4 Interactions found for:

The following applies to the ingredients: Omeprazole

Professional Content

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

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: Epidemiologic studies have demonstrated that major malformative risks with use in pregnant patients are unlikely.

Comment: Some experts recommend that use is considered acceptable.

Animal models have revealed evidence of dose-related increases in embryolethality, fetal resorptions, and pregnancy disruptions when animal models were given this drug during organogenesis. Major fetal malformations were not frequently observed in animal models. Embryofetal and postnatal developmental toxicities were observed in offspring of parents given at least 3.4 times an oral human dose of 40 mg.

Embryofetal toxicity is associated with maternally toxic doses given throughout gestation as well as in high doses given to males prior to mating.

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 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)

Professional Content

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: Omeprazole

Professional Content

Use is not recommended.

Excreted into human milk: Yes

Comments:
-This drug is associated with tumorigenicity in animal models, and may suppress gastric acid secretion in the nursing infant.
-The American Academy of Pediatrics state that this drug should be avoided until additional studies can confirm the safe use of this drug during breastfeeding.

In animal models, decreased postpartum offspring growth rates were observed when this drug was administered during late gestation and throughout lactation at oral doses of at least 138 mg/kg/day and IV doses of 3.2 mg/kg/day.

The following applies to the ingredients: Tiotropium (found in Spiriva)

Professional Content

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.