Converide Use In Pregnancy & Lactation

Pregnancy: Converide is not recommended during the first trimester of pregnancy (see Precautions). The use of angiotensin-II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see Contraindications and Precautions).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs. Unless continued therapy with angiotensin-II receptor antagonists is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin-II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Angiotensin-II receptor antagonists therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See Pharmacology: Toxicology: Preclinical safety data under Actions.)
Thiazides cross the placental barrier and appear in cord blood. They may cause decrease placental perfusion and foetal electrolyte disturbances. Cases of neonatal thrombocytopenia, or foetal or neonatal jaundice have been reported with maternal thiazide therapy. Since Converide contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Lactation: Because of the potential adverse effects on the nursing infant, Converide is contraindicated during breast-feeding (see Contraindications). It is not known if irbesartan is excreted in human milk. It is excreted in the milk of lactating rats. Thiazides appear in human milk and may inhibit lactation.