5 Interactions found for:

The following applies to the ingredients: Levothyroxine

Professional Content

Use is considered acceptable

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

Risk Summary: No increased rates of major birth defects or miscarriages have been reported with use during pregnancy; untreated hypothyroidism during pregnancy is associated with risks to the mother and fetus

Comments:
-Thyroid replacement therapy should not be discontinued during pregnancy; hypothyroidism diagnosed during pregnancy should be promptly treated.
-Monitor TSH levels and adjust doses as needed.

Animal studies have not been conducted. There is a long history of using this drug in pregnant women and this experience has not shown increased rates of fetal malformations, miscarriages or other adverse maternal or fetal outcomes. Hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, pre-eclampsia, stillbirth and premature delivery. Maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. Pregnant women taking this drug should have their TSH measured during each trimester and dose adjusted as appropriate. Patients will generally return to their pre-pregnancy dose after delivery. There are no controlled data in human pregnancy.

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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: Montelukast (found in Singulair)

Professional Content

The manufacturer makes no recommendation regarding use during pregnancy.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Comments:
-Available data from decades of studies have not established a drug-associated increase in major birth defects when used during pregnancy.
-Animal studies at up to 110 times the maximum recommended human daily oral dose administered during organogenesis did not show adverse developmental effects.
-Poorly or moderately controlled asthma increases maternal risk and the risk of adverse perinatal outcomes (e.g. preeclampsia, prematurity, low birth weight, small for gestational age).

Animal studies of oral administration during organogenesis at up to 110 times the maximum recommended human daily oral dose did not cause any averse developmental effects. Human data from prospective and retrospective cohort studies have not identified an increase in major birth defects when this drug was used during pregnancy; limitations of the studies include small sample size, retrospective data collection, and inconsistent comparator groups. 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 TGA pregnancy category B1: 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 not shown 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: Levothyroxine

Professional Content

Use is considered acceptable

Excreted into human milk: Yes

Comments:
-Levothyroxine (T4) is a normal component of human milk; limited data on exogenous replacement doses during breastfeeding have not shown an adverse effect in nursing infants.
-Levothyroxine dose requirements may be increased in the postpartum period compared to prepregnancy requirements in patients with Hashimoto's thyroiditis.
-The presence of thyroid hormone in breast milk does not appear to interfere with neonatal thyroid screening.

The following applies to the ingredients: Montelukast (found in Singulair)

Professional Content

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-A published study reports presence of this drug in human milk.
-Available data do not suggest significant risk of adverse events in the infant from exposure through breast milk or direct exposure.
-There is no information regarding this drug on the 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.