5 Interactions found for:

The following applies to the ingredients: Trazodone

Professional Content

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-Some experts recommend: Use with caution; use should be avoided during the first trimester of pregnancy.

US FDA pregnancy category: C

Comment: When this drug is used until delivery, newborns should be monitored for the occurrence of withdrawal symptoms.

Animal studies have revealed evidence of increased fetal resorption and congenital anomalies in adolescents. Other animal models have failed to reveal evidence of adverse effects on embryofetal development, parturition, or postnatal development when given at therapeutic doses. There are no controlled data in human pregnancy.

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: 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: Trazodone

Professional Content

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some experts recommend: Caution is recommended.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern.

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.