4 Interactions found for:

The following applies to the ingredients: Prednisone

Professional Content

This drug should only be used during pregnancy if the benefit outweighs the potential risk to the fetus

AU TGA pregnancy category: A
US FDA pregnancy category: C
US FDA pregnancy category: D (delayed-release tablets)

Comments:
-Observe for signs and symptoms of hypoadrenalism in infants exposed to this drug in utero.
-Women who become pregnant while using this drug should be apprised of the potential fetal risks.
-The short-term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or newborn infant.

Teratogenicity including increased incidence of cleft palate have occurred in animal studies. A number of cohort and case controlled studies in humans suggest maternal corticosteroid use in the first trimester produces a slight increased risk of cleft lip with or without cleft palate (increased from 1 out of 1000 to 3 to 5 out of 1000 infants). Reduced placental and birth weight have been recorded in animals and humans after long term treatment. There is the possibility of adrenal cortex suppression in the newborn with long term use in the mother; however the short term use of corticosteroids antepartum for the prevention of respiratory distress syndrome does not seem to pose a risk to the fetus or the newborn infant. Maternal pulmonary edema has been reported with inhibition of uterine contractions and fluid overload. There are no adequate and well controlled studies in pregnant women.

Use of prednisolone (active metabolite) at high doses for an extended period of time (30 mg/day for a minimum of 4 weeks) has caused reversible disturbances of spermatogenesis that persisted for several months after discontinuation.

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 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.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or 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: Prednisone

Professional Content

This drug should be used only if clearly needed

Excreted into human milk: Yes

Comments:
-If this drug is necessary, the lowest dose should be prescribed; theoretically, if high maternal doses are necessary, the dose the infant receives may be minimized by avoiding breastfeeding for 4 hours following dosing and using prednisolone instead of prednisone.

Amounts of glucocorticoids excreted into breast milk are low with a total infant daily dose calculated to be up to 0.23% of the maternal daily dose. For doses up to 10 mg/day, the amount of drug an infant receives via breast milk is undetectable; however the milk/plasma ratio increases with doses above 10 mg/day (e.g., 25% of the serum concentration is found in breast milk when dose is 80 mg/day). If this drug is necessary, the lowest dose should be prescribed as high doses of corticosteroids for long periods could produce infant growth and development problems and interfere with endogenous corticosteroid production. High doses might occasionally cause temporary loss of milk supply.

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.