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Triamterene Pregnancy and Breastfeeding Warnings

Triamterene is also known as: Dyrenium

Triamterene Pregnancy Warnings

Triamterene has been assigned to pregnancy category C by the FDA. Animal studies in rats have failed to reveal evidence of teratogenicity at doses up to 20 times the maximum recommended human dose. There are no controlled data in human pregnancy. In general, diuretics are often considered contraindicated in pregnancy, except for patients with heart disease, since they decrease placental perfusion. Triamterene should only be used in pregnancy when need has been clearly established.

Triamterene crosses the human placenta. A retrospective study of 271 human exposures to triamterene during pregnancy revealed no increase in malformations. Limited reports on the use of triamterene during human pregnancy reveal no adverse effects on the fetus, but experience is limited. Many experts believe that diuretics, in general, are contraindicated during pregnancy except in cases of some cardiovascular disorders that require diuretics, because of the increased risk of decreased placental perfusion and the lack of proven benefit of the routine use of diuretics to treat edema or toxemia during pregnancy. Data from the Michigan Medicaid Birth Defects Study failed to reveal an association between the use of triamterene and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 318 were exposed to triamterene at some time during the first trimester and 640 were exposed to the drug at any time during pregnancy. Of these pregnancies, 15 total and 3 cardiovascular defects were observed (13 and 3 were expected, respectively). A single case of cleft palate was observed. These observations did not achieve statistical significance. These data do not support an association between triamterene and birth defects.

Triamterene Breastfeeding Warnings

There are no data on the excretion of triamterene into human milk. It does appear in animal milk, and is likely to appear in human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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