Pregnancy

No clinical experience of the use in pregnancy and lactating women is available.

Safe use of local anaesthetics during pregnancy has not been established with respect to adverse effects on foetal development. The product should only be used in pregnancy when the benefits are considered to outweigh the risks.

When articaine was administered subcutaneously to rats throughtout gestation and lactation, 80 mg/kg/day (approximately 2 times the maximum recommended human dose on a mg/m² basis) increased the number of stillbirths, delayed eye opening, and adversely affected passive avoidance, a measure of learning, in pups, along with maternal toxicity were observed. A dose of 40 mg/kg/day (approximately the maximum recommended human dose on a mg/m² basis) did not produce these effects.

Nursing Mothers

The excretion of articaine or its metabolites in human milk is unknown. As many drugs are excreted in human milk, caution should be exercised when articaine is administered to a nursing woman. If administered, nursing women should not breast feed for at least 48 hours following anaesthesia with articaine.

Carcinogenesis, Mutagenesis and Fertility

Studies to evaluate the carcinogenic potential of articaine in animals have not been conducted. Articaine was negative in bacterial and mammalian assays for gene mutation and a chromosomal aberration test in Chinese hamster ovary cells. In vivo clastogenicity (mouse micronucleous) assays with articaine were negative at a low subcutaneous dose (same as the maximal recommended clinical dose on a mg/m² basis).

Effects on Ability to Drive and Use Machines

In a controlled study on healthy volunteers articaine was shown to have no effect on the level of attentiveness, reaction time to visual stimulations or motor co-ordination. Patients who experience systemic adverse effects during or immediately following administration of articaine should be advised to avoid driving or operating machinery until resolution of signs or symptoms.