Amoclav Suspension Use In Pregnancy & Lactation

Pregnancy: 156.25 mg/5 mL & 312.5 mg/5 mL powder for oral suspension: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical safety data under Actions). 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.
228.5 mg/5 mL & 457 mg/5 mL powder for suspension and 642.9 mg/5 mL powder for oral suspension: (Pregnancy Category B). There are no adequate or controlled studies in pregnant women. The safe use in pregnancy has not been definitely established. However, oral Co-amoxiclav has been administered to pregnant women, particularly in the treatment of urinary tract infections, without evidence of adverse effects to the fetus.
In a single study in women with preterm, premature rupture of the fetal membrane (pPROM), it was reported that prophylactic treatment with Co-amoxiclav may be associated with an increased risk of necrotizing enterocolitis in neonates. Co-amoxiclav use should be avoided in pregnancy unless considered essential by the physician.
Breast-feeding: 156.25 mg/5 mL & 312.5 mg/5 mL powder for oral suspension: 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 breast-feeding after benefit/risk assessment by the physician in charge.
Lactation: 228.5 mg/5 mL & 457 mg/5 mL powder for suspension and 642.9 mg/5 mL powder for oral suspension: Co-amoxiclav is distributed in human milk and may cause diarrhea, fungal infection of the mucous membrane and sensitization in the breastfed infant. Caution should be exercised if Co-amoxiclav is to be administered to a nursing mother.