6 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: Levothyroxine (found in Synthroid)

Use is considered acceptable

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

Risk Summary: No increased rates of major birth defects or miscarriages have been reported with use during pregnancy; untreated hypothyroidism during pregnancy is associated with risks to the mother and fetus

Comments:
-Thyroid replacement therapy should not be discontinued during pregnancy; hypothyroidism diagnosed during pregnancy should be promptly treated.
-Monitor TSH levels and adjust doses as needed.

Animal studies have not been conducted. There is a long history of using this drug in pregnant women and this experience has not shown increased rates of fetal malformations, miscarriages or other adverse maternal or fetal outcomes. Hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, pre-eclampsia, stillbirth and premature delivery. Maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. Pregnant women taking this drug should have their TSH measured during each trimester and dose adjusted as appropriate. Patients will generally return to their pre-pregnancy dose after delivery. There are no controlled data in human pregnancy.

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: 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: Levothyroxine (found in Synthroid)

Use is considered acceptable

Excreted into human milk: Yes

Comments:
-Levothyroxine (T4) is a normal component of human milk; limited data on exogenous replacement doses during breastfeeding have not shown an adverse effect in nursing infants.
-Levothyroxine dose requirements may be increased in the postpartum period compared to prepregnancy requirements in patients with Hashimoto's thyroiditis.
-The presence of thyroid hormone in breast milk does not appear to interfere with neonatal thyroid screening.