5 Interactions found for:

The following applies to the ingredients: Pravastatin

Professional Content

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments:
-This drug should only be used in women of childbearing potential who are highly unlikely to conceive and have been informed of the potential hazards.
-If the patient becomes pregnant while taking this drug, therapy should be immediately discontinued and the patient should be apprised of the potential hazard to the fetus.
-Use of adequate methods of contraception should be encouraged.

Animal studies have failed to reveal evidence of teratogenicity, however, oral gavage doses of 4, 20, 100, 500, and 1000 mg/kg/day given to rats from gestation day 7 through 17 increased mortality of offspring and skeletal anomalies and developmental delays were observed at 100 mg/kg/day (10 times the human exposure of 80 mg/day). Rare cases of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been reported. There are no controlled data in human pregnancy.

Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol products are essential for fetal development (including synthesis of steroids and cell membranes). Since HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. Atherosclerosis is a chronic process and discontinuation of lipid-lowering drugs during pregnancy should have little impact on long term outcomes of primary hypercholesterolemia therapy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

The following applies to the ingredients: Omega-3 Polyunsaturated Fatty Acids (found in Fish Oil)

Professional Content

Use is recommended only if clearly needed.

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

Comments:
-There is insufficient data on use in pregnancy to identify drug-associate risks for major birth defects, miscarriage, or adverse fetal or maternal outcomes.
-Animal studies of dams given oral omega-3-acid ethyl esters from mating through lactation did not show adverse reproductive or developmental effects at 5 times the maximum recommended human dose (MRHD).
-Animal studies of oral dosing at clinically relevant doses during organogenesis did not show teratogenicity.
-There is no official RDA for omega-3 fatty acids during pregnancy, but the US Institute of Medicine and the Food and Nutrition Board suggest that 1400 mg per day should be adequate during lactation.
-Pregnant women may not consume adequate amounts of omega-3 fatty acids from their diet due to recommendations to limit fish consumption to no more than twice weekly (due to mercury content of fish).

Animal studies of oral administration from 2 weeks prior to mating through lactation showed no adverse effects at 5 times the recommended human dose (MRHD). A dose ranging study of oral administration from 2 weeks prior to mating to postpartum day 7 showed a 20% reduction in live births and a 40% reduction in pup survival to postnatal day 4 at or above 3000 mg/kg/day (7 times the MRHD). Oral doses up to 14 times the MRHD (a maternotoxic dose) administered during organogenesis showed no fetal adverse effects. Animals given oral doses up to 5 times the MRHD from gestation day 14 through lactation day 21 showed no adverse effects. Skeletal malformations and reduced fetal growth were seen at maternally toxic doses (4 times the MRHD) and embryolethality occurred at 7 times the MRHD in rabbits. There are no controlled data in human pregnancy. Adequate omega-3 fatty acid intake during pregnancy may reduce preterm birth, increase birth length, weight, and head circumference, improve cognitive and visual development, and reduce risk of allergies. 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: Pravastatin

Professional Content

Use is contraindicated.

Excreted into human milk: Yes (in small amounts)

Comments:
-This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism.

The excretion of this drug into breast milk was evaluated in 11 women following oral administration of 20 mg orally twice a day for a total of 5 doses. The maximum concentrations of this drug and its major metabolite in milk following the last dose averaged 3.9 mcg/L and 2.1 mcg/L, respectively. Using these peak levels, a fully breastfed infant would receive a maximum of 900 mcg/kg per day or about 1.4% of the maternal weight adjusted dose.

The following applies to the ingredients: Omega-3 Polyunsaturated Fatty Acids (found in Fish Oil)

Professional Content

Safety has not been established; use is not recommended.

Excreted into human milk: Yes

Comments:
-There is no information regarding this drug on 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 medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Higher omega-3 fatty acid levels have been seen in lactating patients receiving oral omega-3 fatty acid supplementation.
-Infant needs for docosahexaenoic acid (DHA) is approximately 70 to 80 mg per day.
-There is no official RDA for omega-3 fatty acids during lactation, but the US Institute of Medicine and the Food and Nutrition Board suggest that 1300 mg per day should be adequate during lactation.