Tribenzor Pregnancy Warnings
AU: Use is contraindicated.
UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters.
US: Use should be avoided.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Comments: Female patients of childbearing age should be informed of the consequences of exposure to this drug during pregnancy. Discuss treatment options with women planning to become pregnant and advise patients to report pregnancies as soon as possible.
Animal studies have not been reported for this combination product. Animal studies with amlodipine have revealed increased intrauterine deaths, decreased litter size, and prolonged gestation and labor. Animal studies with olmesartan have revealed decreases in pup birth weight and weight gain, as well as developmental delays and a dose-dependent increase in the incidence of renal pelvis dilation. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy.
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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
Tribenzor Breastfeeding Warnings
AU: Use is contraindicated.
UK and US: 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 (amlodipine, hydrochlorothiazide); Unknown (olmesartan)
Excreted into animal milk: Yes (olmesartan)
See references
