative developmental effects.
-Placental transfer of this drug and its metabolite have been reported.
-The available data on the use of this drug during pregnancy is limited and inconclusive. Pregnant women should be apprised of the potential risk to the fetus.
-This drug has been used widely for many years without apparent harmful effects.
-Infertility and impotence in men rarely occur during treatment with this drug, and studies have not confirmed an association with it.

Animal studies have failed to reveal evidence of fetotoxicity or teratogenicity. However, intraperitoneal administration of this drug in pregnant mice on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects (cleft palate, harelip, and digital defects). In another study, this drug after oral administration to pregnant rats during organogenesis caused embryonic resorptions, growth retardation, decreased fetal weight, and skeletal, liver, kidney, and brain abnormalities. A 2013 report analyzed 31 pregnancies exposed to this drug during the first trimester, finding that major birth defects and miscarriages were within the general population's range, but one child had severe defects. There is insufficient data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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)

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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: Allopurinol

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Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.

Excreted into human milk: Yes

Comments:
-This drug and its active metabolite were detected in human milk.
-There was no report of effects of this drug on the nursing infant or on milk production.
-If the mother requires this drug, she does not have to stop nursing, but the nursing infant should be monitored for allergic reactions (such as rash) and undergo periodic CBC and differential blood counts.

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

Professional Content

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.