Natrixam Use In Pregnancy & Lactation

Given the effects of the individual components in this combination product on pregnancy and lactation: Indapamide + Amlodipine (Natrixam) is not recommended during pregnancy.
Indapamide + Amlodipine (Natrixam) is contraindicated during lactation.
Pregnancy: Linked to indapamide: There are no or limited amount of data from the use of indapamide in pregnant women. Prolonged exposure to thiazide during the third trimester of pregnancy can reduce maternal plasma volume as well as uteroplacental blood flow, which may cause a feto-placental ischemia and growth retardation. Moreover, rare cases of hypoglycemia and thrombocytopenia in neonates have been reported following exposure near term.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Linked to amlodipine: The safety of amlodipine in human pregnancy has not been established.
In animal studies, reproductive toxicity was observed at high doses.
Breastfeeding: Linked to indapamide: There is insufficient information on the excretion of indapamide/metabolites in human milk. Hypersensitivity to sulfonamide-derived medicines and hypokalemia might occur. A risk to newborns/infants cannot be excluded.
Indapamide is closely related to thiazide diuretics which have been associated, during breastfeeding, with a decrease or even suppression of milk lactation.
Linked to amlodipine: It is not known whether amlodipine is excreted in breast milk.
Fertility: Linked to indapamide: Reproductive toxicity studies showed no effect on fertility in female and male rats. No effects on human fertility are anticipated.
Linked to amlodipine: Reversible biochemical changes in the head of spermatozoa have been reported in some patients treated by calcium channel blockers. Clinical data are insufficient regarding the potential effect of amlodipine on fertility. In one rat study, adverse reactions were found on male fertility.