5 Interactions found for:

The following applies to the ingredients: Prednisone

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

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

Risk summary: Available data suggest a small but inconsistent increased risk of orofacial clefts with corticosteroid use during the first trimester. Intrauterine growth restriction and decreased birth weight have also been reported with maternal use of corticosteroids during pregnancy, but the underlying maternal condition may have contributed to these risks.

Comments:
-Women who become pregnant while using this drug should be apprised of the potential fetal risks.
-Observe for signs and symptoms of hypoadrenalism in infants exposed to this drug in utero.
-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.

Animal studies have revealed evidence of teratogenicity at a maternal dose equivalent to 100 mg in a 60 kg human based on body surface area (BSA); fetolethality and fetotoxicity were observed at a maternal dose equivalent to 290 mg in a 60 kg human based on BSA; constriction of the fetal ductus arteriosus has also been observed. There are no adequate and well controlled studies in pregnant women. However, placental and birth weights have been reduced in humans after long term treatment with corticosteroids. Maternal pulmonary edema with inhibition of uterine contractions and fluid overload has also been reported with corticosteroids. Additionally, adrenal cortex suppression may occur in newborns with long term maternal corticosteroid use.

Menstrual irregularities and altered motility and number of spermatozoa have been reported with clinical use of corticosteroids. Animal studies with corticosteroids have revealed impaired male fertility.

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: Tiotropium (found in Spiriva)

The manufacturer makes no recommendation regarding use during pregnancy.

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

Comments:
-The limited data available on use in pregnant women are insufficient to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Poorly controlled asthma during pregnancy increases the risk of preeclampsia, premature birth, low birth weight, and small for gestational age.
-Closely monitor asthma control during pregnancy and adjust therapy as needed for optimal control.

Animal studies showed no structural abnormalities when doses 8 and 790 times the maximum recommended human dose were administered during organogenesis; animal models showed increased fetal resorption, litter loss, and decreased numbers of live pups and pup weights, as well as a delay in pup sexual maturation at doses 40 times and 430 times the maximum recommended human dose, as well as maternal toxicity. There are no controlled data in human pregnancy. The limited human data are insufficient to inform a drug-associated risk of adverse pregnancy outcomes. 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: Tiotropium (found in Spiriva)

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse events on the child from this drug or the mother's underlying condition.
-Lactating rats given 10 mg/kg tiotropium IV had higher concentrations of tiotropium and/or its metabolites in milk than in plasma; due to species specific differences in lactation physiology, the clinical relevance of this is unclear.

The following applies to the ingredients: Prednisone

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.