5 Interactions found for:

The following applies to the ingredients: Hydrochlorothiazide

The manufacturer recommends that hydrochlorothiazide should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: B

The routine use of diuretics during pregnancy is not indicated or recommended.

Animal studies have failed to reveal evidence of fetal harm. There are no data from controlled human studies, but retrospective reviews have shown an increased risk of malformations associated with thiazide diuretics. In addition, use of thiazide diuretics during pregnancy has been associated with fetal or neonatal electrolyte abnormalities, jaundice, and/or thrombocytopenia.

The Collaborative Perinatal Project monitored 50,282 mother-child pairs, of whom 233 were exposed to thiazide or related diuretics during the first trimester. An increased risk of malformations was found for thiazide diuretics. Use of thiazides after the first trimester does not seem to carry this risk. Thiazide diuretics may, however pose metabolic risks to the mother and fetus (hyponatremia, hypokalemia, thrombocytopenia, hyperglycemia), and may have a direct effect on smooth muscle, resulting in inhibition of labour.

Data from the U.S. Michigan Medicaid Birth Defects Study has revealed an association between the use of hydrochlorothiazide and congenital abnormalities. This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 567 were exposed to hydrochlorothiazide at some time during the first trimester, and 1,173 were exposed to the drug at any time during pregnancy. Of the 567 pregnancies, there were 24 total and 7 cardiovascular birth defects (22 and 6 were expected, respectively). There were no observations of cleft palate, spina bifida, limb reduction, or hypospadias. The one instance of polydactyly did not achieve statistical significance. These data are consistent with an association between the use of hydrochlorothiazide and birth defects, although other factors, including underlying disease(s) of the mother are not accounted for.

Cases of neonatal thrombocytopenia associated with antepartum administration of thiazide diuretics have been reported.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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

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: Hydrochlorothiazide

Manufacturer recommendation: Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

According to LactMed this drug has been used without apparent harmful effects in the nursing infant at doses of 50 mg daily or less. Large doses may cause intense diuresis resulting in a decrease in breastmilk production.

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

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.