Coveram Use In Pregnancy & Lactation

Use in pregnancy: Coveram (Perindopril/Amlodipine): Coveram should not be initiated during pregnancy. Unless continued, Coveram 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 Coveram should be stopped immediately, and, if appropriate, alternative therapy should be started (see Contraindications). Perindopril: The use of perindopril is not recommended during the 1st trimester of pregnancy and contraindicated during the 2nd and 3rd trimesters of pregnancy (see Contraindications).
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 the risk cannot be excluded. Unless continued, ACE inhibitors therapy is considered essential, patients planning pregnancy should change to an alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with Coveram should be stopped immediately, and if appropriate, alternative therapy should be started.
ACE inhibitors therapy exposure 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, hyperkalemia) (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 (see Contraindications, Precautions and Cautions for Usage).
Amlodipine: Data on a limited number of exposed pregnancies indicate no adverse effects of amlodipine and other calcium-receptor antagonists on the health of the fetus. However, there may be a risk of prolonged delivery. Animal studies have not shown teratogenic effect (see Toxicology under Actions).
Consequently, amlodipine is not recommended during the 1st trimester of pregnancy. When a pregnancy is planned or confirmed, the switch to an alternative treatment should be initiated as soon as possible.
Coveram is contraindicated during the 2nd and 3rd trimesters of pregnancy.
Should exposure to Coveram occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants exposed in utero to ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalemia.
Use in lactation: There is no clinical experience of the use of perindopril or amlodipine, alone or in combination, during lactation. Therefore, the use of Coveram is not recommended in women who are breast-feeding.