Bioprexum Plus

Bioprexum Plus Use In Pregnancy & Lactation

perindopril + indapamide

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Full Prescribing Info
Use In Pregnancy & Lactation
Angiotensin-converting enzymes inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy 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 ACE inhibitors should be stopped immediately and, if appropriate, alternative therapy should be started.
Use of perindopril is not recommended during breastfeeding.
Perindopril: The use of ACE inhibitors is not recommended during the 1st trimester of pregnancy. The use of ACE inhibitors is contraindicated during the 2nd and 3rd trimesters of pregnancy.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the 1st trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy 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 ACE inhibitors should be stopped immediately and, if appropriate, alternative therapy should be started.
Exposure to ACE inhibitor therapy during the 2nd and 3rd trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See Toxicology under Actions.)
Should exposure to ACE inhibitors have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension.
Indapamide: Prolonged exposure to thiazide during the 3rd trimester of pregnancy can reduce maternal plasma volume as well as uteroplacental blood flow, which may cause a fetoplacental ischemia and growth retardation. Moreover, rare cases of hypoglycemia and thrombocytopenia in neonates have been reported following exposure near term.
Bioprexum Plus is contraindicated during lactation.
Use of perindopril is not recommended during breastfeeding.
Indapamide is excreted in human milk. Indapamide is closely related to thiazide diuretics which have been associated, during breastfeeding, with decrease or even suppression of milk lactation. Hypersensitivity to suphonamide-derived drugs, hypokalaemia and nuclear icterus might occur.
As with both drugs, serious adverse reactions might occur in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy taking account the importance of this to the mother.
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