CoAprovel Contraindications

irbesartan + hydrochlorothiazide




Full Prescribing Info
Hypersensitivity to irbesartan and hydrochlorothiazide, to any of the excipients of CoAprovel, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance).
The following are the contraindications associated with hydrochlorothiazide: Severe renal impairment (creatinine clearance <30 mL/min); refractory hypokalemia, hypercalcemia; severe hepatic impairment, biliary cirrhosis and cholestasis.
Use in pregnancy: Thiazides cross the placental barrier and appear in cord blood. They may cause fetal electrolyte disturbances and possibly other reactions that have occurred in the adults. Cases of neonatal thrombocytopenia, or fetal or neonatal jaundice have been reported with maternal thiazide therapy. Since CoAprovel contains hydrochlorothiazide, it is not recommended during the 1st trimester of pregnancy. A switch to a suitable alternative treatment should be carried-out in advance of a planned pregnancy.
CoAprovel is contraindicated in the 2nd and 3rd trimesters of pregnancy.
In the 2nd and 3rd trimesters, substances that act directly on the renin-angiotensin system can cause fetal or neonatal renal failure, fetal skull hypoplasia and even fetal death. If pregnancy is diagnosed, CoAprovel should be discontinued as soon as possible skull and renal function should be checked with echography if, inadvertently, the treatment was taken for a long period.
Use in lactation: Because of the potential adverse effects on the nursing infant, CoAprovel is contraindicated during lactation. It is not known if irbesartan is excreted in human milk. Irbesartan is excreted in the milk of lactating rats. Thiazides appear in human milk and may inhibit lactation.
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