5 Interactions found for:

The following applies to the ingredients: Lisdexamfetamine (found in Vyvanse)

Professional Content

Benefit should outweigh risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-The active metabolite of this drug, dexamphetamine, crosses the placenta.
-Premature delivery, low birth weight, and other adverse pregnancy outcomes have been seen in infants born to mothers dependent on amphetamines.
-Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness.

There are no controlled data of this drug in human pregnancy, but there are some available data for amphetamines in pregnant women. Two case control studies of over a thousand patients exposed to amphetamines at different gestational ages did not show an increase in congenital abnormalities. Additionally, animal studies have revealed no effects on embryofetal morphological development and survival, nor on fertility.

AU TGA pregnancy category B3: 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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: Lisdexamfetamine (found in Vyvanse)

Professional Content

Use should be avoided during breastfeeding.

Excreted into human milk: Yes

Comments:
-This drug is a prodrug of dextroamphetamine. The effect of dextroamphetamine in milk on the neurological development of a breastfed infant has not been well studied.
-Large dosages of this drug might interfere with milk production, especially in women whose lactation is not well established.

-Blood levels of dextroamphetamine in 3 breastfed infants were up to 14% of the maternal plasma level.
-Four breastfed infants whose mothers took an average dose of 18 mg/day of dextroamphetamine had no adverse effects and showed normal progress with weights between the 10th and 75th percentiles.
-In a study of 20 postpartum women, dextroamphetamine reduced serum prolactin by 25% to 32% (7.5 mg IV dose) and 30% to 37% (15 mg IV dose). Another study showed a 20 mg oral dose produced a sustained suppression of serum prolactin by 40%.

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.