Alclav Neo/Alclav Kids/Alclav Hospi Use In Pregnancy & Lactation

Pregnancy: Alclav Neo 625 mg/Alclav Kids/Alclav Hospi: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Limited data on the use of amoxicillin/clavulanic acid during pregnancy in humans do not indicate an increased risk of congenital malformations. In a single study in women with preterm, premature rupture of the foetal membrane it was reported that prophylactic treatment with amoxicillin/clavulanic acid may be associated with an increased risk of necrotising enterocolitis in neonates. Use should be avoided during pregnancy, unless considered essential by the physician.
Alclav Neo 1 g: There is limited experience of the use of co-amoxiclav in human pregnancy. As with all medicines, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.
Breastfeeding: Alclav Neo 625 mg/Alclav Kids/Alclav Hospi: Both substances are excreted into breast milk (nothing is known of the effects of clavulanic acid on the breast-fed infant). Consequently, diarrhoea and fungus infection of the mucous membranes are possible in the breast-fed infant, so that breast-feeding might have to be discontinued.
The possibility of sensitisation should be taken into account. Amoxicillin/clavulanic acid should only be used during breastfeeding after benefit/risk assessment by the physician in charge.
Alclav Neo 1 g: Amoxicillin is excreted in breast milk; there are no data on the excretion of clavulanic acid in human milk. Therefore, caution should be exercised when administering to a nursing woman.