Levobupivacaine Kabi Use In Pregnancy & Lactation

Pregnancy: Levobupivacaine solutions are contraindicated for use in paracervical block in obstetrics. Based on experience with bupivacaine foetal bradycardia may occur following paracervical block (see Contraindications).
For levobupivacaine, there are no clinical data on first trimester-exposed pregnancies. Animal studies do not indicate teratogenic effects but have shown embryo-foetal toxicity at systemic exposure levels in the same range as those obtained in clinical use (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for human is unknown. Levobupivacaine should therefore not be given during early pregnancy unless clearly necessary.
Nevertheless, to date, the clinical experience of bupivacaine for obstetrical surgery (at the term of pregnancy or for delivery) is extensive and has not shown a foetotoxic effect.
Breastfeeding: It is unknown whether levobupivacaine or its metabolites are excreted in human breast milk. As for bupivacaine, levobupivacaine is likely to be poorly transmitted in the breast milk. Thus breastfeeding is possible after local anaesthesia.
Fertility: There are no or only limited data available for Levobupivacaine to assess its impact on fertility.